1. GAITHERSBURG, Md., April 8, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in a fireside chat during the Goldman Sachs Recovery Inoculated: The Current Outlook for COVID-19 Vaccines, Treatments, Testing and the Economy virtual conference. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

    Fireside chat details:


    Date:

    Tuesday, April 13, 2021

    Time:

    2:30 – 3:20 p.m. Eastern Time (ET)

    Panel title:

    COVID-19 Vaccines – Staying Ahead of the Curve

    Novavax participant:

    Vivek Shinde, M.D., M.P.H., Vice President, Clinical Development



    This event is open to Goldman Sachs clients.

    About Novavax

    GAITHERSBURG, Md., April 8, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in a fireside chat during the Goldman Sachs Recovery Inoculated: The Current Outlook for COVID-19 Vaccines, Treatments, Testing and the Economy virtual conference. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

    Fireside chat details:



    Date:

    Tuesday, April 13, 2021

    Time:

    2:30 – 3:20 p.m. Eastern Time (ET)

    Panel title:

    COVID-19 Vaccines – Staying Ahead of the Curve

    Novavax participant:

    Vivek Shinde, M.D., M.P.H., Vice President, Clinical Development





    This event is open to Goldman Sachs clients.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Novavax, Inc.

    Erika Schultz | 240-268-2022

    Solebury Trout

    Jennifer Porcelli | 646-378-2962

    Media

    Laura Keenan | 410-419-5755

    Amy Speak | 617-420-2461

     

    Cision View original content:http://www.prnewswire.com/news-releases/novavax-to-participate-in-fireside-chat-at-goldman-sachs-virtual-conference-301265038.html

    SOURCE Novavax, Inc.

    View Full Article Hide Full Article
    • Crossover allows participants to continue in trials and remain blinded
    • Ensures that all trial participants receive active vaccine
    • South Africa and UK crossover arms initiated; US/Mexico PREVENT-19 crossover planned

    GAITHERSBURG, Md., April 5, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the company's COVID-19 vaccine candidate. Crossover ensures the administration of active vaccine to all participants in the trials and has begun for Novavax' Phase 2b trial in South Africa and its pivotal Phase 3 trial in the United Kingdom.

    Under Novavax' updated clinical…

    • Crossover allows participants to continue in trials and remain blinded
    • Ensures that all trial participants receive active vaccine
    • South Africa and UK crossover arms initiated; US/Mexico PREVENT-19 crossover planned

    GAITHERSBURG, Md., April 5, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the initiation of crossover arms in two ongoing clinical trials of NVX-CoV2373, the company's COVID-19 vaccine candidate. Crossover ensures the administration of active vaccine to all participants in the trials and has begun for Novavax' Phase 2b trial in South Africa and its pivotal Phase 3 trial in the United Kingdom.

    Under Novavax' updated clinical trial protocols[1], all participants in the UK and US Phase 3 trials will be offered the opportunity to receive an additional round of injections. Participants who elect to do so will receive an additional two-dose regimen of either vaccine (for those who originally received placebo) or placebo (for those who originally received vaccine). Participants in the South Africa Phase 2b trial will receive either active vaccine for those who initially received placebo, or a booster dose of active vaccine for those who initially received active vaccine. Participants across all three trials will remain blinded to their courses of treatment to preserve the ability to assess efficacy in each trial, and all will be followed for up to two years to monitor the safety and durability of protection the vaccine. In the trials taking place in South Africa and the United Kingdom, half of the participants initially received the active vaccine while two-thirds of participants in PREVENT-19, the trial being conducted in the US and Mexico, initially received active vaccine.

    "The crossover arms ensure that all participants have access to an active vaccine candidate while allowing Novavax to continue to monitor the safety and efficacy of our vaccine over the long term," said Filip Dubovsky, M.D., Chief Medical Officer, Novavax. "We are grateful to the volunteers who stepped forward to take part in our clinical trials, without whom we would be unable to develop, study and ultimately deliver what we hope will be a significant tool in the fight against COVID-19."

    The company is also planning a crossover in the PREVENT-19 study, for which the company expects to read out initial clinical data during the second quarter. In addition, the company is planning to expand the trial to include pediatric and adolescent arms, which are also expected to begin in the second quarter.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.

    NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K that demonstrated efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 48.6% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia.

    NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release s0peak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    ____________________

    1 Clinical trial protocols may be found in the Resources section of the Novavax website and will be updated as appropriate.

    Contacts:

    Investors

    Novavax, Inc.

    Erika Schultz | 240-268-2022

    Solebury Trout

    Jennifer Porcelli | 617-974-8659

    Media

    Laura Keenan | 410-419-5755

    Amy Speak | 617-420-2461

    Cision View original content:http://www.prnewswire.com/news-releases/novavax-initiates-covid-19-vaccine-clinical-trial-crossover-301262318.html

    SOURCE Novavax, Inc.

    View Full Article Hide Full Article
  2. GAITHERSBURG, Md., April 5, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Stanley C. Erck, President and Chief Executive Officer, will participate in a panel discussion during the virtual Longwood Healthcare Leaders 2021 Webconference taking place April 5-6. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

    Panel details are as follows:  

    Date:

    Tuesday, April 6, 2021

    Time:

    7:30 – 8:00 a.m. Eastern Daylight Time (EDT)

    Location:

    Webconference

    Title:

    Progress Towards Sustainable Vaccines for COVID-19

    Novavax
    panelist:

    Stanley C. Erck, CEO

    Moderator: Michael Mina, Asst. Professor, Epidemiology, Harvard

    GAITHERSBURG, Md., April 5, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Stanley C. Erck, President and Chief Executive Officer, will participate in a panel discussion during the virtual Longwood Healthcare Leaders 2021 Webconference taking place April 5-6. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion.

    Panel details are as follows:  

    Date:

    Tuesday, April 6, 2021

    Time:

    7:30 – 8:00 a.m. Eastern Daylight Time (EDT)

    Location:

    Webconference

    Title:

    Progress Towards Sustainable Vaccines for COVID-19

    Novavax

    panelist:

    Stanley C. Erck, CEO

    Moderator: Michael Mina, Asst. Professor, Epidemiology, Harvard School of Public Health

    For more information or to register for the meeting, visit: www.longwoodhealthcareleaders.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Novavax, Inc.

    Erika Schultz | 240-268-2022

    Solebury Trout

    Jennifer Porcelli | 617-974-8659

    Media

    Laura Keenan | 410-419-5755

    Cision View original content:http://www.prnewswire.com/news-releases/novavax-ceo-stan-erck-to-participate-in-longwood-healthcare-leaders-meeting-301262027.html

    SOURCE Novavax, Inc.

    View Full Article Hide Full Article
  3. LONDON and GAITHERSBURG, Md., March 29, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, GSK and the UK Government Vaccines Taskforce announced that they have reached an agreement in principle to support manufacturing of up to 60 million doses of Novavax' COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK. GSK will provide 'fill and finish' manufacturing capacity at its Barnard Castle facility in the North East of England beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately. GSK and Novavax will negotiate a final agreement to include additional terms and conditions.

    The UK Government…

    LONDON and GAITHERSBURG, Md., March 29, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, GSK and the UK Government Vaccines Taskforce announced that they have reached an agreement in principle to support manufacturing of up to 60 million doses of Novavax' COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK. GSK will provide 'fill and finish' manufacturing capacity at its Barnard Castle facility in the North East of England beginning as early as May 2021, with a rapid technology transfer between the two companies beginning immediately. GSK and Novavax will negotiate a final agreement to include additional terms and conditions.

    The UK Government has secured 60 million doses of the vaccine under an advance purchase agreement with Novavax. The protein antigen component of NVX-CoV2373 is also produced in the North East of England by Novavax' manufacturing partner, FUJIFILM Diosynth Biotechnologies, at their site in Billingham, Stockton-on-Tees. 

    Fill and finish, to be provided by GSK, is the completion stage of vaccine manufacturing, preparing vials of the final vaccine and packaging them for distribution and use. The GSK site at Barnard Castle, which will deliver the vaccine doses under this collaboration, is a specialised facility in GSK's global manufacturing network, which supports production of GSK pharmaceutical and vaccine products.  

    Roger Connor, President, GSK vaccines, said: "GSK is delighted to support Novavax and the UK Vaccines Taskforce with this manufacturing arrangement for the UK and our Barnard Castle facility is now undertaking the rapid preparation work required to manufacture up to 60m doses of this vaccine. We have ensured that we can deliver these volumes without impacting supply of our other vital medicines and vaccines, and without disruption to the other COVID-19 collaborations GSK is engaged in globally."

    "This partnership with GSK continues the expansion of our global supply network, which we expect to increase overall production capacity and, if approved by regulatory agencies, support access to a potentially important new vaccine against COVID-19," said Rick Crowley, Executive Vice President and Chief Operations Officer, Novavax. "We thank the UK government's Vaccine Taskforce for its instrumental role in ensuring the progress of our COVID-19 vaccine, from both a clinical and now manufacturing perspective, as well as GSK for making their facilities available to help fight the pandemic."

    Prime Minister Boris Johnson said: "I'm delighted by GSK's investment, which shows the strength of UK manufacturing, and will further boost our vaccine rollout. The Vaccines Taskforce has worked hand in glove with business to successfully deliver vaccines to the whole of the UK, and this agreement will continue to support our approach. We remain on track to offer a first jab to all over 50s by 15 April, and all adults by the end of July, and I want to once again encourage everyone to come forward for a vaccine when you're called."

    Health and Social Care Secretary Matt Hancock said: "We've all seen just how important onshore vaccine manufacturing capabilities are, and this fantastic deal will ensure more of these vital products can be produced here in the UK. The UK's vaccination programme has been a national success, with over 30 million people now having received a first dose of a COVID-19 vaccine. Should the Novavax vaccine meet our medicines regulator's high standards of safety and effectiveness, the agreement reached today will boost these efforts over the coming months."

    The Novavax vaccine candidate has demonstrated strong potential efficacy in Phase 3 clinical trials, including against the B.1.1.7 variant circulating in the UK. Submission of the vaccine for review by regulatory authorities in the UK is expected during the second quarter.  

    GSK commitment to tackling COVID-19

    GSK's response to COVID-19 has been one of the broadest in the industry, with two potential treatments in addition to our vaccine candidates in development.

    GSK is collaborating with several organisations around the world on COVID-19 vaccines by providing access to our adjuvant technology. Our collaboration with Canada's Medicago, combining our pandemic adjuvant with its plant-derived vaccine candidate is in Phase 3 clinical trials, and a collaboration with French company Sanofi on an adjuvanted, protein-based vaccine candidate is in Phase 2. An earlier stage collaboration with SK Bioscience of South Korea, with funding from CEPI and the Bill and Melinda Gates Foundation, aims to develop differentiated, affordable COVID-19 vaccines for supply globally through the COVAX facility. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people.

    GSK is working with German mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac's first generation COVID-19 vaccine at our facilities in Belgium.

    GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. We recently reported that an Independent Data Monitoring Committee recommended that the Phase 3 COMET-ICE trial evaluating VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalisation be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are now seeking Emergency Use Authorization in the US and authorisations in other countries. We are also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K that demonstrated efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa that demonstrated 48.65% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia. NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    GSK Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic.

    Novavax enquires:

    Investor enquiries:

    Novavax, Inc.

    Erika Schultz | 240-268-2022

    Solebury Trout

    Jennifer Porcelli | 617-974-8659

    Media enquiries:

    Amy Speak | 617-420-2461

    Laura Keenan | 410-419-5755

    GSK enquiries:







    Media enquiries:

    Simon Steel

    +44 (0) 20 8047 5502

    (London)



    Simon Moore

    +44 (0) 20 8047 5502

    (London)



    Kristen Neese

    +1 804 217 8147

    (Philadelphia)



    Kathleen Quinn

    +1 202 603 5003

    (Washington DC)









    Analyst/Investor enquiries:

    James Dodwell

    +44 (0) 20 8047 2406

    (London)



    Sonya Ghobrial

    +44 (0) 7392 784784

    (Consumer)



    Jeff McLaughlin

    +1 215 751 7002

    (Philadelphia)



    Frannie DeFranco

    +1 215 751 4855

    (Philadelphia)

     

    Cision View original content:http://www.prnewswire.com/news-releases/gsk-to-support-manufacture-of-novavax-covid-19-vaccine-301257664.html

    SOURCE Novavax, Inc.

    View Full Article Hide Full Article
  4. - 100% protection against severe disease

    - Final analysis in U.K. trial confirms 96% efficacy against original strain of COVID-19

    - Efficacy against variants confirmed in U.K. and South Africa

    GAITHERSBURG, Md., March 11, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19 strain in a pivotal Phase 3 trial in the United Kingdom (U.K.) of NVX–CoV2373, the company's vaccine candidate. The company also announced the complete analysis of its Phase 2b trial taking place in South Africa, with efficacy of 55.4% among the HIV- negative trial participants…

    - 100% protection against severe disease

    - Final analysis in U.K. trial confirms 96% efficacy against original strain of COVID-19

    - Efficacy against variants confirmed in U.K. and South Africa

    GAITHERSBURG, Md., March 11, 2021 /PRNewswire/ -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced final efficacy of 96.4% against mild, moderate and severe disease caused by the original COVID-19 strain in a pivotal Phase 3 trial in the United Kingdom (U.K.) of NVX–CoV2373, the company's vaccine candidate. The company also announced the complete analysis of its Phase 2b trial taking place in South Africa, with efficacy of 55.4% among the HIV- negative trial participants in a region where the vast majority of strains are B1.351 escape variants. Across both trials, NVX-CoV2373 demonstrated 100% protection against severe disease, including all hospitalization and death. Both studies achieved their statistical success criteria. Today's final analyses build on the successful interim results announced in January 2021, adding substantially more COVID-19 cases and statistical power.

    "We are very encouraged by the data showing that NVX-CoV2373 not only provided complete protection against the most severe forms of disease, but also dramatically reduced mild and moderate disease across both trials. Importantly, both studies confirmed efficacy against the variant strains," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Today marks one year since the WHO officially declared the COVID-19 pandemic, and with this data in hand, we are even more motivated to advance our vaccine as a potential weapon in the fight to end the suffering caused by COVID-19."

    United Kingdom Phase 3 Trial

    The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65. The primary endpoint of the U.K. Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

    Efficacy was 96.4% (95% CI: 73.8, 99.5) against the original virus strain and 86.3% (95% CI: 71.3, 93.5) against the B.1.1.7/501Y.V1 variant circulating in the U.K (post hoc). The primary efficacy endpoint demonstrated an overall vaccine efficacy of 89.7% (95% CI: 80.2, 94.6). 106 cases were observed, with 10 in the vaccine group and 96 in the placebo group. NVX-CoV2373 was effective against severe disease: five severe1 cases were observed in the study, and all occurred in the placebo group. Four of the five severe cases were attributed to the B.1.1.7/501Y.V1 variant. Fourteen days after dose 1, vaccine efficacy was 83.4% (95% CI: 73.6, 89.5).

    In volunteers 65 years of age and older, 10 cases of COVID-19 were observed, with 90% of those cases occurring in the placebo group. Older adults are among the groups most impacted by the disease and are at high risk of complications from COVID-19.

    Novavax expects the data to serve as the basis for submission for authorization to various regulatory agencies worldwide.

    South Africa Phase 2b Trial

    The South Africa trial was a randomized, observer-blinded, placebo-controlled Phase 2b clinical trial of NVX-CoV2373. One cohort evaluated efficacy, safety and immunogenicity in approximately 2,665 healthy adults. The second cohort evaluated safety and immunogenicity in approximately 240 medically stable, HIV-positive adults.

    A complete analysis of vaccine efficacy among 147 PCR-positive cases (51 cases in the vaccine group and 96 in the placebo group) demonstrated an overall efficacy of 48.6% against predominantly variant strains (95% CI: 28.4, 63.1). The vast majority of cases circulating during the efficacy analysis were due to the B.1.351/501Y.V2 variant circulating in South Africa. All five cases of severe disease observed in the trial occurred in the placebo group. Among HIV-negative participants, 55.4% efficacy was observed (95% CI: 35.9, 68.9). The complete analysis shows that vaccine-induced protection began 14 days after dose 1 (42.7% 95% CI: 25.0, 56.3), although increased efficacy was observed 7 days after dose 2, the primary endpoint for the study.

    A previously reported initial analysis from the study through 60 days indicated that prior infection with the original COVID-19 strain might not completely protect against subsequent infection by the variant predominantly circulating in South Africa. However, the complete analysis of the South Africa trial indicates that there may be a late protective effect of prior exposure with the original COVID-19 strain. In placebo recipients, at 90 days the illness rate was 7.9% in baseline seronegative individuals, with a rate of 4.4% in baseline seropositive participants.

    In both the U.K. and South Africa trials, these analyses showed that the vaccine is well-tolerated, with low levels of severe, serious (SAEs) and medically attended adverse events at day 35, balanced between vaccine and placebo groups.

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials, a trial in the U.K that demonstrated efficacy of 96.4% against the original virus strain and 89.7% overall, and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa that demonstrated 48.65% efficacy against a newly emerging escape variant, and a Phase 1/2 continuation in the U.S. and Australia.

    NVX-CoV2373 is stored and stable at 2°- 8°C, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

     

    1 Please see trial protocols for endpoint definitions of COVID-19 severity at https://www.novavax.com/resources#protocols

    Cision View original content:http://www.prnewswire.com/news-releases/novavax-confirms-high-levels-of-efficacy-against-original-and-variant-covid-19-strains-in-united-kingdom-and-south-africa-trials-301246019.html

    SOURCE Novavax, Inc.

    View Full Article Hide Full Article
  5. GAITHERSBURG, Md., March 08, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in a fireside chat during the H.C. Wainwright Virtual Global Life Sciences conference. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be the topic of discussion.

    Fireside Chat details:
    Date:Tuesday, March 9, 2021
    Time:Available on-demand starting at 7:00 a.m. Eastern Time (ET)
    Participants:Gregory M. Glenn, M.D., President, Research and Development and John Trizzino, Executive Vice President, Chief Commercial Officer and Chief Business Officer

    A replay of the recorded fireside session will be available through the events…

    GAITHERSBURG, Md., March 08, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in a fireside chat during the H.C. Wainwright Virtual Global Life Sciences conference. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be the topic of discussion.

    Fireside Chat details:
    Date:Tuesday, March 9, 2021
    Time:Available on-demand starting at 7:00 a.m. Eastern Time (ET)
    Participants:Gregory M. Glenn, M.D., President, Research and Development and John Trizzino, Executive Vice President, Chief Commercial Officer and Chief Business Officer

    A replay of the recorded fireside session will be available through the events page of the Company's website at ir.novavax.com for 90 days.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Novavax, Inc.

    Erika Schultz | 240-268-2022

    Solebury Trout

    Jennifer Porcelli | 617-974-8659

    Media

    Amy Speak | 617-420-2461

    Laura Keenan | 410-419-5755



    Primary Logo

    View Full Article Hide Full Article
    • 96% vaccine efficacy against original COVID-19 in UK Phase 3 trial
    • Vaccine cross-protection demonstrated against both variants circulating in the UK and South Africa
    • Full enrollment (~30,000 participants) in PREVENT-19 Phase 3 trial
    • Agreements for ~300 million doses to date
    • Additional 1.1 billion doses to be supplied to the COVAX Facility (jointly with Serum Institute of India)
    • Clinical trial of variant strain vaccines as standalone and bivalent candidates expected mid-2021
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., March 01, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational…

    • 96% vaccine efficacy against original COVID-19 in UK Phase 3 trial
    • Vaccine cross-protection demonstrated against both variants circulating in the UK and South Africa
    • Full enrollment (~30,000 participants) in PREVENT-19 Phase 3 trial
    • Agreements for ~300 million doses to date
    • Additional 1.1 billion doses to be supplied to the COVAX Facility (jointly with Serum Institute of India)
    • Clinical trial of variant strain vaccines as standalone and bivalent candidates expected mid-2021
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., March 01, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the fourth quarter and twelve months ended December 31, 2020.

    "Novavax continues to make significant strides towards bringing NVX-CoV2373, our COVID-19 vaccine candidate, to market," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "With positive efficacy results, including against evolving variant strains, NVX-CoV2373 offers a highly unique profile, including the ability to ship and store the vaccine at traditional refrigerated temperatures. We believe these attributes support emergency use authorization and have initiated dialogue with regulators to pursue appropriate regulatory authorization. In addition, we have secured agreements for the delivery of approximately 300 million doses of NVX-CoV2373. In our efforts to provide fair and equitable access to our vaccine around the world, we are proud to partner with the Serum Institute of India to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi through the COVAX Facility. We continue to work tirelessly to make final commercial preparations in advance of delivering our product across the globe."

    Fourth Quarter 2020 and Recent Highlights

    COVID-19 Program

    • Commenced regulatory process for authorization for NVX-CoV2373
      • Rolling submission initiated with the UK Medicines and Healthcare products Regulatory Agency; potential to file for authorization in the UK by early second quarter 2021
      • Engaged in ongoing dialogue with US Food and Drug Administration (FDA) through submissions to our open investigational new drug application, with potential for EUA filing in the second quarter of 2021
      • Rolling reviews initiated with:
        • European Medicines Agency
        • Health Canada
        • Australian Therapeutic Goods Administration
        • Medsafe New Zealand
    • Reported positive top-line data from Phase 3 UK clinical trial
      • Observed 95.6% efficacy against the original strain of COVID-19 and 85.6% against the UK variant strain
        • Overall primary endpoint met with a vaccine efficacy of 89.3%
      • Generally well-tolerated with a reassuring safety profile
      • Trial included 15,000 participants between 18-84 years of age, including 27 percent over the age of 65



    • Reported successful Phase 2b South Africa efficacy study

      • Observed 60% efficacy for HIV-negative portion of study population (94% of study participants were HIV-negative)
      • Demonstrated clinically meaningful protection from South Africa escape variant, which accounted for 93% of sequenced cases
      • Achieved primary efficacy endpoint in overall trial population of 49.4%
      • Trial included 4,404 participants, including 245 medically stable, HIV-positive participants
      • Supported in part by a $15 million grant from Bill & Melinda Gates Foundation (BMGF)
    • Completed enrollment in pivotal PREVENT-19 Phase 3 efficacy trial in the US and Mexico
      • 30,000 participants enrolled in two-to-one study design, with highly diverse population
        • 20% Latin American, 12% African American, 6% Native American, 5% Asian American and 13% adults over the age of 65
      • Interim data expected in the second quarter of 2021 dependent on the overall COVID-19 attack rate
      • Blinded crossover protocol, ensuring all participants are provided active vaccine, submitted to the FDA
      • Trial design harmonized to align with other Phase 3 clinical studies supported by the U.S. government
    • Ongoing clinical development of NVX-CoV2373
      • 6-month boost dose as part of Phase 1/2 clinical trial in the US and Australia
    • Developing variant strain vaccines as standalone and bivalent candidates
      • Evaluation of candidates ongoing in non-human primates
      • Planning clinical evaluation of variant vaccine candidates in mid-2021



    • Secured cumulative funding of over $2 billion to date through US government, CEPI and BMGF for development of NVX-CoV2373

      • US government funding through partnership formerly known as Operation Warp Speed increased up to $1.75 billion
      • Coalition for Epidemic Preparedness Innovations (CEPI) funding up to $400 million



    • Increased projected global manufacturing capacity to over 2 billion annualized doses when at full-capacity, expected to occur in mid-2021

      • Approximately one billion doses to be manufactured by Serum Institute of India Private Limited (SIIPL)
    • Completed collaborations for global manufacturing, commercialization and distribution of NVX-CoV2373
      • Finalized exclusive license agreement with Takeda for the development, manufacturing and commercialization of NVX-CoV2373
        • Takeda to manufacture over 250 million doses of NVX-CoV2373 annually
      • Advanced joint commitment with SIIPL for the equitable access of 1.1 billion doses of NVX-CoV2373 for distribution by the COVAX Facility
      • Reached Memorandum of Understanding with Canadian government for plans to produce NVX-CoV2373 at the National Research Council's Biologics Manufacturing Centre in Montreal
      • Expanded existing partnership with SK bioscience to include license agreement for the manufacturing and commercialization of NVX-CoV2373
        • SK bioscience to supply 40 million doses to the Republic of Korea



    • Secured agreements for approximately 200 million doses of NVX-CoV2373

      • Government of Canada to be supplied 52 million doses with an option for up to an additional 24 million
      • UK government to be supplied 60 million doses
      • Commonwealth of Australia to be supplied 51 million doses with an option for up to an additional 10 million
      • Government of New Zealand to be supplied 11 million doses
      • Government of Switzerland to be supplied 6 million doses

    NanoFlu™ Program

    • Continued to advance NanoFlu program, including exploration of a combined NanoFlu/NVX-CoV2373 vaccine that could be used in a post-pandemic setting

    Corporate Highlights

    • Appointed three individuals with extensive pharmaceutical industry experience to Novavax' Board of Directors
      • Gregg Alton, J.D.
        • Brings extensive industry experience, including more than 20 years at Gilead Pharmaceuticals, serving in an array of leadership roles including Chief Executive Officer and Chief Patient Officer
      • Margie McGlynn, R. Ph.
        • Brings extensive pharmaceutical industry, vaccine and non-profit experience, including more than two decades at Merck; held roles of increasing responsibility, including President of Merck Vaccines and Infectious Diseases and President, US Hospital and Specialty Products Division
      • David Mott
        • Brings more than three decades of global management, board and investment experience across numerous biopharmaceutical companies, including previously having served as President and Chief Executive Officer of MedImmune

    Financial Results for the Three and Twelve Months Ended December 31, 2020

    Novavax reported a net loss of $177.6 million, or $2.70 per share, for the fourth quarter of 2020, compared to a net loss of $31.8 million, or $1.13 per share, for the fourth quarter of 2019. For the twelve months ended December 31, 2020, the net loss was $418.3 million, or $7.27 per share, compared to a net loss of $132.7 million, or $5.51 per share, for the same period in 2019.

    Novavax revenue in the fourth quarter of 2020 was $279.7 million, compared to $8.8 million in the same period in 2019. The significant increase in revenue was comprised of revenue for services performed under the CEPI agreement and participation in OWS.

    Research and development expenses increased to $401.2 million in the fourth quarter of 2020, compared to $29.3 million in the same period in 2019. The increase was primarily due to increased development activities relating to NVX-CoV2373 and increased employee-related costs, including stock-based compensation expense.

    General and administrative expenses increased to $61.3 million in the fourth quarter of 2020, compared to $8.2 million for the same period in 2019. The increase was primarily due to increased employee-related costs, primarily stock-based compensation expense, and increased professional fees to support of our NVX-CoV2373 program.

    As of December 31, 2020, Novavax had $806.4 million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019. Net cash used in operating activities for the twelve months of 2020 was $42.5 million, compared to $136.6 million for same period in 2019.

    Through utilization of At-the-market (ATM) offerings, Novavax raised net proceeds of $428 million and $874 million during the three and twelve months of 2020, respectively. In addition, in the second quarter of 2020, Novavax received gross proceeds of $200 million upon entering into an agreement to sell Series A Convertible preferred stock, convertible into 4,388,850 shares of common stock, to an investment fund affiliated with RA Capital Management (RA Capital) in a private placement. There shares were converted to common stock in the fourth quarter of 2020.

    Conference Call

    Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 3797013. A replay of the conference call will be available starting at 7:30 p.m. ET on March 1, 2021 until 7:30 p.m. ET on March 8, 2021. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 3797013.

    A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until June 1, 2021.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of the spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated 50-60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

    About NanoFlu™

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix-M™ adjuvant.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    NOVAVAX, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (in thousands, except per share information)

     Three Months Ended

    December 31,
     Twelve Months Ended

    December 31,
     2020 2019 2020 2019
     (unaudited)     
                    
    Revenue$ 279,659   $8,816  $475,598  $18,662 
                 
    Expenses:            
    Research and development401,199   29,341  747,027

      113,842 
    Gain on sale of assets--  --  --

      (9,016)
    General and administrative61,313   8,180  145,290

      34,417 
    Total expenses462,512   37,521  892,317

      139,243 
    Loss from operations(182,853) (28,705) (416,719) (120,581)
    Interest income (expense), net(3,737) (3,127) (14,131) (12,100)
    Other income (expense)9,026   2  12,591

      (13)
    Net loss$ (177,564) $(31,830) $ (418,259) $(132,694)
               
    Basic and diluted net loss per share$ (2.70) $(1.13) $ (7.27) $(5.51)
    Basic and diluted weighted average number of common shares outstanding65,725  28,063  57,554

      24,100 
               

    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (in thousands)

     December 31,

    2020
     December 31,

    2019
        
    Cash and cash equivalents$553,398 $78,823 
    Marketable securities 157,649  -- 
    Total restricted cash 95,340  3,357 
    Total current assets 1,248,203  97,247 
    Working capital 668,531  71,452 
    Total assets 1,582,479  172,957 
    Notes payable 322,035  320,611 
    Total stockholders' equity (deficit) 627,209  (186,017)
           

    Contacts:

    Investors

    Novavax, Inc.

    Erika Schultz | 240-268-2022



    Solebury Trout

    Jennifer Porcelli | 617-974-8659

    Media

    Amy Speak | 617-420-2461

    Laura Keenan | 410-419-5755



    Primary Logo

    View Full Article Hide Full Article
    • Agreement includes COVID-19 vaccine technology transfer to Takeda for local manufacturing and commercialization in Japan
    • Takeda doses first participant in immunogenicity and safety study to support local regulatory application

    GAITHERSBURG, Md., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced progress in its collaboration with Takeda Pharmaceutical Company Limited, originally announced in August. The companies have signed an exclusive license agreement for Takeda's development, manufacturing and commercialization of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, in Japan. Additionally, Takeda dosed the first participants…

    • Agreement includes COVID-19 vaccine technology transfer to Takeda for local manufacturing and commercialization in Japan

    • Takeda doses first participant in immunogenicity and safety study to support local regulatory application

    GAITHERSBURG, Md., Feb. 26, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced progress in its collaboration with Takeda Pharmaceutical Company Limited, originally announced in August. The companies have signed an exclusive license agreement for Takeda's development, manufacturing and commercialization of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, in Japan. Additionally, Takeda dosed the first participants in a Phase 2 clinical trial to test the immunogenicity and safety of Novavax' vaccine candidate in the Japanese population.

    "This agreement progresses our collaboration with Takeda as we rapidly work together to make our vaccine candidate available in Japan," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "It is vital that we extend the reach and availability of vaccines like NVX-CoV2373 to stop the COVID-19 pandemic, and Takeda is well positioned to make that happen."

    Novavax and Takeda are collaborating on manufacturing, clinical development and regulatory activities in Japan. Novavax will transfer the technology for manufacturing of the vaccine antigen and will supply its Matrix-M™ adjuvant to Takeda. Takeda anticipates the capacity to manufacture over 250 million doses of the COVID-19 vaccine per year. Novavax will be entitled to receive payments based on the achievement of certain development and commercial milestones, as well as a portion of proceeds from the vaccine.

    In addition, Takeda has begun a placebo-controlled, observer-blinded Phase 1/2 study in Japan to evaluate the immunogenicity and safety of NVX-CoV2373 (known as TAK-019 in Japan) in 200 healthy volunteers aged 20 years and older. Participants will receive two doses of either vaccine or placebo 21 days apart and will be followed for 12 months following the second dose. Takeda is responsible for regulatory submission to Japan's Pharmaceutical and Medical Devices Agency (PMDA) and will manufacture and commercialize NVX-CoV2373 (TAK-019) in Japan.

    Novavax has previously reported positive interim efficacy results of NVX-CoV2373, its recombinant protein-based vaccine candidate, in an ongoing Phase 3 clinical trial taking place in the United Kingdom.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated 50-60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:
    
    Investors
    Novavax, Inc.
    Erika Schultz | 240-268-2022
    
    
    Solebury Trout
    Jennifer Porcelli | 617-974-8659
    
    
    Media
    Amy Speak | 617-420-2461
    Laura Keenan | 410-419-5755
    

    Primary Logo

    View Full Article Hide Full Article
    • PREVENT-19 enrolls 30,000 volunteers across 118 sites in the U.S. and Mexico

    GAITHERSBURG, Md., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the complete enrollment of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of the company's COVID-19 vaccine. Novavax has previously reported positive interim efficacy results of NVX-CoV2373, its recombinant protein-based vaccine candidate, in an ongoing Phase 3 clinical trial taking place in the United Kingdom.

    "The full enrollment of PREVENT-19 is another important step in building a body of evidence to…

    • PREVENT-19 enrolls 30,000 volunteers across 118 sites in the U.S. and Mexico

    GAITHERSBURG, Md., Feb. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the complete enrollment of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of the company's COVID-19 vaccine. Novavax has previously reported positive interim efficacy results of NVX-CoV2373, its recombinant protein-based vaccine candidate, in an ongoing Phase 3 clinical trial taking place in the United Kingdom.

    "The full enrollment of PREVENT-19 is another important step in building a body of evidence to demonstrate that NVX-CoV2373 will be safe and effective across diverse, representative populations," said Gregory M. Glenn, President of Research and Development, Novavax. "We thank the thousands of volunteers and individuals, including our partners at NIH, the COVID-19 Prevention Network and trial sites in the U.S. and Mexico, who enabled rapid recruitment and enrollment in the trial, which we believe is a critical aspect to building vaccine trust and uptake across the globe."

    PREVENT-19 was planned with specific recruitment diversity and representation goals and enrolled 30,000 volunteers. Location of trial sites emphasized communities and demographic groups most impacted by the disease, including those living with co-morbid conditions that place them at higher risk of complications from COVID-19. The trial largely reached its demographic goals amid the concurrent rollout of vaccines authorized for emergency use.

    The trial enrolled diverse participants as follows:

    • LatinX: 20%
    • African American: 13%
    • Native American: 6%
    • Asian American: 5%
    • Older adults (65 years and older): 13%

    PREVENT-19 is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. Two thirds of the participants are assigned to randomly receive two intramuscular injections of the vaccine, administered 21 days apart, while one third of the trial participants receive placebo. Trial sites were also selected in locations where transmission rates were high to accelerate the accumulation of positive cases that could show efficacy.

    PREVENT-19 is being conducted with support from the U.S. government partnership (formerly Operation Warp Speed), which includes the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is also providing up to $1.75 billion under a Department of Defense agreement.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of the spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated 50-60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. 



    Contacts:
    
    Investors
    Novavax, Inc.
    Erika Schultz | 240-268-2022
    
    
    Solebury Trout
    Jennifer Porcelli | 617-974-8659
    
    
    Media
    Amy Speak | 617-420-2461
    Laura Keenan | 410-419-5755
    

    Primary Logo

    View Full Article Hide Full Article
    • Advances joint commitment from Novavax, Serum Institute of India and Gavi to ensure equitable access to NVX-CoV2373 worldwide across low-, middle- and high-income countries
    • Memorandum of understanding (MOU) between Gavi and Novavax to make available a cumulative volume of 1.1 billion doses of the Novavax vaccine to the COVAX Facility

    GAITHERSBURG, Md., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a Memorandum of Understanding (MOU) with Gavi, the Vaccine Alliance (Gavi), to provide 1.1 billion cumulative doses of NVX-CoV2373, Novavax' recombinant protein-based COVID-19 vaccine candidate, for the COVAX Facility. The vaccine…

    • Advances joint commitment from Novavax, Serum Institute of India and Gavi to ensure equitable access to NVX-CoV2373 worldwide across low-, middle- and high-income countries

    • Memorandum of understanding (MOU) between Gavi and Novavax to make available a cumulative volume of 1.1 billion doses of the Novavax vaccine to the COVAX Facility

    GAITHERSBURG, Md., Feb. 18, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced a Memorandum of Understanding (MOU) with Gavi, the Vaccine Alliance (Gavi), to provide 1.1 billion cumulative doses of NVX-CoV2373, Novavax' recombinant protein-based COVID-19 vaccine candidate, for the COVAX Facility. The vaccine doses will be manufactured and distributed globally by Novavax and Serum Institute of India (SII), the latter under an existing agreement between Gavi and SII. NVX-CoV2373 is being studied in two ongoing pivotal Phase 3 clinical trials: in the United States and Mexico, as well as in the United Kingdom (U.K.), for the prevention of COVID-19. Novavax has previously reported positive interim efficacy results from its U.K. trial.

    COVAX is the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator, which is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, and the World Health Organization (WHO), who are working in partnership with developed and developing country vaccine manufacturers, UNICEF, the World Bank, civil society organisations and others to guarantee fair and equitable access to the vaccine for every country in the world. COVAX currently includes more than 190 participating economies.

    "We are proud to partner with all the COVAX collaborators and Serum Institute of India to provide global public health leadership and ensure that all countries have broad access to NVX-CoV2373," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Novavax will play a critical role in the worldwide effort to provide access to safe and effective vaccines to end the pandemic."

    Gavi leads the design and implementation of the COVAX Facility and will work with Novavax to finalize an advance purchase agreement (APA) for vaccine supply and global distribution allocation via the COVAX Facility and its partners.

    "This agreement brings the COVAX Facility one step closer to its goal of supplying vaccines globally and ending the acute phase of the pandemic," said Dr. Seth Berkley, CEO of Gavi. "It helps us close in on our goal of delivering two billion doses in 2021 and increases the range of vaccines available to us as we build a portfolio suitable for all settings and contexts."

    CEPI has provided critical support to Novavax, including the commitment of approximately $400 million to advance early clinical development and manufacturing scale-up in multiple facilities around the globe. Novavax has created a global supply network to ensure there can be adequate and equitable supply of NVX-CoV2373 across the globe. Consistent with its mission to increase global manufacturing capacity and ensure broad, equitable supply distribution, Novavax licensed its NVX-CoV2373 technology to SII with no upfront, milestone or technology transfer payments. With this strategic partnership in place, Novavax and SII are jointly committed to deliver 1.1 billion doses to the COVAX Facility. For supply of NVX-CoV2373 to COVAX, Novavax is expected to supply doses primarily to high-income countries (HICs), with SII providing the majority of supply for low-, middle, and upper-middle-income countries, (LMICs, UMICs), utilizing a tiered pricing schedule.

    "With this MOU in place, the vaccine candidate developed by our partners at Novavax is poised to play a significant role in combatting COVID-19 around the world," said Dr. Richard Hatchett, CEO of CEPI. "CEPI's investments in this vaccine have been pivotal to enabling equitable access to a significant volume of this vaccine through COVAX."

    "We are pleased to deepen our partnership with Novavax and COVAX to increase the doses of vaccine available to benefit humanity," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India." This global collaboration is vital to ensure that the largest possible amount of vaccine is available to reach individuals across the broadest segment of countries.

    NVX-CoV2373 was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa. NVX-CoV2373 can neither cause COVID-19 nor can it replicate. It is shipped in a ready-to-use liquid formulation. Because it is stable at 2°C to 8°C (refrigerated), existing vaccine supply chain channels can be used for its distribution.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    
    Investors
    Novavax, Inc.
    Erika Schultz | 240-268-2022
    
    
    Solebury Trout
    Jennifer Porcelli | 617-974-8659
    
    
    Media
    Laura Keenan | 410-419-5755
    Amy Speak | 617-420-2461
    

    Primary Logo

    View Full Article Hide Full Article
  6. GAITHERSBURG, Md., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its fourth quarter 2020 financial results and operational highlights following the close of U.S. financial markets on Monday, March 1, 2021.

    Conference call details are as follows:
    Date:
    Time:
    Dial-in number:
    Passcode:
    Webcast:
    March 1, 2021
    4:30 p.m. U.S. Eastern Time (ET)
    (877) 212-6076 (Domestic) or (707) 287-9331 (International)
    3797013
    www.novavax.com/events
       
    Conference call and webcast replay:
    Date:
    Dial-in number:
    Passcode:
    Webcast:
    Starting at 7:30 p.m. ET, March 1, 2021
    (855) 859-2056 (Domestic) or (404) 537-3406 (International)
    3797013
    www.novavax.com/events

    GAITHERSBURG, Md., Feb. 16, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its fourth quarter 2020 financial results and operational highlights following the close of U.S. financial markets on Monday, March 1, 2021.

    Conference call details are as follows:
    Date:

    Time:

    Dial-in number:

    Passcode:

    Webcast:
    March 1, 2021

    4:30 p.m. U.S. Eastern Time (ET)

    (877) 212-6076 (Domestic) or (707) 287-9331 (International)

    3797013

    www.novavax.com/events

       

    Conference call and webcast replay:
    Date:

    Dial-in number:

    Passcode:

    Webcast:
    Starting at 7:30 p.m. ET, March 1, 2021

    (855) 859-2056 (Domestic) or (404) 537-3406 (International)

    3797013

    www.novavax.com/events, until June 1, 2021

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:         

    Investors

    Novavax, Inc.

    Erika Schultz | 240-268-2022

    Solebury Trout

    Jennifer Porcelli | 617-974-8659

    Media

    Amy Speak | 617-420-2461

    Laura Keenan | 410-419-5755



    Primary Logo

    View Full Article Hide Full Article
  7. GAITHERSBURG, Md., Feb. 15, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, and SK Bioscience, a vaccine business subsidiary of SK Group, today announced an expanded collaboration and license agreement. In addition to the already existing manufacturing arrangement, SK Bioscience has obtained a license to manufacture and commercialize NVX-CoV2373, Novavax' COVID-19 vaccine, for sale to the Korean government. SK Bioscience will add significant production capacity under this new agreement. Novavax recently reported positive interim efficacy results for the vaccine candidate in an ongoing Phase 3 clinical trial in the United Kingdom and is also currently…

    GAITHERSBURG, Md., Feb. 15, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, and SK Bioscience, a vaccine business subsidiary of SK Group, today announced an expanded collaboration and license agreement. In addition to the already existing manufacturing arrangement, SK Bioscience has obtained a license to manufacture and commercialize NVX-CoV2373, Novavax' COVID-19 vaccine, for sale to the Korean government. SK Bioscience will add significant production capacity under this new agreement. Novavax recently reported positive interim efficacy results for the vaccine candidate in an ongoing Phase 3 clinical trial in the United Kingdom and is also currently conducting a Phase 3 trial in the U.S. and Mexico.

    The agreement expands on an existing manufacturing arrangement between Novavax and SK Bioscience and calls for technology transfer related to the manufacturing of Novavax' protein antigen, supply of Matrix MTM adjuvant, and support to SK Bioscience as needed to secure regulatory approval. Concurrently, SK Bioscience has finalized an advance purchase agreement with the Korean government to supply 40 million doses of NVX-CoV2373 to the Republic of Korea beginning in 2021.

    "SK Bioscience shares our sense of urgency to deliver a safe and effective COVID-19 vaccine to protect the global population, including the people of South Korea," said Stanley C. Erck, President and CEO, Novavax. "We are proud to expand our partnership, which is another great milestone for both companies toward increasing the supply of NVX-CoV2373."

    Technology transfer and production scaleup is progressing well under the previously announced collaboration for SK Bioscience to produce the protein antigen component of NVX-CoV2373 for Novavax, which Novavax expects to deliver to global markets, including the COVAX Facility.

    "We are honored to continue to manufacture Novavax' innovative COVID-19 vaccine and provide a supply to the Korean Government through this agreement," said Jaeyong Ahn, CEO, SK Bioscience. "We appreciate the collaboration of the Korean Government and Novavax to make possible this momentous step forward."

    NVX-CoV2373 was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa. NVX-CoV2373 can neither cause COVID-19 disease nor can it replicate. It is shipped in a ready-to-use liquid formulation. It is stable at 2°C to 8°C (refrigerated), meaning that existing vaccine supply chain channels can be used for its distribution.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated efficacy of 89.3 percent overall and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    
    Investors
    Novavax, Inc.
    Erika Schultz | 240-268-2022
    
    
    Solebury Trout
    Jennifer Porcelli | 617-974-8659
    
    
    Media
    Amy Speak | 617-420-2461
    Laura Keenan | 410-419-5755
    

    Primary Logo

    View Full Article Hide Full Article
    • Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada

    GAITHERSBURG, Md., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations.

    "The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite…

    • Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada

    GAITHERSBURG, Md., Feb. 04, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the start of the rolling review process for authorization of NVX-CoV2373, its COVID-19 vaccine, by multiple regulatory agencies. The reviews will continue while the company completes its pivotal Phase 3 trials in the United Kingdom (U.K.) and United States (U.S.) and through initial authorization for emergency use granted under country-specific regulations.

    "The rolling review of our submission by regulatory authorities of non-clinical data and early clinical studies will help expedite the review process and bring us that much closer to delivering a safe and effective vaccine worldwide," said Gregory M. Glenn, MD, President of Research and Development, Novavax. "We appreciate the agencies' confidence in Novavax based on our early data and the collective sense of urgency to ensure speedier access to much-needed COVID-19 vaccination."

    To date, Novavax has begun the rolling review process with several regulatory agencies worldwide, including the European Medicines Agency (EMA), U.S. Food and Drug Administration (FDA), U.K. Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada. As part of the rolling review, the company will continue to submit additional information, including clinical and manufacturing data.

    Novavax' recombinant protein-based vaccine candidate is currently in Phase 3 clinical development in both the U.K. and U.S. for the prevention of COVID-19. It was the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:
    
    Investors
    Novavax, Inc.
    Erika Schultz | 240-268-2022
    
    
    Solebury Trout
    Jennifer Porcelli | 617-974-8659
    
    
    Media
    Amy Speak | 617-420-2461
    Laura Keenan | 410-419-5755
    

    Primary Logo

    View Full Article Hide Full Article
  8. GAITHERSBURG, Md., Feb. 03, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the company has executed a binding Heads of Terms agreement with the government of Switzerland to supply six million doses of its protein-based COVID-19 vaccine candidate, NVX-CoV2373, to the country.

    "The government of Switzerland is working proactively to ensure a sufficient supply of our vaccine that could protect its citizens from COVID-19," said John J. Trizzino, Chief Commercial Officer and Chief Business Officer of Novavax. "Addressing this global public health crisis requires collaboration, and we appreciate their partnership to provide an…

    GAITHERSBURG, Md., Feb. 03, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the company has executed a binding Heads of Terms agreement with the government of Switzerland to supply six million doses of its protein-based COVID-19 vaccine candidate, NVX-CoV2373, to the country.

    "The government of Switzerland is working proactively to ensure a sufficient supply of our vaccine that could protect its citizens from COVID-19," said John J. Trizzino, Chief Commercial Officer and Chief Business Officer of Novavax. "Addressing this global public health crisis requires collaboration, and we appreciate their partnership to provide an urgently needed vaccine to stem the pandemic."

    Novavax and Switzerland will negotiate a final agreement, with initial delivery of vaccine doses slated to ship following successful clinical development and regulatory review.

    NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19. It is the first vaccine to demonstrate clinical efficacy against the original strain of COVID-19 and both of the rapidly emerging variants in the United Kingdom and South Africa. NVX-CoV2373 can neither cause COVID-19 nor can it replicate. It is shipped in a ready-to-use liquid formulation. Because it is stable at 2°C to 8°C (refrigerated), existing vaccine supply chain channels can be used for its distribution.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    
    Investors
    Novavax, Inc.
    Erika Schultz | 240-268-2022
     
    
    Solebury Trout
    Jennifer Porcelli | 617-974-8659
    
    
    Media
    Amy Speak | 617-420-2461
    Laura Keenan | 410-419-5755
    

    Primary Logo

    View Full Article Hide Full Article
  9. GAITHERSBURG, Md., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced memorandum of understanding with the Canadian government to produce NVX-CoV2373, the Company's protein-based vaccine candidate against COVID-19 in Canada.

    "Since the beginning of the pandemic, our top priority has been the health and safety of all Canadians," said Prime Minister Justin Trudeau. "Today, we are investing in our biomanufacturing capacity so that we have the made-in-Canada vaccines and treatments we need to protect Canadians, now and in the future, and recover from the impacts of COVID-19."

    "The Canadian government has been diligent in partnering…

    GAITHERSBURG, Md., Feb. 02, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced memorandum of understanding with the Canadian government to produce NVX-CoV2373, the Company's protein-based vaccine candidate against COVID-19 in Canada.

    "Since the beginning of the pandemic, our top priority has been the health and safety of all Canadians," said Prime Minister Justin Trudeau. "Today, we are investing in our biomanufacturing capacity so that we have the made-in-Canada vaccines and treatments we need to protect Canadians, now and in the future, and recover from the impacts of COVID-19."

    "The Canadian government has been diligent in partnering with Novavax to ensure broad access of our COVID-19 vaccine candidate to the citizens of Canada," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Establishing a manufacturing foothold in Canada will be an important step forward in our quest to deliver an urgently needed safe and effective vaccine."

    Novavax plans to produce its COVID-19 vaccine at the National Research Council's Biologics Manufacturing Centre in Montréal once both the vaccine candidate and the facility receive Health Canada approvals. The memorandum of understanding also includes a broader intention for the Government of Canada and Novavax to work together to increase the company's Canadian presence. They will explore a range of partnership opportunities for Novavax to expand vaccine production in Canada, including partnerships with Canadian contract manufacturers.

    The Government of Canada has previously signed an agreement with Novavax to provide up to 76 million doses of Novavax' COVID-19 vaccine candidate. Novavax recently initiated the rolling submission process for regulatory approval to Health Canada.

    "Our Government is bringing back the vaccine manufacturing capacity that Canadians expect and need," said The Hon. François-Philippe Champagne, Minister of Innovation, Science and Industry. "Pursuing domestic manufacturing of Novavax' COVID-19 vaccine at the National Research Council's Royalmount facility is part of our government's commitment to protect the health and safety of all Canadians today, and in the future."

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that demonstrated 89.3 percent overall efficacy and 95.6 percent against the original strain in a post-hoc analysis, and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa that demonstrated up to 60 percent efficacy against newly emerging escape variants, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:         

    Investors

    Erika Trahan



    240-268-2022

    Media

    Amy Speak



    617-420-2461

    Laura Keenan

    410-419-5755



    Primary Logo

    View Full Article Hide Full Article
  10. GAITHERSBURG, Md., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D, President of Research & Development, will present on NVX-CoV2373, the company's COVID-19 vaccine, at The New York Academy of Science (NYAS) event, ‘The Quest for a COVID-19 Vaccine.'

    Webinar details are as follows:

    Presentation title:Efficacy Data Updates from Novavax' Protein-based Vaccine Candidate
    Date:February 2, 2021
    Time:4:00 pm ET
    Presenter:Dr. Glenn

    Novavax announced interim data last week on its protein-based COVID-19 vaccine candidate that demonstrated efficacy of 89.3% in a pivotal Phase 3 clinical trial taking place…

    GAITHERSBURG, Md., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D, President of Research & Development, will present on NVX-CoV2373, the company's COVID-19 vaccine, at The New York Academy of Science (NYAS) event, ‘The Quest for a COVID-19 Vaccine.'

    Webinar details are as follows:

    Presentation title:Efficacy Data Updates from Novavax' Protein-based Vaccine Candidate
    Date:February 2, 2021
    Time:4:00 pm ET
    Presenter:Dr. Glenn

    Novavax announced interim data last week on its protein-based COVID-19 vaccine candidate that demonstrated efficacy of 89.3% in a pivotal Phase 3 clinical trial taking place in the United Kingdom (UK). The data from this UK Phase 3 trial and a South Africa Phase 2b study were the first to demonstrate clinical efficacy against newer circulating UK and South Africa COVID-19 variants.

    To register for the webinar please visit the NYAS website. Presentation slides will be posted to the company's website following the presentation here.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    
    Investors
    Erika Trahan | 
    (240) 268-2022
    
    Solebury Trout
    Jennifer Porcelli | 
    (617) 974-8659
    
    Media
    Amy Speak | 
    (617) 420-2461

    Primary Logo

    View Full Article Hide Full Article
  11. First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants

    • Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
    • Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
    • Company to host investor conference call today at 4:30pm ET

    GAITHERSBURG, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine…

    First to Demonstrate Clinical Efficacy Against COVID-19 and Both UK and South Africa Variants

    • Strong efficacy in Phase 3 UK trial with over 50% of cases attributable to the now-predominant UK variant and the remainder attributable to COVID-19 virus
    • Clinical efficacy demonstrated in Phase 2b South Africa trial with over 90% of sequenced cases attributable to prevalent South Africa escape variant
    • Company to host investor conference call today at 4:30pm ET

    GAITHERSBURG, Md., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that NVX-CoV2373, its protein-based COVID-19 vaccine candidate, met the primary endpoint, with a vaccine efficacy of 89.3%, in its Phase 3 clinical trial conducted in the United Kingdom (UK). The study assessed efficacy during a period with high transmission and with a new UK variant strain of the virus emerging and circulating widely. It was conducted in partnership with the UK Government's Vaccines Taskforce. Novavax also announced successful results of its Phase 2b study conducted in South Africa.

    "With today's results from our UK Phase 3 and South Africa Phase 2b clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2 and 3 trials involving over 20,000 participants. In addition, our PREVENT-19 US and Mexico clinical trial has randomized over 16,000 participants toward our enrollment goal of 30,000. NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging UK and South Africa variants," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "NVX-CoV2373 has the potential to play an important role in solving this global public health crisis. We look forward to continuing to work with our partners, collaborators, investigators and regulators around the world to make the vaccine available as quickly as possible."

    NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax' recombinant nanoparticle technology and the company's proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C (refrigerated) and is shipped in a ready-to-use liquid formulation that permits distribution using existing vaccine supply chain channels.

    UK Phase 3 Results: 89.3% Efficacy

    The study enrolled more than 15,000 participants between 18-84 years of age, including 27% over the age of 65. The primary endpoint of the UK Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least 7 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline.

    The first interim analysis is based on 62 cases, of which 56 cases of COVID-19 were observed in the placebo group versus 6 cases observed in the NVX-CoV2373 group, resulting in a point estimate of vaccine efficacy of 89.3% (95% CI: 75.2 – 95.4). Of the 62 cases, 61 were mild or moderate, and 1 was severe (in placebo group).

    Preliminary analysis indicates that the UK variant strain that was increasingly prevalent was detected in over 50% of the PCR-confirmed symptomatic cases (32 UK variant, 24 non-variant, 6 unknown). Based on PCR performed on strains from 56 of the 62 cases, efficacy by strain was calculated to be 95.6% against the original COVID-19 strain and 85.6% against the UK variant strain [post hoc].

    The interim analysis included a preliminary review of the safety database, which showed that severe, serious, and medically attended adverse events occurred at low levels and were balanced between vaccine and placebo groups.

    "These are spectacular results, and we are very pleased to have helped Novavax with the development of this vaccine. The efficacy shown against the emerging variants is also extremely encouraging. This is an incredible achievement that will ensure we can protect individuals in the UK and the rest of the world from this virus," said Clive Dix, Chair, UK Vaccine Taskforce.

    Novavax expects to share further details of the UK trial results as additional data become available. Additional analysis on both trials is ongoing and will be shared via prepublication servers as well as submitted to a peer-reviewed journal for publication. The company initiated a rolling submission to the United Kingdom's regulatory agency, the MHRA, in mid-January.

    South Africa Results:   Approximately 90% of COVID-19 cases attributed to South Africa escape variant

    In the South Africa Phase 2b clinical trial, 60% efficacy (95% CI: 19.9 – 80.1) for the prevention of mild, moderate and severe COVID-19 disease was observed in the 94% of the study population that was HIV-negative. Twenty-nine cases were observed in the placebo group and 15 in the vaccine group. One severe case occurred in the placebo group and all other cases were mild or moderate. The clinical trial also achieved its primary efficacy endpoint in the overall trial population, including HIV-positive and HIV-negative subjects (efficacy of 49.4%; 95% CI: 6.1 – 72.8).

    This study enrolled over 4,400 patients beginning in August 2020, with COVID-19 cases counted from September through mid-January. During this time, the triple mutant variant, which contains three critical mutations in the receptor binding domain (RBD) and multiple mutations outside the RBD, was widely circulating in South Africa. Preliminary sequencing data is available for 27 of 44 COVID-19 events; of these, 92.6% (25 out of 27 cases) were the South Africa escape variant.  

    Importantly in this trial, approximately 1/3 of the patients enrolled (but not included in the primary analyses described above) were seropositive, demonstrating prior COVID-19 infection at baseline. Based on temporal epidemiology data in the region, the pre-trial infections are thought to have been caused by the original COVID-19 strain (i.e., non-variant), while the subsequent infections during the study were largely variant virus. These data suggest that prior infection with COVID-19 may not completely protect against subsequent infection by the South Africa escape variant, however, vaccination with NVX-CoV2373 provided significant protection.

    "The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa," says Professor Shabir Maddi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator in the Novavax COVID-19 vaccine trial in South Africa. "I am encouraged to see that Novavax plans to immediately begin clinical development on a vaccine specifically targeted to the variant, which together with the current vaccine is likely to form the cornerstone of the fight against COVID-19."

    Novavax initiated development of new constructs against the emerging strains in early January and expects to select ideal candidates for a booster and/or combination bivalent vaccine for the new strains in the coming days. The company plans to initiate clinical testing of these new vaccines in the second quarter of this year.

    "A primary benefit of our adjuvanted platform is that it uses a very small amount of antigen, enabling the rapid creation and large-scale production of combination vaccine candidates that could potentially address multiple circulating strains of COVID-19," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "Combined with the safety profile that has been observed in our studies to-date with our COVID-19 vaccine, as well as prior studies in influenza, we are optimistic about our ability to rapidly adapt to evolving conditions."

    The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial, which was supported in part by a $15 million grant from the Bill & Melinda Gates Foundation.

    Significant progress on PREVENT-19 Clinical Trial in US and Mexico

    To date, PREVENT-19 has randomized over 16,000 participants and expects to complete our targeted enrollment of 30,000 patients in the first half of February.  PREVENT-19 is being conducted with support from the U.S. government partnership formerly known as Operation Warp Speed, which includes the Department of Defense, the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response, and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) at HHS. BARDA is also providing up to $1.75 billion under a Department of Defense agreement.

    PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a Phase 3, randomized, placebo-controlled, observer-blinded study in the US and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.

    The trial's primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

    Conference Call

    Novavax will host a conference call today at 4:30pm ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 7470222. A replay of the conference call will be available starting at 7:30 p.m. ET on January 28, 2021 until 7:30 p.m. ET on February 4, 2021. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 7470222.

    A webcast of the conference call can also be accessed on the Novavax website at novavax.com/events. A replay of the webcast will be available on the Novavax website until April 28, 2021.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Over 37,000 participants have participated to date across four different clinical studies in five countries. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    
    Investors
    Novavax, Inc.
    Erika (Trahan) Schultz
    
    240-268-2022
    
    Solebury Trout
    Jennifer Porcelli
    
    617-974-8659
    
    Media
    Edna Kaplan
     
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  12. GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has finalized an agreement with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, the company's recombinant protein-based COVID-19 vaccine. Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19.

    "We thank the Government of Canada for their confidence in our program and ongoing partnership in the regulatory review and delivery of a safe, effective COVID-19…

    GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has finalized an agreement with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, the company's recombinant protein-based COVID-19 vaccine. Canada has committed to purchase 52 million doses of the vaccine with the option for up to an additional 24 million doses. NVX-CoV2373 is currently in Phase 3 clinical development for the prevention of COVID-19.

    "We thank the Government of Canada for their confidence in our program and ongoing partnership in the regulatory review and delivery of a safe, effective COVID-19 vaccine for the citizens of Canada," said John J. Trizzino, Chief Commercial Officer and Chief Business Officer, Novavax. "Novavax is proud to play our part in working tirelessly together with governments, scientists, regulators and others in the global effort to put an end to the pandemic."

    The company expects to supply NVX-CoV2373 to Canada beginning as early as the second quarter of 2021, following authorization by Canada's regulatory agency.

    Novavax is currently conducting three efficacy, safety and immunogenicity studies of NVX-CoV2373 and expects to announce initial efficacy results as early as the first quarter of 2021.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. It was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: A Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:
    
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  13. GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Madelyn ‘Lyn' Caltabiano, Ph.D. to the position of Senior Vice President, Global Program Management. In this newly created role, Dr. Caltabiano will lead and expand the Global Program Management organization for the company's pipeline and will develop appropriate strategies to assess the company's operational performance, including areas related to portfolio valuation, milestone decision making and prioritization. She will report directly to Stanley C. Erck, President and Chief Executive Officer.

    "Lyn's deep experience in…

    GAITHERSBURG, Md., Jan. 22, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Madelyn ‘Lyn' Caltabiano, Ph.D. to the position of Senior Vice President, Global Program Management. In this newly created role, Dr. Caltabiano will lead and expand the Global Program Management organization for the company's pipeline and will develop appropriate strategies to assess the company's operational performance, including areas related to portfolio valuation, milestone decision making and prioritization. She will report directly to Stanley C. Erck, President and Chief Executive Officer.

    "Lyn's deep experience in managing complex global programs will be critical as we work to simultaneously advance NVX-CoV2373 regulatory activities forward in multiple regions," said Mr. Erck. "We welcome her invaluable project management experience as Novavax works to effectively deliver our vaccine candidate in the fight against the COVID-19 pandemic."

    Dr. Caltabiano joins Novavax from NexEos Diagnostics, Inc., where she was Development Lead and a core member of the management team. Previously, as Senior Vice President, Global Project and Alliance Management at Merck Research Laboratories, she rebuilt the R&D project and Alliance Management organizations and led the development of critical portfolio management and executive decision-making processes. Earlier, Dr. Caltabiano spent more than a decade at GlaxoSmithKline where she built the Alliance Management organization, headed project operations in Oncology R&D, and led the development of several new therapeutics.

    Dr. Caltabiano graduated summa cum laude from Drexel University with a Bachelor of Science in biological sciences and earned a doctorate in pathology from the University of Pennsylvania.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  14. GAITHERSBURG, Md., Jan. 15, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Henrietta Ukwu, M.D., FACP, FRAPS, to the position of Senior Vice President, Chief Regulatory and Quality Officer. In this newly created role, Dr. Ukwu will lead global regulatory strategy and execution as well as the quality assurance function for the company's development-stage vaccine candidates, including its recombinant protein-based COVID-19 candidate vaccine, NVX-CoV2373.

    "Dr. Ukwu brings extensive regulatory affairs and quality expertise and leadership experience at precisely the right time for Novavax, as we advance…

    GAITHERSBURG, Md., Jan. 15, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Henrietta Ukwu, M.D., FACP, FRAPS, to the position of Senior Vice President, Chief Regulatory and Quality Officer. In this newly created role, Dr. Ukwu will lead global regulatory strategy and execution as well as the quality assurance function for the company's development-stage vaccine candidates, including its recombinant protein-based COVID-19 candidate vaccine, NVX-CoV2373.

    "Dr. Ukwu brings extensive regulatory affairs and quality expertise and leadership experience at precisely the right time for Novavax, as we advance toward data readouts and regulatory submissions in 2021," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We welcome her medical perspective and intricate knowledge of the regulatory process at this extraordinary time for the company and the race against the global pandemic."

    Dr. Ukwu most recently served as Chief Regulatory Officer and Global Head of Quality and Regulatory at Otsuka Pharmaceuticals. While there, she globalized and led the regulatory and quality organizations with a focus on compliance excellence, inspection readiness, engagement with health authorities and regulatory agencies and successful outcomes. Prior to Otsuka, she held senior leadership roles at PPD as Senior Vice President and Head of Global Regulatory Affairs, where she had responsibilities for regulatory services across all PPD lines of business; Wyeth Pharmaceuticals, Inc. (Pfizer), where she was Vice President, Regulatory Affairs, with responsibility that spanned vaccines, biologics and pharmaceuticals across all regions; and at Merck & Co., Inc., as Head of Vaccine Regulatory Development, Vice President of Global Regulatory Affairs and Global Regulatory Policy. Dr. Ukwu has led approval of many products, including for Varivax®, a chickenpox varicella vaccine, and Crixivan®, (indinavir), an HIV protease inhibitor that significantly impacted the treatment paradigm of HIV/AIDS.

    Dr. Ukwu's significant contributions to medicine, science and the pharmaceutical industry include developing and enriching the regulatory and quality profession, as well as serving as a mentor to others who have progressed into senior leadership positions. These contributions have been recognized with numerous prestigious awards.

    Dr. Ukwu earned her medical and surgical degrees from the University of Jos School of Medicine in Nigeria. She completed her residency in internal medicine at Baptist Hospital, and a fellowship in infectious diseases at Vanderbilt University, both in Nashville, Tennessee. She is a Fellow of both the American College of Physicians (FACP) and the Regulatory Affairs Professional Society (FRAPS) and is a pioneer professor at the Graduate School of Pharmacy at Temple University in Ambler, Pennsylvania.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should consider these risks and uncertainties.



    Contacts:         
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • Advance Purchase Agreement signed for NVX-CoV2373, Novavax' adjuvanted protein vaccine candidate
    • Initial doses expected to be delivered as early as mid-2021

    GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. This follows an agreement in principle that was announced in November 2020. NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax' proprietary Matrix-M™ to enhance the immune response.

    Novavax is currently conducting…

    • Advance Purchase Agreement signed for NVX-CoV2373, Novavax' adjuvanted protein vaccine candidate
    • Initial doses expected to be delivered as early as mid-2021

    GAITHERSBURG, Md., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has executed an Advance Purchase Agreement with the Commonwealth of Australia for 51 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. This follows an agreement in principle that was announced in November 2020. NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax' proprietary Matrix-M™ to enhance the immune response.

    Novavax is currently conducting late-stage clinical studies to demonstrate the efficacy, safety and immunogenicity of NVX-CoV2373 for the prevention of COVID-19. This includes two large pivotal Phase 3 clinical trials in the United States/Mexico (the PREVENT-19 trial) and in the United Kingdom, as well as a Phase 2b trial in South Africa.

    "The continued increase in significant COVID-19 transmission in virtually all parts of the world underscores the need for multiple safe, efficacious vaccines in enormous quantities to stop the pandemic," said Stanley C. Erck, Novavax President and Chief Executive Officer. "We appreciate the confidence of the Australian government and the opportunity to play a role in ensuring that its citizens will have access to a protein-based vaccine that can be distributed using existing distribution channels, should it receive regulatory approval."

    Novavax will work with Australia's regulatory agency, the Therapeutics Goods Administration (TGA), to obtain product approvals upon demonstrating efficacy in clinical studies. The company aims to deliver initial doses by mid-2021. As part of the agreement, Australia will have the option to purchase up to an additional 10 million doses.

    Additional terms of the agreement were not disclosed.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody response numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and the PREVENT-19 trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  15. GAITHERSBURG, Md., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in two upcoming investor conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be the topic of discussion in each presentation.

    J.P. Morgan 39th Annual Healthcare Conference
    Presentation
    Date:Monday, January 11, 2021
    Time:8:20 a.m. Eastern Time (ET)
    Presenters:Stanley C. Erck, President and Chief Executive Officer and
    Gregory M. Glenn, M.D., President, Research and Development
    Webcast:www.novavax.com, "Investors" / "Events"
      
    Conference
    Event:Investor meetings
    Date:Monday, January 11, 2021 – Wednesday, January

    GAITHERSBURG, Md., Jan. 06, 2021 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in two upcoming investor conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be the topic of discussion in each presentation.

    J.P. Morgan 39th Annual Healthcare Conference

    Presentation

    Date:Monday, January 11, 2021
    Time:8:20 a.m. Eastern Time (ET)
    Presenters:Stanley C. Erck, President and Chief Executive Officer and

    Gregory M. Glenn, M.D., President, Research and Development
    Webcast:www.novavax.com, "Investors" / "Events"
      
    Conference

    Event:Investor meetings
    Date:Monday, January 11, 2021 – Wednesday, January 13, 2021



    13th Annual Biotech Showcase

    Panel

    Date:Friday, January 8, 2021
    Time:11:00 a.m. Eastern Time (ET)
    Panel title:In Conversation with COVID-19 Leaders: The Novavax COVID-19 Journey
    Moderator:Kimberly Ha, Founder and Chief Executive Officer, KKH Advisors
    Panelist:John J. Trizzino, Executive Vice President, Chief Commercial Officer and Chief Business Officer, Novavax
    Webcast:A replay of the recorded fireside session will be available through the events page of the Company's website at ir.novavax.com for 90 days.
      

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is currently being evaluated in two pivotal Phase 3 trials: a trial in the U.K that completed enrollment in November and a trial in the U.S. and Mexico that began in December. It is also being tested in two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:         

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659



    Primary Logo

    View Full Article Hide Full Article
    • PREVENT-19 will assess the efficacy, safety and immunogenicity of NVX-CoV2373 in the prevention of COVID-19
    • Trial to enroll up to 30,000 volunteers across approximately 115 sites in the U.S. and Mexico
    • Two-thirds of enrollees to receive active vaccine

    GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company's COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune…

    • PREVENT-19 will assess the efficacy, safety and immunogenicity of NVX-CoV2373 in the prevention of COVID-19

    • Trial to enroll up to 30,000 volunteers across approximately 115 sites in the U.S. and Mexico
    • Two-thirds of enrollees to receive active vaccine

    GAITHERSBURG, Md., Dec. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced initiation of PREVENT-19, its pivotal Phase 3 study in the United States and Mexico to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, the Company's COVID-19 vaccine candidate. The trial builds on research from Phase 1/2 studies demonstrating that the vaccine provoked a robust immune response, generated highly neutralizing antibodies against the virus and was generally well-tolerated.

    "With the COVID-19 pandemic raging around the globe, this trial is a critical step in building the global portfolio of safe and effective vaccines to protect the world's population," said Stanley C. Erck, president and chief executive officer, Novavax. "We thank our colleagues and partners who continue to work with us to urgently advance our commercial-scale manufacturing processes, and we are grateful for the hard work and assistance from Operation Warp Speed, the U.S. FDA and the government of Mexico on this program."

    NVX-CoV2373 contains a full-length, prefusion spike protein made using Novavax' recombinant nanoparticle technology and the company's proprietary saponin-based Matrix-M™ adjuvant. The purified protein is encoded by the genetic sequence of the SARS-CoV-2 spike (S) protein and is produced in insect cells. It can neither cause COVID-19 nor can it replicate, is stable at 2°C to 8°C and is shipped in a ready-to-use liquid formulation that permits distribution using standard vaccine supply chain channels.

    PREVENT-19 is being conducted with support from Operation Warp Speed partners, including the Department of Defense and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response. BARDA is also providing up to $1.6 billion under a Department of Defense agreement (identifier MCDC OTA agreement number W15QKN-16-9-1002).

    The company is also currently conducting a large pivotal Phase 3 clinical study in the United Kingdom (U.K.), a Phase 2b safety and efficacy study in South Africa, and an ongoing Phase1/2 trial in the U.S. and Australia. Data from these trials are expected as soon as early first quarter 2021, although timing depends on transmission rates in the regions.

    About the PREVENT-19 Phase 3 Study

    PREVENT-19 (the PRE-fusion protein subunit Vaccine Efficacy Novavax Trial | COVID-19) is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 30,000 subjects 18 years of age and older compared with placebo. The trial design has been harmonized to align with other Phase 3 trials conducted under the auspices of Operation Warp Speed, including the use of a single external independent Data and Safety Monitoring Board to evaluate safety and conduct an unblinded review when predetermined interim analysis events are reached.

    The trial's primary endpoint is the prevention of PCR-confirmed, symptomatic COVID-19. The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints will be assessed at least seven days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2.

    Two thirds of the participants will be assigned to randomly receive two intramuscular injections of the vaccine, administered 21 days apart, while one third of the trial participants will receive placebo. Trial sites were selected in locations where transmission rates are currently high, to accelerate the accumulation of positive cases that could show efficacy.

    The primary efficacy analysis is event-driven, based on the number of participants with symptomatic mild, moderate or severe COVID-19 disease. Participants will be followed for 24 months following the second injection.

    Enrollment and Study Population

    Information about the trial and how to enroll in PREVENT-19 is available on clinicaltrials.gov under trial identifier NCT04611802 and www.Novavax.com/PREVENT-19.

    Novavax plans to recruit, enroll, and study a diverse population with an emphasis on communities and demographic groups most impacted by the disease as well as to maximize participation of older adults and those living with co-morbid conditions (e.g., obesity, hypertension and diabetes) that place them at higher risk of complications from COVID-19. Enrollment goals are:

    • ≥ 25 percent of the study population is intended to be in the 65 years of age or older group
    • ≥ 15 percent black/African American
    • 10-20 percent LatinX
    • 1-2 percent American Indian

    "We are encouraged by the data generated to-date on NVX-CoV2373 and are optimistic about our ability to positively build on the body of evidence with this trial," said Gregory M. Glenn, M.D, president of research and development, Novavax. "We recognize that volunteers considering our trial may have questions about the potential impact on their ability to receive an authorized vaccine when it becomes available to them. We wish to reassure participants that we are working to ensure that their involvement in our trial does not negatively impact their ability to be vaccinated at the appropriate time."

    Many of the trial sites participating in PREVENT-19 are part of the NIAID-supported COVID-19 Prevention Network (CoVPN), which includes existing NIAID-supported clinical research networks with infectious disease expertise and was designed for rapid and thorough evaluation of vaccine candidates and monoclonal antibodies for preventing COVID-19.

    "This trial underscores the importance of private/public partnerships in solving the need for globally available vaccines to interrupt the ongoing COVID-19 epidemic," said Larry Corey, M.D., virologist at the Fred Hutchinson Cancer Research Center and co-leader of the CoVPN.

    In the interest of transparency and scientific exchange and to demonstrate the rigor with which the study is being executed, Novavax has posted the Phase 3 trial protocol on its website at novavax.com/resources.

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. It is adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.





    Contacts:
    
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  16. GAITHERSBURG, Md., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Rick Crowley to the newly created position of Executive Vice President, Chief Operations Officer. In this role, Mr. Crowley will have leadership responsibility for all operations, including Quality, Manufacturing, Supply Chain and Regulatory Affairs. He takes over manufacturing from Ben Machielse, who will continue with the company as an executive advisor to the Chief Executive Officer, supporting the development of the COVID vaccine.

    "Rick's wealth of biopharmaceutical experience and record of on-time FDA approvals comes…

    GAITHERSBURG, Md., Dec. 21, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Rick Crowley to the newly created position of Executive Vice President, Chief Operations Officer. In this role, Mr. Crowley will have leadership responsibility for all operations, including Quality, Manufacturing, Supply Chain and Regulatory Affairs. He takes over manufacturing from Ben Machielse, who will continue with the company as an executive advisor to the Chief Executive Officer, supporting the development of the COVID vaccine.

    "Rick's wealth of biopharmaceutical experience and record of on-time FDA approvals comes at the perfect time to help ensure that Novavax delivers on our global manufacturing mission and supply commitments," said Stanley C. Erck, Novavax President and Chief Executive Officer. "We welcome his leadership as we work to advance not only our COVID-19 candidate, but also influenza and RSV vaccines."

    Prior to joining Novavax, Mr. Crowley was Executive Vice President, Technical Operations for TerSera Pharmaceuticals, where he was responsible for technical support as well as development and strategy for the company's products, created the initial quality systems, and managed all CMC activities. He served as Senior Vice President, Operations and Quality Assurance for Crealta Pharmaceuticals 2014-2016, where he led all aspects of the supply chain function, managed suppliers and testing, and held responsibility for the management of Regulatory Affairs. Previously, he held the role of Co-President and Chief Operating Officer at Savient Pharmaceuticals, with responsibility for Commercial Operations, Clinical Affairs, Manufacturing/Technical Operations, Regulatory Affairs, Quality Assurance, Quality Control, Project Management, Logistics and Planning. Earlier in his career he held roles of increasing responsibility at ImClone Systems, Incorporated and BASF Bioresearch Corp.

    "Novavax is well-positioned to execute on a strategic global operations plan that leverages the company's strengths and the expertise of its partners to deliver in the near and long term," said Mr. Crowley. "I am impressed with the astounding progress to-date and look forward to contributing to continue the momentum."

    Mr. Crowley earned a Bachelor of Science degree in chemistry from Denison University and a Master of Science in chemical engineering from the University of Pennsylvania.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659



    Primary Logo

    View Full Article Hide Full Article
  17. GAITHERSBURG, Md., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, Novavax' candidate vaccine against COVID-19.

    Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax' proprietary Matrix-M™ to enhance the immune response.

    "The global reach of the pandemic requires that all regions of the world have an adequate supply of vaccine available to protect their entire citizenry," said Stanley…

    GAITHERSBURG, Md., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an Advance Purchase Agreement with the government of New Zealand for the purchase of 10.7 million doses of NVX-CoV2373, Novavax' candidate vaccine against COVID-19.

    Currently in Phase 3 clinical testing in the United Kingdom for the prevention of COVID-19, NVX-CoV2373 is a recombinant protein vaccine adjuvanted with Novavax' proprietary Matrix-M™ to enhance the immune response.

    "The global reach of the pandemic requires that all regions of the world have an adequate supply of vaccine available to protect their entire citizenry," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We appreciate the confidence of the government of New Zealand and are pleased to contribute to ensuring that New Zealanders will have access to a protein-based vaccine through standard distribution channels, should it receive regulatory approval."

    Under the terms of the agreement, Novavax will manufacture NVX-CoV2373 with a target of delivering initial doses by mid-2021. The company will work with Medsafe, New Zealand's regulatory agency, to obtain product approvals as needed. Given the urgency of timely approval and delivery of vaccine during the pandemic, the regulatory review process may leverage review by prioritized regulatory bodies such as the U.S. Food and Drug Administration, European Medicines Agency and/or Medicines and Healthcare products Regulatory Authority in the United Kingdom.

    Additional terms of the agreement were not disclosed.

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in an ongoing Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. 



    Contacts:         
    
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  18. GAITHERSBURG, Md., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Margaret G. McGlynn, R. Ph. to its board as an independent director. Ms. McGlynn brings extensive pharmaceutical industry, vaccine and non-profit experience to her role on the Novavax Board of Directors.

    "Margie's deep experience in vaccine commercialization and understanding of global public health will be invaluable as we move closer to collecting Phase 3 clinical data and submitting NVX-CoV2373, our COVID-19 vaccine candidate, for regulatory authorization and approval," said Stanley C. Erck, Novavax President and Chief…

    GAITHERSBURG, Md., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Margaret G. McGlynn, R. Ph. to its board as an independent director. Ms. McGlynn brings extensive pharmaceutical industry, vaccine and non-profit experience to her role on the Novavax Board of Directors.

    "Margie's deep experience in vaccine commercialization and understanding of global public health will be invaluable as we move closer to collecting Phase 3 clinical data and submitting NVX-CoV2373, our COVID-19 vaccine candidate, for regulatory authorization and approval," said Stanley C. Erck, Novavax President and Chief Executive Officer.

    Ms. McGlynn is currently President and Board Chair for HCU Network America, an advocacy organization she founded in 2016 that is dedicated to supporting the needs of those impacted by the rare genetic condition homocystinuria (HCU) and related disorders. Prior to founding HCU Network America, Ms. McGlynn served as President and Chief Executive Officer of the International AIDS Vaccine Initiative (IAVI), where she led extensive partnership efforts to advance the development, global launch and access to a broadly effective HIV vaccine. She previously spent more than two decades at Merck, where she held roles of increasing responsibility, including President of Merck Vaccines and Infectious Diseases, and President, U.S. Hospital and Specialty Products Division.

    "This is a very exciting time to be joining the Novavax Board, and I look forward to working with my fellow directors to support Novavax' critical priority to advance and deploy NVX-CoV2373 globally to help end this devastating pandemic, as well as progress the broader vaccine portfolio," said Ms. McGlynn.

    She currently serves on the boards of directors of Amicus Therapeutics and Vertex Pharmaceuticals. In addition to her corporate experience, Ms. McGlynn has served as a Board member for several non-profit organizations, including Hilleman Institute for Developing World Vaccine Research, Gavi, the Vaccine Alliance, the Biotechnology Innovation Organization (BIO), and Life Science Cares Philadelphia.

    Ms. McGlynn holds a Bachelor of Science degree in pharmacy, a Master of Business Administration in marketing, and an honorary doctorate from the State University of New York at Buffalo.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The Company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:         
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • Pivotal Phase 3 trial in United Kingdom completes enrollment
    • Phase 2b efficacy trial in South Africa completes enrollment
    • U.S./Mexico Phase 3 trial expected to begin in the coming weeks

    GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax' proprietary Matrix‑M™.

    "Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately…

    • Pivotal Phase 3 trial in United Kingdom completes enrollment

    • Phase 2b efficacy trial in South Africa completes enrollment
    • U.S./Mexico Phase 3 trial expected to begin in the coming weeks

    GAITHERSBURG, Md., Nov. 30, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today provided an update on its COVID-19 vaccine program. NVX‑CoV2373 is a stable, prefusion protein antigen derived from the genetic sequence of the SARS-CoV-2 coronavirus spike (S) protein and adjuvanted with Novavax' proprietary Matrix‑M™.

    "Novavax is in a leading position to significantly contribute to the need for safe and efficacious vaccines that will ultimately end the worldwide COVID-19 pandemic," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We continue to make meaningful progress as we work to test, manufacture and ultimately deliver NVX-CoV2373 with unprecedented speed, as well as put partnerships in place that would ensure widespread and equitable access worldwide."

    Two of the three planned late-stage efficacy trials for NVX-CoV2373 sponsored by Novavax are fully enrolled, and more than 20,000 participants have been dosed to-date. The primary efficacy endpoints for these trials have been harmonized and reviewed by global regulatory agencies in order to facilitate regulatory approval and ensure that the results are generalizable across global populations. In alignment with Novavax' commitment to transparency, Phase 3 clinical trial protocols are posted to the company's website at Novavax.com/resources upon finalization.

    United Kingdom (U.K.) pivotal Phase 3 trial update

    Novavax completed enrollment of 15,000 participants in a pivotal Phase 3 clinical trial being conducted in the U.K. to determine efficacy and safety of NVX-CoV2373. The U.K. Vaccines Taskforce and National Institute for Health Research played pivotal roles in the rapid recruitment and enrollment of volunteers.

    Interim data in this event-driven trial are expected as soon as early first quarter 2021, although the timing depends on the overall COVID-19 rate in the region. These data are expected to serve as the basis for licensure application in the U.K., European Union and other countries. More than 25 percent of enrollees in the trial are over the age of 65, while a large proportion of volunteers had underlying co-morbid medical conditions generally representative of the population.

    South Africa Phase 2b trial update

    The Phase 2b trial taking place in South Africa to evaluate safety and provide an early indication of efficacy is now fully enrolled. A total of 4,422 volunteers are taking part in the trial, which includes 245 medically stable, HIV-positive participants.

    This trial is expected to increase the body of efficacy data of NVX-CoV2373 in racially and geographically diverse populations as well as in older adults. As in the U.K., availability of efficacy data depends on the illness rate in South Africa and may be available as soon as the first quarter 2021. The trial is being conducted in collaboration with Professor Shabir Mahdi and Wits University and is funded in part by the Bill & Melinda Gates Foundation. The Coalition for Epidemic Preparedness Innovations (CEPI) funded the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.

    U.S./Mexico pivotal Phase 3 trial update

    Novavax expects its pivotal Phase 3 clinical trial in the United States and Mexico to begin in the coming weeks. More than 100 trial sites have been selected with some alternate sites in place, should they be needed.

    Preliminary blinded data on NVX-CoV2373 in older adults needed to proceed to Phase 3 has previously been positively reviewed by the Food and Drug Administration (FDA). Additional clinical data from the Phase 2 trial conducted in the U.S. and Australia are expected to be unblinded in Q1 and will be targeted for publication.

    Novavax will use vaccine material produced at commercial scale for this trial. Therefore, the Company has been working closely with the FDA to complete trial-initiation gating activities related to its commercial-scale production at FUJIFILM Diosynth Biotechnologies in Research Triangle Park, North Carolina.

    Novavax was awarded $1.6 billion in funding from the U.S. government to meet its Operation Warp Speed goals to expedite the delivery of millions of doses of safe, effective vaccines for COVID-19. The award is funding the U.S. and Mexico pivotal Phase 3 trial and manufacturing scale-up. 

    About NVX-CoV2373

    NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein adjuvanted with Novavax' patented saponin-based Matrix-M™ to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19. In preclinical studies, NVX-CoV2373 induced antibodies that block binding of spike protein to cellular receptors and provided protection from infection and disease. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in Phase 1/2 clinical testing. NVX-CoV2373 is being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and more than $1.6 billion from the U.S. Government's Operation Warp Speed program.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.



    Contacts:
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  19. GAITHERSBURG, Md., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Novavax Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in two upcoming investor conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion in each conference.

    Piper Sandler 32nd Annual Virtual Healthcare Conference
    Panel
    Date:

    Tuesday, December 1, 2020
    Time:10:00 a.m. Eastern Time (ET)
    Panel title:The Road Ahead for COVID-19 Vaccines: What We Know and Questions Still to Be Answered into 2021
    Moderators:Edward A. Tenthoff and Yasmeen Rahimi, Ph.D.
    NVAX Panelist:Gregory M. Glenn, M.D., President of Research and Development, Novavax
    Additional panelists:

    GAITHERSBURG, Md., Nov. 25, 2020 (GLOBE NEWSWIRE) -- Novavax Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in two upcoming investor conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion in each conference.

    Piper Sandler 32nd Annual Virtual Healthcare Conference
    Panel

    Date:


    Tuesday, December 1, 2020
    Time:10:00 a.m. Eastern Time (ET)
    Panel title:The Road Ahead for COVID-19 Vaccines: What We Know and Questions Still to Be Answered into 2021
    Moderators:Edward A. Tenthoff and Yasmeen Rahimi, Ph.D.
    NVAX Panelist:Gregory M. Glenn, M.D., President of Research and Development, Novavax

    Additional panelists: Moderna, Inc., Arcturus Therapeutics Holdings, Inc. and Altimmune, Inc.

    This event is open to Piper Sandler clients
      
    Conference 
    Event:

    Participants:
    Fireside chat

    Stanley C. Erck, President and Chief Executive Officer, and Dr. Glenn
    Webcast:

    A replay of the recorded fireside session is available through the events page of the Company's website at ir.novavax.com for 90 days.
      
    Event:

    Date:



    Investor meetings

    Wednesday, December 2, 2020
    Evercore ISI 3rd Annual HealthCONx Conference
    Date:Thursday, December 3, 2020
    Time:2:15 p.m. Eastern Time (ET)
    Participation:Fireside chat and investor meetings
    Live webcast:www.novavax.com, "Investors"/ "Events"

      

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.        

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659



    Primary Logo

    View Full Article Hide Full Article
  20. GAITHERSBURG, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, will host a conference call for the investment community to pose questions related to the Company's third quarter 2020 financial and operating results. The call will be held because of technical issues experienced by the Company's external conference call host during the earnings call that took place on November 9 at 4:30 pm. The call will be held following the close of U.S. financial markets on Tuesday, November 10, 2020.

    Conference call details are as follows:

    Date:November 10, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 212-6076 (Domestic)

    GAITHERSBURG, Md., Nov. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, will host a conference call for the investment community to pose questions related to the Company's third quarter 2020 financial and operating results. The call will be held because of technical issues experienced by the Company's external conference call host during the earnings call that took place on November 9 at 4:30 pm. The call will be held following the close of U.S. financial markets on Tuesday, November 10, 2020.

    Conference call details are as follows:

    Date:November 10, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 212-6076 (Domestic) or (707) 287-9331 (International)
    Conference ID: 1376583
    Webcast:www.novavax.com, "For Investors"/ "Events"
      
    Conference call webcast replay:
      
    Dates: Starting at 7:30 p.m. ET, November 10, 2020 until 7:30 p.m. ET November 17, 2020
    Dial-in number:(855) 859-2056 (Domestic) or (404) 537-3406 (International)
    Conference ID:1376583
    Webcast:www.novavax.com, "For Investors"/ "Events" until 11/17/2020



    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age.  NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:         

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • Covino brings global biopharmaceutical finance experience to Novavax
    • John Trizzino, Chief Business Officer, takes on additional role as Chief Commercial Officer
    • Filip Dubovsky, M.D. promoted to Executive Vice President, Chief Medical Officer
    • Biegie Lee promoted to Senior Vice President, Chief Information Officer

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced updates to its leadership team, including the appointment of Gregory F. Covino as Executive Vice President and Chief Financial Officer (CFO). Executive Vice President John Trizzino, who previously served as CFO, will now become the Chief…

    • Covino brings global biopharmaceutical finance experience to Novavax
    • John Trizzino, Chief Business Officer, takes on additional role as Chief Commercial Officer
    • Filip Dubovsky, M.D. promoted to Executive Vice President, Chief Medical Officer
    • Biegie Lee promoted to Senior Vice President, Chief Information Officer

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced updates to its leadership team, including the appointment of Gregory F. Covino as Executive Vice President and Chief Financial Officer (CFO). Executive Vice President John Trizzino, who previously served as CFO, will now become the Chief Commercial Officer while continuing in his role as Chief Business Officer.

    "We welcome Greg's multifaceted and extensive global financial experience at a pivotal time as Novavax transforms into a commercial stage company," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "His expertise will be of significant value as we advance both our COVID-19 vaccine candidate, NVXCoV2373, and our NanoFlu influenza vaccine toward commercialization."

    Prior to joining Novavax, Mr. Covino was Group CFO at GlaxoSmithKline's TESARO Oncology Division, where he also served as Senior Vice President and Chief Accounting Officer. He previously served as Chief Accounting Officer at leading biopharmaceutical company Biogen Inc. He held earlier positions as Vice President, Corporate Internal Audit, and Vice President, International Finance for Boston Scientific. Earlier in his career, Mr. Covino spent 10 years at international accounting and consulting firm PricewaterhouseCoopers.

    "I look forward to contributing to Novavax' positive impact on reducing the global burden of serious infectious diseases around the world, including COVID-19 and influenza," said Mr. Covino. "This is a very exciting time to join Novavax and play a role in the company's rapid strategic growth."

    Executive Updates

    Since re-joining Novavax in 2014, John Trizzino has held roles of increasing responsibility across Finance, Commercial and executive management. With his newly created role of Chief Commercial Officer, Mr. Trizzino will focus on advancing NVX-CoV2373, the Company's protein-based vaccine candidate for the prevention of COVID-19, and NanoFlu™ toward commercialization, applying his broad vaccine industry experience in previous roles overseeing commercialization, vaccine policy, strategic development, business development, financing, investor relations and public relations as the company prepares to enter global markets.

    Chief Medical Officer, Filip Dubovsky, M.D. was promoted to Executive Vice President. Since joining Novavax in June 2020, Dr. Dubovsky has played a key role in leading global clinical development planning and trial execution for NVX-CoV2373 in multiple trials in various global locations.

    Biegie Lee was promoted to Senior Vice President and Chief Information Officer. Since joining the Company in 2017, he has led the Information Technology (IT) function's modernization, encompassing technology operations and network operations, enterprise applications and project management. He is also leading the transformation of Novavax' state-of-the-art cybersecurity programs.

    "I congratulate John on his expanded responsibilities, and Filip and Biegie on their promotions, as Novavax grows quickly into a global vaccine leader," continued Mr. Erck. "Their continued leadership will help the Company successfully navigate this crucial time."

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August: a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

    About NanoFlu

    NanoFlu™ is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix-M™ adjuvant.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:        
    
    Investors
    Erika Trahan
     
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • Advanced clinical development of NVXCoV2373 with initiation of first Phase 3 trial to evaluate efficacy, safety and immunogenicity
    • U.K. Phase 3 interim data expected as soon as early first quarter 2021
    • Secured additional large-scale manufacturing for NVX-CoV2373 with expected global capacity over two billion doses by mid-2021
    • Formed leadership team to advance NanoFlu through global licensure
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the third quarter ended September 30, 2020.

    • Advanced clinical development of NVXCoV2373 with initiation of first Phase 3 trial to evaluate efficacy, safety and immunogenicity
    • U.K. Phase 3 interim data expected as soon as early first quarter 2021
    • Secured additional large-scale manufacturing for NVX-CoV2373 with expected global capacity over two billion doses by mid-2021
    • Formed leadership team to advance NanoFlu through global licensure
    • Company to host conference call today at 4:30 p.m. ET

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced its financial results and operational highlights for the third quarter ended September 30, 2020.

    "Novavax continued to deliver remarkable progress this quarter, with our most notable achievement being the initiation of a 15,000-person pivotal Phase 3 trial in the U.K. of NVX-CoV2373, our COVID-19 vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "With multiple clinical trials ongoing worldwide, we expect initial efficacy data potentially by early first quarter 2021. In the U.S., we made significant progress in large-scale manufacturing and expect to launch a pivotal Phase 3 trial by the end of November. We also announced a newly formed team to lead the NanoFlu program to licensure in the U.S. and look forward to providing updates as the team finalizes its strategy."

    Third Quarter 2020 and Recent Highlights

    COVID-19 Program

    • Secured funding for late-stage clinical development of NVX‑CoV2373
      • U.S. Government funding through Operation Warp Speed (OWS) up to $1.6 billion
      • Coalition for Epidemic Preparedness Innovations (CEPI) funding increased up to a total of $399 million
      • Cumulative $2 billion funding to date through OWS, CEPI and Department of Defense (DoD)



    • Advanced ongoing clinical trials for NVX‑CoV2373
      • Phase 3 clinical trial in the United Kingdom (U.K.) initiated
        • Trial expanded to 15,000 participants with full enrollment expected by the end of November
        • Enrollment approximately 9,000 participants, over 60% as of today
        • Event-driven interim data expected as soon as early first quarter 2021
      • Pivotal Phase 3 clinical trial in the U.S. expected to begin by end of November
        • U.S. Food and Drug Administration granted Fast Track designation
        • Conducted with support from the U.S. Government through OWS
        • Enrollment of up to 30,000 participants in the U.S. and Mexico, with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities
      • Phase 2b clinical trial in South Africa initiated
        • Includes two cohorts, one in healthy adults and one in medically stable, HIV-positive adults, to allow for evaluation across a diverse, representative study population
        • Trial expanded to approximately 4,404 participants
        • Enrollment over 50% as of today
        • Supported in part by a $15 million grant from Bill & Melinda Gates Foundation
      • Phase 2 portion of Phase 1/2 clinical trial in the U.S. and Australia initiated
        • Enrollment completed with 1,288 healthy volunteers
        • Presented favorable preliminary reactogenicity data during the CDC Advisory Committee on Immunization Practices meeting

           
    • Published Phase 1 data in The New England Journal of Medicine from the Phase 1/2 clinical trial of NVX‑CoV2373 in healthy adults 18-59 years of age in September 2020

       
    • Completed collaborations for global development, manufacture, supply and commercialization of NVX‑CoV2373 with:
      • Australian Federal Government to be supplied 40 million doses
        • Novavax to supply doses beginning as early as the first half of 2021
      • Government of Canada to be supplied up to 76 million doses
      • U.K. Government for the purchase of 60 million doses and support for the Phase 3 clinical trial to assess the efficacy in the U.K. population
        • Novavax to supply doses beginning as early as the first quarter of 2021
      • SK bioscience for development and supply in global markets including the COVAX Facility
        • Signed letter of intent with Republic of Korea's Ministry of Health and Welfare
        • SK bioscience to manufacture the vaccine antigen component for use in the final drug product
      • AGC Biologics for manufacture of Matrix-M™ adjuvant in Copenhagen, Denmark and Seattle, Washington in the U.S.
      • Takeda Pharmaceutical Company Limited for development, manufacture and commercialization in Japan
        • Novavax to receive payments based on achievement of certain development and commercial milestones
        • Novavax shares in proceeds from vaccine sales
      • Serum Institute of India (SII) for development and commercialization in India and low- and middle-income countries
        • Novavax and SII will split revenue from sale of product, net of agreed costs
        • SII to manufacture the antigen component
      • FUJIFILM Diosynth Biotechnologies (FDB) to manufacture bulk drug substance in North Carolina, Texas and in the U.K.
    • Increased manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online anticipated by mid-2021

    NanoFlu™ Program

    • Formed a leadership team to advance NanoFlu to regulatory licensure and accelerate all activities required to file a biologics licensing application (BLA), including exploration of a combined NanoFlu/NVX-CoV2373 vaccine that could be used in a post-pandemic setting.
      • Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President and NanoFlu General Manager
    • Published Phase 2 data in Clinical Infectious Diseases

    Corporate

    • Strengthened corporate leadership with additional executive management promotions and hiring
      • Gregory F. Covino as Chief Financial Officer
      • John J. Trizzino as Chief Commercial Officer and Chief Business Officer
      • Filip Dubovsky, M.D. to Executive Vice President, Chief Medical Officer
      • Biegie Lee to Senior Vice President, Chief Information Officer

        Click here to read today's leadership announcement
    • Appointed Gregg Alton, J.D. to Novavax' Board of Directors
      • Provides extensive industry experience, including more than 20 years at Gilead Pharmaceuticals in an array of leadership roles across a portfolio of responsibilities
    • Expanded facilities to support global vaccine development
      • 170,000 square feet in Gaithersburg, Maryland for manufacturing, research and development, and general operational purposes
      • 9.7-acre parcel of land in Gaithersburg, Maryland to develop in the future to accommodate growth

    Financial Results for the Three and Nine Months Ended September 30, 2020

    Novavax reported a net loss of $197.3 million, or $3.21 per share, for the third quarter of 2020, compared to a net loss of $18.0 million, or $0.74 per share, for the third quarter of 2019. For the nine months ended September 30, 2020, the net loss was $240.7 million, or $4.39 per share, compared to a net loss of $100.9 million, or $4.43 per share, for the same period in 2019.

    Novavax revenue in the third quarter of 2020 was $157.0 million, compared to $2.5 million in the same period in 2019. This significant increase was due to increased development activities relating to NVX-CoV2373 under the CEPI agreement, participation in OWS and the DOD contract.

    Research and development expenses increased to $294.1 million in the third quarter of 2020, compared to $18.6 million in the same period in 2019. The increase was primarily due to increased development activities relating to NVX-CoV2373, including an expense of $187.2 million associated with its manufacturing supply agreements for NVX-CoV2373. Of the $187.2 million expense, approximately $122 million was non-cash in the period, and is based on Novavax' determination that certain supply agreements contain an embedded lease under U.S. accounting principles. Given that determination, Novavax recognized a financing lease liability and a right-of-use (ROU) asset. As Novavax is in the research and development phase of its vaccine development, the ROU asset was expensed in the third quarter, as it did not have an alternative use. Research and development expenses also increased due to increased employee-related costs, primarily stock-based compensation expense.

    General and administrative expenses increased to $56.9 million in the third quarter of 2020, compared to $7.9 million for the same period in 2019. This increase was primarily due to increased employee-related costs, primarily stock-based compensation expenses, and increased professional fees relating to the integration of Novavax CZ and supporting our NVX-CoV2373 program.

    As of September 30, 2020, Novavax had $571.6 million in cash, cash equivalents, marketable securities and restricted cash, compared to $82.2 million as of December 31, 2019. Net cash provided by operating activities for the first nine months of 2020 was $86.0 million, compared to net cash used in operating activities of $112.9 million for same period in 2019.

    Through utilization of At-the-market (ATM) offerings during the third quarter of 2020, Novavax raised net proceeds of $53.3 million and $445.6 million since the beginning of the year. In addition, in the second quarter of 2020, Novavax entered into an agreement to sell Series A Convertible preferred stock, convertible into 4,388,850 shares of common stock, to an investment fund affiliated with RA Capital Management (RA Capital) in a private placement. Novavax received gross proceeds of $200 million.

    Conference Call

    Novavax will host its quarterly conference call today at 4:30 p.m. ET. The dial-in numbers for the conference call are (877) 212-6076 (Domestic) or (707) 287-9331 (International), passcode 8059421. A replay of the conference call will be available starting at 7:30 p.m. ET on November 9, 2020 until 7:30 p.m. ET on November 16, 2020. To access the replay by telephone, dial (855) 859-2056 (Domestic) or (404) 537-3406 (International) and use passcode 8059421.

    A webcast of the conference call can also be accessed via a link on the home page of the Novavax website (novavax.com) or through the "For Investors"/"Events" tab on the Novavax website. A replay of the webcast will be available on the Novavax website until February 9, 2021.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

    About NanoFlu™

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix-M™ adjuvant.

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended September 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.





     NOVAVAX, INC. 
     CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS 
     (in thousands, except per share information) 
     (unaudited) 
                
        Three Months Ended Nine Months Ended 
        September 30, September 30, 
        2020

     2019  2020  2019 
            

       
    Revenue$157,024   $2,507  $195,939   $9,846  
               
    Expenses:        
     Research and development 294,087    18,611   345,828   84,502  
     Gain on Catalent transaction --   (9,016)  --   (9,016) 
     General and administrative 56,879    7,899   83,977    26,236  
      Total expenses 350,966    17,494   429,805    101,722  
    Loss from operations (193,942)  (14,987)  (233,866)  (91,876) 
    Interest income (expense), net (4,320)  (3,061)  (10,394)  (8,973) 
    Other income (expense) 952    5   3,565    (15) 
    Net loss$(197,310) $(18,043) $(240,695) $(100,864) 
               
    Basic and diluted net loss per share$(3.21) $(0.74) $(4.39) $(4.43) 
    Basic and diluted weighted average        
     number of common shares outstanding 61,554    24,327   54,810    22,761  

    SELECTED CONSOLIDATED BALANCE SHEET DATA

    (in thousands)

     September 30,

    2020
     December 31,

    2019
     (unaudited)  
    Cash and cash equivalents$334,171 $78,823 
    Marketable securities 169,860  -- 
    Total restricted cash 67,565  3,357 
    Total current assets 671,217  97,247 
    Working capital 431,999  71,452 
    Total assets 944,020  172,957 
    Notes payable 321,679  320,611 
    Total stockholders' equity (deficit) 106,440  (186,017)

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan

     

    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  21. GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company's COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes its proprietary MatrixM™ adjuvant.

    "The FDA's decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access…

    GAITHERSBURG, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NVX-CoV2373, the Company's COVID-19 vaccine candidate. Currently in late-phase clinical development, NVXCoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes its proprietary MatrixM™ adjuvant.

    "The FDA's decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "While the regulatory review of this clinical program will be expedited, Novavax remains committed to a data-driven and scientifically rigorous approach in demonstrating safety and efficacy, which we believe will support confidence in the vaccine in the U.S. and globally."

    Novavax expects to begin its pivotal Phase 3 clinical trial in the United States and Mexico by the end of November. Data from the event-driven trial could support global authorization and approval, including in the U.S. The Company's ongoing Phase 3 clinical trial in the UK to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 is expected to be fully enrolled by the end of November. Depending on the overall COVID-19 attack rate, interim data in the UK trial, which is also event-driven, are expected as soon as early first quarter 2021.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $399 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and almost $1.7 billion from the U.S. government.

    About Fast Track Designation

    Fast Track Designation by the U.S. FDA is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need, with the intent of getting important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions. Specifically, Fast Track Designation facilitates meetings with FDA to discuss all aspects of development to support licensure and provides the opportunity to submit sections of a BLA on a rolling basis as data become available.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:
    Investors
    Erika Trahan 
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan 
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  22. GAITHERSBURG, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the signing of a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the Company's COVID-19 vaccine candidate, NVX-CoV2373, for the Australian community.

    "This arrangement with the Australian Government reflects the importance of the ongoing clinical development of NVX-CoV2373, and will ensure that the citizens of Australia will have access to its supply," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are pleased with the progress of our ongoing Phase 3 clinical trial…

    GAITHERSBURG, Md., Nov. 04, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the signing of a non-binding Heads of Terms document with the Australian Government to supply 40 million doses of the Company's COVID-19 vaccine candidate, NVX-CoV2373, for the Australian community.

    "This arrangement with the Australian Government reflects the importance of the ongoing clinical development of NVX-CoV2373, and will ensure that the citizens of Australia will have access to its supply," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are pleased with the progress of our ongoing Phase 3 clinical trial in the UK, and are pressing forward to deliver efficacy data for NVX-CoV2373, with interim data in this event-driven trial expected as soon as early first quarter 2021."

    The Heads of Terms provides for the delivery of NVX-CoV2373 to Australia starting as early as the first half of 2021, subject to the successful completion of Phase 3 clinical development and approval of the vaccine by Australia's Therapeutic Goods Administration (TGA). The vaccine regimen is expected to require two doses per individual, administered 21 days apart.

    To date, Novavax has established various agreements for the supply of NVX-CoV2373 directly to the United States and the United Kingdom, Canada and now Australia, and through partnerships, supply to Japan, South Korea and India.

    Australia's clinical trial contribution

    Australia has played a pivotal role in the clinical development program for NVX-CoV2373. Australian clinical researchers led the global Phase 1 clinical trial in August. This trial involved 131 Australians across two trial sites (Melbourne and Brisbane). In addition, approximately 690 Australians have participated in the Phase 2 arm of the clinical trial, which has been conducted across up to 40 sites in Australia and the U.S.

    The planned global Phase 3 clinical programs evaluating NVX-CoV2373 will assess immunity, safety and COVID-19 disease prevention. The trials seek to recruit members of the community most vulnerable to COVID-19 – the elderly, those with underlying medical conditions as well as diverse racial and ethnic representation.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Manufacturing

    Novavax is progressing large-scale manufacturing of NVX-CoV2373 across multiple locations around the world. Delivery of initial doses of the vaccine is expected as early as the end of this year, with the goal to expand the production to enable delivery of over 2 billion doses annually, once all production is online.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age.  NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Additional Contacts:

    Novavax Investors:

    Erika Trahan



    + 1 240-268-2022

    International Media:

    Edna Kaplan

    (for Novavax outside Australia)

    +1 617-974-8659

    In Australia:

    Anne-Marie Sparrow



    +61 417 421 560



    +61 424 785 063

     

    Primary Logo

    View Full Article Hide Full Article
  23. GAITHERSBURG, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Gregg Alton, J.D. to its Board as an independent Director. Mr. Alton brings extensive industry experience to his role on the Novavax Board of Directors, including more than 20 years at Gilead Sciences, where he served in an array of leadership roles across a portfolio of responsibilities.

    Mr. Alton served as Gilead's interim Chief Executive Officer from January 2019 until March 2019, before and after which he was Chief Patient Officer. During his tenure at Gilead, his wide-ranging roles included leadership of commercial operations…

    GAITHERSBURG, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Gregg Alton, J.D. to its Board as an independent Director. Mr. Alton brings extensive industry experience to his role on the Novavax Board of Directors, including more than 20 years at Gilead Sciences, where he served in an array of leadership roles across a portfolio of responsibilities.

    Mr. Alton served as Gilead's interim Chief Executive Officer from January 2019 until March 2019, before and after which he was Chief Patient Officer. During his tenure at Gilead, his wide-ranging roles included leadership of commercial operations in Europe, Asia, Latin America and Africa, as well as government affairs, public affairs and global medical affairs. He also served as General Counsel and Chief Compliance Officer.

    "We welcome Gregg's broad global experience at a pivotal time for Novavax, as we prepare to launch a Phase 3 trial in the U.S. for our COVID-19 vaccine candidate, and to progress NanoFlu toward FDA registration," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Gregg's broad perspective across multiple areas of the business and deep insight in infectious disease will be invaluable as we build our commercial organization and advance in our mission to promote improved health globally."

    Prior to joining Gilead, Mr. Alton was an attorney at the law firm of Cooley Godward, LLP, where he specialized in corporate finance transactions for healthcare and information technology companies. He currently serves on the Boards of Directors of Corcept Therapeutics, Enochian Biosciences, and was previously on the Boards of Pharmozyme Inc., Celladon Corp. and Oculus Innovative Sciences.

    In addition to his corporate experience, Mr. Alton has served as a trusted advisor to several health-related advisory boards, including the President's Advisory Council on HIV/AIDS at the U.S. Department of Health and Human Services. He also participates as a board member for a number of non-profit organizations, including Black Women's Health Imperative, AIDSVu and the Boys and Girls Clubs of Oakland.

    Mr. Alton received a bachelor's degree in legal studies from the University of California at Berkeley and a law degree from Stanford University.

    "I am delighted to join Novavax' Board of Directors and look forward to working with my fellow Board members and Novavax' management team, who share my passion for helping protect millions of people across the globe from serious infectious diseases," said Mr. Alton.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.  Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age.  NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:
    Investors
    Erika Trahan 
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan 
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  24. GAITHERSBURG, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its third quarter 2020 financial and operating results following the close of U.S. financial markets on Monday, November 9, 2020.

    Conference call details are as follows:

    Date:November 9, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 212-6076 (Domestic) or (707) 287-9331 (International)
    Passcode:8059421
    Webcast:www.novavax.com, "For Investors"/ "Events"

    Conference call and webcast replay:

    Dates: Starting at 7:30 p.m. ET, November 9, 2020 until 
     7:30 p.m. ET November 16, 2020
    Dial-in number:(855) 859-2056 (Domestic)

    GAITHERSBURG, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its third quarter 2020 financial and operating results following the close of U.S. financial markets on Monday, November 9, 2020.

    Conference call details are as follows:

    Date:November 9, 2020
    Time:4:30 p.m. U.S. Eastern Time (ET)
    Dial-in number:(877) 212-6076 (Domestic) or (707) 287-9331 (International)
    Passcode:8059421
    Webcast:www.novavax.com, "For Investors"/ "Events"

    Conference call and webcast replay:

    Dates: Starting at 7:30 p.m. ET, November 9, 2020 until 
     7:30 p.m. ET November 16, 2020
    Dial-in number:(855) 859-2056 (Domestic) or (404) 537-3406 (International)
    Passcode:8059421
    Webcast:www.novavax.com, "For Investors"/ "Events", until February 9, 2021

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is currently conducting multiple clinical trials for NVX-CoV2373, its vaccine candidate against the virus that causes COVID-19, including a pivotal Phase 3 clinical trial in the United Kingdom to evaluate the efficacy, safety and immunogenicity in individuals aged 18-84 years of age. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both candidate vaccines incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • Expands campus with two properties to support vaccine research and development, manufacturing, business operations

    GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company's rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. Novavax has secured two additional properties in Gaithersburg, Maryland to support the Company's immediate need for additional laboratory and office space for manufacturing, R&D and business operations.

    The Company currently has a large…

    • Expands campus with two properties to support vaccine research and development, manufacturing, business operations

    GAITHERSBURG, Md., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the expansion of its Maryland campus to accommodate the company's rapid growth as it works to develop its candidate vaccine against COVID-19 and advance its influenza vaccine for global markets. Novavax has secured two additional properties in Gaithersburg, Maryland to support the Company's immediate need for additional laboratory and office space for manufacturing, R&D and business operations.

    The Company currently has a large pivotal Phase 3 trial underway in the UK with another slated to begin in the United States and Mexico in November, as well as several Phase 2 trials ongoing and in the planning phases around the globe. Novavax has also created a global production network to enable manufacturing and rapid distribution across the U.S., Asia and Europe if and when its COVID-19 vaccine is approved for use. The Company also reported positive Phase 3 data for its influenza vaccine candidate, NanoFlu, earlier this year. Novavax has received $2 billion in funding for its COVID-19 vaccine efforts, including up to $1.6 billion from the U.S. government to help address the global pandemic and up to $388 million from the Coalition for Epidemic Preparedness Innovations (CEPI).

    "The expansion of our physical footprint reflects Novavax' significant growth as we work to both rapidly deliver a COVID-19 vaccine and progress NanoFlu, our influenza vaccine candidate, for regulatory submission and potential commercialization," said Stanley C. Erck, President and CEO, Novavax. "We appreciate the support, partnership and speed of the Maryland Department of Commerce, Montgomery County, and the City of Gaithersburg, which have enabled the expansion of our operations, enhanced our ability to retain and attract highly skilled employees, and reinforced our longstanding commitment to the biotechnology sector in Maryland."

    Real Estate Transactions

    Novavax entered into a 15-year lease for approximately 122,000 square feet located at 700 Quince Orchard Road, Gaithersburg, to be used for manufacturing, research and development, and offices. The Company will immediately invest in the buildout of the site to prepare for use beginning in early 2021

    In addition, the Company's affiliate, 14 Firstfield Holdings, LLC, purchased a 9.7-acre parcel of land at 14 Firstfield Road, Gaithersburg, that the Company plans to develop in the future to accommodate growth of the Company.

    Novavax currently occupies approximately 79,000 square feet of office and laboratory space in Gaithersburg.

    Government Support and Incentives

    The Maryland Department of Commerce, Montgomery County, and the City of Gaithersburg are providing a combination of incentives, including conditional loans, grants and tax credits to enable the expansion. Additional terms were not disclosed.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About NanoFlu™

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based MatrixM adjuvant.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:
    Investors
    Erika Trahan
    
    240-268-2022
    
    Media
    Brandzone/KOGS Communication
    Edna Kaplan
    
    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • 5,500 volunteers enrolled to date in pivotal Phase 3 clinical trial in the U.K.
      • Study expanded to 15,000 participants
      • Full enrollment expected by end of November
      • Event-driven interim data expected as soon as early first quarter 2021
    • U.S. pivotal Phase 3 clinical trial planned to begin by end of November
      • Significant progress in large-scale manufacturing achieved with some delay from original timeline
    • Company to present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, during public CDC Advisory Committee on Immunization Practices (ACIP) meeting on October 30

    GAITHERSBURG, Md., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines…

    • 5,500 volunteers enrolled to date in pivotal Phase 3 clinical trial in the U.K.
      • Study expanded to 15,000 participants
      • Full enrollment expected by end of November
      • Event-driven interim data expected as soon as early first quarter 2021
    • U.S. pivotal Phase 3 clinical trial planned to begin by end of November
      • Significant progress in large-scale manufacturing achieved with some delay from original timeline
    • Company to present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, during public CDC Advisory Committee on Immunization Practices (ACIP) meeting on October 30

    GAITHERSBURG, Md., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, announced updates on its Phase 3 clinical development program of NVX-CoV2373, its COVID-19 vaccine candidate. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant. The Company also announced that it will present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, on Friday, October 30 during the United States (U.S.) Center for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices' (ACIP) meeting.

    U.K. Phase 3 Clinical Trial Update

    Novavax has enrolled over 5,500 participants to date in the United Kingdom (U.K.) trial, which it has expanded to 15,000 volunteers. The increased enrollment is likely to facilitate assessment of safety and efficacy in a shorter time period. Novavax expects this trial to be fully enrolled by the end of November, and dependent on the overall COVID-19 attack rate, interim data in this event-driven trial are expected as soon as early first quarter 2021. These data are expected to serve as the basis for global licensure.

    "We are pleased with the significant progress made in our Phase 3 clinical trial since it began in the United Kingdom at the end of September," said Gregory M. Glenn, M.D., President of Research and Development at Novavax. "We are grateful for the support of the U.K. Government's Vaccines Taskforce (VTF) and the National Institute for Health Research (NIHR) for our pivotal trial. Recognizing the recent, large increase in the number of COVID-19 cases in the U.K., as well as the rapid progress in participant enrollment for our trial, in consultation with the VTF and NIHR, we adjusted our plans and increased enrollment."

    In alignment with Novavax' commitment to transparency, the Company has posted the protocol for this trial on its website at https://www.novavax.com/resources#protocols.

    U.S. Phase 3 Clinical Trial Update

    Novavax currently expects the pivotal clinical trial to begin in the United States and Mexico by the end of November. The Company has made significant progress in large-scale manufacturing, with delays experienced versus original timing estimates.

    Novavax has been developing large-scale manufacturing processes at multiple sites around the world and plans to use production from its contract manufacturing site at FUJIFILM Diosynth Biotechnologies' Morrisville, North Carolina site in this Phase 3 clinical trial.

    Additional Phase 3 Clinical Trial Information

    United Kingdom

    Novavax' first pivotal Phase 3 clinical trial, begun in September in partnership with the U.K. Government's Vaccines Taskforce, will be expanded from 10,000 to 15,000 volunteers, some of whom have been recruited through the National Health Service (NHS) Vaccine Registry. The trial protocol calls for unblinding of data once 152 participants have achieved mild, moderate or severe endpoints. Two interim analyses are planned once 66 and 110 endpoints have occurred.

    United States/Mexico

    Novavax' pivotal Phase 3 clinical trial is being conducted with support from the U.S. Government through Operation Warp Speed. The trial design is harmonized with those of other leading companies, and calls for the enrollment of up to 30,000 participants in the U.S. and Mexico, with proportional representation among diverse populations most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities. The trial protocol will be posted on Novavax' website upon initiation.

    ACIP Presentation Friday, October 30

    Novavax' Senior Vice President and Chief Medical Officer, Filip Dubovsky, M.D., will present an update during a public meeting of the CDC's ACIP between 10:00 am and 12:30 am ET on Friday, October 30. For more information, please visit www.cdc.gov/vaccines/acip/meetings/index.html.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the U.K. and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:         

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  25. GAITHERSBURG, Md., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D, President of Research & Development, will present on NVX-CoV2373, the Company's COVID-19 vaccine, at the 2020 World Vaccine Congress Europe. The Congress takes place virtually October 19 - 21, 2020.

    Presentation Title:Recombinant nanoparticle COVID-19 vaccine: Platform technology for Emerging Infectious Diseases (EID)
    Time:14:10 CET/8:10 am ET

    For more information on the Congress or to register, please click here.

    About NVX-CoV2373
    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2…

    GAITHERSBURG, Md., Oct. 20, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that Gregory M. Glenn, M.D, President of Research & Development, will present on NVX-CoV2373, the Company's COVID-19 vaccine, at the 2020 World Vaccine Congress Europe. The Congress takes place virtually October 19 - 21, 2020.

    Presentation Title:Recombinant nanoparticle COVID-19 vaccine: Platform technology for Emerging Infectious Diseases (EID)
    Time:14:10 CET/8:10 am ET

    For more information on the Congress or to register, please click here.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • Team will focus on global NanoFlu licensure and evaluation of post-pandemic influenza/COVID-19 combination vaccine with NVX-CoV2373
    • Russell (Rip) Wilson promoted to Executive Vice President and NanoFlu General Manager

    GAITHERSBURG, Md., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX) Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the formation of a leadership team to advance NanoFlu to regulatory licensure and the promotion of Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President and the newly-created role of NanoFlu™ General Manager. Mr. Wilson will focus exclusively on leading efforts to advance NanoFlu, the company's…

    • Team will focus on global NanoFlu licensure and evaluation of post-pandemic influenza/COVID-19 combination vaccine with NVX-CoV2373
    • Russell (Rip) Wilson promoted to Executive Vice President and NanoFlu General Manager

    GAITHERSBURG, Md., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX) Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the formation of a leadership team to advance NanoFlu to regulatory licensure and the promotion of Russell (Rip) Wilson, J.D./M.B.A., to Executive Vice President and the newly-created role of NanoFlu™ General Manager. Mr. Wilson will focus exclusively on leading efforts to advance NanoFlu, the company's influenza vaccine candidate, through global licensure, as well as the exploration of a combined influenza/COVID-19 vaccine that could be used in a post-pandemic setting. Novavax announced results of its successful NanoFlu pivotal Phase 3 clinical trial earlier this year and intends to seek regulatory approval from the U.S. Food and Drug Administration (FDA) under the accelerated approval pathway previously granted to the company.

    "The formation of this dedicated team enables Novavax to accelerate all activities required to file a biologics licensing application (BLA) for NanoFlu in parallel with the extensive development and manufacturing work underway for NVX-CoV2373, our COVID-19 vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer. "I have full confidence in Rip and our team, which has brought NanoFlu from inception through successful Phase 3 testing. I am excited about the potential to develop a combined influenza/COVID-19 vaccine for use after the pandemic."

    Mr. Wilson joined Novavax in 2011 and was most recently responsible for global business development, quality and program management functions across the company's entire pipeline. In his new role, he will lead a team that will work closely with the broader Novavax team to obtain licensure for NanoFlu from FDA and other global authorities, as well as evaluate the development of a pentavalent NanoFlu/NVX-CoV2373 vaccine.

    "Currently available flu vaccines provide inconsistent, inadequate protection against seasonal influenza," said Mr. Wilson. "NanoFlu has already completed its pivotal Phase 3 clinical trial, in which it achieved all of its primary endpoints, so I am excited about the potential to provide this important vaccine option to the patients who need it most, the difficult-to-protect older adult population. I am committed to leading our team to licensure with a strong sense of urgency."

    The new NanoFlu leadership team includes several Novavax veterans who led the successful development of the vaccine through completion of its successful pivotal Phase 3 clinical trial. This team has also recently completed key activities related to the development of NVX-CoV2373. In addition to Mr. Wilson, the team will be comprised of the following leaders:

    • Tim Hahn, Ph.D., Senior Vice President of CMC for NanoFlu, has led all CMC activities for NanoFlu since the beginning of the program. Most recently, Dr. Hahn led the establishment of a global supply chain for Novavax' Matrix-M adjuvant. Matrix-M is a key component of both the NanoFlu and NVX-CoV2373 vaccines.



    • Vivek Shinde, M.D., Vice President of Clinical Development for NanoFlu, has served as the clinical lead for the NanoFlu program since its inception and through Phase 3. Dr. Shinde also recently led the initiation of the Phase 2b clinical trial in South Africa for NVX-CoV2373.

    The new team will establish a separate NanoFlu development unit within Novavax, building on the company's established knowledge base in the discovery and development of innovative vaccines to prevent serious infectious diseases. The team will also benefit from joint shared services with key cross-functional departments within Novavax.

    About NanoFlu

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based Matrix-M™ adjuvant.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated induction of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undertaking clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Investors

    Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  26. GAITHERSBURG, Md., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Novavax Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in four upcoming investor and industry conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, is expected to be discussed in each conference.

    Maryland Life Sciences Bio Innovation Conference
    Date:Monday, October 5, 2020
    Time:10:25 -11:25 a.m. ET
    Panel title:Discussion on Pandemic & Risk Mitigation: A Focus on Preparation & Resiliency
    Three Maryland biotech leaders discuss how to prepare for the unforeseen and what is needed to pivot for the future.
    Panelist:John Trizzino, Executive Vice President, Chief Business Officer

    GAITHERSBURG, Md., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Novavax Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will participate in four upcoming investor and industry conferences. Novavax' COVID-19 vaccine candidate, NVX-CoV2373, is expected to be discussed in each conference.

    Maryland Life Sciences Bio Innovation Conference
    Date:Monday, October 5, 2020
    Time:10:25 -11:25 a.m. ET
    Panel title:Discussion on Pandemic & Risk Mitigation: A Focus on Preparation & Resiliency

    Three Maryland biotech leaders discuss how to prepare for the unforeseen and what is needed to pivot for the future.
    Panelist:John Trizzino, Executive Vice President, Chief Business Officer and Chief Financial Officer
    To attend:Click here to register.
     
    Guggenheim First Annual Vaccines and Infectious Diseases Conference
    Date:Monday, October 5, 2020
    Time:4:15 - 4:45 p.m. ET
    Participation:Fireside chat and investor meetings
    Novavax participants:Gregory M. Glenn, M.D., President of Research and Development, and John J. Trizzino, Executive Vice President, Chief Business Officer and Chief Financial Officer
    Webcast:A replay of the session will be available within 48 hours through the events page of the Company's website at ir.novavax.com for 90 days following the event.

     
    Goldman Sachs Virtual Event: Inoculating the Recovery --A Discussion on COVID-19 Vaccines, Treatments, Testing of the Economy
    Date:Thursday, October 8, 2020
    Time:12:00 - 12:55 p.m. ET
    Panel title:Vaccines – Approaching the Light at the End of the Tunnel
    Panelist:Gregory M. Glenn, M.D. President of Research and Development

    This event is open to Goldman Sachs clients.

     
    BioHealth Capital Region Forum
    Date:Monday, October 19, 2020
    Time:12:45 - 1:30 p.m. ET
    Panel title:Strengths of our Region: Combatting Infectious Disease
    Panelist:Vivek, Shinde, M.D., Vice President of Clinical Development
    To attend:Click here to register.
      

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies that began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs. For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  27. GAITHERSBURG, Md., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will present on its lead vaccine candidates, NVX-CoV2373, NanoFlu™ and ResVax™, the Company's COVID-19, influenza and respiratory syncytial virus (RSV) vaccines. The presentations are part of the 2020 World Vaccine Congress Washington, taking place virtually September 28-October1, 2020.

    Gregory Glenn, M.D, President of Research & Development, and Vivek Shinde, M.D., Vice President, Clinical Development, will join global public health, epidemiology, regulatory and industry leaders to share expertise and the latest research related…

    GAITHERSBURG, Md., Sept. 28, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it will present on its lead vaccine candidates, NVX-CoV2373, NanoFlu™ and ResVax™, the Company's COVID-19, influenza and respiratory syncytial virus (RSV) vaccines. The presentations are part of the 2020 World Vaccine Congress Washington, taking place virtually September 28-October1, 2020.

    Gregory Glenn, M.D, President of Research & Development, and Vivek Shinde, M.D., Vice President, Clinical Development, will join global public health, epidemiology, regulatory and industry leaders to share expertise and the latest research related to the SARS-CoV-2 virus and vaccine development to address global health.



    September 28 
    Presentation Title:Recombinant nanoparticle COVID-19 vaccine: Platform technology for EID (Emerging Infectious Diseases)
    Time:2:35 p.m. ET
    Presenter:Dr. Gregory Glenn
      
    October 1 
    Presentation Title:Phase 3 and beyond: Maternal RSV & older adult influenza vaccine program
    Time:8:30 am ET
    Presenter:Dr. Gregory Glenn

      
    Presentation Title:New Phase 3 NanoFlu data (features new Cell-mediated Immunity data)
    Time:4:50 pm ET
    Presenter:Dr. Vivek Shinde
      

    For more information on the congress or to register, please click here.

    About NVX-CoV2373

    NVX-CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in a Phase 3 trial in the UK and two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About ResVax

    ResVax is an RSV fusion (F) protein recombinant nanoparticle vaccine with aluminum phosphate as an adjuvant. It is being developed to protect infants from RSV disease via maternal immunization, which may offer the best method of protection from RSV disease in infants through the first months of life. ResVax is being evaluated in Prepare™, a global Phase 3 clinical trial in 4,636 pregnant women, at least 3,000 of whom received the vaccine, and their infants. Prepare is supported by an $89.1 million grant from the Bill & Melinda Gates Foundation (BMGF).

    About NanoFlu

    NanoFlu is a recombinant hemagglutinin (HA) protein nanoparticle influenza vaccine produced by Novavax in its SF9 insect cell baculovirus system. NanoFlu uses HA amino acid protein sequences that are the same as the recommended wild-type circulating virus HA sequences. NanoFlu contains Novavax' patented saponin-based MatrixM adjuvant.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:         

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  28. DUBLIN, Sept. 25, 2020 /PRNewswire/ -- Endo International plc (NASDAQ:ENDP) today announced that its subsidiary, Par Sterile Products, LLC (Par Sterile) has entered into a non-exclusive agreement with Novavax, Inc. to provide fill-finish manufacturing services at its plant in Rochester, Michigan for NVX-CoV2373, Novavax' COVID-19 vaccine candidate.

    Under the terms of the agreement, Par Sterile's Rochester facility has begun production of NVX-CoV2373 final drug product, with initial batches to be used in Novavax' pivotal Phase 3 clinical trial in the United States. Par Sterile will also fill-finish NVX-CoV2373 vaccine intended for commercial distribution in the United States.  Financial and other terms of the agreement were not disclosed.

    "This agreement puts an important piece in place as we finalize our supply chain for the U.S. clinical trial and eventually, commercial distribution of NVX-CoV2373, our nanoparticle vaccine adjuvanted with Matrix-M™," said Stanley C. Erck, President and CEO, Novavax. "Endo's partnership and expertise are enabling rapid delivery of the vaccine for pivotal clinical testing, which we expect to get underway very soon."

    "We are very pleased to help bring Novavax' COVID-19 vaccine to the public," said Blaise Coleman, President and CEO of Endo. "Our Rochester, Michigan facility has a long history of manufacturing critical vaccines and sterile injectable products for the U.S. market and we are proud to partner with Novavax on such a critical initiative. This partnership further underscores Endo's commitment to helping everyone we serve live their best life through the delivery of life-enhancing therapies."

    NVX-CoV2373 is currently in multiple Phase 2 clinical trials. A Phase 2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August 2020 in the United States and Australia building on positive Phase 1 results and expanding to include older adults. A Phase 2b clinical trial to assess efficacy began in South Africa in August 2020. Interim data for these trials is expected before the end of 2020.

    About NVX-CoV2373

    NVX–CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS–CoV–2, the virus that causes COVID-19 disease. NVX–CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX–CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX–CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Endo International plc

    Endo International plc (NASDAQ:ENDP) is a specialty pharmaceutical company committed to helping everyone we serve live their best life through the delivery of quality, life-enhancing therapies. Our decades of proven success come from a global team of passionate employees collaborating to bring the best treatments forward. Together, we boldly transform insights into treatments benefiting those who need them, when they need them. Endo has global headquarters in Dublin, Ireland and U.S. headquarters in Malvern, Pennsylvania. Learn more at www.endo.com.

    Forward Looking Statement

    This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Canadian securities legislation, including the statements by Messrs. Erck and Coleman and other statements regarding product potential, clinical trial outcomes, quality, availability and affordability. Statements including words such as "believes," "expects," "anticipates," "intends," "estimates," "plan," "will," "may," "look forward," "intend," "guidance," "future" or similar expressions are forward-looking statements. Because these statements reflect Endo's and Novavax's current views, expectations and beliefs concerning future events, they involve risks and uncertainties. Although Endo and Novavax believe that these forward-looking statements and information are based upon reasonable assumptions and expectations, readers should not place undue reliance on them, or any other forward-looking statements or information in this news release. Investors should note that many factors, as more fully described in the documents filed by Endo and Novavax with the Securities and Exchange Commission and, in Endo's case, with securities regulators in Canada on the System for Electronic Document Analysis and Retrieval, including under the caption "Risk Factors" in Endo's and Novavax's Form 10-K, Form 10-Q and Form 8-K filings, and as otherwise enumerated herein or therein, could affect Endo's and Novavax's future results and could cause Endo's and Novavax's actual results to differ materially from those expressed in forward-looking statements contained in this communication. The forward-looking statements in this press release are qualified by these risk factors. Endo and Novavax assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required under applicable securities laws.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/endo-announces-fill-finish-manufacturing-and-services-agreement-for-novavax-covid-19-vaccine-candidate-301138018.html

    SOURCE Endo International plc

    View Full Article Hide Full Article
  29. GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Today, Maryland Governor Larry Hogan and Dr. Michelle McMurry-Heath, President & CEO of Biotechnology Innovation Organization (BIO), joined Novavax President & CEO Stanley Erck to discuss the importance of the biotechnology sector in Maryland, the industry's efforts to address COVID-19, and progress being made by Novavax to develop a vaccine for the deadly virus. A video of the remarks is now available.

    A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d8746b2f-e840-4d4c-a066-c88332388b2a

    "When the COVID-19 crisis began, even before we had our first confirmed cases, I said that our state was home to some of the top health…

    GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Today, Maryland Governor Larry Hogan and Dr. Michelle McMurry-Heath, President & CEO of Biotechnology Innovation Organization (BIO), joined Novavax President & CEO Stanley Erck to discuss the importance of the biotechnology sector in Maryland, the industry's efforts to address COVID-19, and progress being made by Novavax to develop a vaccine for the deadly virus. A video of the remarks is now available.

    A video accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d8746b2f-e840-4d4c-a066-c88332388b2a

    "When the COVID-19 crisis began, even before we had our first confirmed cases, I said that our state was home to some of the top health research facilities in the world, and I hoped that we might be a part of developing treatments and perhaps even a vaccine for this deadly virus," said Governor Hogan. "Novavax took that challenge and immediately hit the ground running. The State of Maryland is proud to support the efforts of Novavax and our entire hub of life sciences companies, which is at the forefront in the fight against COVID-19."

    Dr. Michelle McMurry-Heath spoke about the unprecedented response by the biotechnology industry to fight COVID-19. "Novavax is a shining example of that response, that galvanized intellectual capacity, and the ability to put the power of science to healing the world," she said. "We at the Biotechnology Innovation Organization couldn't be prouder of how our companies, our scientists, our entrepreneurs, have really mobilized to change the world."

    "We are about to enter three different phase 3 trials, including a trial that is starting imminently in the UK in 10,000 people, a trial that is starting in the U.S. in a few weeks that will be 30,000 people and a third phase 3 trial in India. We have a global presence. This is a global disease. I don't think it's sufficient that we have a vaccine that is just used for the United States. To protect the United States, you need to protect the world. It is a global economy. And that's what we're doing," Erck said. "We feel a tremendous responsibility in our role at the forefront of vaccine development and in our mission to deliver a safe and effective vaccine as rapidly as possible to help combat the COVID-19 pandemic. As a science-based organization dedicated to improving health, it has been gratifying to see many like-minded stakeholders in our region come together to that end."

    The remarks were made on-site at Novavax in Gaithersburg, Maryland. Full video of the remarks is available here.

    Media contacts:

    BIO

    Theresa Brady

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    About BIO

    BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

    For more information visit: https://www.bio.org/

    Follow us on Twitter @IAmBiotech

    Find us on LinkedIn

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About NVX-CoV2373

    NVXCoV2373 is a vaccine candidate engineered from the genetic sequence of SARSCoV2, the virus that causes COVID-19 disease. NVXCoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVXCoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Primary Logo

    View Full Article Hide Full Article
  30. Event Highlighted Leadership in Vaccine Development and Regional Growth in Biotechnology Innovation

    Today, Maryland Governor Larry Hogan and Dr. Michelle McMurry-Heath, President & CEO of Biotechnology Innovation Organization (BIO), joined Novavax President & CEO Stanley Erck to discuss the importance of the biotechnology sector in Maryland, the industry's efforts to address COVID-19, and progress being made by Novavax to develop a vaccine for the deadly virus. A video of the remarks is now available.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005894/en/

    Left to right, Novavax CEO, Stanley Erck, MD Gov Larry Hogan, BIO CEO Dr. Michelle McMurry-Heath (Photo: Business Wire)

    Left to right, Novavax CEO, Stanley Erck, MD Gov Larry Hogan, BIO CEO Dr. Michelle McMurry-Heath (Photo: Business Wire…

    Event Highlighted Leadership in Vaccine Development and Regional Growth in Biotechnology Innovation

    Today, Maryland Governor Larry Hogan and Dr. Michelle McMurry-Heath, President & CEO of Biotechnology Innovation Organization (BIO), joined Novavax President & CEO Stanley Erck to discuss the importance of the biotechnology sector in Maryland, the industry's efforts to address COVID-19, and progress being made by Novavax to develop a vaccine for the deadly virus. A video of the remarks is now available.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005894/en/

    Left to right, Novavax CEO, Stanley Erck, MD Gov Larry Hogan, BIO CEO Dr. Michelle McMurry-Heath (Photo: Business Wire)

    Left to right, Novavax CEO, Stanley Erck, MD Gov Larry Hogan, BIO CEO Dr. Michelle McMurry-Heath (Photo: Business Wire)

    "When the COVID-19 crisis began, even before we had our first confirmed cases, I said that our state was home to some of the top health research facilities in the world, and I hoped that we might be a part of developing treatments and perhaps even a vaccine for this deadly virus," said Governor Hogan. "Novavax took that challenge and immediately hit the ground running. The State of Maryland is proud to support the efforts of Novavax and our entire hub of life sciences companies, which is at the forefront in the fight against COVID-19."

    Dr. Michelle McMurry-Heath spoke about the unprecedented response by the biotechnology industry to fight COVID-19. "Novavax is a shining example of that response, that galvanized intellectual capacity, and the ability to put the power of science to healing the world," she said. "We at the Biotechnology Innovation Organization couldn't be prouder of how our companies, our scientists, our entrepreneurs, have really mobilized to change the world."

    "We are about to enter three different phase 3 trials, including a trial that is starting imminently in the UK in 10,000 people, a trial that is starting in the U.S. in a few weeks that will be 30,000 people and a third phase 3 trial in India. We have a global presence. This is a global disease. I don't think it's sufficient that we have a vaccine that is just used for the United States. To protect the United States, you need to protect the world. It is a global economy. And that's what we're doing," Erck said. "We feel a tremendous responsibility in our role at the forefront of vaccine development and in our mission to deliver a safe and effective vaccine as rapidly as possible to help combat the COVID-19 pandemic. As a science-based organization dedicated to improving health, it has been gratifying to see many like-minded stakeholders in our region come together to that end."

    The remarks were made on-site at Novavax in Gaithersburg, Maryland. Full video of the remarks is available here.

    About BIO

    BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. BIO also produces the BIO International Convention, the world's largest gathering of the biotechnology industry, along with industry-leading investor and partnering meetings held around the world.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVX-CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    View Full Article Hide Full Article
  31. GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government's Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.

    "With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic…

    GAITHERSBURG, Md., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has initiated its first Phase 3 study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. The trial is being conducted in the United Kingdom (UK), in partnership with the UK Government's Vaccines Taskforce, and is expected to enroll and immunize up to 10,000 individuals between 18-84 (inclusive) years of age, with and without relevant comorbidities, over the next four to six weeks.

    "With a high level of SARS-CoV-2 transmission observed and expected to continue in the UK, we are optimistic that this pivotal Phase 3 clinical trial will enroll quickly and provide a near-term view of NVX-CoV2373's efficacy," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "The data from this trial is expected to support regulatory submissions for licensure in the UK, EU and other countries. We are grateful for the support of the UK Government, including from its Department of Health and Social Care and National Institute for Health Research, to advance this important research."

    NVX-CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology that includes Novavax' proprietary MatrixM™ adjuvant. The vaccine has a favorable product profile that will allow handling in an unfrozen, liquid formulation that can be stored at 2°C to 8°C, allowing for distribution using standard vaccine channels.

    Novavax has continued to scale-up its manufacturing capacity, currently at up to 2 billion annualized doses, once all capacity has been brought online by mid-2021.

    About the Phase 3 Study

    Consistent with its long-standing commitment to transparency and in order to enhance information-sharing during the worldwide pandemic, Novavax will be publishing its UK study protocol in the coming days.

    The UK Phase 3 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373 with Matrix-M in up to 10,000 subjects aged 18 to 84 years. Half the participants will receive two intramuscular injections of vaccine comprising 5 µg of protein antigen with 50 µg Matrix‑M adjuvant, administered 21 days apart, while half of the trial participants will receive placebo.

    The trial is designed to enroll at least 25 percent of participants over the age of 65 as well as to prioritize groups that are most affected by COVID-19, including racial and ethnic minorities. Additionally, up to 400 participants will also receive a licensed seasonal influenza vaccine as part of a co-administration sub-study.

    The trial has two primary endpoints. The first primary endpoint is first occurrence of PCR-confirmed symptomatic COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The second primary endpoint is first occurrence of PCR-confirmed symptomatic moderate or severe COVID-19 with onset at least 7 days after the second study vaccination in volunteers who have not been previously infected with SARS-CoV-2. The primary efficacy analysis will be an event-driven analysis based on the number of participants with symptomatic or moderate/severe COVID-19 disease. An interim analysis will be performed when 67% of the desired number of these cases has been reached.

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About NVX-CoV2373

    NVXCoV2373 is a vaccine candidate engineered from the genetic sequence of SARSCoV2, the virus that causes COVID-19 disease. NVXCoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigens and cannot replicate, nor can it cause COVID-19. In preclinical trials, NVXCoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its the Phase 1 portion of its Phase 1/2 clinical trial, NVXCoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. NVX-CoV2373 is also being evaluated in two ongoing Phase 2 studies, which began in August; a Phase 2b trial in South Africa, and a Phase 1/2 continuation in the U.S. and Australia. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:         

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • Serum Institute of India to manufacture ~1 billion doses of NVX-CoV2373 in 2021

    • Increases global manufacturing capacity for NVX-CoV2373 to over 2 billion annualized doses when at full capacity in 2021

    • Agreement expands Novavax partnership with world's largest vaccine developer to increase global delivery of NVX-CoV2373

    GAITHERSBURG, Md., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX‑CoV2373, Novavax' COVID‑19 vaccine candidate. With this agreement…

    • Serum Institute of India to manufacture ~1 billion doses of NVX-CoV2373 in 2021



    • Increases global manufacturing capacity for NVX-CoV2373 to over 2 billion annualized doses when at full capacity in 2021



    • Agreement expands Novavax partnership with world's largest vaccine developer to increase global delivery of NVX-CoV2373

    GAITHERSBURG, Md., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced an amendment to its existing agreement with Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX‑CoV2373, Novavax' COVID‑19 vaccine candidate. With this agreement, Novavax increases its manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online by mid-2021. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' recombinant protein nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    "Today's agreement with Serum Institute enhances Novavax' commitment to equitable global delivery of our COVID-19 vaccine. With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We continue to work with extraordinary urgency to develop our vaccine, now in Phase 2 clinical trials, and for which we anticipate starting Phase 3 efficacy trials around the world in the coming weeks."

    The agreement with SIIPL augments a global supply chain that will deliver over two billion doses of NVX-CoV2373 annually as of 2021. 

    The antigen component of NVX-CoV2373 is being manufactured at Novavax CZ in Bohumil, Czech Republic (formerly Praha Vaccines), as well as at the following partnered manufacturing sites:

    • Biofabri in Spain
    • FUJIFILM Diosynth Biotechnologies (FDB) in both North Carolina and Texas in the United States
    • FDB in the United Kingdom
    • SIIPL in India
    • SK Bioscience in the Republic of Korea
    • Takeda Pharmaceutical Company Limited in Japan

    Novavax' Matrix-M adjuvant is now being manufactured at Novavax AB in Uppsala, Sweden and the following partnered manufacturing sites:

    • AGC Biologics in the United States and Denmark
    • PolyPeptide Group will manufacture two key intermediaries used in Matrix-M in the United States and Sweden

    "Signing of the manufacturing agreement with Novavax for NVX-CoV2373 is another great milestone for both companies, which will further strengthen our existing relationship. SIIPL expertise to scale-up and manufacture NVX-CoV2373 will help ensure the supply of this most-needed vaccine," said Adar Poonawalla, Chief Executive Officer of Serum Institute of India.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Serum Institute of India

    Serum Institute of India Pvt. Ltd. was founded in 1966 by Dr. Cyrus Poonawalla with a mission of manufacturing life-saving immuno-biologics. Serum is the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses). It is estimated that about 65% of the children in the world receive at least one vaccine manufactured by Serum Institute. Vaccines manufactured by Serum are accredited by the World Health Organization, Geneva and are being used in approximately 170 countries across the globe.

    Serum is ranked as India's No. 1 biotechnology company, manufacturing highly specialized lifesaving biologics like vaccines using cutting edge genetic and cell-based technologies, antisera and other medical specialties.

    The philanthropic philosophy of Serum continues with its work on newer vaccines and biologicals.

    Learn more about Serum Institute of India at https://www.seruminstitute.com/.

    About CEPI

    CEPI is an innovative partnership between public, private, philanthropic, and civil society organizations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 9 partnerships to develop vaccines against the novel coronavirus. The programs will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

    Before the emergence of COVID-19 CEPI's priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  32. GAITHERSBURG, Md., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will participate in five upcoming investor conferences. A topic of discussion will be Novavax' COVID-19 vaccine candidate, NVX-CoV2373.

    Conference details are as follows:

    Citi 15th Annual BioPharma Virtual Conference

    Date:September 10, 2020
    Event:Investor meetings only

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date:September 14, 2020
    Time:9:30 a.m. U.S. Eastern Time (ET)
    Event:Corporate presentation and investor meetings
    Live Webcast:www.novavax.com, "Investors"/ "Events"

    Cantor Virtual Global Healthcare Conference

    Date:

    GAITHERSBURG, Md., Sept. 10, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will participate in five upcoming investor conferences. A topic of discussion will be Novavax' COVID-19 vaccine candidate, NVX-CoV2373.

    Conference details are as follows:

    Citi 15th Annual BioPharma Virtual Conference

    Date:September 10, 2020
    Event:Investor meetings only

    H.C. Wainwright 22nd Annual Global Investment Conference

    Date:September 14, 2020
    Time:9:30 a.m. U.S. Eastern Time (ET)
    Event:Corporate presentation and investor meetings
    Live Webcast:www.novavax.com, "Investors"/ "Events"

    Cantor Virtual Global Healthcare Conference

    Date:September 15, 2020
    Time:11:20 a.m. U.S. Eastern Time (ET)
    Event:Fireside chat and investor meetings
    Live Webcast:www.novavax.com, "Investors"/ "Events"

    Morgan Stanley Virtual 18th Annual Global Healthcare Conference

    Date:September 16, 2020
    Time:12:30 p.m. U.S. Eastern Time (ET)
    Event:Fireside chat and investor meetings
    Live Webcast:www.novavax.com, "Investors"/ "Events"

    Leerink CyberRx Series: Vaccine Forum

    Date:September 23, 2020
    Time:9:00 a.m. U.S. Eastern Time (ET)
    Event:Fireside chat

    A replay of the presentations will also be accessible under the "Investors/Events" section www.novavax.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Contacts:      

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- The CEOs of AstraZeneca (NYSE:AZN), BioNTech SE (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed…

    • Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    NEW YORK, Sept. 08, 2020 (GLOBE NEWSWIRE) -- The CEOs of AstraZeneca (NYSE:AZN), BioNTech SE (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed the following pledge:

    We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

    The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA's guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

    Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

    • Always make the safety and well-being of vaccinated individuals our top priority.



    • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.



    • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.



    • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

    We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

    Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world's most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

    About AstraZeneca

    AstraZeneca (NYSE:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

    For more information, please visit https://biontech.de/.

    About GlaxoSmithKline

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

    Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.

    About Merck

    For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

    For further information, please visit www.sanofi.com

    Forward Looking Statements of BioNTech

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning BioNTech's efforts to combat COVID-19. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    Forward-Looking Statement of the Janssen Pharmaceutical Companies of Johnson & Johnson

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    Forward-Looking Statement of Moderna, Inc., Cambridge, MA, USA

    This news release of Moderna, Inc. ("Moderna") contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: statements regarding the conduct of clinical trials for Moderna's vaccine candidate against COVID-19 ("mRNA-1273"), the process for obtaining regulatory approval for mRNA-1273 in the United States and other jurisdictions, and the global supply of mRNA-1273.  If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks, uncertainties, and other factors include, among others:  no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; and those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    Forward-Looking Statements of Novavax

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Pfizer Disclosure Notice

    The information contained in this release is as of September 8, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19 and the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from current and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for any potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate's benefits outweigh its known risks and determination of the vaccine candidate's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    Forward Looking Statement of Sanofi

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the  ultimate outcome of such litigation,  trends in exchange rates and prevailing interest rates, volatile economic and market conditions,  cost containment initiatives and subsequent changes thereto, and  the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole.  Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

    AstraZeneca Media Contact:

    Michele Meixell

    +1 (302) 885-2677

    BioNTech Media Contact:

    Jasmina Alatovic

    +49 (0)6131 9084 1513 or +49 (0)151 1978 1385

    GlaxoSmithKline Media Contact:

    Simon Moore

    +44 (0)20 8047 5502

    Johnson & Johnson Media Contact:

    Jake Sargent

    +1 (202) 569-5086

    Merck Media Contact:

    Patrick Ryan

    +1 (973) 275-7075

    Moderna Media Contact:

    Colleen Hussey

    +1 (203) 470-5620

    Novavax Media Contacts:

    Edna Kaplan



    Amy Speak

    Pfizer Media Contact:

    Amy Rose

    +1 (212) 733-7410

    Sanofi Media Contact:

    Ashleigh Koss

    +1 (908) 205-2572

    Primary Logo

    View Full Article Hide Full Article
  33. -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed the following pledge:

    We, the undersigned…

    -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    All nine CEOs signed the following pledge:

    We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

    The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA's guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

    Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

    • Always make the safety and well-being of vaccinated individuals our top priority.
    • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
    • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
    • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

    We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.

    Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world's most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

    About AstraZeneca

    AstraZeneca (NYSE:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

    For more information, please visit https://biontech.de/.

    About GlaxoSmithKline

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

    Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.

    About Merck

    For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

    For further information, please visit www.sanofi.com

    Forward Looking Statements of BioNTech

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning BioNTech's efforts to combat COVID-19. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

    Forward-Looking Statement of the Janssen Pharmaceutical Companies of Johnson & Johnson

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    Forward-Looking Statement of Moderna, Inc., Cambridge, MA, USA

    This news release of Moderna, Inc. ("Moderna") contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: statements regarding the conduct of clinical trials for Moderna's vaccine candidate against COVID-19 ("mRNA-1273"), the process for obtaining regulatory approval for mRNA-1273 in the United States and other jurisdictions, and the global supply of mRNA-1273. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks, uncertainties, and other factors include, among others: no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; and those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    Forward-Looking Statements of Novavax

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Pfizer Disclosure Notice

    The information contained in this release is as of September [8], 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19 and the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from current and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for any potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate's benefits outweigh its known risks and determination of the vaccine candidate's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    Forward Looking Statement of Sanofi

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

    View Full Article Hide Full Article
  34. -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines --

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    This press release features multimedia. View the full release…

    -- Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines --

    The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NASDAQ:BNTX), GlaxoSmithKline plc (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), known as MSD outside the United States and Canada, Moderna, Inc. (NASDAQ:MRNA), Novavax, Inc. (NASDAQ:NVAX), Pfizer Inc. (NYSE:PFE), and Sanofi (NASDAQ:SNY), today announced a historic pledge, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200908005282/en/

    All nine CEOs signed the following pledge:





    We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles.

    The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA's guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.

    Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to:

    • Always make the safety and well-being of vaccinated individuals our top priority.
    • Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.
    • Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.
    • Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

    We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved.





    Together, these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world's most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.

    About AstraZeneca

    AstraZeneca (NYSE:AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Regeneron, Genevant, Fosun Pharma, and Pfizer.

    For more information, please visit https://biontech.de/.

    About GlaxoSmithKline

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    About Johnson & Johnson

    At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at Learn more at www.jnj.com. Follow us at @JNJNews.

    About the Janssen Pharmaceutical Companies of Johnson & Johnson

    At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

    Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenGlobal or www.twitter.com/JanssenUS.

    About Merck

    For more than 125 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter, Facebook, Instagram, YouTube and LinkedIn.

    About Moderna

    Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body's cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. Moderna's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing the Company the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune and inflammatory diseases, independently and with strategic collaborators.

    Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense; the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS) and the Coalition for Epidemic Preparedness Innovations (CEPI). Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    About Sanofi

    Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

    With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

    Sanofi, Empowering Life

    For further information, please visit www.sanofi.com

    Forward Looking Statements of BioNTech

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning BioNTech's efforts to combat COVID-19. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for COVID-19; the ability to produce comparable clinical results in larger and more diverse clinical trials; the ability to effectively scale our productions capabilities; and other potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

    GSK Cautionary Statement Regarding Forward-Looking Statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and as set out in GSK's "Principal risks and uncertainties" section of the Q2 Results and any impacts of the COVID-19 pandemic.

    Forward-Looking Statement of the Janssen Pharmaceutical Companies of Johnson & Johnson

    This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

    Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

    This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

    Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the recent global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

    The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's 2019 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site (www.sec.gov).

    Forward-Looking Statement of Moderna, Inc., Cambridge, MA, USA

    This news release of Moderna, Inc. ("Moderna") contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, as amended, including but not limited to: statements regarding the conduct of clinical trials for Moderna's vaccine candidate against COVID-19 ("mRNA-1273"), the process for obtaining regulatory approval for mRNA-1273 in the United States and other jurisdictions, and the global supply of mRNA-1273. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. These risks, uncertainties, and other factors include, among others: no commercial product using mRNA technology has been approved, and may never be approved; mRNA drug development has substantial clinical development and regulatory risks due to the novel and unprecedented nature of this new class of medicines; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with Moderna's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; and those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    Forward-Looking Statements of Novavax

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Pfizer Disclosure Notice

    The information contained in this release is as of September [8], 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19 and the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary data, including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from current and future preclinical and clinical studies; whether and when any biologics license and/or emergency use authorization applications may be filed in any jurisdictions for any potential vaccine candidates; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine candidate's benefits outweigh its known risks and determination of the vaccine candidate's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; manufacturing capabilities or capacity, including whether the estimated numbers of doses can be manufactured within the projected time periods; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    Forward Looking Statement of Sanofi

    This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

    View Full Article Hide Full Article
  35. GAITHERSBURG, Md., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the publication in The New England Journal of Medicine of Phase 1 data from its Phase 1/2 clinical trial of NVX‑CoV2373, its COVID‑19 vaccine candidate adjuvanted with Matrix‑M™, in healthy adults 18-59 years of age. The publication offers further detail on the previously announced results, in which NVX‑CoV2373 demonstrated a reassuring safety and reactogenicity profile and induced robust antibody responses numerically superior to that seen in human convalescent sera. The manuscript is available at https://www.nejm.org/doi/full/10.1056/NEJMoa2026920?query=featured_coronavirus

    GAITHERSBURG, Md., Sept. 02, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the publication in The New England Journal of Medicine of Phase 1 data from its Phase 1/2 clinical trial of NVX‑CoV2373, its COVID‑19 vaccine candidate adjuvanted with Matrix‑M™, in healthy adults 18-59 years of age. The publication offers further detail on the previously announced results, in which NVX‑CoV2373 demonstrated a reassuring safety and reactogenicity profile and induced robust antibody responses numerically superior to that seen in human convalescent sera. The manuscript is available at https://www.nejm.org/doi/full/10.1056/NEJMoa2026920?query=featured_coronavirus.

    "The rapid publication of Phase 1 results from our trial in a prestigious peer-reviewed journal reflects both the importance of the data and the urgent need for an effective vaccine to slow the COVID-19 pandemic," said Gregory M. Glenn, M.D., President of Research and Development at Novavax. "Based on the positive Phase 1 results, we have begun multiple Phase 2 clinical trials, from which we expect to collect preliminary efficacy. Novavax is committed to generating the safety, immunogenicity and efficacy data that will support confident usage of the vaccine, both in the US and globally, and the data published today further bolsters our conviction that this is possible."

    The Phase 1 portion of the Phase 1/2 clinical trial was randomized, observer-blinded, and placebo-controlled.

    NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the United States and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August.

    The trial was supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI) and was conducted at two sites in Australia.

    Phase 1 Results Summary

    • NVX-CoV2373 was well-tolerated and reactogenicity events were generally mild
    • There were no severe (Grade 3) unsolicited adverse events (AEs); the vast majority of AEs were mild and deemed not related to vaccination. No serious AEs were reported. Safety follow-up continues.
    • All subjects in the 5 µg group developed anti-spike IgG antibodies after a single dose of vaccine, many of which included neutralizing antibody responses to wild-type virus
    • 100 percent of participants developed wild-type virus neutralizing antibody responses after Dose 2
    • Both 5 µg and 25 adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300
    • Anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease
    • Matrix-M adjuvant was dose-sparing, with the lower 5 µg dose of NVX‑CoV2373 performing comparably with the of 25 µg dose
    • Cellular immune responses measured in a subset of participants demonstrated induction of antigen-specific polyfunctional CD4+ T cell responses with a strong Th1 phenotype bias
    • NVX-CoV2373 has a favorable product profile; it is stable and will allow handling in a liquid formulation that can be stored at 2°C to 8°C, allowing for successful cold chain management with existing infrastructure

    Further details may be found in Novavax' August 4 announcement of Phase 1 results and may be accessed here.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 portion of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August 2020. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan

    kaplan

    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
  36. •  Canadian government to purchase up to 76 million doses of NVX-CoV2373

    GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine.

    "We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in…

    •  Canadian government to purchase up to 76 million doses of NVX-CoV2373

    GAITHERSBURG, Md., Aug. 31, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has reached an agreement in principle with the Government of Canada to supply up to 76 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine.

    "We are pleased to work with the Canadian government on supply of our COVID-19 vaccine, an essential step to ensure broad access of our vaccine candidate," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "We are moving forward with clinical development of NVX-CoV2373 with a strong sense of urgency in our quest to deliver a vaccine to protect the world."

    "We are pleased to announce this agreement with Novavax, which will give Canadians access to a promising COVID-19 vaccine candidate. This is an important step in our government's efforts to secure a vaccine to keep Canadians safe and healthy, as the global pandemic evolves," said The Honourable Anita Anand, Minister of Public Services and Procurement, Government of Canada.

    Novavax and Canada expect to finalize an advance purchase agreement under which Novavax will supply doses of NVX-CoV2373 to Canada beginning as early as the second quarter of 2021. This purchase arrangement will be subject to licensure of the Novavax vaccine by Health Canada.

    NVX-CoV2373 is currently in multiple Phase 2 clinical trials. The Phase 2 portion of the Phase 1/2 clinical trial to evaluate the safety and immunogenicity of NVX-CoV2373 began in August in the United States and Australia, and expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial population. Secondary objectives include preliminary evaluation of efficacy. In addition, a Phase 2b clinical trial to assess efficacy began in South Africa in August.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 10-Q for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:      

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/Speak Life Science

    Amy Speak



    617-420-2461

    Primary Logo

    View Full Article Hide Full Article
    • Primary objectives expand evaluation of immunogenicity and safety
    • Secondary objectives include preliminary efficacy assessment
    • Trial to enroll up to 1,500 volunteers in United States and Australia, with approximately 50 percent between 60 and 84 years of age
    • Interim immunogenicity and safety data expected in fourth quarter of 2020

    GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the first volunteers have been enrolled in the Phase 2 portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. The Phase 2 clinical trial…

    • Primary objectives expand evaluation of immunogenicity and safety

    • Secondary objectives include preliminary efficacy assessment
    • Trial to enroll up to 1,500 volunteers in United States and Australia, with approximately 50 percent between 60 and 84 years of age
    • Interim immunogenicity and safety data expected in fourth quarter of 2020

    GAITHERSBURG, Md., Aug. 24, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that the first volunteers have been enrolled in the Phase 2 portion of its ongoing clinical trial to evaluate the immunogenicity and safety of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. The Phase 2 clinical trial expands on the age range of the Phase 1 portion by including older adults 60-84 years of age as approximately 50 percent of the trial's population. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    "We expect this Phase 2 portion of the trial to expand on the encouraging Phase 1 safety and immunogenicity data for NVX-CoV2373, and we will now look for robust immune responses in older adults," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "Our Phase 3 trial of NanoFlu, which we reported in March of 2020, provided us with a deep understanding of the unique needs of older adults, who are particularly vulnerable to COVID-19. We know that the world is closely watching all of these trials, and we anticipate interim data from this trial in the fourth quarter of this year."

    The Phase 2 portion of the ongoing Phase 1/2 clinical trial is a randomized, placebo-controlled, observer-blinded study to evaluate the safety and immunogenicity of NVX-CoV2373 with Matrix-M in subjects aged 18 to 84 years. The clinical trial will assess two dose sizes (5 and 25 µg), each with 50 µg of Matrix‑M. Although the trial was designed to confirm immunogenicity and safety in adults, secondary objectives include preliminary evaluation of efficacy. The study is targeting enrollment of up to 1,500 healthy volunteers, with approximately 50 percent of participants ≥60 years of age, at up to 40 sites in the U.S. and Australia

    The trial is supported by funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    In the Phase 1 portion of the Phase 1/2 clinical trial, conducted in Australia, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. These data have been submitted for peer-review to a scientific journal and are posted online at the preprint server medRxiv.org.

    For further information, including media-ready images, b-roll, downloadable resources and more, click here.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials began in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Novavax

    Investors and media

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/KOGS Communication

    Edna Kaplan



    617-974-8659

    Primary Logo

    View Full Article Hide Full Article
    • Phase 2b clinical trial in collaboration with Professor Shabir Madhi and Wits University
    • Bill & Melinda Gates Foundation providing $15 million grant toward trial
    • Mature trial infrastructure along with significant levels of seasonal transmission may allow for rapid efficacy evaluation

    GAITHERSBURG, Md., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the beginning of a Phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. Dr. Shabir Madhi, Professor of Vaccinology at Wits University, will lead the clinical trial, which is supported in part by a $15…

    • Phase 2b clinical trial in collaboration with Professor Shabir Madhi and Wits University
    • Bill & Melinda Gates Foundation providing $15 million grant toward trial
    • Mature trial infrastructure along with significant levels of seasonal transmission may allow for rapid efficacy evaluation

    GAITHERSBURG, Md., Aug. 17, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the beginning of a Phase 2b clinical trial in South Africa to evaluate the efficacy of NVX-CoV2373, Novavax' COVID-19 vaccine candidate. Dr. Shabir Madhi, Professor of Vaccinology at Wits University, will lead the clinical trial, which is supported in part by a $15 million grant from the Bill & Melinda Gates Foundation. NVX‑CoV2373 is a stable, prefusion protein made using Novavax' proprietary nanoparticle technology and includes Novavax' proprietary Matrix‑M™ adjuvant.

    "Because South Africa is experiencing a winter surge of COVID-19 disease, this important Phase 2b clinical trial has the potential to provide an early indication of efficacy, along with additional safety and immunogenicity data for NVX-CoV2373," said Gregory M. Glenn, M.D., President, Research and Development at Novavax. "We appreciate the continued support of the Bill & Melinda Gates Foundation and CEPI, and our strong ongoing collaboration with Wits University, all of whom are united with us in our commitment to produce and deliver a safe, effective vaccine across the globe."

    The randomized, observer-blinded, placebo-controlled Phase 2b clinical trial of NVX-CoV2373 will include two cohorts. One cohort will evaluate efficacy, safety and immunogenicity in approximately 2,665 healthy adults. The second cohort will evaluate safety and immunogenicity in approximately 240 medically stable, HIV-positive adults. This allows for evaluation of the vaccine across a diverse, representative study population. Novavax expects that, if approved in South Africa, its COVID-19 vaccine would ultimately be supplied to South Africa through Novavax' recently announced collaboration with the Serum Institute of India.

    "The major motivation for the COVID-19 vaccines being evaluated at an early stage in South Africa is to generate evidence in the African context on how well these vaccines work in settings such as our own," said Shabir Madhi, M.B.B.C.H., FCPaeds, Ph.D. "I am pleased to work with Novavax as the principal investigator in this clinical trial, following Novavax' COVID-19 vaccine's positive Phase 1 data, which provides strong rationale for moving development forward in a larger subset of adults."

    In the Phase 1 portion of the Phase 1/2 clinical trial, conducted in Australia, NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. These data have been submitted to the U.S. Food and Drug Administration (FDA) and an independent safety monitoring committee, and have also been submitted for peer-review to a scientific journal and are posted online at the preprint server medRxiv.org. Novavax intends to initiate the Phase 2 portion of this trial in the U.S. and Australia in the near future. This trial will include approximately 1,500 subjects and will include older adults.

    The Coalition for Epidemic Preparedness Innovations (CEPI) is funding the manufacturing of doses of NVX-CoV2373 for this Phase 2b clinical trial.

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials will begin in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:     

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/Speak Life Science

    Amy Speak



    617-420-2461 

    Primary Logo

    View Full Article Hide Full Article
    • UK government to purchase 60 million doses of NVX-CoV2373
    • Novavax to partner with FUJIFILM Diosynth Biotechnologies to manufacture antigen component of NVX-CoV2373 in the UK
    • Novavax and UK government to collaborate on Phase 3 clinical trial in UK commencing in the third quarter of this year
    • Novavax intends to make additional capacity available to global markets

    GAITHERSBURG, Md., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has signed a Heads of Terms (Term Sheet) with the Government of the United Kingdom (UK) for the purchase of 60 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine, and a Phase 3…

    • UK government to purchase 60 million doses of NVX-CoV2373

    • Novavax to partner with FUJIFILM Diosynth Biotechnologies to manufacture antigen component of NVX-CoV2373 in the UK
    • Novavax and UK government to collaborate on Phase 3 clinical trial in UK commencing in the third quarter of this year
    • Novavax intends to make additional capacity available to global markets

    GAITHERSBURG, Md., Aug. 14, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it has signed a Heads of Terms (Term Sheet) with the Government of the United Kingdom (UK) for the purchase of 60 million doses of NVX-CoV2373, Novavax' COVID-19 vaccine, and a Phase 3 clinical trial to assess the efficacy of the vaccine in the UK population. Novavax will also expand its collaboration with FUJIFILM Diosynth Biotechnologies, which will manufacture the antigen component of NVX-CoV2373 from its Billingham, Stockton-on-Tees site in the UK, in addition to its sites in North Carolina and Texas in the United States. The FUJIFILM Diosynth Biotechnologies site in the UK is expected to produce up to 180 million doses annually, which further boosts the global supply of NVX-CoV2373 for additional markets.

    "We are honored to partner with the UK government to deliver a vaccine that could provide vital protection in the fight against the global health crisis," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Our Phase 3 clinical trial in the UK will be a critical component to assess the efficacy of NVX-CoV2373, which in a Phase 1 trial has already demonstrated to be generally well-tolerated and to elicit robust antibody responses. We are also delighted to expand our collaboration with FUJIFILM Diosynth Biotechnologies to manufacture our antigen at its UK site."

    "It is encouraging that Novavax' recent clinical data shows their vaccine triggers an immune response greater than that in patients who have recovered from the disease," said Kate Bingham, Chair of the UK Government's Vaccines Taskforce. "We believe that Novavax has a highly innovative vaccine that could be the first in its class of protein-based vaccine options. We are happy to partner with them and global organizations such as CEPI to further our mutual commitments to ensure global access to the vaccine."

    The Phase 3 clinical trial will be a randomized, double-blind, placebo-controlled efficacy study in approximately 9,000 adults 18-85 years of age in the UK. The trial is expected to begin in the third quarter of this year, with the UK government supporting and providing infrastructure to Novavax in the execution of the trial. The trial will assess the ability of NVX-CoV2373 to protect against symptomatic COVID-19 disease as well as evaluate antibody and T-cell responses.

    Under the terms of the agreement, Novavax will supply 60 million doses of NVX-CoV2373 to the UK beginning as early as the first quarter of 2021. Excess supply of antigen manufactured at the FUJIFILM Diosynth Biotechnologies site in Billingham, Stockton-on-Tees may be available for Novavax to sell to additional markets outside the UK.

    "To change the course of the pandemic, FUJIFILM Diosynth Biotechnologies is excited to expand our partnership with Novavax to manufacture their COVID-19 vaccine candidate at our UK site," said Paul Found, Chief Operating Officer, FUJIFILM Diosynth Biotechnologies, UK site. "We are honored to support the UK government and Novavax with the shared goal of delivering a safe and effective vaccine to the British people."

    About NVX-CoV2373

    NVX‑CoV2373 is a vaccine candidate engineered from the genetic sequence of SARS‑CoV‑2, the virus that causes COVID-19 disease. NVX‑CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. In preclinical trials, NVX‑CoV2373 demonstrated indication of antibodies that block binding of spike protein to receptors targeted by the virus, a critical aspect for effective vaccine protection. In its Phase 1 data of the Phase 1/2 clinical trial, NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera. Phase 2 clinical trials will begin in August. Novavax has secured $2 billion in funding for its global coronavirus vaccine program, including up to $388 million in funding from the Coalition for Epidemic Preparedness Innovations (CEPI).

    About Matrix-M™

    Novavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

    About Novavax

    Novavax, Inc. (NASDAQ:NVAX) is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX‑CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 data of the Phase 1/2 clinical trial. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax' proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.

    For more information, visit www.novavax.com and connect with us on Twitter and LinkedIn.

    Novavax Forward-Looking Statements

    Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2019, and Quarterly Report on Form 8-K for the period ended June 30, 2020, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

    Contacts:

    Novavax

    Investors

    Silvia Taylor and Erika Trahan



    240-268-2022

    Media

    Brandzone/Speak Life Science

    Amy Speak



    617-420-2461

     

    Primary Logo

    View Full Article Hide Full Article
    • SK bioscience to manufacture antigen component of NVX-CoV2373
    • Builds on and complements Novavax-CEPI collaboration to develop and distribute NVX-CoV2373
    • Novavax, SK bioscience and Republic of Korea intend to partner for manufacture and supply of vaccine for global markets including South Korea

    GAITHERSBURG, Md. and SEOUL, South Korea, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and SK bioscience, a vaccine business subsidiary of SK Group, today announced a development and supply agreement for the antigen component of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, for supply to global markets including the COVAX Facility…

    • SK bioscience to manufacture antigen component of NVX-CoV2373

    • Builds on and complements Novavax-CEPI collaboration to develop and distribute NVX-CoV2373
    • Novavax, SK bioscience and Republic of Korea intend to partner for manufacture and supply of vaccine for global markets including South Korea

    GAITHERSBURG, Md. and SEOUL, South Korea, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ:NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, and SK bioscience, a vaccine business subsidiary of SK Group, today announced a development and supply agreement for the antigen component of NVX-CoV2373, Novavax' COVID-19 vaccine candidate, for supply to global markets including the COVAX Facility. In addition, the companies have signed a letter of intent with the Republic of Korea's Ministry of Health and Welfare to work toward broad and equitable access to NVX-CoV2373 for the global market as well as to make the vaccine available in South Korea.

    Under the terms of the agreement, SK bioscience will manufacture the vaccine antigen component for use in the final drug product globally during the pandemic period.

    NVX-CoV2373 was developed using Novavax' recombinant nanoparticle technology to generate a stable, prefusion antigen derived from the coronavirus spike (S) protein. It contains Novavax' patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Phase 1 data from the Company's Phase 1/2 randomized, observer-blinded, placebo-controlled trial shows that NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

    SK bioscience, using its cell culture and recombinant protein capability,