PFE Pfizer Inc.

39.41
+1.1  (+3%)
Previous Close 38.31
Open 39.4
52 Week Low 27.88
52 Week High 41.99
Market Cap $219,056,409,967
Shares 5,558,396,599
Float 5,556,331,530
Enterprise Value $257,968,105,380
Volume 74,569,012
Av. Daily Volume 33,750,595
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Upcoming Catalysts

Drug Stage Catalyst Date
GMI-1070 (rivipansel)
Vaso-occlusive crisis of sickle cell disease
Phase 3
Phase 3
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BNT162b2
COVID-19 vaccine
Phase 3
Phase 3
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PF-06700841
Psoriasis
Phase 2
Phase 2
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Tanezumab
Cancer pain
Phase 3
Phase 3
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PF-06425090
C. difficile Infection
Phase 3
Phase 3
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PF-06700841
Atopic Dermatitis
Phase 2
Phase 2
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Xalkori (Crizotinib)
ALK-positive Anaplastic Large Cell Lymphoma
PDUFA priority review
PDUFA priority review
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Tanezumab
Osteoarthritis
PDUFA
PDUFA
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Abrocitinib
Atopic Dermatitis
PDUFA priority review
PDUFA priority review
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PF-06651600
Alopecia areata
Phase 3
Phase 3
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PF-06939926
Duchenne muscular dystrophy (DMD)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
IBRANCE (palbociclib) - PALLAS
Early stage breast cancer
Phase 3
Phase 3
Phase 3 trial unlikely to show a statistically significant improvement in the primary endpoint following futility analysis - May 29, 2020.
Marstacimab (PF-06741086) - BASIS
Hemophilia A or B
Phase 3
Phase 3
Phase 3 initiation of dosing announced November 23, 2020.
Tofacitinib - Xeljanz
Ankylosing spondylitis
Phase 3
Phase 3
Phase 3 trial met primary endpoint - November 6, 2020.
Vupanorsen (AKCEA-ANGPTL3-LRx) - (TRANSLATE-TIMI 70)
Non-alcoholic fatty liver disease (NAFLD), Hypertriglyceridemia and Type 2 Diabetes Mellitus
Phase 2b
Phase 2b
Phase 2b trial initiation announced November 3, 2020.
Protease inhibitor against SARS-CoV-2
COVID-19 Coronavirus
Phase 1b
Phase 1b
Phase 1b trial commenced September 2020. Phase 2/3 study start in late 2020/early 2021.
20vPnC vaccine
Pneumococcal conjugate vaccine (18 yrs +)
BLA Filing
BLA Filing
BLA filed early October 2020.
PF-06482077
Pneumococcal Disease
Phase 3
Phase 3
Phase 3 trial ongoing.
IBRANCE (palbociclib) - PENELOPE-B
Early stage breast cancer
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - October 9, 2020.
Giroctocogene fitelparvovec (SB-525) AFFINE
Hemophilia A
Phase 3
Phase 3
Phase 3 initiation of dosing announced October 7, 2020.
Tofacitinib
Juvenile idiopathic arthritis (JIA)
Approved
Approved
FDA approval announced September 28, 2020.
Encorafenib, Binimetinib and Cetuximab (ANCHOR-CRC)
BRAF V600E-mutant Metastatic Colorectal Cancer
Phase 2
Phase 2
Phase 3 trial to commence late 2020.
Lorlatinib
Anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial met progression-free survival primary endpoint - August 5, 2020.
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma
Approved
Approved
FDA approval announced April 22, 2019.
Xeljanz
Psoriatic arthritis
Approved
Approved
Approval announced December 14, 2017.
PF-06886992
Meningococcal Vaccine
Phase 3
Phase 3
Phase 3 trial initiated June 2020.
PF-0692831
Respiratory Syncytial Virus (RSV)
Phase 3
Phase 3
Phase 3 trial initiated in June 2020.
Fostemsavir
HIV
Approved
Approved
FDA Approval announced July 2, 2020.
Bavencio (Avelumab) - JAVELIN Bladder 100
Bladder cancer
Approved
Approved
FDA approval announced June 30, 2020.
NYVEPRIA
Biosimilar to Neulasta (pegfilgrastim)
Approved
Approved
FDA Approval announced June 11, 2020.
ARRY 797
LMNA A/C-related dilated cardiomyopathy (DCM)
Phase 3
Phase 3
Phase 3 trial enrolling - November 2018.
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer
Approved
Approved
FDA Approval announced April 8, 2020.
Lorlatinib
ALK+ NSCLC
Approved
Approved
FDA approval announced November 2, 2018.
Avelumab (JAVELIN Head and Neck100)
Head and Neck Cancer
Phase 3
Phase 3
Phase 3 trial terminated - unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival (PFS).
Tanezumab
Chronic low back pain
Phase 3
Phase 3
Phase 3 data released February 19, 2019. 10mg dose met primary endpoint. 5mg dose did not meet endpoint.
Dolutegravir + rilpivirine
HIV
CRL
CRL
Complete Response Letter issued December 21, 2019.
XTANDI (ARCHES)
Metastatic hormone sensitive prostate cancer
Approved
Approved
FDA Approval announced December 16, 2019.
ABRILADA (adalimumab-afzb)
Bosimilar to Humira (adalimumab)
Approved
Approved
FDA Approval announced November 18, 2019.
Avelumab - JAVELIN Gastric 100
Gastric cancer
Phase 3
Phase 3
Phase 3 endpoint not met - November 8, 2019.
Binimetinib - COLUMBUS
BRAF mutant melanoma cancer
Approved
Approved
Approval announced June 27, 2018.
Ruxience (Biosimilar to Rituxan)
CD20-positive, low tumor burden, follicular lymphoma.
Approved
Approved
FDA approval announced July 23, 2019.
Sildenafil and inhaled nitric oxide (iNO)
Persistent Pulmonary Hypertension (PPHN)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - June 28, 2019.
PF-06439535
Biosimilar bevacizumab
Approved
Approved
FDA Approval announced June 28, 2019.
LYRICA (pregabalin)
Primary generalized tonic-clonic (PGTC) seizures - epilepsy
Phase 3
Phase 3
Phase 3 data released May 24, 2019 did not meet primary endpoint.
BAVENCIO (avelumab) and INLYTA (axitinib)
Renal cell carcinoma (RCC)
Approved
Approved
FDA Approval announced May 14, 2019.
Tafamidis (tafamidis free acid form)
Transthyretin amyloid cardiomyopathy (ATTR-CM)
Approved
Approved
FDA Approval announced May 6, 2019.
Tafamidis
Transthyretin amyloid cardiomyopathy (ATTR-CM)
Approved
Approved
FDA approval announced May 6, 2019.
IBRANCE (palbociclib)
HR+/HER2- advanced breast cancer in men
Approved
Approved
FDA approval of sNDA announced April 4, 2019.
PF-05280014 TRAZIMERA
Herceptin biosimilar
Approved
Approved
FDA Approval March 11, 2019.
Avelumab - JAVELIN Ovarian 100
Ovarian cancer
Phase 3
Phase 3
Phase 3 trial to be terminated due to lack of efficacy.
Glasdegib
Acute myeloid leukemia (AML)
Approved
Approved
FDA approval announced November 21, 2018.
Talazoparib
BRCA-mutated breast cancer
Approved
Approved
FDA Approval announced October 16, 2018.
Dacomitinib
Non-small cell lung cancer (NSCLC)
Approved
Approved
FDA Approval announced September 27, 2018.
Inotuzumab Ozogamicin
Relapsed or Refractory Acute Lymphoblastic Leukemia in Adults
Approved
Approved
Approval announced August 17, 2017.
Domagrozumab
Duchenne muscular dystrophy (DMD)
Phase 2
Phase 2
Phase 2 development terminated due to lack of efficacy.
XTANDI (PROSPER)
Non-metastatic high risk hormone-sensitive prostate cancer
Approved
Approved
FDA approval announced July 13, 2018.
Xeljanz
Ulcerative colitis
Approved
Approved
Approval announced May 30, 2018.
Avelumab
Urothelial Carcinoma
Approved
Approved
Approval announced May 9, 2017.
INLYTA (axitinib)
Recurrent renal cell carcinoma (RCC)
Phase 3
Phase 3
Phase 3 trial discontinued due to futility.
XTANDI
Cancer - mCRPC who have not received chemotherapy
Approved
Approved
Approved Sept 10 2014
IBRANCE (palbociclib)
HR+, HER2- Metastatic Breast Cancer
Approved
Approved
sNDA acceptance announced December 21, 2016. Approval announced March 31, 2017.
Avelumab
Metastatic Merkel cell carcinoma
Approved
Approved
Priority review announced November 29, 2016. Approval announced March 23, 2017.
BOSULIF (BOSUTINIB)
First-Line Treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Approved
Approved
Approval announced December 19, 2017.
Ertugliflozin
Type 2 diabetes
Approved
Approved
Approval announced December 20, 2017.
Sutent (Sunitinib)
Renal cell carcinoma (RCC)
Approved
Approved
Approval announced 16 November, 2017.
XTANDI (ENDEAR)
Triple negative breast cancer
Phase 3
Phase 3
Phase 3 trial terminated - noted May 17, 2017.
Epoetin alfa biosimilar
CRL
CRL
CRL issued June 22, 2017.
Mylotarg (gemtuzumab ozogamicin)
Acute myeloid leukemia (AML)
Approved
Approved
Approval announced September 1, 2017.
Staphylococcus aureus vaccine
PDUFA
PDUFA
Advisory Committee Meeting held November 7, 2017. No votes cast.
LYRICA (pregabalin)
Postherpetic neuralgia (PHN)
Approved
Approved
Approval announced October 12, 2017.
Avelumab
Gastric cancer
Phase 3
Phase 3
Phase 3 data released November 28, 2017 - primary endpoint not met.
IXIFI
Remicade (infliximab) biosimilar
Approved
Approved
Approval announced December 13, 2017.

Latest News

    • U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediately
    • First authorization for a COVID-19 vaccine represents a breakthrough scientific achievement to help combat this devastating pandemic
    • The companies previously signed an agreement to supply a total of 40 million doses to the U.K. with delivery in 2020 and 2021
    • U.S. FDA and EU EMA decisions on authorization are expected in December

    NEW YORK and MAINZ, GERMANY, December 2, 2020Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency…

    • U.K. regulator, MHRA, authorizes supply of COVID-19 mRNA vaccine for emergency supply under Regulation 174; Companies are ready to deliver the first doses to the U.K. immediately
    • First authorization for a COVID-19 vaccine represents a breakthrough scientific achievement to help combat this devastating pandemic
    • The companies previously signed an agreement to supply a total of 40 million doses to the U.K. with delivery in 2020 and 2021
    • U.S. FDA and EU EMA decisions on authorization are expected in December

    NEW YORK and MAINZ, GERMANY, December 2, 2020Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) announced today that the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. has granted a temporary authorization for emergency use for their COVID-19 mRNA vaccine (BNT162b2), against COVID-19. This constitutes the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Pfizer and BioNTech are anticipating further regulatory decisions across the globe in the coming days and weeks and are ready to deliver vaccine doses following potential regulatory authorizations or approvals. The distribution of the vaccine in the U.K. will be prioritized according to the populations identified in guidance from the Joint Committee on Vaccination and Immunisation (JCVI).

    "Today's Emergency Use Authorization in the U.K. marks a historic moment in the fight against COVID-19. This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the U.K.," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "As we anticipate further authorizations and approvals, we are focused on moving with the same level of urgency to safely supply a high-quality vaccine around the world. With thousands of people becoming infected, every day matters in the collective race to end this devastating pandemic." 

    "The Emergency Use Authorization in the U.K. will mark the first time citizens outside of the trials will have the opportunity to be immunized against COVID-19," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "We believe that the roll-out of the vaccination program in the U.K. will reduce the number of people in the high-risk population being hospitalized. Our aim is to bring a safe and effective vaccine upon approval to the people who need it. The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program."

    The MHRA's decision is based on a rolling submission, including data from the Phase 3 clinical study, which demonstrated a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. The first primary objective analysis is based on 170 cases of COVID-19, as specified in the study protocol. Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%. In the trial, BNT162b2 was generally well tolerated with no serious safety concerns reported by the Data Monitoring Committee to date. Today's decision also is based on a review of Pfizer's and BioNTech's Chemistry, Manufacturing and Control (CMC) data for BNT162b2.

    In July 2020, Pfizer and BioNTech announced an agreement with the U.K. to supply 30 million doses of the BNT162b2 mRNA-based vaccine, once authorized for emergency use. That agreement was increased to 40 million doses in early October. The delivery of the 40 million doses will occur throughout 2020 and 2021, in stages, to ensure an equitable allocation of vaccines across the geographies with executed contracts. Now that the vaccine is authorized in the U.K., the companies will take immediate action to begin the delivery of vaccine doses. The first doses are expected to arrive in the U.K. in the coming days, with complete delivery fulfilment expected in 2021.

    The companies have filed a request for Emergency Use Authorization with the U.S. Food and Drug Administration (FDA) and have submitted the final Conditional Marketing Authorization Application (CA) following rolling submissions with the European Medicines Agency (EMA) and several other regulatory agencies around the world. 

    Manufacturing and Delivery Capabilities

    Pfizer and BioNTech continue to work in collaboration with governments and Ministries of Health around the world that will distribute the vaccine, subject to country authorization or approval, to help ensure it can reach those most in need as quickly as possible. The companies are leveraging leading vaccine manufacturing and distribution capabilities to quickly scale, manufacture and distribute large quantities of the vaccine at high quality, complementing the mRNA manufacturing expertise of BioNTech gained over almost a decade. Pfizer has a 171-year track record of researching, developing, manufacturing and delivering innovative medicines and vaccines to patients in need. Pfizer and BioNTech are confident in their ability to safely and effectively deliver the vaccine to the people in the U.K. Based on current projections, Pfizer's and BioNTech's combined manufacturing network has the potential to supply globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021 (subject to manufacturing capacity and regulatory approval or authorization).

    Through its existing mRNA production sites in Mainz and Idar-Oberstein, Germany, BioNTech is able to produce mRNA for commercial supply after having already produced the vaccine candidate doses for the clinical trials. BioNTech will also increase its manufacturing capacity in 2021, once a third site in Germany will start manufacturing to provide further capacities for a global supply of the potential vaccine. Critical to distribution in the U.K. will be Pfizer's manufacturing site in Puurs, Belgium, one of Pfizer's largest sterile injectable sites. The Puurs site is being used primarily for European supply but will also serve as back up supply to Kalamazoo, Michigan, for the U.S. market.

    Pfizer has vast experience and expertise in cold-chain shipping and has an established infrastructure to supply the vaccine worldwide, including distribution hubs that can store vaccine doses for up to six months. The company's distribution is built on a flexible just-in-time system that can ship the frozen vials quickly to designated points of vaccination at the time of need. So, this will minimize the need for long term storage anywhere. Vaccination in a pandemic situation is expected to be rapid, with high demand, and we do not expect that the product will need to be stored at any location for more than 30 days.

    To assure product quality, the companies have developed specially designed, temperature-controlled shippers for the BNT162b2 vaccine candidate, which can maintain recommended storage conditions (-70°C ±10°C) for extended periods of time without any additional equipment but dry ice. The shipper can maintain temperature for 10 days unopened which allows for transportation to markets globally. Once open, a vaccination center may use the specially designed shippers as a temporary storage solution to maintain the recommended storage conditions (-70°C ±10°C) up to 30 days with re-icing every five days in accordance with the handling instructions. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment 24 hours a day, seven days a week. Once thawed, the vaccine vial can be stored for up to five days at refrigerated (2-8°C) conditions.

    From the start of the research program earlier this year, Pfizer and BioNTech have successfully supplied and distributed their investigational vaccine to more than 150 clinical trial sites across the U.S., as well as Europe, Latin America and South Africa reaching approximately 44,000 participants. Based on their collective experience, the companies believe in their capability to distribute the vaccine globally upon approval or authorization. BioNTech will hold the regulatory authorization in the U.K., and, if granted, in the U.S., the EU, Canada and other countries. Pfizer will have the commercialization right worldwide with the exception of China, Germany and Turkey.

    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.



    Pfizer Disclosure Notice


    The information contained in this release is as of December 2, 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, the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, the BNT162 mRNA vaccine program and modRNA candidate BNT162b2 (including qualitative assessments of available data, potential benefits, expectations for clinical trials, a temporary authorization for emergency use in the U.K., regulatory submissions, including a pending request for Emergency Use Authorization in the U.S. and rolling submissions with the EMA and several other regulatory agencies around the world, the anticipated timing of regulatory submissions, regulatory approvals or authorizations and anticipated manufacturing, distribution and supply), 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 clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial or in larger, more diverse populations upon commercialization; 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 and when data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any other biologics license and/or Emergency Use Authorization applications may be filed in any jurisdictions for BNT162b2 or any other potential vaccine candidates; whether and when any applications that may be pending or filed for BNT162b2 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; whether and when the U.K. temporary use authorization may be superseded by the grant of a Marketing Authorisation; 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; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine candidate's ultra-low temperature formulation and attendant storage, distribution and administration requirements, including risks related to handling after delivery by Pfizer; the risk that we may not be able to successfully develop non-frozen formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate within the projected time periods indicated; whether and when additional supply agreements will be reached; 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; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; 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.

    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 www.BioNTech.de.



    BioNTech Forward-looking Statements


    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; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial use based on data observations to date; the expected timepoint for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; the timing for submission of manufacturing data to the FDA; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. 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: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; 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 Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, 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.

    Pfizer Contacts:

    Media Relations

    Andy Widger

    +44 7970 149098

    Investor Relations

    Chuck Triano

    +1 (212) 733-3901

    BioNTech Contacts:

    Media Relations

    Jasmina Alatovic

    +49 89 62 81 75 46

    Investor Relations

    Sylke Maas, Ph.D.

    +49 (0)6131 9084 1074



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    • EMA confirms successful application for Conditional Marketing Authorization for BNT162b2, which Pfizer and BioNTech submitted yesterday
    • In addition to submission to EMA, FDA and U.K. MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world
    • Data from the Phase 3 clinical study demonstrated a vaccine efficacy rate for BNT162b2 of 95% against COVID-19, with no safety concerns observed to date

    NEW YORK and MAINZ, GERMANY, December 1, 2020Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have submitted on Monday, November 30, 2020, a formal Application for Conditional Marketing Authorization (CMA…

    • EMA confirms successful application for Conditional Marketing Authorization for BNT162b2, which Pfizer and BioNTech submitted yesterday
    • In addition to submission to EMA, FDA and U.K. MHRA, the companies have also initiated additional rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world
    • Data from the Phase 3 clinical study demonstrated a vaccine efficacy rate for BNT162b2 of 95% against COVID-19, with no safety concerns observed to date

    NEW YORK and MAINZ, GERMANY, December 1, 2020Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have submitted on Monday, November 30, 2020, a formal Application for Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) for their mRNA vaccine candidate, BNT162b2, against COVID-19. This submission completes the rolling review process initiated on October 6, 2020, with nonclinical data and partial Chemistry, Manufacturing, and Controls (CMC) data, followed by emerging clinical data submitted by Pfizer and BioNTech. If EMA concludes that the benefits of the vaccine candidate outweigh its risks in protecting against COVID‑19, it will recommend granting a CMA that could potentially enable use of BNT162b2 in Europe before the end of 2020.

    The submitted clinical data demonstrated a vaccine efficacy rate of 95% (p<0.0001) in the companies' Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose. Efficacy was consistent across age, gender, race and ethnicity demographics, with an observed efficacy in adults age 65 and over of more than 94%. The first primary objective analysis was based on 170 confirmed cases of COVID-19. In the trial, BNT162b2 also showed an overall favorable tolerability with no safety concerns reported by the Data Monitoring Committee to date. Approximately 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age.

    "Today's announcement marks another key milestone in our efforts to fulfill our promise to do everything we can to address this dire crisis given the critical public health need," said Dr. Albert Bourla, Pfizer Chairman and CEO. "We have known since the beginning of this journey that patients are waiting, and we stand ready to ship COVID-19 vaccine doses as soon as potential authorizations will allow us."

    "As a company located in the heart of Europe, today's milestone is important to us as we continue to seek to enable a worldwide supply upon potential approval of BNT162b2," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. "We will continue to work with regulatory agencies around the world to enable the rapid distribution, should the vaccine receive the approval, contributing to the joint efforts to let the world heal and regain its normal pace of life."

    The vaccine candidate will be assessed according to EMA's normal stringent standards for quality, safety and efficacy. The BNT162b2 vaccine candidate is currently not approved for distribution anywhere in the world.  

    In addition to submission to EMA, U.S. Food and Drug Administration (FDA) and U.K. Medicines and Healthcare Products Regulatory Agency (MHRA), the companies have initiated rolling submissions across the globe including in Australia, Canada and Japan, and plan to submit applications to other regulatory agencies around the world.

    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.

    Pfizer Disclosure Notice

    The information contained in this release is as of December 1, 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, the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, the BNT162 mRNA vaccine program and modRNA candidate BNT162b2 (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the submission of a formal application for Conditional Marketing Authorization to the EMA and other regulatory submissions, the anticipated timing of regulatory submissions, regulatory approval or authorization and anticipated manufacturing, distribution and supply), 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 clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial or in larger, more diverse populations upon commercialization; 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 and when data from the BNT162 mRNA vaccine program will be published in scientific journal publications and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any other biologics license and/or emergency use authorization applications may be filed in any jurisdictions for BNT162b2 or any other potential vaccine candidates; whether and when any applications that may be pending or filed 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; disruptions in the relationships between us and our collaboration partners or third-party suppliers; risks related to the availability of raw materials to manufacture a vaccine; challenges related to our vaccine candidate's ultra-low temperature formulation and attendant storage, distribution and administration requirements, including risks related to handling after delivery by Pfizer; the risk that we may not be able to successfully develop non-frozen formulations; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or have access to logistics or supply channels commensurate with global demand for any potential approved vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine candidate within the projected time periods indicated; whether and when additional supply agreements will be reached; 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; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; 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.

    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 www.BioNTech.de.

    BioNTech Forward-looking Statements

    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; the collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine; our expectations regarding the potential characteristics of BNT162b2 in our Phase 2/3 trial and/or in commercial use based on data observations to date; the expected timepoint for additional readouts on efficacy data of BNT162b2 in our Phase 2/3 trial; the nature of the clinical data, which is subject to ongoing peer review, regulatory review and market interpretation; the timing for submission of data for, or receipt of, any marketing approval or Emergency Use Authorization; the timing for submission of manufacturing data to the FDA; our contemplated shipping and storage plan, including our estimated product shelf life at various temperatures; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand, including our production estimates for 2020 and 2021. 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: the ability to meet the pre-defined endpoints in clinical trials; competition to create a vaccine for COVID-19; the ability to produce comparable clinical or other results, including our stated rate of vaccine effectiveness and safety and tolerability profile observed to date, in the remainder of the trial or in larger, more diverse populations upon commercialization; 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 Quarterly Report for the Three and Nine Months Ended September 30, 2020, filed as Exhibit 99.2 to its Current Report on Form 6-K filed with the SEC on November 10, 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.

    Pfizer Contacts:

    Media Relations

    Amy Rose

    +1 (212) 733-7410

    Investor Relations

    Chuck Triano

    +1 (212) 733-3901

    BioNTech Contacts:

    Media Relations

    Jasmina Alatovic

    +49 89 62 81 75 46

    Investor Relations

    Sylke Maas, Ph.D.

    +49 (0)6131 9084 1074

     



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  1. ViiV Healthcare and Shutterstock Studios today announced the launch of a new online photo gallery ‘HIV in View', produced by Shutterstock in collaboration with ViiV Healthcare. The collection, curated with the support of people living with HIV, leverages Shutterstock's global network of over one million creators to deliver a repository of high-resolution images depicting what it means to live with HIV today. Across four countries (the United Kingdom, Kenya, Uruguay, Portugal), people living with HIV stepped forward to be among the first photographed for this gallery, embarking on a shared ambition to help shift the world's perception of HIV and move away from outdated stereotypes. From World AIDS Day 2020, the gallery will be free for all to…

    ViiV Healthcare and Shutterstock Studios today announced the launch of a new online photo gallery ‘HIV in View', produced by Shutterstock in collaboration with ViiV Healthcare. The collection, curated with the support of people living with HIV, leverages Shutterstock's global network of over one million creators to deliver a repository of high-resolution images depicting what it means to live with HIV today. Across four countries (the United Kingdom, Kenya, Uruguay, Portugal), people living with HIV stepped forward to be among the first photographed for this gallery, embarking on a shared ambition to help shift the world's perception of HIV and move away from outdated stereotypes. From World AIDS Day 2020, the gallery will be free for all to access and use in projects, campaigns and communications* in the hope that it will increase awareness around HIV and break down barriers to stigma that still exist.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201201005521/en/

    ViiV Healthcare and Shutterstock Studios unite to tackle outdated perceptions of HIV with ‘HIV in View' - a first-of-its-kind online HIV photography gallery (Photo: Business Wire)

    ViiV Healthcare and Shutterstock Studios unite to tackle outdated perceptions of HIV with ‘HIV in View' - a first-of-its-kind online HIV photography gallery (Photo: Business Wire)

    Doreen Moracha, aged 28, from Nairobi, Kenya, one of the first people to be photographed for the gallery and HIV Advocate, said, "I am so proud to be one of the first people to be photographed for the ‘HIV in View' gallery and to be part of a movement for change to represent real people living with HIV, their stories and experiences. Until the world sees HIV for what it really is, we are not going to make the progress we need to disrupt stereotypes of what it's like to live with HIV. If my photographs can change just one person's opinion of what it means to live with HIV today, I will know we are a step closer to reaching this goal."

    Today, living with HIV is a very different experience from just ten years ago. Advances in prevention, treatment and care mean that people living with HIV can live longer, healthier lives, with a person starting treatment at 20 years old now able to expect to see their 77th birthday.1 Despite these advances, people living with HIV face unique challenges that affect their quality of life every day. Stigma remains a stubbornly persistent threat to the health and well-being of many people living with HIV, and can often impact their ability to consistently access life-saving treatments and social support systems.2 In the battle to challenge the negative assumptions about HIV, shining a light on the truth can be a potent strategy. Sharing the true picture and experiences of people living with HIV is key to undermining stigma.

    Deborah Waterhouse, CEO, ViiV Healthcare, said, "At ViiV Healthcare, our mission is to leave no person living with HIV behind and reducing HIV-related stigma is key to achieving this. For too long, the public has been presented with outdated representations of what it is to live with HIV. Working with Shutterstock has underlined how a lack of widely accessible, present-day HIV imagery continues to hold us back. With the launch of the ‘HIV in View' gallery, people across the world can now download authentic photography for free. As a company, we are making a pledge to use images of real people living with HIV across all our platforms, where applicable, moving forward and we encourage others to do the same. Living with HIV has changed, and we invite the world to help us show this."

    Michael Carfagnini, GM Global Shutterstock Studios, said, "ViiV Healthcare's work in continuing to fight HIV-related stigma until people living with HIV are understood and accepted sparked a unique opportunity for Shutterstock to collaborate through powerful visuals. There is always a need for authentic and fresh imagery accurately depicting what it's like to live with HIV. At Shutterstock, we strive to empower the world's storytellers through our content and services such as those offered through our new Studios division enabling brands and agencies to tell their unique stories. This presented an opportunity to prove the effectiveness and adaptability of our global network of contributors who would be tasked with safely depicting this crucial story, in a much more challenging time to do photography and videography with a pandemic limiting production around the world. This project and the various teams involved both at Shutterstock and ViiV Healthcare truly demonstrated the impact passion brings to creative projects, and we saw the same quality from our contributors and people living with HIV featured in the imagery."

    The ‘HIV in View' gallery is produced by Shutterstock and created in collaboration with ViiV Healthcare. All images can be downloaded royalty free here: https://www.shutterstock.com/explore/viiv-collaboration.

    Notes to editor

    *The HIV in View collection will be offered for free under Shutterstock's standard license to use in projects, campaigns and communications. Users who require the enhanced license will be charged the higher license fee, of which 100% of the proceeds will be donated to (RED), a non-profit organisation helping fund the fight to end AIDS, at the discretion of Shutterstock. For additional information on the license comparison, visit: https://www.shutterstock.com/license-comparison.

    About Shutterstock, Inc.

    Shutterstock, Inc. (NYSE:SSTK), directly and through its group subsidiaries, is a leading global provider of high-quality licensed photographs, vectors, illustrations, videos and music to businesses, marketing agencies and media organizations around the world. Working with its growing community of over 1 million contributors, Shutterstock adds hundreds of thousands of images each week, and currently has more than 350 million images and more than 20 million video clips available.

    Headquartered in New York City, Shutterstock has offices around the world and customers in more than 150 countries. The company's brands also include Bigstock, a value-oriented stock media offering; Shutterstock Custom, a custom content creation platform; Offset, a high-end image collection; PremiumBeat, a curated royalty-free music library; and Shutterstock Editorial, a premier source of editorial images and videos for the world's media.

    For more information, please visit www.shutterstock.com and follow Shutterstock on Twitter and on Facebook.

    About ViiV Healthcare

    ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE:PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aims are to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

    For more information on the company, its management, portfolio, pipeline, and commitment, please visit www.viivhealthcare.com.

    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.

    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 Q3 Results and any impacts of the COVID-19 pandemic.

    Registered in England & Wales:

    No. 3888792

    Registered Office:

    980 Great West Road

    Brentford, Middlesex

    TW8 9GS

    1. May et al. Impact on life expectancy of HIV-1 positive individuals of CD4+ cell count and viral load response to antiretroviral therapy. Available at: https://pubmed.ncbi.nlm.nih.gov/24556869/ Last accessed: December 2020.

    2. Avert. HIV stigma and discrimination. Available at: https://www.avert.org/professionals/hiv-social-issues/stigma-discrimination Last accessed: December 2020.

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    • Second indication under review following mucormycosis

    Basel, Switzerland, November 25, 2020

    Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the marketing authorization application (MAA) for the antifungal isavuconazole (Cresemba®) for the treatment of adult patients with invasive aspergillosis, which was submitted by Basilea's license partner Pfizer Inc. (NYSE:PFE, "Pfizer"))), has been accepted for regulatory review by the Center for Drug Evaluation at the National Medical Products Administration (NMPA) of China. In August 2020, Basilea had announced that an MAA for Cresemba for the treatment of mucormycosis was accepted for review by the NMPA.

    David Veitch, Chief Executive Officer, said: "Invasive aspergillosis and mucormycosis…

    • Second indication under review following mucormycosis



    Basel, Switzerland, November 25, 2020

    Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the marketing authorization application (MAA) for the antifungal isavuconazole (Cresemba®) for the treatment of adult patients with invasive aspergillosis, which was submitted by Basilea's license partner Pfizer Inc. (NYSE:PFE, "Pfizer"))), has been accepted for regulatory review by the Center for Drug Evaluation at the National Medical Products Administration (NMPA) of China. In August 2020, Basilea had announced that an MAA for Cresemba for the treatment of mucormycosis was accepted for review by the NMPA.

    David Veitch, Chief Executive Officer, said: "Invasive aspergillosis and mucormycosis are the two most frequent forms of invasive mold infections and important causes of morbidity and mortality in patients with hematologic malignancies undergoing intensive chemotherapy regimens. China is commercially a very important market for Cresemba, accounting for more than 15 percent of the global market for newer antifungals. We are therefore very pleased with the progress Pfizer is making in China. The acceptance of the isavuconazole marketing authorization applications for regulatory review is an important milestone in bringing Cresemba to the Chinese market and addressing the unmet medical needs of patients suffering from invasive mold infections."

    In November 2017, Basilea and Pfizer extended their existing license agreement for Europe (excluding the Nordics), Russia, Turkey and Israel, to include China, including Hong Kong and Macao, and sixteen countries in the Asia Pacific region. Under the agreement with Pfizer, Basilea is still eligible for regulatory and sales milestone payments of up to approximately USD 630 million, in addition to receiving mid-teen royalties on sales.

    Cresemba has been approved in more than 50 countries to date and is currently marketed in 48 countries, including the United States, most EU member states and several additional countries inside and outside of Europe. For the twelve-month period to the end of June 2020, total "in-market" sales of Cresemba amounted to USD 230 million, a 30 percent growth year-on-year.1

    About Cresemba (isavuconazole)

    Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. In the 27 European Union member states, as well as in Iceland, Liechtenstein, Norway and the U.K., isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.2 Cresemba is also approved in the United States and several additional countries in Europe and beyond.3 It has orphan drug designation in the U.S., Europe and Australia for its approved indications. Basilea has entered into several license and distribution agreements for isavuconazole covering the United States, Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa region, Canada, Russia, Turkey and Israel.

    About Basilea

    Basilea Pharmaceutica Ltd. is a commercial-stage biopharmaceutical company, focused on the development of products that address the medical challenges in the therapeutic areas of oncology and infectious diseases. With two commercialized drugs, the company is committed to discovering, developing and commercializing innovative pharmaceutical products to meet the medical needs of patients with serious and life-threatening conditions. Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's website www.basilea.com.

    Disclaimer

    This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd. and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    For further information, please contact:

    Peer Nils Schröder, PhD



    Head of Corporate Communications & Investor Relations
    Phone+41 61 606 1102
    E-mail

     This press release can be downloaded from www.basilea.com.

    References

    1. IQVIA, June 2020. In-market sales reported as moving annual total (MAT) in U.S. Dollar corrected for currency fluctuations.
    2. European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: November 24, 2020]
    3. The registration status and approved indications may vary from country to country.



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  2. If approved, marstacimab has potential to be a best-in-class treatment option among novel non-factor agents –

    Pfizer Inc. (NYSE:PFE) today announced that the first participant has been dosed in the Phase 3 BASIS study of marstacimab (PF-06741086), an anti-tissue factor pathway inhibitor (anti-TFPI) being evaluated for the treatment of people with severe hemophilia A or B, with or without inhibitors.

    BASIS is a global Phase 3, open-label, multicenter study that will evaluate annualized bleed rate (ABR) through 12 months on prophylaxis treatment with marstacimab, an investigational, novel subcutaneous therapy, in adolescents and adults with hemophilia A or B compared to a run-in period on replacement therapy with FVIII or FIX clotting factor…

    If approved, marstacimab has potential to be a best-in-class treatment option among novel non-factor agents –

    Pfizer Inc. (NYSE:PFE) today announced that the first participant has been dosed in the Phase 3 BASIS study of marstacimab (PF-06741086), an anti-tissue factor pathway inhibitor (anti-TFPI) being evaluated for the treatment of people with severe hemophilia A or B, with or without inhibitors.

    BASIS is a global Phase 3, open-label, multicenter study that will evaluate annualized bleed rate (ABR) through 12 months on prophylaxis treatment with marstacimab, an investigational, novel subcutaneous therapy, in adolescents and adults with hemophilia A or B compared to a run-in period on replacement therapy with FVIII or FIX clotting factor, respectively, or bypass therapy (i.e., treatments that "bypass" the need for clotting factor treatment to help the body form a normal clot). The primary endpoint is impact on ABR through 12 months following prophylaxis treatment with marstacimab. The incidence and severity of thrombotic events will also be assessed.

    "Our approach to hemophilia research includes the investigation of multiple mechanisms to help address the needs of all people with hemophilia, including those with hemophilia A or B, and with or without inhibitors, and targeting TFPI provides a novel approach to improve blood coagulation," said Brenda Cooperstone, Chief Development Officer, Rare Disease, Pfizer Global Product Development. "Based on the Phase 2 study findings to date, marstacimab may have the potential to offer improved bleed control via subcutaneous injection and potentially eliminate the need for prophylactic factor replacement, providing an enhanced treatment option compared to factor replacement therapy."

    The completed Phase 2 study results demonstrated that treatment with marstacimab showed significant (>75%) reductions in ABR for all participants in the study population. The participants were monitored in a long-term extension study, which showed sustained efficacy up to 12 months and no thrombotic events or treatment-related serious adverse events in 20 participants receiving weekly subcutaneous marstacimab doses at or above the dose to be studied in the BASIS Phase 3 pivotal trial (300 mg subcutaneous loading followed by 150 mg subcutaneous weekly).

    About the BASIS study

    BASIS is a global Phase 3, open-label, multicenter study evaluating annualized bleed rate through 12 months on treatment with marstacimab, an investigational, novel subcutaneous therapy option, in approximately 145 adolescent and adult participants between ages 12 to <75 years with severe hemophilia A or B (defined as factor VIII or factor IX activity <1%, respectively), with or without inhibitors. Approximately 20% of participants will be adolescents (ages between 12 to <18 years old). This study is comparing treatment with a run-in period on patients' prescribed factor replacement therapy or bypass therapy during a 6-month Observational Phase with a 12-month Active Treatment Phase, during which participants will receive prophylaxis (a 300 mg subcutaneous loading dose of marstacimab, followed by 150 mg subcutaneously once weekly) with potential for dose escalation to 300 mg once weekly.

    About Marstacimab (PF-06741086)

    Marstacimab (PF-06741086) is a human monoclonal immunoglobulin G isotype, subclass 1 (IgG1) that targets the Kunitz 2 domain of tissue factor pathway inhibitor (TFPI). Marstacimab is in development as a prophylactic treatment to prevent or reduce the frequency of bleeding episodes in individuals with severe hemophilia A or B (defined as factor VIII or factor IX activity <1%, respectively) with or without inhibitors. In September 2019, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to marstacimab for use in combination with inhibitors as a potential treatment for hemophilia A and B.

    About Hemophilia

    Hemophilia is a genetic hematological rare disease that results in a deficiency of a protein that is required for normal blood clotting—clotting factor VIII in hemophilia A and clotting factor IX in hemophilia B. The severity of hemophilia that a person has is determined by the amount of factor in the blood. The lower the amount of the factor, the more likely it is that bleeding will occur which can lead to serious health problems.

    Hemophilia A occurs in approximately one in every 5,000-10,000 male births worldwide, and the incidence of hemophilia B is one in 25,000 male births. For people who live with hemophilia, there is an increased risk of spontaneous bleeding as well as bleeding following injuries or surgery. It is a lifelong disease that requires constant monitoring and therapy.

    About Pfizer Rare Disease

    Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

    Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

    Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

    Pfizer Inc.: 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.

    PFIZER DISCLOSURE NOTICE:

    The information contained in this release is as of November 23, 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 an investigational hemophilia A / B therapy, marstacimab, including its potential benefits, 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 our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications for any potential indications for marstacimab may be filed in any jurisdictions; whether and when regulatory authorities in any jurisdictions may approve any such applications, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether marstacimab 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 marstacimab; uncertainties regarding the impact of COVID-19 on Pfizer's business, operations and financial results; 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.

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