GSK GlaxoSmithKline PLC

Westport, CT, April 09, 2021 (GLOBE NEWSWIRE) --

• Global leaders, including Amazon, Bayer, and GE Healthcare, joined the AAIH to date to collaborate on developing novel solutions to improve the quality of care and reduce failure rates
• The Company recently launched a new AI program with the Mayo Foundation for Medical Education

BioSig Technologies, Inc. (NASDAQ:BSGM) ("BioSig" or the "Company"), a medical technology company commercializing an innovative signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals, today announced that it had been invited by, and accepted, an invitation to join the Alliance for Artificial Intelligence in Healthcare (AAIH), following BioSig's major patent awards for its AI-based platform that the Company recently won from the U.S. Patent Office.

The AAIH is the global advocacy organization for the advancement and use of artificial intelligence in healthcare to improve patients' lives and create more efficient, sustainable, and accessible healthcare systems. The AAIH and its member companies and organizations are dedicated to developing novel interventions and product solutions to reduce failure rates and costs while improving quality across the entire healthcare spectrum from biomedical discovery, clinical research, medical diagnostics and devices, and precision medicine. The initiative, which spans out of the Alliance for Regenerative Medicine, was formally launched in 2019 with 22 founders, including Amazon WS (NASDAQ:AMZN), Bayer (XETR: BAYN), GE Healthcare (NYSE:GE), GlaxoSmithKline (NYSE:GSK), and the University of Pittsburg.

 "Artificial intelligence excels at analyzing and uncovering patterns in vast volumes of clinical data – a fundamental building block in improving patient care. BioSig is a company that is committed to providing superior technological solutions based on precise signal information. We believe that a joint effort between various healthcare community representatives is a much-needed step towards solving common challenges and accelerating the adoption of AI-powered solutions. We are excited to join the Alliance and collaborate with its members on our shared goals for improving the standards of patient care,' commented Kenneth L. Londoner, Chairman and CEO of BioSig Technologies, Inc.

BioSig recently launched a strategic collaboration with the Mayo Foundation for Medical Education and Research to develop a next-generation AI- and machine learning-powered software for the PURE EP™ System. The Company's platform technology provides signal information during the cardiac ablations for the treatments of arrhythmias or irregular heartbeats, a condition that affects over 33 million people worldwide^[1]. Under the terms of the newly launched  AI initiative, the Company aims to develop novel technological solutions to improve existing therapies by combining the PURE EP™'s electrophysiological signals and other data sources.

 The Company has also announced major strategic collaborations with other subject-matter experts to further the AI and machine learning applications of the PURE EP™ System in their collaboration for AI technical advisory services with Harvard- and MIT-trained computer scientist and physicist, Dr. Wissner-Gross, of Reified. In 2020, the Company co-authored an abstract with Reified, titled ‘Computational Reconstruction of Electrocardiogram Lead Placement,' that presented a new method for analyzing electrocardiograms that may ultimately help to improve the automated classification of patient conditions.

"This is an exciting time for artificial intelligence and machine learning applications in healthcare, and we look forward to contributing to next-generation technological solutions in the space," responded Dr. Wissner-Gross.

The global market for AI in healthcare is expected to grow from $4.9 billion in 2020 to $45.2 billion by 2026 at an estimated compound annual growth rate (CAGR) of 44.9%. According to Accenture, key clinical health AI applications, when combined, can potentially create $150 billion in annual savings for the United States healthcare economy by 2026.

About AAIH

The AAIH is a coalition of technology developers, pharmaceutical companies, and research organizations who have expressed the common goal of realizing the potential for AI and machine learning in healthcare to significantly improve quality of care, but who also recognize the need to address substantial industry challenges. By convening stakeholders to present a unified voice, we are working to establish responsible, ethical, and reasonable standards for the development and implementation of AI in healthcare. As an organization, the AAIH brings together industry, academia, research institutions, government NGOs, key opinion leaders, and other international stakeholders to develop appropriate regulatory principles. By engaging with a wide array of participants across the healthcare spectrum, the AAIH works to actualize the promise of artificial intelligence in medicine thereby improving patients' lives and creating more efficient, sustainable, and accessible healthcare systems. Learn more on www.theaaih.org. 

About BioSig Technologies

BioSig Technologies is a medical technology company commercializing a proprietary biomedical signal processing platform designed to improve signal fidelity and uncover the full range of ECG and intra-cardiac signals (www.biosig.com).

The Company's first product, PURE EP™ System is a computerized system intended for acquiring, digitizing, amplifying, filtering, measuring and calculating, displaying, recording and storing of electrocardiographic and intracardiac signals for patients undergoing electrophysiology (EP) procedures in an EP laboratory.

Forward-looking Statements

This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward- looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on our ability to conduct our business and raise capital in the future when needed, (ii) our inability to manufacture our products and product candidates on a commercial scale on our own, or in collaboration with third parties; (iii) difficulties in obtaining financing on commercially reasonable terms; (iv) changes in the size and nature of our competition; (v) loss of one or more key executives or scientists; and (vi) difficulties in securing regulatory approval to market our products and product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

¹ Top 10 Things You should Know About Heart Rhythm; Scripps Health

Andrew Ballou
BioSig Technologies, Inc. 
Vice President, Investor Relations 
54 Wilton Road, 2nd floor
Westport, CT 06880

203-409-5444, x133

WARREN, N.J., April 1, 2021 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) announced today that Flonase Allergy Relief (Flonase) is partnering with World Series champion and seasonal allergy-sufferer Cody Bellinger of the Los Angeles Dodgers as the new face of the brand's "Change The Game" campaign. The commitment is part of a larger partnership with Major League Baseball (MLB), recognizing Flonase as the Official Allergy Relief Partner of MLB.

"Baseball is a game that requires extreme focus, but unfortunately the field is full of common allergy triggers like grass pollen that can cause uncomfortable symptoms, like itchy and watery eyes," said Obehi Remi-John, Senior Brand Manager, Flonase. "As the Official Allergy Relief Partner of MLB, we are excited to bring allergy relief to athletes who play the game and fans who support them."

Bellinger is one of the 19.2 million Americans who suffer from seasonal allergies each year^*, making the start of baseball season especially challenging, as it also marks the start of allergy season.  Now a World Series champion, Bellinger knows what it takes to change the game – and isn't going to let spring allergy symptoms get in the way. This season, Bellinger is switching to Flonase to change the game on his allergy symptoms and get ahead of seasonal allergies.

"In this game, you have to be willing to change. Whether it's your stance, grip, or swing, the best players are constantly evolving," said Bellinger. "For years I struggled with allergies on the field, turning to pills that didn't offer complete relief^** of all my worst symptoms and I knew I had to make a change. Flonase gives me 24-hour all-in-one relief^***, so I can stay focused on the game."

With this new partnership, Flonase plans to focus baseball-themed marketing around their line of allergy relief sprays across a variety of digital and broadcast media, including MLB.com, and in-store at major retailers. 

Bellinger is also encouraging allergy sufferers to change their allergy game by trying Flonase with a 100% Money Back Guarantee. To learn more about Flonase and how they are helping Bellinger change the game, visit www.flonase.com/ChangeTheGame.   

^*according to the CDC (https://www.cdc.gov/nchs/fastats/allergies.htm)

^**Vs. single-ingredient antihistamines which do not treat nasal congestion.

^***Flonase relieves nasal congestion, sneezing, runny nose, itchy nose, itchy eyes and watery eyes.

About Flonase Sensimist Allergy Relief

Flonase Sensimist Allergy Relief (fluticasone propionate 50 mcg spray) is an approved over-the-counter (OTC) treatment indicated for hay fever symptoms including nasal congestion, runny nose, sneezing, itchy nose and itchy, watery eyes in adults and children 12 years of age and older.

About GSK Consumer Healthcare 

GSK Consumer Healthcare combines science and consumer insights to create innovative world-class health care brands that consumers trust and experts recommend for oral health, pain relief, respiratory and wellness. 

View original content to download multimedia:http://www.prnewswire.com/news-releases/flonase-teams-up-with-major-league-baseball-and-world-series-champion-cody-bellinger-to-change-the-game-on-allergy-season-301260068.html

SOURCE GSK Consumer Healthcare

INDIANAPOLIS and SAN FRANCISCO and LONDON, March 29, 2021 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE:LLY), Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19. Results showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70 percent (p<0.001) relative reduction in persistently high viral load (> 5.27; cycle threshold value < 27.5) at day 7 compared to placebo, meeting the primary endpoint.

In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5 and 7 in SARS-CoV-2 viral load. There were no events for the secondary endpoint of COVID-19 related hospitalization or death by day 29 in either study arm. One patient (in the treatment arm) visited the emergency room for COVID-19 related symptoms. No serious adverse events were seen with co-administration of bamlanivimab and VIR-7831.

Bamlanivimab and VIR-7831 bind to different regions of the spike protein of SARS-CoV-2. Preclinical data suggest the administration of these two investigational antibodies together may provide protection against current variants of SARS-CoV-2 that are resistant to bamlanivimab.

Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, said: "The reduction in persistently high viral load is an important virology endpoint that was demonstrated in Lilly's Phase 2 BLAZE-1 trial, and subsequently validated in the Phase 3 trial, to be strongly correlated with the clinical outcome of COVID-19 related hospitalizations and deaths in high-risk patients. These virology data support our belief that bamlanivimab and VIR-7831 together could be a promising option for COVID-19 treatment."

George Scangos, Ph.D., chief executive officer of Vir, said: "This virologic evaluation of two antibodies with distinct resistance profiles is an encouraging advance in our fight against the pandemic. VIR-7831 demonstrated positive results in the COMET-ICE trial and recent pre-clinical data suggest that VIR-7831 maintains activity against current circulating variants of concern. Now, with these exciting new data from the BLAZE-4 trial, we believe that VIR-7831 has an important role to play as both monotherapy and in combination with other mAbs. We look forward to continuing conversations with the FDA about VIR-7831 as monotherapy and co-administered with bamlanivimab."

Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "These early data from the BLAZE-4 trial, coupled with the results of the COMET-ICE trial demonstrating an 85 percent reduction in progression to hospitalization or death using VIR-7831, support our hypothesis that by targeting a highly conserved epitope, VIR-7831 may help deliver benefits to patients. We're continuing to work with regulators to bring VIR-7831 as a monotherapy and potentially co-administered with other monoclonal antibodies to patients in need."

VIR-7831 is an investigational compound, not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. An Emergency Use Authorization (EUA) application for VIR-7831 has been submitted to the FDA, based on the results of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which stopped enrollment early based on data from an interim analysis demonstrating an 85 percent reduction in hospitalisation or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible. The three companies anticipate engaging with global regulators, including the FDA, regarding the possible co-administration of bamlanivimab and VIR-7831 for the treatment of COVID-19.

Important Information about bamlanivimab

Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.

Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers (English) (Spanish).

Authorized Use and Important Safety Information

Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Limitations of Authorized Use

• Bamlanivimab is not authorized for use in patients:
  • who are hospitalized due to COVID-19, OR
  • who require oxygen therapy due to COVID-19, OR
  • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
• Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.
  
  

Important Safety Information

There are limited clinical data available for bamlanivimab. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab use.

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

Infusion-related reactions have been observed with administration of bamlanivimab. These reactions may be severe or life threatening. Signs and symptoms of infusion-related reactions may include:

• fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness, and diaphoresis.
  
  

If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

Clinical Worsening After Bamlanivimab Administration

Clinical worsening after administration of bamlanivimab has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to bamlanivimab use or were due to progression of COVID-19.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. See Limitations of Authorized Use.

Adverse Events

Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), Diarrhea (1% vs 5%), Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and Vomiting (1% vs 3%).

Use in Specific Populations

Pregnancy

There are insufficient data on the use of bamlanivimab during pregnancy. Bamlanivimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bamlanivimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

About BLAZE-4

BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies including VIR-7831 (GSK4182136) versus placebo for the treatment of symptomatic low-risk COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.

The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include viral load change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

About COMET-ICE

COMET-ICE is a multi-center, double-blind, placebo-controlled Phase 3 trial evaluating VIR-7831 in adults with mild or moderate COVID-19 at high risk of progression to severe disease. The trial was stopped for enrollment on March 10, 2021, based on an interim analysis, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo.

About bamlanivimab 

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About the Vir and GSK Coronavirus Collaboration

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Lilly's COVID-19 Efforts

Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Visit Lilly's COVID-19 disease area page for resources related to Lilly's COVID-19 efforts.

GSK Commitment to Tackling COVID-19

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

GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation 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 also working with 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.

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 hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and authorizations 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 Eli Lilly and Company  

Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

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.

Lilly Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a potential treatment for patients with or at risk of infection from COVID-19, alone and in combination with other antibodies, including VIR-7831, and Lilly's development plans and collaboration efforts, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization and in drug collaborations. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that bamlanivimab alone or administered with VIR-7831 or any other therapy will prove to be a safe and effective treatment or preventative for COVID-19, that bamlanivimab alone or administered with VIR-7831 or any other therapy will receive regulatory approvals or additional authorizations, that patients will volunteer to participate in a study of bamlanivimab alone or administered with VIR-7831 or any other therapy or achieve positive outcomes or that Lilly and its partners can provide an adequate supply of bamlanivimab alone or administered with VIR-7831 or any other therapy in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. 

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 to treat and/or prevent COVID-19 (as monotherapy and in combination with bamlanivimab), the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir's collaboration with GSK, and statements related to regulatory authorizations and approvals, including plans to continue discussions with the FDA, the EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

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.

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LONDON and SAN FRANCISCO, March 26, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the submission of an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for VIR-7831 (GSK4182136), an investigational dual-action SARS-CoV-2 monoclonal antibody for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with mild-to-moderate COVID-19 who are at risk for progression to hospitalization or death.

The FDA EUA submission is based on an interim analysis of efficacy and safety data from the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which evaluated VIR-7831 as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization. Results of the interim analysis, based on data from 583 patients enrolled in the trial, demonstrated an 85% (p=0.002) reduction in hospitalization or death in those receiving VIR-7831 compared to placebo, the primary endpoint of the trial. As a result, the Independent Data Monitoring Committee recommended that the trial be stopped for enrollment due to evidence of profound efficacy. Data from the registrational COMET-ICE trial also will form the basis for a Biologics License Application (BLA) submission to the FDA.

Preclinical data suggest VIR-7831 targets a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. New in vitro data from pseudotyped virus assays published online in bioRxiv in March 2021 support this hypothesis as they demonstrate that VIR-7831 maintains activity against current circulating variants of concern including the UK, South African and Brazilian variants. Based on additional soon to be published preclinical data, VIR-7831 also appears to maintain activity against the California variant.

GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible. 

About COMET-ICE 

The multi-center, double-blind, placebo-controlled COMET-ICE trial investigated VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 2 lead-in portion of the trial, which served as the first-in-human assessment, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults enrolled across the United States. In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial.

In March 2021, an Independent Data Monitoring Committee recommended that the COMET-ICE trial be stopped for enrollment due to evidence of profound efficacy but is continuing to follow study participants for 24 weeks. Additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.

The Phase 3 portion of the trial assessed the safety and efficacy of a single IV infusion of VIR-7831 (500 mg) or placebo in non-hospitalized participants globally. The interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization.

About the VIR-7831 Clinical Development Program

In addition to the COMET-ICE trial, the full COMET clinical development program for VIR-7831 includes:

• COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
• COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
• COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.
  
  

VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. Additionally, VIR-7831, along with VIR-7832 will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority. 

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration 

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

GSK Commitment to Tackling COVID-19 

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

GSK is collaborating with several organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with Sanofi on an adjuvanted, protein-based vaccine candidate is now in Phase 2. An earlier stage collaboration with SK Bioscience is also ongoing. SK Bioscience receives funding from CEPI and the Bill and Melinda Gates Foundation 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 also working with 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.

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 hospitalization be stopped for enrolment due to evidence of profound efficacy, based on an interim analysis of data from the trial. We are seeking Emergency Use Authorization in the US and authorizations 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 Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of preclinical and clinical data, clinical development program updates, and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus, Vir's collaboration with GSK, and statements related to regulatory authorizations and approvals, including Vir's plans to submit a BLA to the FDA and continue discussions with the EMA and other global regulators. Many factors may cause differences between current expectations and actual results, including challenges in obtaining regulatory approval, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

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.

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- The first two programs selected under the agreement are for oncology and CNS disorders -

Boston Pharmaceuticals announced today a pioneering three-year out-license and option agreement with GlaxoSmithKline PLC (NYSE:GSK). Boston Pharmaceuticals will become a preferred GSK partner for select pre-phase 2 programs. This new agreement builds on the relationship established in 2018 with Boston Pharmaceuticals' acquisition of five GSK programs.

"This new agreement validates Boston Pharmaceuticals as a trusted development partner with whom pharmaceutical companies can collaborate," said Robert Armstrong, Ph.D., CEO of Boston Pharmaceuticals. "GSK has been an excellent partner and we look forward to advancing these pre-phase 2 assets into and through the clinic to evaluate their potential to improve patient lives."

Initially, GSK will out-license and option two programs to Boston Pharmaceuticals:

• GSK3903371 - a monoclonal antibody targeting the Interleukin-1 Receptor Accessory Protein (IL1RAP), a tumor-associated antigen driving tumor growth and immunosuppression.
• GSK3502421 - an orally available, small molecule inhibitor for potential neurological disorders that targets Receptor Interacting Serine/Threonine Kinase 1 (RIPK1), a key component of the TNF-driven inflammation and necroptosis pathway.

"We are pleased to further strengthen our relationship with Boston Pharmaceuticals as they continue to help us translate great science into medicines," said John Lepore, SVP, Research of GSK. "This agreement makes strong strategic sense as it helps us assess the potential of multiple early-stage programs and focus on progressing our own internal assets, while maintaining pipeline optionality for the future."

Under the agreement, Boston Pharmaceuticals will be responsible for further development of select programs through proof-of-concept (PoC). Following the completion of PoC studies, GSK will have the option to reacquire each program under pre-agreed terms for subsequent development and worldwide commercialization.

If GSK exercises its repurchase option, Boston Pharmaceuticals will receive a one-time payment, as well as be eligible for approval and sales milestones and royalties. In the event GSK chooses not to reacquire a program, Boston Pharmaceuticals may continue development and potential commercialization of the program. GSK will then be eligible to receive milestones and royalty payments.

About Boston Pharmaceuticals

Boston Pharmaceuticals is a clinical stage biopharmaceutical company that leverages an experienced drug development team to advance a portfolio of high value candidates that address important unmet medical needs. The Company partners with innovative biotechnology and pharmaceutical companies to acquire drug development candidates. We employ unencumbered decision making, follow the data and advance only those programs that meet our stringent development hurdles. Following clinical proof of concept, we establish value creating partnerships with the world's leading biotechnology and pharmaceutical companies or advance programs through commercialization. We are continuously seeking new opportunities to leverage our model to create a path to value for our partners and patients. Boston Pharmaceuticals is a portfolio company of Gurnet Point Capital, a Cambridge, MA based private equity firm focused on healthcare investing. For more information, please visit www.bostonpharmaceuticals.com or follow us on Twitter @BosPharma and LinkedIn.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210318005100/en/

– Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalization or death –

– Vir and GSK plan to immediately seek Emergency Use Authorization in the U.S. and authorizations in other countries –

– Additional new in vitro studies indicate VIR-7831 maintains activity against major circulating COVID-19 variants –

SAN FRANCISCO and LONDON, March 10, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced that an Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial evaluating VIR-7831 (GSK4182136) as monotherapy for the early treatment of COVID-19 in adults at high risk of hospitalization be stopped for enrollment due to evidence of profound efficacy.

The IDMC recommendation was based on an interim analysis of data from 583 patients enrolled in the COMET-ICE trial, which demonstrated an 85% (p=0.002) reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. VIR-7831 was well tolerated. As the trial remains ongoing and blinded with patients continuing to be followed for 24 weeks, additional results, including epidemiology and virology data, will be forthcoming once the trial is completed.

Based on these results, Vir and GSK plan to submit an Emergency Use Authorization (EUA) application to the U.S. Food and Drug Administration (FDA) and for authorizations in other countries. Data from this registrational trial will also form the basis for a Biologics License Application (BLA) submission to the FDA.

The companies also announced today the results of a new study submitted and pending online publication in bioRxiv, demonstrating that VIR-7831 maintains activity against current circulating variants of concern, including the UK, South African and Brazilian variants, based on in vitro data from pseudotyped virus assays. In contrast to other monoclonal antibodies, VIR-7831 binds to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop.

In addition to COMET-ICE, the full COMET clinical development program for VIR-7831 includes:

• COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered VIR-7831 to 500 mg intravenously administered VIR-7831 among low-risk adults with mild to moderate COVID-19 and to evaluate the similarity in pharmacokinetics between VIR-7831 manufactured by different processes.
• COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 in high-risk adults to assess whether IM-administered VIR-7831 can reduce hospitalization or death due to COVID-19.
• COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered VIR-7831 can prevent symptomatic infection.
  
  

George Scangos, Ph.D., chief executive officer of Vir, said: "These exciting data with a single antibody against a conserved epitope bring us one step closer to delivering an effective new solution to patients around the globe. The dual-action design of VIR-7831 to both block viral entry into healthy cells and clear infected cells, as well as its high barrier to resistance, are key distinguishing characteristics. These findings, paired with our pending publication of resistance data, demonstrate the potential of VIR-7831 to prevent the most severe consequences of COVID-19 and highlight its potential ability to protect against the current circulating strains of the virus."

Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "We are pleased that this unique monoclonal antibody was able to bring such a profound benefit to patients. We look forward to the possibility of making VIR-7831 available to patients as soon as possible and to further exploring its potential in other settings."

The Phase 3 portion of the COMET-ICE trial assessed the safety and efficacy of a single intravenous infusion of VIR-7831 (500 mg) or placebo in non-hospitalized participants globally, and this interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization for at least 24 hours or death within 29 days of randomization. Among those studied, 63% were Hispanic or Latinx and 7% were Black or African American. According to the Centers for Disease Control and Prevention, these populations are approximately three times more likely to be hospitalized¹ and approximately two times more likely to die² of COVID-19.

VIR-7831 is also being evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by Eli Lilly and Company, designed to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19.

Additionally, VIR-7831, along with VIR-7832 will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority. 

COMET-ICE Clinical Trial Design

The multi-center, double-blind, placebo-controlled COMET-ICE trial is investigating VIR-7831 in adults with mild or moderate COVID-19 who are at high risk of progression to severe disease. The Phase 1 lead-in portion of the trial, which served as the first-in-human assessment, evaluated the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in 21 non-hospitalized adults enrolled across the United States.

In October 2020, based on a positive evaluation of safety and tolerability data of VIR-7831 from the lead-in part of the trial by an Independent Data Monitoring Committee, the trial began enrolling patients in North America and additional sites in South America and Europe in the global Phase 3 portion of the trial. This part of the trial is assessing the safety and efficacy of a single IV infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally.

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

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 organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to work with Sanofi, our collaboration with Medicago on an adjuvanted, protein-based vaccine candidate is now in late-stage clinical trials. An earlier stage collaboration with SK Bioscience is also ongoing, with funding from CEPI and Bill and Melinda Gates Foundation, 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, contributing to protecting more people.

GSK is also working with 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, if approved.

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.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

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.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of clinical data, program updates and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus, the ability of VIR-7831 to maintain full activity against variant strains of the virus and statements related to the planned full analysis of the COMET-ICE trial. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

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 published on 9 March 2021 or contained in the Company's Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

Inside Information

This announcement contains inside information. The person responsible for arranging the release of this announcement on behalf of GSK is Victoria Whyte, Company Secretary.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

_______________________________

<sup>¹ Data source: COVID-NET (https://www.cdc.gov/coronavirus/2019-ncov/covid-data/covid-net/purpose-methods.html, accessed March 1, 2020, through January 30, 2021). Numbers are ratios of age-adjusted rates standardized to the 2019 US standard COVID-NET catchment population.

² Data source: NCHS provisional death counts (https://data.cdc.gov/NCHS/Deaths-involving-coronavirus-disease-2019-COVID-19/ks3g-spdg, data through January 30, 2021). Numbers are ratios of age-adjusted rates standardized to the 2019 US intercensal population estimate.</sup>

Vir Biotechnology Contacts: 
Cara Miller
VP, Corporate Communications

+1 415 941 6746

GSK Contacts:
    
Media:

Simon Steel
+44 (0) 20 8047 5502 
(London)

Tim Foley
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+1 202 603 5003 
(Washington DC)
    
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Frannie DeFranco
+1 215 751 4855 
(Philadelphia)

SAN FRANCISCO and LONDON, March 03, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today provided an update on the VIR-7831 (GSK4182136) arm of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. The companies were informed that while VIR-7831 met initial pre-specified criteria to continue to the next phase of the ACTIV-3 trial and there were no reported safety signals, sensitivity analyses of the available data raised concerns about the magnitude of potential benefit. The independent Data and Safety Monitoring Board (DSMB) has recommended that the VIR-7831 arm of the trial be closed to enrollment while the data mature. The companies will continue discussions with the NIH about appropriate ways to further assess the potential of VIR-7831 in the hospitalized population as all parties gain a fuller understanding of the still-emerging data. 

The DSMB recommendation was based on a routine, pre-planned safety and efficacy data review of the first 300 patients hospitalized with COVID-19 enrolled in ACTIV-3.

George Scangos, Ph.D., chief executive officer of Vir, said: "While we are disappointed with the recommendation of the DSMB, we are encouraged by the safety profile of VIR-7831 and by the possibility of a benefit on top of remdesivir and corticosteroids in this advanced cohort of patients. We want to thank NIH for their work to assess the benefits of VIR-7831 and other agents, and look forward to working with them to further understand the potential of VIR-7831 to provide a benefit in this population. In addition, we are eagerly anticipating the upcoming data from the Phase 3 COMET-ICE trial in newly-diagnosed COVID-19 patients at high risk of hospitalization."

Christopher Corsico, Senior Vice President Development, GSK, said: "We want to thank the patients who participated in this study and the NIH for investing in the ACTIV trial to evaluate the four monoclonal antibodies, as it recognizes the need for differentiated treatments, especially as new variants emerge globally. These and other anticipated data will provide valuable insights about how VIR-7831 can contribute to the fight against this pandemic."

VIR-7831 is an investigational, dual-action monoclonal antibody that has been shown in preclinical trials to both block viral entry into healthy cells and clear infected cells, which may protect patients from disease progression.

The antibody has also shown the ability to neutralize the SARS-CoV-2 live virus by binding to a highly conserved epitope of the spike protein, which may make it more difficult for resistance to develop. So far, the variants of concern, including the UK, South African and Brazilian variants, do not overlap with the VIR-7831 targeted epitope of the virus, and, therefore, VIR and GSK believe that it should maintain full activity against these strains.

In addition to the ACTIV-3 trial, VIR-7831 is also being evaluated in the outpatient setting in the following clinical trials:

• COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early): A Phase 3 trial to evaluate VIR-7831 for the early treatment of COVID-19 in adults at high risk of hospitalization or death.
• BLAZE-4 (sponsored by Eli Lilly and Company): A Phase 2 trial designed to assess the safety and efficacy of Eli Lilly's bamlanivimab (LY-CoV555) alone and bamlanivimab with other neutralizing antibodies, including VIR-7831, versus placebo in low-risk adults with mild to moderate COVID-19. 

Additionally, VIR-7831, along with VIR-7832, will be evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment.

VIR-7831 and VIR-7832 are investigational compounds, not approved by the U.S. Food and Drug Administration or any other regulatory authority. 

About VIR-7831 / GSK4182136

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831, which incorporates Xencor's Xtend™ technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About VIR-7832 / GSK4182137

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832, which incorporates Xencor's Xtend and other Fc technologies, has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 also has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

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 organizations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to work with Sanofi, our collaboration with Medicago on an adjuvanted, protein-based vaccine candidate is now in late-stage clinical trials. An earlier stage collaboration with SK Bioscience is also ongoing, with funding from CEPI and Bill and Melinda Gates Foundation, 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, contributing to protecting more people.

GSK is also working with 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, if approved.

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.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

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.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing of availability of clinical data, program updates and data disclosures related to VIR-7831, the ability of VIR-7831 and VIR-7832 to treat and/or prevent COVID-19, the potential of VIR-7831 in the hospitalized population, the ability of VIR-7831 to neutralize the SARS-CoV-2 live virus and the ability of VIR-7831 to maintain full activity against variant strains of the virus. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

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.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

Vir Biotechnology Contacts: 
Cara Miller
VP, Corporate Communications

+1 415 941 6746

GSK Contacts:
    
Media:

Simon Steel
+44 (0) 20 8047 5502 
(London)

Tim Foley
+44 (0) 20 8047 5502 
(London)

Kristen Neese
+1 804 217 8147 
(Philadelphia)

Kathleen Quinn    
+1 202 603 5003 
(Washington DC)
    
Analysts/Investors:

Sarah Elton-Farr
+44 (0) 20 8047 5194 
(London)

Sonya Ghobrial       
+44 (0) 7392 784784 
(Consumer)

Danielle Smith
+44 (0) 20 8047 0932 
(London)

James Dodwell       
+44 (0) 20 8047 2406 
(London)

Jeff McLaughlin       
+1 215 751 7002 
(Philadelphia)

Frannie DeFranco
+1 215 751 4855 
(Philadelphia)

PLANEGG/MUNICH, GERMANY / ACCESSWIRE / March 2, 2021 / MorphoSys AG ((FSE:MOR, Prime Standard Segment, MDAX &, TecDAX, NASDAQ:MOR), a commercial-stage biopharmaceutical company and a leader in antibody, protein and peptide technologies, announced today that its licensing partner GlaxoSmithKline plc (NYSE:GSK) reported preliminary results of the OSCAR (Otilimab in Severe COVID-19 Related Disease) study using otilimab (formerly MOR103/GSK3196165) for the treatment of severe pulmonary COVID-19 related disease. Given these data suggest an important clinical benefit in a pre-defined sub-group of high-risk patients and the urgent public health need, GSK has amended the OSCAR study to expand this cohort to confirm these potentially significant findings.

This event of the first patient dosed in the expanded study triggers milestone payments of a total of €16 million to MorphoSys.

Otilimab is an investigational human monoclonal antibody directed against GM-CSF (granulocyte-macrophage colony-stimulating factor) that was generated by MorphoSys and outlicensed to GSK in 2013. GSK is also developing otilimab for the treatment of rheumatoid arthritis in the ongoing Phase 3 ContRAst trials.

"The preliminary study results with otilimab are encouraging news for patients 70 and older with severe COVID-19 related pulmonary disease," said Dr. Malte Peters, Chief Research and Development Officer of MorphoSys AG. "We are pleased that our licensing partner GSK is expanding the study in order to further explore otilimab as a potential treatment option for this group of older adults suffering from severe forms of COVID-19."

About the OSCAR study

This global, randomised, double-blind, placebo-controlled, multi-centre, proof-of-concept phase 2a OSCAR study (NCT04376684) assessed the efficacy and safety of a single intravenous infusion of otilimab 90 mg given over an hour or placebo in addition to standard of care in 806 hospitalised adults (ages 18 to 79 years) with severe COVID-19 related pulmonary disease. Standard of care permitted the use of corticosteroids (including dexamethasone), remdesivir, and convalescent plasma according to local hospital/institutional policies. Study participants were enrolled at 130 sites around the world, including in the United States, Europe, Asia, Russia, South Africa and South America. All participants had a positive SARS-CoV-2 test result; been hospitalised due to a diagnosis of pneumonia; had new onset of oxygenation impairment requiring high-flow oxygen, non-invasive ventilation or mechanical ventilation <48 hours before dosing; and had increased biological markers of systemic inflammation.

Participants were considered ‘alive and free of respiratory failure' if they were off significant oxygen support measured using a GlaxoSmithKline (GSK) modified version ordinal scale adapted from World Health Organization (WHO) scale 2020. A full analysis is ongoing and will be made available in an upcoming pre-print publication when available.

About MorphoSys

MorphoSys is a commercial-stage biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies for patients suffering from cancer and autoimmune diseases. Based on its leading expertise in antibody, protein and peptide technologies, MorphoSys, together with its partners, has developed and contributed to the development of more than 100 product candidates, of which 27 are currently in clinical development. In 2017, Tremfya^®, developed by Janssen Research & Development, LLC and marketed by Janssen Biotech, Inc., for the treatment of plaque psoriasis, became the first drug based on MorphoSys' antibody technology to receive regulatory approval. In July 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval of the company's proprietary product Monjuvi^® (tafasitamab-cxix) in combination with lenalidomide in patients with a certain type of lymphoma.

Headquartered near Munich, Germany, the MorphoSys group, including the fully owned U.S. subsidiary MorphoSys US Inc., has more than 600 employees. More information at www.morphosys.com or www.morphosys-us.com.

Monjuvi^® and HuCAL^® are registered trademarks of MorphoSys AG.

Tremfya^® is a registered trademark of Janssen Biotech, Inc.

MorphoSys Forward-Looking Statements

This communication contains certain forward-looking statements concerning the MorphoSys group of companies, including the expectations regarding Monjuvi's ability to treat patients with relapsed or refractory diffuse large B-cell lymphoma, the further clinical development of tafasitamab-cxix, including ongoing confirmatory trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "would," "could," "potential," "possible," "hope" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements contained herein represent the judgment of MorphoSys as of the date of this release and involve known and unknown risks and uncertainties, which might cause the actual results, financial condition and liquidity, performance or achievements of MorphoSys, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if MorphoSys' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are MorphoSys' expectations regarding risks and uncertainties related to the impact of the COVID-19 pandemic to MorphoSys' business, operations, strategy, goals and anticipated milestones, including its ongoing and planned research activities, ability to conduct ongoing and planned clinical trials, clinical supply of current or future drug candidates, commercial supply of current or future approved products, and launching, marketing and selling current or future approved products, the global collaboration and license agreement for tafasitamab, the further clinical development of tafasitamab, including ongoing confirmatory trials, and MorphoSys' ability to obtain and maintain requisite regulatory approvals and to enroll patients in its planned clinical trials, additional interactions with regulatory authorities and expectations regarding future regulatory filings and possible additional approvals for tafasitamab-cxix as well as the commercial performance of Monjuvi, MorphoSys' reliance on collaborations with third parties, estimating the commercial potential of its development programs and other risks indicated in the risk factors included in MorphoSys' Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. MorphoSys expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

For more information, please contact:

SOURCE: MorphoSys AG

– Companies applying their combined expertise in immunology and infectious diseases to accelerate the development of promising monoclonal antibody candidates for influenza –

– Functional genomics collaboration expanded to include respiratory viruses, Vir's unique technology, and access to GSK's small molecule compounds –

– Additional exploration of up to three other antibodies for pathogens

beyond influenza and coronaviruses –

– GSK is increasing its equity investment by $120 million and making an upfront

payment of $225 million –

LONDON and SAN FRANCISCO, Feb. 17, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (NYSE:GSK) and Vir Biotechnology, Inc. (NASDAQ:VIR) today announced they have signed a binding agreement to expand their existing collaboration to include the research and development of new therapies for influenza and other respiratory viruses.

The expanded collaboration, which builds on the agreement signed in 2020 to research and develop therapies for coronaviruses, provides GSK exclusive rights to collaborate with Vir on the development of potential best-in-class monoclonal antibodies (mAbs) for the prevention or treatment of influenza. These include VIR-2482, an intramuscularly administered investigational mAb designed as a universal prophylactic for influenza A that has completed a Phase 1 trial, as well as next-generation antibodies for the prevention or treatment of influenza during a three-year research period. GSK will have the exclusive option to co-develop VIR-2482 after Vir completes and reports Phase 2 trial outcomes, and will share development costs on the development of all other influenza mAbs.

Influenza causes up to 500,000 hospitalizations and 34,000 deaths each year in the United States alone,¹ approximately 75% of which are caused by influenza A.² The protection provided by current vaccines varies from season to season, based on the virus strains circulating. People over 65 years of age with at least one comorbidity, such as cardiovascular disease, diabetes or who are immunocompromised, are at significantly increased risk of flu and flu-related hospitalization and mortality. This is also a population where the currently available vaccines have historically had lower efficacy.

As part of the new collaboration agreement, the companies will also engage in two additional research programs. The first is an expansion of their current functional genomics collaboration to develop potential pan-coronavirus therapeutics to now include other respiratory virus targets. Under the second program, the companies will collaborate to develop up to three neutralizing monoclonal antibodies identified using Vir's antibody technology platform to target non-influenza pathogens during a three-year research period.

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "We believe, now more than ever, that it is very important to develop new therapies to treat and ideally prevent infectious diseases. I am delighted that we are expanding our collaboration with Vir whose focus on novel antibodies, expertise in functional genomics, unique technology and talented scientists will further strengthen GSK's position as a world leader in infectious diseases."

George Scangos, Ph.D., CEO, Vir Biotechnology, said: "GSK has been a valuable strategic partner and scientific collaborator in the fight against COVID-19. As part of our functional genomics collaboration directed at COVID-19, we have turned up multiple targets that have the potential to treat influenza and other respiratory viruses, and it makes sense to extend the scope of our collaboration to include these new targets. This expanded collaboration supports the rapid advancement of multiple promising investigational compounds in our pipeline, increasing the likelihood that these potential life-saving treatments will reach patients sooner, and will advance our shared goal of developing single drugs that can address multiple ‘bugs.'"

Under the terms of the agreement, GSK will make an upfront payment of $225 million and a further equity investment in Vir of $120 million. Initially, Vir will continue to fund the development of VIR-2482 through completion of Phase 2 trials, after which time, if GSK exercises its option to co-develop VIR-2482, it will pay an option fee of $300 million. Following option exercise for VIR-2482, and for each other program in the expanded collaboration, the companies will share the development costs and related profits associated with this agreement. GSK will also pay Vir up to $200 million based on the successful delivery of pre-defined regulatory milestones. The equity investment and collaboration agreement are conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.

GSK and Vir entered into an initial strategic collaboration in April 2020 to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The focus of the collaboration to date has been the development of specific antibody candidates identified by Vir's monoclonal antibody platform, VIR-7831 and VIR-7832, that have demonstrated the potential to both block viral entry into healthy cells and clear infected cells, and to provide a high barrier to resistance. VIR-7831 is currently in two global Phase 3 studies as monotherapy and one Phase 2 study as combination therapy, with initial results from the first of the Phase 3 studies expected in the first quarter of 2021. VIR-7832 has been accepted into the NHS-supported AGILE Phase 1b/2a study with a planned start in February 2021.

About Vir's Antibody Platform

Vir has a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. The platform is used to identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. Vir engineers the fully human antibodies that it discovers to enhance their therapeutic potential. This platform has been used to identify and develop antibodies for pathogens including SARS-CoV-2, hepatitis B virus, influenza A, Ebola (mAb114, approved for use in the U.S. as Ebanga^TM and marketed by Ridgeback Therapeutics LP), malaria and others.

About VIR-2482

VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a universal prophylactic for influenza A. It has the potential to overcome the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482 has been half-life engineered so that a single dose has the potential to last the entire flu season.

About VIR-7831 / GSK4182137

VIR-7831 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About VIR-7832 / GSK4182136

VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 has also been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About the Vir and GSK Collaboration

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies are leveraging GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They are also applying their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

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.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include statements regarding the potential benefits of the collaboration with GSK, the completion of a definitive collaboration agreement, the total potential deal value of the collaboration, the ability to obtain clearance under the HSR Act and to satisfy the other closing conditions, the potential benefits of VIR-2482, and Vir's ability to address influenza, respiratory diseases, coronaviruses, including the current COVID-19 pandemic, and future outbreaks of any such diseases. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

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 Q4 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 2018-2019 flu season data from the Centers for Disease Control and Prevention.

² Zhou et al. Clinical Infectious Diseases. 2012:54:1427-1436.

Vir Biotechnology Contact:
Cara Miller
VP, Corporate Communications

+ 1 415 941 6746

GSK Contacts:

Media:

Simon Steel
+44 (0) 20 8047 5502
(London)

Tim Foley
+44 (0) 20 8047 5502
(London)

Kristen Neese
+1 804 217 8147
(Philadelphia)

Kathleen Quinn
+1 202 603 5003
(Washington DC)

Analysts/Investors:

Sarah Elton-Farr
+44 (0) 20 8047 5194
(London)

Sonya Ghobrial
+44 (0) 7392 784784
(Consumer)

James Dodwell
+44 (0) 20 8047 2406
(London)

Jeff McLaughlin
+1 215 751 7002
(Philadelphia)

Frannie DeFranco
+1 215 751 4855
(Philadelphia)

WARREN, N.J., Feb. 16, 2021 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced the launch of TUMS Naturals, a new naturally-powered antacid joining the TUMS portfolio. As America's #1 heartburn relief medicine, TUMS is building its already expansive portfolio to meet growing consumer preferences for natural products by adding antacids that are free-from artificial flavors and dyes to its wide-range of heartburn relief offerings. Like all the brands' products, new TUMS Naturals deliver fast and powerful multi-symptom relief from the discomforts of burning in the chest, acid indigestion, sour and upset stomach, so heartburn sufferers can enjoy "worth the burn" or #TUMSworthy moments.

Research has continued to demonstrate that a growing number of consumers prefer products with natural ingredients but struggle to find options from brands they love and trust. This insight sparked TUMS to adapt their long-trusted products to satisfy this consumer desire, without having to sacrifice the fast heartburn relief consumers depend on from TUMS.

"As consumers are increasingly aware of the ingredients they consume, we saw an opportunity to offer them the efficacy they rely on and expect from TUMS, while delivering on their desire for more natural-leaning solutions to their medicinal needs," says Amy Sharon, Director at TUMS. "Millions of people suffer from heartburn, caused by things like stress and the foods they consume, and our mission is to continue ensuring they have access to relief that fits their personal preferences, so heartburn isn't something they have to worry about."  

TUMS Naturals goes to work in seconds by travelling directly to the source of heartburn, dissolving swiftly to neutralize stomach acid on contact. It is available in two fruity flavor combinations – Black Cherry & Watermelon and Coconut Pineapple – both of which feature the natural active ingredient Calcium Carbonate and do not contain artificial flavors, dyes, GMOs or gluten. Additionally, the packaging is 100% recyclable.

TUMS Naturals are available now at drugstores nationwide in a variety of sizes joining a large portfolio of products that provide fast heartburn relief. From TUMS Chewy Bites which feature a chewy outer shell to the deliciously smooth and tasty TUMS Smoothies – there's a TUMS flavor and form to ensure everyone can get back to enjoying #TUMSworthy moments. For more information on TUMS and the new products, visit www.TUMS.com.

About TUMS

TUMS Antacid Tablets go to work in seconds for delicious, chewable heartburn relief. Featuring the active ingredient calcium carbonate, these chewable antacid tablets provide heartburn, sour stomach and acid indigestion relief, as well as upset stomach relief associated with these symptoms. TUMS antacid tablets are the #1 recommended adult antacid brand by doctors, pharmacists and OBGYNs. As America's #1 antacid and trusted as a heartburn medicine for 90 years, TUMS is fully supported with a satisfaction guarantee.

About GSK Consumer Healthcare

We are the world's largest Consumer Healthcare company following our new joint venture with Pfizer. We develop and market a portfolio of consumer-preferred and expert-recommended brands including TUMS, Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu. For further information please visit www.gsk.com.

View original content to download multimedia:http://www.prnewswire.com/news-releases/tums-expands-portfolio-to-meet-consumer-demands-for-naturally-sourced-products-301227635.html

SOURCE GSK Consumer Healthcare

• Companies aim to develop a multi-valent candidate vaccine to address emerging variants for pandemic and endemic use
• Development to begin immediately targeting vaccine availability in 2022, subject to regulatory approval
• GSK will also support manufacture of up to 100 million doses of CureVac's first generation COVID-19 vaccine CVnCoV in 2021

LONDON, UK / TUBINGEN, GERMANY / BOSTON, MA / ACCESSWIRE / February 3, 2021 / GlaxoSmithKline plc (NYSE:GSK) and CureVac N.V. (NASDAQ:CVAC) today announced a new €150m collaboration, building on their existing relationship, to jointly develop next generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine.

GSK will also support the manufacture of up to 100 million doses of CureVac's first generation COVID-19 vaccine candidate CVnCoV in 2021

Through this new exclusive co-development agreement, GSK and CureVac will contribute resources and expertise to research, develop, and manufacture a number of novel mRNA vaccine candidates, including multi-valent and monovalent approaches. The aim of this work is to offer broader protection against a variety of different SARS-CoV2 variants, and to enable a quick response to new variants potentially emerging in the future. The development programme will begin immediately, with the target of introducing the vaccine in 2022, subject to regulatory approval.

The increase in emerging variants with the potential to reduce the efficacy of first generation COVID-19 vaccines requires acceleration of efforts to develop vaccines against new variants to keep one step ahead of the pandemic. These next generation COVID-19 vaccines may either be used to protect people who have not been vaccinated before, or to serve as boosters in the event that COVID-19 immunity gained from an initial vaccination reduces over time. In addition, the collaboration will assess the development of novel mRNA vaccines to protect against multiple respiratory viruses, including COVID-19.

This collaboration will build on CureVac's first generation COVID-19 vaccine candidate CVnCoV, which is currently in Phase 2b/3 clinical trial and on CureVac's ability to optimise mRNA for a strong immune response, manufacturability, and stability at standard 2-8 C cold chain conditions for vaccines. CureVac's platform is uniquely adapted to designing multi-valent vaccines with a balanced immune response and a low dose of mRNA.

Emma Walmsley, Chief Executive Officer, GSK, said: "We believe that next generation vaccines will be crucial in the continued fight against COVID-19. This new collaboration builds on our existing relationship with CureVac and means that together, we will combine our scientific expertise in mRNA and vaccine development to advance and accelerate the development of new COVID-19 vaccine candidates. At the same time, we will also support the production of CureVac's first generation vaccines with the manufacture of 100 million doses in 2021."

Franz-Werner Haas, Chief Executive Officer of CureVac, said: "We are very pleased to build on our existing relationship with GSK with a new agreement to jointly develop next generation mRNA-based vaccines, in addition to our current candidate CVnCoV. With the help of GSK's proven vaccine expertise, we are equipping ourselves to tackle future health challenges with novel vaccines."

As part of the new collaboration, GSK will also support manufacture of CureVac's first-generation COVID-19 vaccine candidate CVnCoV which is currently in Phase 2b/3 trials. Using its established manufacturing network in Belgium, GSK aims to support manufacturing of up to 100 million doses of the vaccine in 2021.

Under the terms of the new collaboration agreement, GSK will be the marketing authorisation holder for the next generation vaccine, except in Switzerland, and will have exclusive rights to develop, manufacture, and commercialise the next generation COVID-19 vaccine in all countries with the exception of Germany, Austria and Switzerland. GSK will make an upfront payment of €75m and a further milestone payment of €75m, conditional on the achievement of specific milestones.

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 CureVac
CureVac is a global biopharmaceutical company in the field of messenger RNA (mRNA) technology, with more than 20 years of expertise in developing and optimizing the versatile biological molecule for medical purposes. The principle of CureVac's proprietary technology is the use of non-chemically modified mRNA as a data carrier to instruct the human body to produce its own proteins capable of fighting a broad range of diseases. Based on its proprietary technology, the company has built a deep clinical pipeline across the areas of prophylactic vaccines, cancer therapies, antibody therapies, and the treatment of rare diseases. CureVac had its initial public offering on the New York Nasdaq in August 2020. In January 2021 the company entered into a collaboration and services agreement with Bayer. CureVac is headquartered in Tübingen, Germany, and employs more than 500 people at its sites in Tübingen, Frankfurt, and Boston, USA. Further information can be found at www.curevac.com.

CureVac enquiries:

Media enquiries:
Thorsten Schüller, Corporate Communications
CureVac AG, Tübingen, Germany
T: +49 7071 9883-1577

Investor enquiries:
Dr. Sarah Fakih, Vice President Investor Relations
CureVac AG, Tübingen, Germany
T: +49 7071 9883-1298

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 any impacts of the COVID-19 pandemic.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road
Brentford, Middlesex
TW8 9GS

CureVac Forward-Looking Statements
This press release contains statements that constitute "forward looking statements" as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the opinions, expectations, beliefs, plans, objectives, assumptions or projections of CureVac (the "company") regarding future events or future results, in contrast with statements that reflect historical facts. Examples include discussion of the potency efficacy of the company's vaccine candidate and the company's strategies, financing plans, growth opportunities and market growth. In some cases, you can identify such forward-looking statements by terminology such as "anticipate," "intend," "believe," "estimate," "plan," "seek," "project," or "expect," "may," "will," "would," "could," "potential," "intend," or "should," the negative of these terms or similar expressions. Forward-looking statements are based on management's current beliefs and assumptions and on information currently available to the company. However, these forward-looking statements are not a guarantee of the company's performance, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks, uncertainties and other variable circumstances, including negative worldwide economic conditions and ongoing instability and volatility in the worldwide financial markets, ability to obtain funding, ability to conduct current and future preclinical studies and clinical trials, the timing, expense and uncertainty of regulatory approval, reliance on third parties and collaboration partners, ability to commercialize products, ability to manufacture any products, possible changes in current and proposed legislation, regulations and governmental policies, pressures from increasing competition and consolidation in the company's industry, the effects of the COVID-19 pandemic on the company's business and results of operations, ability to manage growth, reliance on key personnel, reliance on intellectual property protection, ability to provide for patient safety, and fluctuations of operating results due to the effect of exchange rates or other factors. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. Many of these risks are outside of the company's control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law.

For further information, please reference the company's reports and documents filed with the U.S. Securities and Exchange Commission (SEC). You may get these documents by visiting EDGAR on the SEC website at www.sec.gov.

SOURCE: CureVac AG

WARREN, N.J., Feb. 1, 2021 /PRNewswire/ -- GlaxoSmithKline (LSE: GSK) (NYSE:GSK) – This year, the #TUMSBingoSweepstakes is the BIG GAME within the BIG GAME and takes place on a day known for indulging in heartburn-inducing food and fans experiencing TUMSworthy moments. TUMS®, America's #1 heartburn medicine that provides fast-acting relief from the pain of heartburn, today is launching the first-ever #TUMSBingoSweepstakes - an interactive digital game of bingo featuring dozens of heartburn-inducing moments that could happen on or off the field. The #TUMSBingoSweepstakes gives both hardcore and casual fans an opportunity to participate in all of the action and earn a chance to win a piece of $55,000 in prizes, and the grand prize winner will take home $35,000.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8845951-tums-bingo-sweepstakes/

Fans can get their official digital game board at TumsworthyBingo.com beginning today and follow along during the BIG GAME on February 7 to experience the event and surrounding spectacle in a new and exciting way, no matter how many spicy wings or footballs may be dropped.

"This year, TUMS® is not only easing symptoms of heartburn, but rewarding people with a fun way to experience all the excitement and action surrounding the BIG GAME," says Amy Sharon, Director at TUMS®. "Through the #TUMSBingoSweepstakes, we can celebrate how TUMSworthy moments offer an extra layer of stress, and at the same time, excitement for everyone watching the BIG GAME - satisfying an appetite for relief from savory food options and competition no matter what kind of fan is watching."

It will be easy for anyone to play along as TUMS® will identify TUMSworthy moments that occur live during the BIG GAME and participants' digital game boards will update automatically following each #TUMSworthy moment announced via @TUMSOfficial. TUMSworthy moments will include everything from action on the field, during halftime, and, of course, the after-effects of gameday food and excitement. For many, the BIG GAME is still worth the burn.

Players who complete a line on their B-I-N-G-O board by the end of the game, and tweet #TUMSBingoSweepstakes, are entered to win the grand prize of $35,000. To earn additional chances to win, players are encouraged to tweet after the completion of each square on their board using #TUMSBingoSweepstakes in their posts and can also choose to share TUMSworthy moments not reflected on their game board. For many, enjoying those inevitable heartburn-inducing options during the BIG GAME is still worth the burn.

TUMS® is partnering with Sports Analyst Kenny White aka the "Wizard of Odds," to leverage his odds making expertise and develop the game board.

"After an unprecedented and uncertain year in sports, TUMS® is giving everyone an even better reason to look forward to game day," says White. "While there are various odds associated with the TUMSworthy moments that will potentially occur, it's certain that the #TUMSBingoSweepstakes will get everyone excited about being part of the BIG GAME, no matter the outcome."

For more information on how to participate or view the official rules, please visit TumsworthyBingo.com.

The #TUMSBingoSweepstakes follows the brand's successful TUMS® Game Day sweepstakes promotion in 2020. For more information on TUMS®, please visit TUMS.com.

About TUMS®

TUMS Antacid Tablets go to work in seconds for delicious, chewable heartburn relief. Featuring the active ingredient calcium carbonate, these chewable antacid tablets provide heartburn, sour stomach and acid indigestion relief, as well as upset stomach relief associated with these symptoms. TUMS antacid tablets are the #1 recommended adult antacid brand by doctors, pharmacists and OBGYNs. As America's #1 antacid and trusted as a heartburn medicine for 90 years, TUMS is fully supported with a satisfaction guarantee.

About GSK Consumer Healthcare

GSK Consumer Healthcare combines science and consumer insights to create innovative world-class health care brands that consumers trust and experts recommend for oral health, pain relief, respiratory and wellness.

View original content:http://www.prnewswire.com/news-releases/tums-kicks-off-55-000-tumsbingosweepstakes-for-the-big-game-301219096.html

SOURCE GlaxoSmithKline

INDIANAPOLIS, SAN FRANCISCO and LONDON, Jan. 27, 2021 (GLOBE NEWSWIRE) -- Eli Lilly and Company (NYSE:LLY), Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced a collaboration to evaluate a combination of two COVID-19 therapies in low-risk patients with mild to moderate COVID-19. Lilly has expanded its ongoing BLAZE-4 trial to evaluate the administration of bamlanivimab (LY-CoV555) 700mg with VIR-7831 (also known as GSK4182136) 500mg, two neutralizing antibodies that bind to different epitopes of the SARS-CoV-2 spike protein. This unique collaboration marks the first time that monoclonal antibodies from separate companies will be brought together to explore potential outcomes.

Bamlanivimab is a neutralizing antibody directed against the spike protein of SARS-CoV-2 designed to block viral attachment and entry into human cells, thus neutralizing the virus. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Bamlanivimab is authorized for emergency use for the treatment of mild to moderate COVID-19 in patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.

VIR-7831 is a dual-action monoclonal antibody that was selected for clinical development based on its potential to both block viral entry into healthy cells and clear infected cells, as well as its potential to provide a high barrier to resistance. In pre-clinical trials, the antibody has shown the ability to neutralize the SARS-CoV-2 live virus by binding to an epitope on SARS-CoV-2 shared with SARS-CoV-1, indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. Vir and GSK are advancing VIR-7831 as part of their collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2.

"Bamlanivimab is a potent antibody – with data from multiple Phase 2 and 3 clinical trials, which have demonstrated robust evidence for both treating and preventing COVID-19," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "With a virus like SARS-CoV-2, it's expected that variants could emerge that require new therapeutic options, which is why Lilly is studying bamlanivimab together with other neutralizing antibodies, including etesevimab. Adding VIR-7831 to our study is an important part of our commitment to develop therapies to treat current and future strains of COVID-19 until vaccines are widely available and utilized."

"We believe that VIR-7831 has significant potential as a single agent, and we are optimistic about the pending interim data from two Phase 3 trials evaluating its potential for early treatment and in hospitalized patients," said George Scangos, Ph.D., chief executive officer of Vir. "As the virus continues to evolve, we, along with Lilly and GSK, share the view that we should pursue all possibilities to help end the pandemic and maximize the number of lives that can be saved. This trial is a first step to assess whether the administration of VIR-7831, with its high barrier to resistance and potent effector function, alongside bamlanivimab, which has strong outcomes data in early treatment, can provide potential benefits beyond monotherapy."

"Despite the significant progress on vaccines, there remains an urgent patient need for multiple therapeutic approaches to prevent the more severe consequences of COVID-19," said Dr. Hal Barron, chief scientific officer and president R&D of GSK. "Partnering with Lilly to study VIR-7831 with bamlanivimab will provide the scientific community with further data on the important role these therapies could play in reducing the impact of this devastating pandemic."

Bamlanivimab alone has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) based on interim data from the Phase 2 BLAZE-1 trial, which was published in the New England Journal of Medicine. These data show the therapy may help patients clear the virus and reduce COVID-19-related hospitalizations when given early in the disease course. The safety and efficacy of bamlanivimab is being evaluated with other neutralizing antibodies to provide a possible safeguard against potential viral resistance.

VIR-7831 is an investigational compound, not approved by the U.S. FDA or any other regulatory authority. VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization.

Important Information about bamlanivimab

Bamlanivimab has not been approved by the FDA for any use. It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.

Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents, and Caregivers (English) (Spanish).

Authorized Use and Important Safety Information

Bamlanivimab 700 mg injection is authorized for use under EUA for treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Limitations of Authorized Use

• Bamlanivimab is not authorized for use in patients:
  
  • who are hospitalized due to COVID-19, OR
  
  • who require oxygen therapy due to COVID-19, OR
  
  • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
• Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.
  
  

Important Safety Information

There are limited clinical data available for bamlanivimab. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab use.

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of bamlanivimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive care.

Infusion-related reactions have been observed with administration of bamlanivimab. Signs and symptoms of infusion-related reactions may include:

• fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness.
  
  

If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. See Limitations of Authorized Use.

Adverse Events

Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and placebo were Nausea (3% vs 4%), Diarrhea (1% vs 5%), Dizziness (3% vs 2%), Headache (3% vs 2%), Pruritus (2% vs 1%) and Vomiting (1% vs 3%).

Use in Specific Populations

Pregnancy

There are insufficient data on the use of bamlanivimab during pregnancy. Bamlanivimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bamlanivimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

About BLAZE-4

BLAZE-4 (NCT04634409) is a randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of bamlanivimab alone, and bamlanivimab with other neutralizing antibodies including VIR-7831 (GSK4182136) versus placebo for the treatment of symptomatic COVID-19 in the outpatient setting. Across all treatment arms, the trial will enroll an estimated 1,000 participants in the United States and Puerto Rico.

The primary outcome measure is percentage of participants who have a viral load greater than 5.27 at day 7. Additional endpoints include change from baseline to day 7 in SARS-CoV-2 viral load, percentage of participants who experience COVID-related hospitalization, ER visit or death from baseline through day 29, as well as safety.

About bamlanivimab

Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody (mAb) directed against the spike protein of SARS-CoV-2. It is designed to block viral attachment and entry into human cells, thus neutralizing the virus, potentially treating COVID-19. Bamlanivimab emerged from the collaboration between Lilly and AbCellera to create antibody therapies for the prevention and treatment of COVID-19. Lilly scientists rapidly developed the antibody in less than three months after it was discovered by AbCellera and the scientists at the National Institute of Allergy and Infectious Diseases (NIAID) Vaccine Research Center. It was identified from a blood sample taken from one of the first U.S. patients who recovered from COVID-19.

Lilly has successfully completed a Phase 1 study of bamlanivimab in hospitalized patients with COVID-19 (NCT04411628). A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. A Phase 3 study of bamlanivimab for the prevention of COVID-19 in residents and staff at long-term care facilities (BLAZE-2, NCT04497987) is ongoing. In addition, bamlanivimab is being tested in the National Institutes of Health-led ACTIV-2 study in ambulatory COVID-19 patients.

Bamlanivimab is authorized in the U.S. for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

About etesevimab

Etesevimab (LY-CoV016, also known as JS016) is a recombinant, fully human monoclonal neutralizing antibody, which specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Point mutations were introduced into the native human IgG1 antibody to mitigate effector function. Lilly licensed etesevimab from Junshi Biosciences after it was jointly developed by Junshi Biosciences and Institute of Microbiology, Chinese Academy of Science (IMCAS). Junshi Biosciences leads development in Greater China, while Lilly leads development in the rest of the world.

Lilly has successfully completed a Phase 1 study (NCT04441931) of etesevimab in healthy U.S. volunteers to evaluate the safety, tolerability, pharmacokinetics and immunogenicity. A Phase 2/3 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is ongoing. Junshi Biosciences has completed a similar Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.

About VIR-7831 / GSK4182136

VIR-7831 (GSK4182136) is an investigational dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

The COMET clinical development program for VIR-7831 includes a planned Phase 3 trial for the prevention of symptomatic infection. VIR-7831 is also being evaluated in a sub-trial of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. 

About Lilly's COVID-19 Efforts

Lilly is bringing the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Existing Lilly medicines are being studied to understand their potential in treating complications of COVID-19, and the company is collaborating with partner companies to discover novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Visit Lilly's COVID-19 disease area page for resources related to Lilly's COVID-19 efforts.

GSK commitment to tackling COVID-19

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

GSK is collaborating with several organisations working on promising COVID-19 vaccines by providing access to our adjuvant technology. In a collaboration with Sanofi that brings together two of the world's largest vaccine companies, GSK is developing an adjuvanted recombinant protein-based COVID-19 vaccine candidate with a phase 2b study expected to start in February 2021. GSK also is collaborating with Medicago and Clover Biopharmaceuticals on adjuvanted, protein-based vaccine candidates, which are progressing into late-stage clinical trials. The use of an adjuvant is of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protecting more people.

GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with Vir Biotechnology to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. Currently, collaborating on the phase 3 clinical development of VIR-7831 (GSK4182136), a dual-action monoclonal antibody that has shown the ability in preclinical trials to both neutralize SARS-CoV-2 live virus in vitro and in vivo and kill already infected cells.

About Eli Lilly and Company 

Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and www.lilly.com/news. 

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio. 

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. 

Lilly Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about bamlanivimab (LY-CoV555) as a potential treatment for patients with or at risk of infection from COVID-19, alone and in combination with other neutralizing antibodies, including VIR-7831 and etesevimab (LY-CoV016), Lilly's development plans and collaboration efforts, and reflects Lilly's current beliefs and expectations. However, as with any such undertaking, there are substantial risks and uncertainties in the process of drug research, development and commercialization and in drug collaborations. Among other things, there can be no guarantee that future study results will be consistent with the results to date, that bamlanivimab alone or administered with VIR-7831or etesevimab will prove to be a safe and effective treatment or preventative for COVID-19, that bamlanivimab alone or administered with VIR-7831 or etesevimab will receive regulatory approvals or additional authorizations, that patients will volunteer to participate in a study of bamlanivimab alone or administered with VIR-7831 or etesevimab or achieve positive outcomes or that Lilly and its partners can provide an adequate supply of bamlanivimab alone or administered with VIR-7831 or etesevimab in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements. 

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-7831 as a single agent and in combination with bamlanivimab in the treatment of COVID-19, the potential benefits of participating in the BLAZE-4 trial, and the potential benefits of Vir, Lilly, and GSK's collaboration in addressing the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. 

GSK's 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. 

Contact:

Investors, Vir
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications

+1-415-506-5256

Media, Vir
Cara Miller
VP, Corporate Communications

+1-415-941-6746

Investors, Lilly
Kevin Hern

+1-317-277-1838

Media, Lilly
Molly McCully

+1-317-478-5423

Media, Lilly
Dani Barnhizer

+1-317-607-6119

Investors, GSK
Jeff McLaughlin

+1-215-751-7002

Media, GSK
Lyndsay Meyer

+1-202-302-4595

• Second monoclonal antibody from Vir-GSK collaboration to be investigated as a potential COVID-19 treatment
• Preclinical data suggest VIR-7832 has two distinguishing properties: enhanced ability to clear infected cells and potential to enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection
• Trial targeted to begin in 1Q:2021 at multiple sites across the UK
  
  

SAN FRANCISCO and LONDON, Jan. 12, 2021 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced an agreement with the U.K.-based AGILE initiative to evaluate VIR-7832 in patients with mild to moderate COVID-19 in a Phase 1b/2a clinical trial. VIR-7832 is a neutralizing COVID-19 antibody that preclinical data suggests has two distinguishing properties: an enhanced ability to clear infected cells and the potential to enhance virus-specific T-cell function, which could help treat and/or prevent COVID-19 infection.

The AGILE trial platform, which will be the first to test VIR-7832 in humans, uses adaptable protocols and statistical models to enable the evaluation of candidate medicines for COVID-19 treatment. The initiative is a collaboration between the University of Liverpool, Liverpool School of Tropical Medicine, Liverpool University Hospitals NHS Foundation Trust, University of Southampton and Lancaster University and coordinated by the National Institute for Health Research Southampton Clinical Trials Unit across the UK Clinical Research Facility Network. The trial is due to begin in the first quarter of 2021.

George Scangos, Ph.D., chief executive officer of Vir, said: "We are pleased to have the support of the NHS behind our efforts to evaluate and advance VIR-7832 for the treatment and potential prevention of COVID-19. This study will be critical to our efforts as we work to understand whether the modifications we have made to this monoclonal antibody increase its potency and stimulate a T cell response to not only provide therapeutic benefits but also potentially confer a vaccine-like effect that could be applicable to prophylaxis."

Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "While vaccine development has been very successful, current infection and hospitalization rates show that multiple vaccines and therapeutic options will be needed to combat and ultimately end this pandemic. We are grateful to everyone involved in the AGILE study for supporting this important research and expect initial results from the study to provide important insights into the use of VIR-7832 early in the course of infection with SARS-CoV-2."

VIR-7832 is set to become the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment. The first antibody, VIR-7831, is currently being investigated in two global phase 3 studies; for the early treatment of COVID-19 in patients who are at high risk of hospitalization, and for the treatment of hospitalized patients with COVID-19.

Phase 1b/2a AGILE Study Design

AGILE is a randomized, controlled, multi-center, seamless, adaptive Phase 1b/2a platform for the rapid evaluation of candidates of COVID-19 treatment in hospitalized patients and also in the community with early disease. The AGILE platform will assess VIR-7832 and VIR-7831 in adult outpatients with mild to moderate COVID-19 infection. The dose-escalation Phase 1b part of the study will evaluate the safety and tolerability of a single dose of VIR-7832 given by intravenous (IV) infusion and determine the dose for evaluation in the Phase 2a part of the study. A total of 24 study participants will be randomized 3:1 to VIR-7832 or placebo. The Phase 2 part of the study will include three treatment arms: 50 patients randomized to VIR-7832, 50 patients to VIR-7831, and 25 patients to placebo. The co-primary endpoints are safety and virologic activity of VIR-7832 as assessed by a change in SARS-CoV-2 viral load from baseline to Day 8. The Phase 2 part of the study also will assess the T cell responses to SARS-CoV-2 of VIR-7832 and VIR-7831. The trial is being conducted at up to five sites in the UK.

About VIR-7832 / GSK4182137

VIR-7832 is a dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7832 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life. Importantly, VIR-7832 has been engineered to potentially enhance virus-specific T cell function, which could help treat and/or prevent COVID-19 infection.

About VIR-7831 / GSK4182136

VIR-7831 is a dual-action monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus which causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831 also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About the Vir and GSK Collaboration

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

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.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the potential benefits of VIR-7832 and VIR-7831 in the treatment of COVID-19, the potential benefits of participating in the AGILE study, and statements around the expected timing of the Phase 1b/2a clinical trial. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes.

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.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

Vir Biotechnology Contacts:
  
Investors
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications

+1 415 506 5256

Media
Cara Miller
VP, Corporate Communications
ir.bio
+1 415 941 6746
    
GSK Contacts:   
    
Media:
Simon Steel   +44 (0) 20 8047 5502   (London)
Tim Foley   +44 (0) 20 8047 5502   (London)
Kristen Neese   +1 804 217 8147   (Philadelphia)
Kathleen Quinn   +1 202 603 5003   (Washington DC)
    
Analysts/Investors:
Sarah Elton-Farr   +44 (0) 20 8047 5194   (London)
Sonya Ghobrial   +44 (0) 7392 784784   (Consumer)
Danielle Smith   +44 (0) 20 8047 0932   (London)
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Seasonal flu vaccine program will cover four seasonal viruses recommended by the World Health Organization (WHO)

HIV vaccine program to accelerate human validation of novel vaccination strategies

Nipah vaccine program established against a virus of public health concern

Moderna now has one commercial medicine and 24 development programs

Multiple therapeutic programs anticipated to see clinical proof of concept data in 2021

Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that it is expanding its pipeline of innovative vaccines with three new development programs based on the clinical success of its infectious disease vaccine portfolio to date. This announcement reflects the Company's commitment to accelerating its infectious disease portfolio based on Moderna's experience with its COVID-19 vaccine. The development programs announced today are mRNA vaccine candidates against seasonal flu, HIV and the Nipah virus. Moderna also announced an expansion of its respiratory syncytial virus (RSV) vaccine program into older adults.

"The uniquely challenging year of 2020 for all of society proved to be an extraordinary proof-of-concept period for Moderna," said Stéphane Bancel, Moderna's chief executive officer. "Even as we have shown that our mRNA-based vaccine can prevent COVID-19, this has encouraged us to pursue more-ambitious development programs within our prophylactic vaccines modality. Today we are announcing three new vaccine programs addressing seasonal flu, HIV and the Nipah virus, some of which have eluded traditional vaccine efforts, and all of which we believe can be addressed with our mRNA technology. Beyond vaccines, we are extending our mRNA development work to a total of 24 programs across five therapeutic areas."

Mr. Bancel will present an update on the Company and its pipeline of mRNA development programs on Monday, January 11, 2021 at 4:30 p.m. ET at the 39th Annual J.P. Morgan Healthcare Conference. The presentation will be followed by a question-and-answer session. A live webcast of both the presentation and question and answer session will be available under "Events & Presentations" in the investors section of Moderna's website at investors.modernatx.com. A replay of the webcast will be archived on Moderna's website for 30 days following the presentation.

Moderna currently has 24 mRNA development programs in its portfolio with 13 having entered the clinic. The Company's updated pipeline can be found at www.modernatx.com/pipeline.

About Moderna's New Infectious Disease Vaccine Development Programs

• Flu vaccine (mRNA-1010, mRNA-1020, mRNA-1030): Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on healthcare systems. The WHO estimates globally about 3,000,000-5,000,000 severe cases of flu each year, and 290,000-650,000 flu-related respiratory deaths. Approximately 8% of the U.S. population experiences symptoms from flu each year in the US, with 140,000-810,000 hospitalizations and 12,000-61,000 deaths per year. Peak flu activity is seen in temperate climates from fall to winter and is reflected in increases in outpatient visits, urgent care visits, and hospitalizations. In the U.S., the estimated average economic burden of flu is approximately $11 billion per year. The Company plans to explore potential combination vaccines against flu, SARS-CoV-2, RSV and human metapneumovirus (hMPV). The Company's first-generation flu program will evaluate multiple candidates comprising multiple antigen combinations against the four seasonal viruses recommended by the WHO. The Company expects to begin phase 1 clinical trials for the program in 2021.
  
  
  
  
• HIV vaccine (mRNA-1644 & mRNA-1574): HIV is the virus responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Approximately 38 million people worldwide are currently living with HIV with 1.2 million in the U.S. Approximately 2 million new infections of HIV are acquired worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS. The primary routes of transmission are sexual intercourse and IV drug use, putting young adults at the highest risk of infection. From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment and prevention of HIV, representing a significant economic burden. mRNA-1644, a collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill and Melinda Gates Foundation (BMGF), is a novel approach to HIV vaccine strategy in humans designed to elicit broadly Neutralizing HIV-1 Antibodies (bNAbs). A Phase 1 study for mRNA-1644 will use iterative human testing to validate the approach and antigens and multiple novel antigens will be used for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the National Institutes of Health (NIH) and includes multiple native-like trimer antigens. The Company expects to begin phase 1 clinical trials for both mRNA-1644 and mRNA-1574 in 2021.
  
  
  
  
• Nipah virus (NiV) Vaccine (mRNA-1215): NiV is a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications of NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000 and is included on the WHO R&D Blueprint list of epidemic threats needing urgent R&D action. mRNA-1215 was co-developed by Moderna and the NIH's Vaccine Research Center (VRC).

Moderna's pipeline is organized into six modalities based on similar mRNA technologies, delivery technologies and manufacturing processes. The Company's approach is to leverage early programs within a modality to generate clinical data and insights that reduce the technology risk of subsequent programs and accelerate the expansion of the pipeline in that modality. Positive phase 1, 2 and 3 data from Moderna's infectious disease vaccine portfolio and positive phase 1 data from its chikungunya antibody program have de-risked its prophylactic vaccines and systemic therapeutics & cell surface modalities respectively. Beyond these core modalities, the Company has four exploratory modalities in which it is actively pursuing clinical proof of concept.

Summary of Program Updates by Modality:

Core Modalities

Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company's global public health portfolio is focused on epidemic and pandemic diseases and often developed in collaborations with governments and non-profit organizations.

Vaccines requiring complex antigens and against highly prevalent infections

• Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive interim data from the phase 2 study assessing the safety, reactogenicity, and immunogenicity of different dose levels of mRNA-1647 were presented at Moderna's annual R&D Day. Based on the interim analysis of the phase 2 study, the 100 μg dose has been chosen for the phase 3 pivotal study, which is expected to begin this year. Moderna owns worldwide commercial rights for mRNA-1647.

• Epstein-Barr virus (EBV) vaccine (mRNA-1189): mRNA-1189 is a vaccine against EBV containing five mRNAs that encode viral proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna's CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system. There is no approved vaccine for EBV. Moderna owns worldwide commercial rights to mRNA-1189.
  
  
  
  

Vaccines against respiratory infections

• Moderna COVID-19 Vaccine (mRNA-1273) authorization: On December 18, the U.S. Food and Drug Administration (FDA) authorized the emergency use of mRNA-1273, Moderna's vaccine against COVID-19, in individuals 18 years of age or older. The Moderna COVID-19 Vaccine is also authorized by Canada, Israel, the United Kingdom and the European Union. Additional authorizations are currently under review in additional markets including Singapore, Switzerland and by the WHO. On December 30, interim safety and primary efficacy results from the Phase 3 trial of the Moderna COVID-19 Vaccine (mRNA-1273) were published in the New England Journal of Medicine. The primary endpoint of the Phase 3 COVE study was based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This final analysis was based on 196 cases, of which 185 cases of COVID-19 were observed in the placebo group versus 11 cases observed in the Moderna COVID-19 Vaccine group, corresponding to a 94% vaccine efficacy (95% CI 89.3-96.8%; p<0.0001). The most common solicited adverse reactions (ARs) after the two-dose series was injection site pain (86.0%). Solicited systemic adverse events occurred more often in the Moderna COVID-19 vaccine group (54.9% and 79.4%) than in the placebo (42.2% and 36.5%) group after both the first dose and the second dose respectively and were most commonly headache, fatigue and myalgia. While the majority of these ARs were mild (grade 1) or moderate (grade 2), there was a higher occurrence of severe (grade 3) reactions in the Moderna COVID-19 Vaccine group after the first (2.9%) and second (15.8%) injections. The majority of local solicited ARs occurred within the first one to two days after injection and generally persisted for a median of one to two days. Safety data continues to accrue, and the study continues to be monitored by an independent Data Safety Monitoring Board (DSMB) appointed by the NIH. All participants in the COVE study will be monitored for two years after their second dose to assess long-term protection and safety. Additional data to be collected will include longer term safety follow-up, duration of protection against COVID-19, and efficacy against asymptomatic SARS-CoV-2 infection. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of mRNA-1273 with federal funding under Contract no. 75A50120C00034. A summary of the Company's work to date on COVID-19 can be found here. Moderna retains worldwide rights to develop and commercialize mRNA-1273.

• Moderna COVID-19 Vaccine (mRNA-1273) additional clinical studies: Moderna is also conducting a phase 2/3 study of the Moderna COVID-19 Vaccine in adolescents 12 to under 18 years of age. Additional studies are planned to evaluate the Moderna COVID-19 Vaccine in pregnant women, children younger than 12 years, and those in special risk groups, such as the immunocompromised.

• Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): Sites have resumed dosing seropositive pediatric participants (12-36 months of age) in the Phase 1 study of hMPV/PIV3 study (mRNA-1653) following the COVID-19 related study disruption. Moderna owns worldwide commercial rights to mRNA-1653.

• Respiratory syncytial virus (RSV) vaccine (mRNA-1345): mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. The first cohort of the phase 1 study of mRNA-1345 is fully enrolled. This phase 1 study includes initial dosing in younger adults, followed by age de-escalation into children. The Company today, announced its plan to amend the protocol to include evaluation of mRNA-1345 in older adults who are also at risk of significant RSV disease. Going forward, the Company intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults. There is no approved vaccine for RSV. Moderna owns worldwide commercial rights to mRNA-1345.

Public Health Vaccines

• Zika virus vaccine (mRNA-1893): All dose cohorts (10, 30, 100 and 250 µg) in the phase 1 study of mRNA-1893 have completed enrollment. Moderna is preparing for a phase 2 study of mRNA-1893. mRNA-1893 is being developed in collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna owns worldwide commercial rights to mRNA-1893.

• Pandemic influenza/H7N9 vaccine (mRNA-1851): Discussions regarding funding the Company's pandemic influenza/H7N9 vaccine program through approval are ongoing.

Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.

• Antibody against the chikungunya virus (mRNA-1944): Positive interim data from the Phase 1 study evaluating escalating doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication cohort and two doses of 0.3 mg/kg (without steroid premedication) given one week apart cohort were presented at Moderna's annual R&D Day and demonstrated dose-dependent increases in levels of antibody against chikungunya. Safety and increased CHKV-IgG production in the two-dose regimen shows the platform's ability for repeat dosing.

Exploratory Modalities

Cancer Vaccines: These programs focus on stimulating a patient's immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.

• Personalized cancer vaccine (PCV) (mRNA-4157): The randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in combination with Merck's pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is ongoing. The Phase 1 study is ongoing. Moderna shares worldwide commercial rights to mRNA-4157 with Merck.
  
  
  
  
  • Presentation of Note: Interim data from the phase 1 dose expansion cohort of mRNA-4157 in combination with pembrolizumab was shared at The Society for Immunotherapy of Cancer's Annual Meeting 2020 and supported the expansion of the Head and Neck Squamous Cell Carcinoma (HNSCC) cancer patient cohort.
    
    
    
    
• Mutant KRAS vaccine (mRNA-5671 or V941): The phase 1 open-label, multi-center study to evaluate the safety and tolerability of mRNA-5671 both as a monotherapy and in combination with pembrolizumab, led by Merck, is ongoing. Moderna shares worldwide commercial rights to mRNA-5671 with Merck.
  
  
  
  

Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

• OX40L (mRNA-2416): The phase 1/2 study of mRNA-2416 alone and in combination with durvalumab (IMFINZI®) is ongoing. The phase 2 dose expansion study of mRNA-2416 in combination with durvalumab in ovarian cancer patients is enrolling and the first patients have been dosed. Moderna owns worldwide commercial rights to mRNA-2416.
  
  
  
  
• OX40L/IL-23/IL-36γ (Triplet) (mRNA-2752): The phase 1 trial evaluating mRNA-2752 as a single agent and in combination with durvalumab in patients with advanced solid tumor malignancies and lymphoma is ongoing. mRNA-2752 is an investigational mRNA immuno-oncology therapy that encodes a novel combination of three immunomodulators. Moderna owns worldwide commercial rights to mRNA-2752.
  
  
  
  
• IL-12 (MEDI1191): The phase 1 open-label, multi-center study of intratumoral injections of MEDI1191 alone and in combination with durvalumab in patients with advanced solid tumors, led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide commercial rights to MEDI1191 with AstraZeneca.

Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.

• VEGF-A (AZD8601): The phase 2a study of AZD8601 VEGF-A, which is being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting (CABG) surgery with moderately impaired systolic function, led by AstraZeneca, is ongoing. Moderna has licensed worldwide commercial rights to AZD8601 to AstraZeneca.
  
  

Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

• Propionic acidemia (PA) (mRNA-3927): Sites are being initiated, with entry into the clinic expected in 2021. The Company will be looking for biomarkers as early indicators for therapeutic impact. Moderna owns worldwide commercial rights to mRNA-3927.
  
  

Information about each development candidate in Moderna's pipeline, including those discussed in this press release, can be found on the investor relations page of Moderna's website: https://investors.modernatx.com.

Corporate Updates

• Continued growth across organization: Moderna ended 2020 with approximately 1,300 full time employees, an increase from approximately 820 full time employees at the end of 2019. Moderna was named a top employer by Science for the sixth year in a row.
  
  
• Announced additions to the Moderna team:
  
  
  • Corinne Le Goff, Pharm.D., MBA, will join Moderna as Chief Commercial Officer effective Tuesday, January 19, 2021. Dr. Le Goff served as senior vice president and president of the U.S. Business Organization at Amgen (NASDAQ:AMGN). Prior to that, Dr. Le Goff held a number of senior international roles at Roche Group (SWX: RO), including President of Roche France and Global Product Strategy Head of Neuroscience & Rare Diseases, and leadership roles at Sanofi (NASDAQ:SNY) and Pfizer (NYSE:PFE) in the United States.
    
    
  • Ruchira Glaser, M.D., MSCE, joined Moderna as the Senior Vice President, Therapeutic Area Head for the Rare Disease, Autoimmune, and Cardiovascular Therapeutic Areas, where she will oversee development for our broad therapeutics portfolio outside of oncology. Dr. Glaser joins from GlaxoSmithKline (NYSE:GSK), where she was most recently Head of Clinical Sciences for the Respiratory and Specialty areas, including rare diseases, immunology and anemia. Prior to that, Dr. Glaser spent 10 years as an interventional cardiologist and clinical researcher at the University of Pennsylvania.
    
    
• Continued strong cash position: The Company expects cash, cash equivalents, and investments as of December 31, 2020 to be approximately $5.25 billion (unaudited), as compared to $1.26 billion as of December 31, 2019, including customer deposits of $2.81 billion for future supply of product.
  
  
• Moderna has signed Advance Purchase Agreements (APAs) for the delivery of its COVID-19 Vaccine. To date, the product revenue associated with these APAs for FY 2021 is $11.7 billion. These doses of Moderna COVID-19 Vaccine are expected to be delivered in 2021. The company is in active discussions to sign additional APAs for deliveries in 2021 and 2022. Moderna has also made a proposal to COVAX via a UNICEF tender to supply low-and-mid income countries.
  
  
• Commitment to access: The Company published seven principles as part of its Commitment to Vaccines and Therapeutics Access.
  
  
• Shareholder Letter: Moderna CEO Stéphane Bancel published a letter to shareholders on January 4, 2021.

Key 2021 Investor and Analyst Event Dates

• Vaccines Day– April 14
• Science Day – May 27
• R&D Day – September 9

About Moderna

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-still-unproven field of messenger RNA (mRNA), to an enterprise with its first medicine having treated millions of people, a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 24 development programs are underway across these therapeutic areas, with 13 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: development programs for vaccines against influenza, HIV and the Nipah virus and the specifics of those programs, including the timing of potential clinical trials; the timing for receipt of proof of concept clinical data from multiple therapeutics; the potential advantages of infectious disease vaccines; the development of combination vaccines against multiple diseases; the conduct of studies for the Company's vaccines against CMV, Zika virus, anti-cancer vaccines (i.e., OX40L, OX40L/IL-23/IL-36γ and IL-12), VEGF-A and PA; the potential for the Moderna COVID-19 Vaccine to prevent COVID-19 disease and slow the spread of SARS-CoV-2, the safety profile for the Moderna COVID-19 Vaccine; plans for further clinical trials for the Moderna COVID-19 Vaccine; the potential for repeat dosing of certain therapeutics; the Company's plans for research and development and timelines for any individual product or the platform as a whole; cash, cash equivalents and investment balances; and discussions related to further sales of the Moderna COVID-19 Vaccine. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the safety, tolerability and efficacy profile of the Moderna COVID-19 Vaccine observed to date may change adversely in ongoing analyses of trial data or subsequent to commercialization; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company's regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; Moderna may encounter delays in meeting manufacturing or supply timelines or disruptions in its distribution plans for the Moderna COVID-19 Vaccine; whether and when any biologics license applications and/or emergency use authorization applications may be filed and ultimately approved by regulatory authorities; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other 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.

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PARIS, Jan. 11, 2021 /PRNewswire/ -- Eligo Bioscience SA (Eligo) today announced that it has entered into a research and option agreement with GlaxoSmithKline (NYSE:GSK) aimed at advancing Eligobiotics® for the treatment or prevention of acne vulgaris with a pioneering CRISPR-based therapeutic for strain-specific microbiome modulation.

Under the terms of the agreement, Eligo will receive an upfront payment and R&D funding to advance EB005, its discovery program in acne, until preclinical proof of concept. If GSK exercises its option, GSK and Eligo will enter into a license and collaboration agreement to jointly continue the development of EB005 in acne. Eligo would be eligible to receive up to a total of $224 million in license fees and potential milestone payments, as well as royalties on global sales.

The EB005 program is applying Eligo's Eligobiotics® technology to precisely modify the composition of the skin's microbiome to treat or reduce the risk of developing moderate to severe acne. Acne is a chronic inflammatory disorder, affecting 85 percent of adolescents and young adults around the world and carrying a significant impact on physical and mental health globally. Eligo is leveraging recent insights in acne showing that otherwise beneficial skin bacteria, when expressing pro-inflammatory molecules, trigger the immune system and drive inflammation. EB005 aims to develop Eligobiotics® for topical application to precisely and selectively remove these pro-inflammatory bacterial strains from the microbiome, while sparing the rest of the skin microbiome.

Eligobiotics® is a first-in-class versatile proprietary modality that uses phage-derived particles to deliver an RNA-guided CRISPR-Cas nuclease into bacterial populations of the microbiome. Inside the bacteria, the nuclease will be guided towards specific genomic sequences, and create targeted lethal DNA double strand-breaks only if such sequences are present in the bacterial genome. This strategy enables a precise engineering of the microbiome, by killing only the strains harboring genomic sequences targeted by the nuclease.

If proven safe and effective throughout its development under the partnership with GSK, this unique approach has the potential to change the paradigm of acne treatment by specifically targeting one of its root causes.

"We are excited to work with GSK on advancing our radically new approach to address acne, combining our unique technology platform with GSK's scientific excellence and capabilities to bring innovation from the lab bench, through clinical development, and to patients. This early-stage partnership demonstrates the translational potential of Eligo's technology platform," said Xavier Duportet, PhD, Chief Executive Officer, Eligo Bioscience.

Emmanuel Hanon, Senior Vice-President and Head of R&D for GSK Vaccines, commented: "We are delighted to join forces with Eligo, a biotech company that is pioneering microbiome engineering by leveraging CRISPR technology to address microbiome-associated diseases. This partnership builds on GSK's strong expertise in immunology, bacteriology and product development, and Eligo's robust bacteriophage science, to help improve acne patients' lives."

About acne

Acne is a common chronic inflammatory disorder with significant impact on physical and mental health globally. More than 4 in 5 adolescents are affected by acne, including 10-20% with moderate to severe acne. Some patients have acne that persists into adulthood. In the US alone, acne affects approximately 40 to 50 million people, where it is the most common skin condition and the top reported cause for dermatologist visits, accounting for about one-fourth of U.S. dermatologists' patient volume. Despite the existing available solutions, there is a significant need for new acne interventions that are well-tolerated and with improved effectiveness in treating the disease, and ideally ones that can help reduce the use of antibiotics.

About Eligobiotics®

Eligobiotics® is a versatile modality based on the delivery of a DNA payload, using phage-derived particles, into bacterial populations of the microbiome to modulate its composition or function with unrivaled precision.

Eligobiotics® can be designed, built and optimized for microbiome species of choice with the automated proprietary platform that leverages Eligo's unique expertise in synthetic biology, phage biology, CRISPR-Cas engineering and bioinformatics.

Eligobiotics® can be used to precisely and selectively remove unwanted bacterial strains carrying deleterious genes while leaving beneficial bacterial strains intact through the targeted delivery of a payload encoding an RNA-guided CRISPR-Cas nuclease. Alternatively, Eligobiotics® can deliver to target bacteria the necessary genetic instructions to produce, display or secrete therapeutic proteins of interest in close vicinity to the host's cells.

About Eligo Bioscience

Eligo Bioscience is the world leader in microbiome gene therapy to address microbiome-associated diseases. Eligo was founded by scientists from The Rockefeller University, where CRISPR-based antimicrobials were invented, and by scientists from MIT. Eligo was named a Technology Pioneer by the World Economic Forum in 2017. With venture capital funding from Khosla Ventures and Seventure Partners, and non-dilutive funding from the European Commission, CARB-X, and Bpifrance, Eligo is rapidly advancing its lead program into clinical development, with the first clinical trials on track to begin in 2021.

Through its novel technology platform and robust intellectual property positions, Eligo is poised to be a catalyst for the growth anticipated across the microbiome-associated diseases industry. For more information about Eligo visit https://www.eligo.bio/. Follow us at https://www.twitter.com/EligoBio and https://www.linkedin.com/company/eligo-bioscience/.

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.

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SOURCE Eligo Bioscience

– Randomized, placebo-controlled, multicenter, global Phase 3 trial will investigate the safety and efficacy of VIR-7831 in hospitalized adults with COVID-19 –

SAN FRANCISCO and LONDON, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced that the first patient has been dosed in a new sub-trial of the National Institutes of Health's (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Program Phase 3 clinical trial. This trial is designed to evaluate the safety and efficacy of VIR-7831 for the treatment of hospitalized adults with COVID-19. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) investigational monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance and achieve high concentrations in the lungs (one of the major sites of infection).

ACTIV-3 is one of several ongoing trials in the NIH's ACTIV program, an NIH led public-private partnership designed to accelerate development of the most promising treatments and vaccine candidates for COVID-19. ACTIV-3 has been designed as a "master protocol" that allows for the simultaneous evaluation of multiple investigational therapeutics as they become available, but within the same clinical trial structure, across multiple trial sites.

George Scangos, Ph.D., chief executive officer of Vir, said: "Recent data suggest that the neutralizing activity of antibodies may be insufficient to protect hospitalized adults from the most severe consequences of COVID-19. We are hopeful that the differentiating factors and broad anti-coronavirus activity of VIR-7831 may allow it to help those patients and add to our preparedness for related coronaviruses that could emerge in the future."

Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "With new infection and hospitalization rates reaching record highs, the world needs multiple options to help combat this pandemic. We are developing solutions to fight this virus, from prevention through treatment, to provide relief from COVID-related illness. Our treatment option, VIR-7831, which has a high barrier to resistance and has the potential to neutralize the virus and kill infected cells, could allow this treatment to be effective for patients in hospital settings, where other antibodies have so far not shown an impact."

In addition to the Phase 3 ACTIV-3 trial, VIR-7831 is also being evaluated in the global Phase 2/3 COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial for the early treatment of COVID-19 in adults at high risk of hospitalization. The Phase 3 part of the COMET-ICE trial is assessing the safety and efficacy of a single intravenous (IV) infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally. The primary efficacy endpoint is the proportion of adults who have progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. The COMET clinical development program for VIR-7831 also includes a planned Phase 3 trial for the prevention of symptomatic infection.

ACTIV-3 Clinical Trial Design

The ACTIV-3 trial arm evaluating VIR-7831 will initially compare 300 participants who have been hospitalized with mild to moderate COVID-19 with fewer than 13 days of symptoms, who will receive either VIR-7831 or placebo. Participants also will receive standard care for COVID-19, including the FDA-approved antiviral remdesivir. Five days after dosing, participants' clinical status will be assessed, based on need for supplemental oxygen, mechanical ventilation, or other supportive care. If the VIR-7831 treatment arm appears to have a positive benefit:risk profile, the trial will enroll an additional 700 participants, including those who are more severely ill (i.e., adults with organ failure requiring mechanical support, or COVID-19-associated dysfunction of organs other than the lungs). Trial participants will be followed for 90 days following enrollment to analyze their response to treatment. The primary efficacy endpoint is the participants' sustained recovery for 14 days after release from the hospital.

About VIR-7831 / GSK4182136

VIR-7831 (GSK4182136) is a monoclonal antibody for which preclinical data suggest its ability to neutralize SARS-CoV-2 live virus in vitro and in vivo. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831/GSK4182136 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.

About the Vir and GSK Collaboration

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting SARS-CoV-2, hepatitis B virus, influenza A, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio.

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.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of VIR-7831 in treating hospitalized patients with COVID-19, the potential benefits of participating in the ACTIV-3 trial, the ability of using a combination of a potent effector function and neutralization capabilities in enhancing the efficacy of monoclonal antibodies to treat hospitalized patients, the efficacy and safety of a single intravenous (IV) infusion of VIR-7831, Vir's plans around the evaluation of interim analyses and the expected timing of clinical study results for VIR-7831, the ability of VIR-7831 to prevent symptomatic infection, the clinical trial design around ACTIV-3 as well as statements around the potential benefits of Vir and GSK's collaboration in addressing the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including delays or failures in planned patient enrollment or retention, clinical site activation rates or clinical trial enrollment rates that are lower than expected, unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by our competitors, changes in expected or existing competition, delays in or disruptions to our business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. 

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.

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LONDON, Dec. 17, 2020 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) announced the US Food and Drug Administration (FDA) has approved BENLYSTA (belimumab) for the treatment of adult patients with active lupus nephritis (LN) who are receiving standard therapy. Lupus nephritis is a serious inflammation of the kidneys caused by systemic lupus erythematosus (SLE), the most common form of lupus, which can lead to end-stage kidney disease, requiring dialysis or a kidney transplant. The approval extends the current indication in the US to include both SLE and LN for both the intravenous and subcutaneous formulations.

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK said: "Approximately 40% of patients with systemic lupus erythematosus develop lupus nephritis, which causes inflammation in the kidneys and can lead to end-stage kidney disease.  BENLYSTA is the first medicine approved to treat systemic lupus and adults with active lupus nephritis, an important treatment advance for patients with this incurable autoimmune disease."

The FDA approval for adult patients with active LN follows a Breakthrough Therapy Designation and Priority Review and is based on the positive results of the BLISS-LN (Efficacy and Safety of Belimumab in Adult Patients with Active Lupus Nephritis) study and the unmet need in this patient population. The BLISS-LN study is the largest and longest phase 3 study conducted in active LN, involving 448 adult patients. The study met its primary endpoint demonstrating that a statistically significant greater number of patients achieved Primary Efficacy Renal Response (PERR) at two years (or 104 weeks) when treated with BENLYSTA plus standard therapy compared to placebo plus standard therapy in adults with active LN (43% vs 32%, odds ratio (95% CI) 1.55 (1.04, 2.32), p=0.0311). Statistical significance compared to placebo across all four major secondary endpoints was achieved, including Complete Renal Response and Time to Renal-Related Event or Death. The safety results are consistent with the known safety profile of BENLYSTA.

Dr. Richard Furie, Chief of the Division of Rheumatology and Professor at the Feinstein Institutes for Medical Research at Northwell Health and Lead Investigator of the BLISS-LN study, commented: "We have long aspired to enhance outcomes for patients with lupus nephritis. In the four decades I have been caring for people with lupus, we have not been able to achieve remission in more than just one-third of patients with lupus nephritis and, despite all of our efforts, 10% to 30% of patients with lupus kidney disease still progress to end-stage kidney disease. The data from the BLISS-LN study show that BENLYSTA added to standard therapy not only increased response rates over two years, but it also prevented worsening of kidney disease in patients with active lupus nephritis compared to standard therapy alone. Therefore, it is gratifying to see the rewards of decades of research."

Dr. Brad Rovin, Director of the Division of Nephrology and Medical Director of the Center for Clinical Research Management at the Ohio State University Wexner Medical Center, commented: "The overarching goal in the management of patients with lupus nephritis is to delay the need for kidney replacement therapies, such as dialysis and transplantation. The BLISS-LN study not only demonstrated that the addition of BENLYSTA to standard therapy significantly increased the PERR, but also showed that patients had a 49% decrease in risk for experiencing a renal-related event. I'm encouraged by the progress we're making in lupus nephritis."

About the BLISS-LN study

BLISS-LN is a phase 3, 104-week, randomised, double-blind, placebo-controlled, post-approval commitment study to evaluate the efficacy and safety of intravenous (IV) BENLYSTA 10 mg/kg plus standard therapy (mycophenolate mofetil for induction and maintenance, or cyclophosphamide for induction followed by azathioprine for maintenance, plus steroids) compared to placebo plus standard therapy in adult patients with active LN. Active LN was confirmed by renal biopsy during screening visit using the 2003 International Society of Nephrology/Renal Pathology Society criteria within the past 6 months, and clinically active kidney disease requiring induction therapy.

For US Patients: Making our products affordable and accessible

GSK is actively involved in creating solutions that allow patients to have access to new scientific breakthroughs. We remain committed to helping patients access GSK medications and have a long history of providing patient assistance programs. Patients and healthcare professionals who need help with prescription coverage should visit www.BENLYSTA.com or call 1-877-4-BENLYSTA (1-877-423-6597) for eligibility information.

About lupus nephritis (LN)

Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. In lupus nephritis (LN), SLE causes kidney inflammation (swelling or scarring) of the small blood vessels that filter wastes in your kidney (glomeruli) and sometimes the kidneys, by attacking them like they would attack a disease¹. LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.^2,3 Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of urinary sediment.

About BENLYSTA (belimumab)

BENLYSTA, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. BENLYSTA does not bind B cells directly. By binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells. First approved in 2011, it is the first and only approved biologic for both SLE and LN in more than 50 years.

The following information is based on the US Prescribing Information for BENLYSTA in licensed indications only. Please consult the full Prescribing Information for all the labelled safety information for BENLYSTA.

INDICATION

BENLYSTA is indicated for patients aged ≥5 years with active, autoantibody-positive systemic lupus erythematosus (SLE) who are receiving standard therapy and patients aged ≥18 with active lupus nephritis who are receiving standard therapy. The subcutaneous (SC) formulation is approved for patients aged ≥18 years. BENLYSTA is not recommended in patients with severe active central nervous system lupus or in combination with other biologics.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATION

Previous anaphylaxis with BENLYSTA.

WARNINGS AND PRECAUTIONS

Serious Infections: Serious and sometimes fatal infections have been reported in patients receiving immunosuppressive agents, including BENLYSTA. The incidence of serious infections was similar in patients receiving BENLYSTA versus placebo, whereas fatal infections occurred more frequently with BENLYSTA.  The most frequent serious infections in adults with SLE treated with BENLYSTA IV included pneumonia, urinary tract infection, cellulitis, and bronchitis. Use caution in patients with severe or chronic infections and consider interrupting therapy in patients with a new infection.

Progressive Multifocal Leukoencephalopathy (PML): Cases of JC virus-associated PML resulting in neurological deficits, including fatal cases, have been reported in patients with SLE receiving immunosuppressants, including BENLYSTA. If PML is confirmed, consider stopping immunosuppressant therapy, including BENLYSTA.

Hypersensitivity Reactions (Including Anaphylaxis): Acute hypersensitivity reactions, including anaphylaxis (eg, hypotension, angioedema, urticaria or other rash, pruritus, and dyspnea) and death, have been reported, including in patients who have previously tolerated BENLYSTA. Generally, reactions occurred within hours of the infusion but may occur later. Non-acute hypersensitivity reactions (eg, rash, nausea, fatigue, myalgia, headache, and facial edema) typically occurred up to a week after infusion. Patients with a history of multiple drug allergies or significant hypersensitivity may be at increased risk. With BENLYSTA SC, systemic hypersensitivity reactions were similar to those in IV trials.

Healthcare providers (HCPs) should monitor patients during and after IV administration and be prepared to manage anaphylaxis; discontinue immediately in the event of a serious reaction. Premedication may mitigate or mask a hypersensitivity response. Advise patients about hypersensitivity symptoms and instruct them to seek immediate medical care if a reaction occurs.

Infusion Reactions: Serious infusion reactions (eg, bradycardia, myalgia, headache, rash, urticaria, and hypotension) were reported in adults. HCPs should monitor patients and manage reactions if they occur. Premedication may mitigate or mask a reaction. If an infusion reaction develops, slow or interrupt the infusion.

Depression and Suicidality: In adult trials, psychiatric events were reported more frequently with BENLYSTA IV related primarily to depression-related events, insomnia, and anxiety; serious psychiatric events included serious depression and suicidality, including 2 completed suicides. No serious depression-related events or suicides were reported in the BENLYSTA SC trial. Before adding BENLYSTA, assess patients' risk of depression and suicide and monitor them during treatment. Instruct patients/caregivers to contact their HCP if they experience new/worsening depression, suicidal thoughts, or other mood changes.

Malignancy: The impact of BENLYSTA on the development of malignancies is unknown; its mechanism of action could increase the risk for malignancies.

Immunization: Live vaccines should not be given for 30 days before or concurrently with BENLYSTA as clinical safety has not been established.

Use With Biologic Therapies: BENLYSTA has not been studied and is not recommended in combination with other biologic therapies, including B-cell targeted therapies.

ADVERSE REACTIONS:

The most common serious adverse reactions in adult SLE clinical trials were serious infections, BENLYSTA IV 6.0% (placebo 5.2%), some of which were fatal infections BENLYSTA IV 0.3% (placebo 0.1%). Adverse reactions occurring in ≥3% of adults and ≥1% more than placebo: nausea 15% (12%); diarrhea 12% (9%); pyrexia 10% (8%); nasopharyngitis 9% (7%); bronchitis 9% (5%);  insomnia 7% (5%); pain in extremity 6% (4%); depression 5% (4%); migraine 5% (4%); pharyngitis 5% (3%); cystitis 4% (3%); leukopenia 4% (2%); viral gastroenteritis 3% (1%).

In adult patients with active lupus nephritis, serious infections occurred in 14% of patients receiving BENLYSTA IV (placebo 17%), some of which were fatal infections, BENLYSTA 0.9% (placebo 0.9%).  Adverse reactions occurring in ≥3% of adults and ≥1% more than placebo were consistent with the known safety profile of BENLYSTA IV in SLE patients. 

Adverse reactions in pediatric patients aged ≥5 years receiving BENLYSTA IV were consistent with those observed in adults.

The safety profile observed for BENLYSTA SC in adults was consistent with the known safety profile of BENLYSTA IV with the exception of local injection site reactions.

USE IN SPECIFIC POPULATIONS

Pregnancy: There are insufficient data in pregnant women to establish whether there is drug-associated risk for major birth defects or miscarriage. After a risk/benefit assessment, if prevention is warranted, women of childbearing potential should use contraception during treatment and for ≥4 months after the final treatment.

Pregnancy Registry: HCPs are encouraged to register patients and pregnant women are encouraged to enroll themselves by calling 1-877-681-6296.

Lactation: No information is available on the presence of belimumab in human milk, the effects on the breastfed infant, or the effects on milk production. Consider developmental and health benefits of breastfeeding with the mother's clinical need for BENLYSTA and any potential adverse effects on the breastfed child or from the underlying maternal condition.

Pediatric Use: The safety and effectiveness have not been established for BENLYSTA IV in SLE patients <5 years of age, and in active LN patients <18 years of age, and for BENLYSTA SC in SLE and LN patients <18 years of age.

GSK's commitment to immunology

GSK is focused on the research and development of medicines for immune-mediated diseases, such as lupus and rheumatoid arthritis, that are responsible for a significant health burden to patients and society. Our world-leading scientists are focusing research on the biology of the immune system with the aim to develop immunological-based medicines that have the potential to alter the course of inflammatory disease. As the only company with a biological treatment approved for adult and pediatric lupus, GSK is leading the way to help patients and their families manage this chronic, inflammatory autoimmune disease. Our aim is to develop transformational medicines that can alter the course of inflammatory disease to help people live their best day, every day.

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:

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Brentford, Middlesex

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¹ National Kidney Foundation, Lupus and Kidney Disease (Lupus Nephritis).  Available at  https://www.kidney.org/atoz/content/lupus

² Gordon C, Hayne D, Pusey C, et al. European Consensus Statement on the Terminology used in the Management of Lupus Glomerulonephritis. Lupus 2009;18:257-26.

³ Waldman M and Appel GB. Update of the Treatment of Lupus Nephritis. Kidney International 2006;70:1403-1412.

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SOURCE GlaxoSmithKline (GSK)

WARREN, N.J., Dec. 1, 2020 /PRNewswire/ -- GlaxoSmithKline (LSE/NYSE: GSK) today announced a donation of $1 million to Direct Relief on behalf of consumers who have purchased its consumer healthcare products since the onset of the COVID-19 pandemic. According to the COVID Tracking Project, hospitalizations have more than doubled in less than two months. GSK recognizes that with cases rising so rapidly, there is a critical need to continuously support health care workers. The monetary donation will be used to purchase personal protective equipment (PPE) and essential medical items for U.S. health workers on the front line dealing with this unrelenting crisis.

Since the outbreak, GSK has been providing its scientific expertise to support the global response to COVID-19 and ensuring its global supply chain continues to deliver vital medicines and consumer healthcare products to the people who depend on them. GSK Consumer Healthcare's portfolio includes leading brands such as Sensodyne, Advil, Voltaren, Excedrin, Theraflu, Flonase, Centrum, and Emergen-C.

"We are so proud to partner with Direct Relief to support the amazing work they are doing to ensure health professionals have the essential items that they need as the COVID-19 pandemic continues," said Lisa Paley General Manager, U.S. and Puerto Rico for GSK Consumer Healthcare. "We know how important maintaining health is, especially as newly diagnosed coronavirus cases and hospitalizations continue to rise. As one of the leading consumer healthcare companies, we have an obligation to pay it forward and give back to frontline workers who have been working tirelessly to keep us safe over the past nine months. Our continued focus remains, ensuring healthcare worker's needs are being met, staying vigilant as the pandemic continues and keeping a steadfast focus on how critical these needs really are."

Direct Relief is coordinating with public health authorities, nonprofit organizations, and businesses to provide personal protective equipment and essential medical items to health workers responding to COVID-19. Since January, Direct Relief has delivered more than 46 million N95 and surgical masks, more than 8 million gloves, and tens of thousands of protective suits and other items to help safeguard health workers

"Direct Relief is so deeply grateful for the leadership and commitment reflected by GSK's action today, which is both keenly needed and will be put to immediate use," said Thomas Tighe, CEO and President of Direct Relief. "This is a perfect example of what's needed as we all face this historic threat to the health of people everywhere."

Since the outbreak, GSK has been providing its scientific expertise to support the global response to COVID-19 and ensuring its global supply chain continues to deliver vital medicines and consumer healthcare products to the people who depend on them.

GSK Consumer Healthcare has been supporting U.S. communities and its employees nationwide in the wake of the COVID-19 crisis in many ways, including:

• Participated in a major industry-wide movement to amplify one resonant message: #StayHome. Save lives. GSK Consumer Healthcare brands in the U.S. added a roof icon to their brand logo and shared assets on brand social channels with the hashtags #StayHome and #AloneTogether.
• Coordinated a donation of ChapStick and Abreva to 12 high-impact areas, including New York, Michigan, California, Washington, Florida, Texas, Illinois, Ohio and Maryland.
• Sponsored the Global Citizen special, One World: Together at Home.
• Donated $10,000 to the NJ Community Food Bank, which serves several hard-hit New Jersey areas. In March, the organization supplied enough food for 4.8 million meals to those in need.
• Shipped 3,000 care packages to every essential GSK Consumer Healthcare manufacturing and distribution center employee across the country.

GSK Consumer Healthcare is also encouraging customers to #BeWellStayWell by taking care of themselves and their families with health and wellness products, more information can be found at  BeWellandStayWell.com

Globally, GSK is closely monitoring the COVID-19 pandemic and supporting efforts to tackle the virus. The company is collaborating with companies and research groups across the world working on promising COVID-19 vaccine candidates through the use of its innovative vaccine adjuvant technology. It is also supporting screening and research into potential medicines for COVID-19, as well as providing expertise and financial support to relief organizations. For more information on GSK's global efforts, visit https://www.gsk.com/en-gb/media/resource-centre/our-contribution-to-the-fight-against-2019-ncov/.

About Direct Relief

A humanitarian organization committed to improving the health and lives of people affected by poverty or emergencies, Direct Relief delivers lifesaving medical resources throughout the world to communities in need—without regard to politics, religion, or ability to pay. For more information, please visit https://www.DirectRelief.org. 

About GSK Consumer Healthcare 

GSK Consumer Healthcare combines science and consumer insights to create innovative world-class health care brands that consumers trust, and experts recommend for oral health, pain relief, respiratory and wellness. 

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 gsk.com.

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SOURCE GSK Consumer Healthcare

WARREN, N.J., Oct. 28, 2020 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced the launch of Robitussin^® Naturals, the brand's first-ever line of drug-free products that provide relief from occasional cough†*. As the #1 cough relief brand** with more than 70 years of experience treating coughs, Robitussin^® knows what it takes to shut a cough down and especially in these trying times, knows that all Americans could use a boost of cheer. To help inspire consumers to take action to shut down their coughs, Robitussin has partnered with Collegiate National Champion Cheer Coach, Monica Aldama.

Aldama is no stranger to a hoarse throat and cough thanks to her intense workdays spent coaching and shouting encouraging words at elite athletes. The famous coach will impart the tough love that she is known for to prompt consumers to overcome their health setbacks and support the brand in championing victory over coughs. A longtime user of Robitussin and advocate of natural wellness products, Aldama has teamed up with the brand for the launch of Robitussin Naturals, which are formulated with ingredients found in nature to help consumers feel good about what they use to help relieve occasional coughs†*.  

Robitussin Naturals Cough Relief Syrup and Robitussin Naturals Cough Relief + Immune Health Syrup are the experts' in coughs first-of-their-kind, drug-free dietary supplements formulated with real True Source certified honey and English ivy to help relieve occasional coughs associated with hoarseness, dry throat or irritants†*. Robitussin Naturals Gummies also include naturally sourced ingredients in a convenient chewable form.

"Anyone who knows me knows I'm equal parts tough and love and I lead my team with both any time they face an obstacle that could interfere with achieving victory," said Cheer Coach Monica Aldama. "After hours of yelling from the sidelines, I often find myself feeling hoarse and experiencing occasional coughing that comes with it, so I'm excited to head into this season with Robitussin Naturals in my personal wellness arsenal to shut those discomforts down before they get in my way." 

When feeling under the weather, daily tasks like changing out of sick day sweatpants can feel like trying to land a standing back tuck. As a coach of collegiate athletes, Coach Aldama knows the power that positive encouragement can have on helping people overcome setbacks, which is the sentiment she will bring to consumers throughout her partnership with Robitussin.

"We know consumers are continually looking for products that align with their lifestyle, which our consumer research has shown often includes using natural ingredients," said Jennifer Yomoah, Robitussin Senior Brand Manager. "Through thoughtful innovation, we are excited that the launch of Robitussin Naturals can help provide a solution for these evolving needs and preferences by harnessing natural ingredients like ivy leaf while continuing to offer the trusted efficacy expected of Robitussin."

Robitussin Naturals Cough Relief Syrups and Gummies are available now at drugstores nationwide in varieties for both adults and children. Robitussin Naturals dietary supplements are the latest addition to an expansive portfolio of products that cater to many needs from daytime and nighttime relief, to multi-symptom relief benefits and products in a variety of forms for everyone in the family. For more information on Robitussin and the new products, visit www.Robitussin.com.

†Ivy leaf relieves occasional cough associated with hoarseness, dry throat and irritants*

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

**Based on IRI data as of 8/9/2020

About Robitussin^®

Robitussin is the #1 cough relief brand with more than 70 years of history providing consumers with powerful cough relief. Boasting a portfolio of more than 20 products, Robitussin® offers medicines and dietary supplements in a number of forms to help provide relief for a variety of symptoms associated with a cough, cold or the flu. For more information on Robitussin® products visit www.Robitussin.com.

About GSK Consumer Healthcare

GSK Consumer Healthcare combines science and consumer insights to create innovative world-class health care brands that consumers trust and experts recommend for oral health, pain relief, respiratory and wellness.

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SOURCE GSK Consumer Healthcare

Noveome Biotherapeutics, Inc., a clinical stage biopharmaceutical company focused on developing next-generation biologics for the restoration of cellular integrity of damaged tissues, has appointed M. Michelle Berrey, M.D., M.P.H. and Annamaria T. Kausz, M.D., M.S. as members of the company's Board of Directors.

"We are delighted to welcome Drs. Berrey and Kausz to our Board of Directors. Each brings a wealth of expertise in medical and regulatory strategy, drug development, commercialization and corporate financing," said William Golden, Founder, Chairman and CEO of Noveome.

"Both Drs. Berrey and Kausz are joining Noveome at a crucial time as we continue our work to advance ST266 for the treatment of ophthalmology indications including persistent corneal epithelial defects, and systemic inflammation including the cytokine storm often seen in COVID-19."

Dr. Berrey has over 25 years of combined industry and clinical experience. She is a seasoned industry executive with a proven track record in first-in-class therapeutics targeting viral diseases. Currently, Dr. Berrey serves on the Scientific Advisory Board for ViiV/GSK, and is on the Executive Committee and Board of the NC Biotechnology Center. Dr. Berrey was most recently president and CEO at Chimerix (NASDAQ:CMRX) and previously served as Chief Medical Officer at Pharmasset (acquired by Gilead Sciences (NASDAQ: GILD) and Vice President of Clinical Development for Antivirals and Metabolic Diseases at GlaxoSmithKline (NYSE:GSK). Throughout her career she has focused on diseases threatening the most immunocompromised patient populations. Dr. Berrey holds an M.P.H. from Emory University and an M.D. from the Medical College of Georgia.

"It's exciting to join the Board of a company like Noveome, rooted in novel science that is unlocking the vast potential of a multi-targeted secretome such as ST266," said Dr. Berrey. "I look forward to working together with the Noveome management team as we aim to improve clinical outcomes in a range of complex diseases."

Dr. Kausz brings 14 years of experience in drug development and regulatory strategy across several disease areas and all phases of development, including post-marketing. She led the successful filing of two new drug approvals in the U.S. and E.U for renal and metabolic indications, and supported their commercial launch in the U.S. Dr. Kausz is currently the Chief Medical Officer of Allena Pharmaceuticals (NASDAQ:ALNA), where she was instrumental in securing agreement with the FDA on an accelerated approval strategy for a novel indication using a novel endpoint, led several clinical trials, and supported financing activities. Dr. Kausz also serves on the Board of Directors for the Kidney Health Initiative (KHI). She previously held various clinical development roles at EMD-Serono, Keryx, Reata, and AMAG. Dr. Kausz has an M.D. from the University of Virginia and an M.S. in Epidemiology with a concentration in Biostatistics from the University of Washington.

"It is an honor to join the Noveome Board and I look forward to working with leadership on regulatory strategy, evaluation of indication expansion and business development opportunities," said Dr. Kausz. "ST266 has exciting potential to address the challenges of severe inflammatory responses that can occur in a wide range of indications, and I am eager to help advance Noveome's programs."

About ST266

ST266 is a cell-free biologic made by culturing a novel population of human amnion-derived cells. Through a proprietary culturing method, these cells produce an array of growth factors and cytokines, known as the secretome, which promote cellular survival and reduce inflammation.

About Noveome Biotherapeutics, Inc.

Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection as well as the post-COVID-19 symptoms experienced by many COVID-19 patients. Noveome has completed a Phase 2 open-label clinical trial that demonstrated the benefit ST266 had in healing persistent corneal epithelial defects (PEDs). ST266 is also being evaluated in a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye. Noveome is currently planning follow-up clinical studies to characterize the efficacy and safety of ST266 further for the treatment of PEDs and a Phase 1 study evaluating the safety of intravenously administered ST266 in COVID-19 patients. For more information, visit www.noveome.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201022005301/en/

• Data demonstrate potential to enhance effector function of monoclonal antibodies and induce a protective T-cell or "vaccinal" response
  
  
• Therapeutic approach previously applied to treatment of oncologic diseases may now have broader implications across a range of infectious diseases
  
  

SAN FRANCISCO, Oct. 09, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of preclinical research in an influenza animal model highlighting a new mechanism for enhancing the efficacy of monoclonal antibodies to treat viral infection and induce a protective response. Data demonstrate that selective engagement of an activating Fc receptor on dendritic cells by antiviral monoclonal antibodies induced protective CD8⁺ T cell adaptive responses. The paper, entitled "Fc-optimized antibodies elicit CD8 immunity to viral respiratory infection," was published in the October 8, 2020 online edition of Nature.

"In the past several years, we've gained a better understanding of how integral Fc mediated effector functions of monoclonal antibodies are for their therapeutic efficacy in pre-clinical models of neoplastic, infectious and inflammatory diseases," said Jeffrey V. Ravetch, M.D., Ph.D., study senior author and Theresa and Eugene M. Lang Professor and Head of the Leonard Wagner Laboratory of Molecular Genetics and Immunology at The Rockefeller University. "These approaches have been successfully applied to anti-tumor therapeutics and have resulted in improved clinical outcomes in a variety of oncologic diseases. Our present studies have uncovered a significant new mechanism by which antibodies, through their Fc region, can not only engage innate immune responses but activate adaptive T cell responses, thereby stimulating protective anti-viral immunity in these models."

The research published in Nature focuses on the role of the Fc domain of monoclonal antibodies, regions with the capacity to bind to other immune cells through a family of receptors (the Fc receptors). By engineering antibodies with modified Fc domains to enhance binding to specific Fc receptors on innate immune cells, investigators observed an enhanced protective immune response. Certain modifications (GAALIE variants) were associated with activation of dendritic cells, as well as antiviral effector T-cells, indicating induction of the adaptive arm of the immune system, which is responsible for long-term immunity. Based on this research, monoclonal antibodies programmed with improved effector function represent a potential new approach in the design of therapeutic antibodies for both the prevention and treatment of infectious diseases.

"By observing and learning from our body's powerful natural defenses, we have discovered how to maximize the capacity of antibodies through the amplification of key characteristics that may enable more effective treatments for viral diseases," said Herbert "Skip" Virgin, M.D., Ph.D., study co-author and executive vice president, research, and chief scientific officer of Vir. "These data may have significant implications across a wide range of infectious diseases, and we look forward to exploring the vaccinal potential of the GAALIE-engineered antibodies we are advancing through clinical development – VIR-3434 for chronic hepatitis B and VIR-7832 for SARS-CoV-2."

The preclinical study was conducted by Dr. Ravetch and Stylianos Bournazos, Ph.D., of the Laboratory of Molecular Genetics and Immunology at The Rockefeller University, in collaboration with Dr. Virgin and Davide Corti, Ph.D., senior vice president of antibody research at Vir's subsidiary Humabs BioMed SA.

"This type of exceptional collaborative partnership between cutting-edge science and clinical application has the potential to significantly improve our ability to address infectious diseases," stated Dr. Virgin.

Vir is currently evaluating several monoclonal antibodies that have been Fc engineered to include the XX2 "vaccinal mutation" (or GAALIE variant) for which Vir has licensed exclusive rights for all infectious diseases. 

About VIR-3434

VIR-3434 is a subcutaneously administered HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and also to reduce the level of virions and subviral particles in the blood. VIR-3434 has been engineered to have an extended half-life as well as to potentially function as a T cell vaccine against HBV in infected patients.

About VIR-7832 

VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine. VIR-7832 is being developed by Vir and its partner GlaxoSmithKline plc (NYSE:GSK) as part of their broader collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2. 

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio. 

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "potential," "may," "will," "could," "expect," "plan," "anticipate," "believe," "estimate," "goal," "intend," "candidate," "continuing," "developing" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the ability of enhanced Fc mediated effector functions in enhancing the efficacy of monoclonal antibodies to treat viral infections and inducing a protective response in animal models, using an oncological therapeutic approach and enhanced effector function in the treatment of infectious diseases, the vaccinal potential of specifically engineered antibodies in the treatment of chronic hepatitis B and SARS-CoV-2, and statements around the company's plans to explore the vaccinal potential of engineered antibodies as it advances through clinical development of VIR-3434 for the treatment of chronic hepatitis B and VIR-7832 for SARS-CoV-2. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in treating chronic hepatitis B and neutralizing SARS-CoV-2, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:

Investors
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications

+1-415-506-5256

Media
Cara Miller
VP, Corporate Communications

+1-415-941-6746

• Independent Data Monitoring Committee recommended on September 30, 2020 that the study continue into Phase 3 based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in
• Initial Phase 3 results may be available as early as the end of 2020; results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021
• If successful, VIR-7831 has the potential to advance outpatient treatment for COVID-19
• Patient enrollment underway; website live at https://vircovid19study.com/

SAN FRANCISCO and LONDON, Oct. 06, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) today announced the global expansion to Phase 3 of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization. VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs (one of the major sites of infection). Following a positive assessment of unblinded safety data from the lead-in portion of the trial by an Independent Data Monitoring Committee on September 30, 2020, the COMET-ICE registrational study will now expand globally to additional sites in North America, South America and Europe.

George Scangos, Ph.D., chief executive officer of Vir, said: "The rapid achievement of this important milestone reflects the urgency with which we're mobilizing our resources in the hope of preventing the worst consequences of this deadly virus. VIR-7831 is an antibody with characteristics that may enable it to prevent hospitalization or death via multiple mechanisms. We look forward to continuing to collaborate with GSK to accelerate its development."

Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "Given the urgent patient need, I am very pleased that we have progressed VIR-7831 from pre-clinical studies to a Phase 3 trial in only six months since announcing our collaboration with Vir. We believe this neutralizing antibody's high barrier to resistance, notable effector function and enhanced delivery into the lung suggest it has best-in-class potential in the fight against this global pandemic."

The Phase 3 portion of the COMET-ICE study will assess the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally (670 patients in the treatment arm and approximately 670 patients in the placebo arm). The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. Interim analyses are planned to evaluate safety, futility and efficacy, the results of which may be available as early as the end of 2020. Results for the primary endpoint are expected in the first quarter of 2021, with current estimates at January 2021.

The COMET clinical development program for VIR-7831 includes two additional planned trials – one for the treatment of hospitalized patients and another for the prevention of symptomatic infection. The companies also expect to start a Phase 1b/2a trial in the second half of 2020 evaluating VIR-7832, a second investigational SARS-CoV-2 neutralizing antibody that shares the same characteristics as VIR-7831, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T-cell response.

About VIR-7831 / GSK4182136

VIR-7831 (GSK4182136) is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro and in vivo. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. VIR-7831/GSK4182136 has been engineered with the potential to enhance lung bioavailability and have an extended half-life.

About VIR-7832 

VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered with the potential to enhance lung bioavailability, have an extended half-life, and function as a therapeutic and/or prophylactic T cell vaccine.

About the Vir and GSK Collaboration

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio. 

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.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of Vir's collaboration with GSK, the expected timing of clinical study results for VIR-7831, Vir-7831's potential to treat COVID-19 and its expected clinical activity, clinical trials for VIR-7832, the ability of VIR-7832 to function as a therapeutic and/or prophylactic vaccine and its clinical activity, as well as Vir's ability to identify new anti-viral antibodies and its technologies, as well as Vir's ability to address the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials, challenges in identifying new anti-viral antibodies, challenges in neutralizing SARS-CoV-2 or in identifying and inhibiting cellular targets, difficulties in obtaining regulatory approval, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

GSK Cautionary Statement Regarding Forward-Looking Statements

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Vir Biotechnology Contacts:

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RESEARCH TRIANGLE PARK, N.C., Oct. 1, 2020 /PRNewswire/ -- ViiV Healthcare announces its new weekly podcast Being Seen, an in-depth exploration of the role culture plays in resolving how we see ourselves and how we are seen by others. Hosted and narrated by Darnell Moore, award-winning writer and activist, the first season explores current cultural representations of the queer and gay Black male experience and the impact on their lives and society. Being Seen is available October 6^th wherever you get your podcasts and at www.beingseenpodcast.com.

Through conversations with leading artists, writers, activists, entertainers, and community leaders including; writer, director, and producer Lee Daniels and Ben Cory Jones; Samira Nasr, Editor-in-Chief at Harper's Bazaar, and activist, writer, George M. Johnson, ViiV Healthcare hopes Being Seen encourages the creation of more accurate cultural portrayals of the queer and gay Black male experience in order to reduce stigma and change perception - impacting everything from HIV to institutional inequality.

"There is nothing else like Being Seen in the podcast universe for Black gay and queer men – it's a safe space and platform for them to express themselves, share their experiences, and bare their souls and identities freely and uncensored," said Marc Meachem, head of US External Affairs for ViiV Healthcare.  "We think it will reduce stigma and bring hope to Black gay and queer men who may find their story in the stories being shared on the podcast and know they are not alone, they are being seen – and we hope it encourages them to write or tell their own story even if it's just for themselves."  

The project has been enriched and informed by creative consultants and partners Emil Wilbekin founder of Native Son; DaShawn Usher founder of MOBI; Emmy winning producer Darius Brown; Photographers Gioncarlo Valentine and Texas Isaiah – both of whom served as curators for Being Seen photography. As well as the incredible group of illustrators and photographers who either licensed work or created original work to help bring the project to life visually and through sound.  Theme music for the podcast is Colouour by Moses Sumney. 

"Being Seen podcast is another medium through which the lives of Black queer and trans men are uplifted and centered. Our contributions to culture matter. The work that so many of us do on behalf Black people matters" said Darnell Moore. "And we have to share our stories, as different and complex as they may be, to push back against the erasure of our work and voices. I hope that audiences end every episode a bit more committed to co-creating a world where the lives of all Black people matter."

ViiV's evolving commitments to communities in the US most disproportionately impacted by HIV, and the reality of current times have motivated support of this new cultural collaboration.  

"Our sole focus on HIV and the HIV community for more than 10 years has given ViiV clear insights into the importance of listening and hearing the community – and we are committed to amplifying those voices through our work" said Lynn Baxter, Head of North America, ViiV Healthcare. "Being Seen brings awareness to the impact of stigma on every aspect of these individual's lives and spotlights the obligation everyone has to end discrimination against marginalized communities, including people living with HIV." 

Being Seen expands on the insights and findings from landmark ethnographic research conducted by ViiV Healthcare, exploring the lives of Black gay men in Baltimore, Maryland, and Jackson, Mississippi.  This research uncovered that these men wanted the freedom to create their own experiences and live without labels. It also gave life to the ground-breaking experiential theater piece As Much As I Can, created and produced by Harley & Co and presented by ViiV Healthcare.

Being Seen is produced by Harley & Co. and Darnell Moore and created in partnership with ViiV Healthcare.

About Darnell Moore – Being Seen host and producer

Darnell L. Moore is an award-winning writer, activist, organizer, and author of No Ashes in the Fire: Coming of Age Black and Free in America. He is Director of Inclusion Strategy for Content & Marketing at Netflix, editor-at-large at CASSIUS and co-managing editor at The Feminist Wire. A prolific writer, Darnell has been published in various media outlets including MSNBC, The Guardian, Huffington Post, EBONY, The Root, The Advocate, OUT Magazine, VICE and others, as well as numerous academic journals. He received the Humanitarian Award from the American Conference on Diversity for his LGBTQ advocacy and has been named among EBONY Magazine's Power 100, Time Out New York's Eight LGBT Influencers, The Root 100, and Planned Parenthood's Top 99 Dream Keepers.

About Harley & Co – Being Seen Producer

Harley & Co. is a New York based creative studio that produces award-winning multi-platform social justice and culture projects such as activist experiential theater, "As Much As I Can." Their work has won numerous awards including Cannes Lions, AD&D, Shorty for Social Good and most recently, Fast Company's World Changing Ideas. Harley & Co. has been featured in the NYTimes, Teen Vogue, NBC, ABC and Bloomberg, among others, for their unique creative design and approach.  

About ViiV Healthcare

ViiV Healthcare is the only pharmaceutical company solely focused on combating, preventing, and ultimately curing HIV and AIDS.  We exist to make sure no one living with HIV and AIDS is left behind, and we are 100% dedicated to addressing the challenges of the HIV epidemic. Our portfolio ambition is to make HIV a smaller part of people lives.  Beyond developing innovative medicines, ViiV Healthcare works with communities to address enduring disparities in HIV care and outcomes. 

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 aim is 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 https://viivhealthcare.com/en-gb/.

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.

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.

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SOURCE ViiV Healthcare

• Third US indication for Nucala demonstrates GSK's commitment to finding new ways to help patients with eosinophil-driven diseases

GlaxoSmithKline plc (GSK) (NYSE:GSK) today announced the US Food and Drug Administration (FDA) has approved Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥ six months without an identifiable non-hematologic secondary cause. The approval makes Nucala the first and only targeted biologic treatment to be approved for patients with this eosinophil-driven disease in the US.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "HES is a complex, life-threatening condition that impacts nearly 5,000 patients in the US. Today's approval gives these patients access to a biologic treatment for the first time and demonstrates our commitment to maximising Nucala's impact on eosinophil-driven diseases."

The FDA approval follows a priority review of data from a clinical development programme that included positive results from a pivotal phase 3 study, recently published in the Journal of Allergy and Clinical Immunology. The study showed 50 percent fewer patients experienced a HES flare (worsening of symptoms or eosinophil threshold requiring an escalation in therapy) when treated with Nucala, compared to placebo, when added to standard of care treatment over the 32-week study period (28% vs 56%; p=0.002).

According to Dr. Gerald Gleich, MD, allergist, immunologist and a HES expert: "Patients with HES often suffer from debilitating flares of their disease. Reducing them is an important treatment goal. For the first time, we now have a biologic treatment option to offer appropriate patients with this complex disease."

Patients with HES have a persistent and marked overproduction of eosinophils, a type of white blood cell. Reducing the overproduction of eosinophils to normal levels can help people with eosinophil-driven diseases such as HES.

Mary Jo Strobel, Executive Director, American Partnership for Eosinophilic Disorders (APFED) added: "HES can take many years to diagnose and most patients go through a long and frustrating journey that continues even after the diagnosis is confirmed as treatment roadmaps are often unclear and limited. APFED welcomes this approval of Nucala for HES as it gives our community hope."

Nucala is currently used as an add-on maintenance therapy for severe eosinophilic asthma and for the treatment of eosinophilic granulomatosis with polyangiitis (EGPA), and is being investigated in several other eosinophil-driven diseases.

Making our products affordable and accessible

GSK is actively involved in creating solutions that allow patients to have access to new scientific breakthroughs. We remain committed to helping patients access GSK medications and have a long history of providing patient assistance programs. Patients and healthcare professionals who need help with prescription coverage should visit www.NUCALA.com or call 1-844-4-NUCALA for eligibility information.

About Hypereosinophilic Syndrome (HES)

HES is a rare and under-diagnosed disorder, making it difficult to estimate its overall prevalence. Patients with HES have a persistent and marked overproduction of eosinophils, a type of white blood cell. People with HES may have eosinophil levels three times greater than normal. When eosinophils infiltrate certain tissues, they can cause inflammation and organ damage which, over time, can impact patients' day-to-day ability to function. Complications can range from fever and malaise to respiratory and cardiac problems. If left untreated, the symptoms of HES become progressively worse and the disease can be life-threatening.

About the phase 3 study

The pivotal phase 3 study, which enrolled 108 patients, was a 32-week, randomised, double-blind, placebo-controlled study to investigate the efficacy and safety of subcutaneous mepolizumab 300mg (3x100) every four weeks compared with placebo in patients aged 12 years and older with uncontrolled HES. Uncontrolled HES was defined by at least two HES flares (worsening of symptoms or eosinophil threshold requiring an escalation in therapy) within the past 12 months and a blood eosinophil count of 1000 cells/µL or higher at screening.

About Nucala (mepolizumab)

First approved in 2015 for severe eosinophilic asthma (SEA), mepolizumab is the first-in-class monoclonal antibody that targets IL-5. It is believed to work by preventing IL-5 from binding to its receptor on the surface of eosinophils, reducing blood eosinophils to normal levels. At normal levels eosinophils may play a role in maintaining health.

Mepolizumab has been developed for the treatment of diseases that are driven by inflammation caused by eosinophils. It has been studied in over 3,000 patients in 26 clinical trials across a number of eosinophilic indications and has been approved under the brand name Nucala in the US, Europe and in over 20 other markets, as an add-on maintenance treatment for patients with SEA. It is approved for paediatric use in SEA from ages six to 17 in Europe and the US and several other markets. In the US, Japan, Canada and a number of other markets, it is approved for use in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA). Regulatory submissions for chronic rhinosinusitis with nasal polyps (CRSwNP) are expected to progress in 2020. Mepolizumab is currently being investigated in COPD. It is not currently approved for use in CRSwNP or COPD anywhere in the world.

Mepolizumab is not approved for the relief of acute bronchospasm or status asthmaticus. Full US Prescribing Information is available at US Prescribing Information Nucala.

Important safety information

The following information is based on the US Prescribing Information for Nucala in licensed indications only. Please consult the full Prescribing Information for all the labelled safety information for Nucala.

CONTRAINDICATIONS

Nucala should not be administered to patients with a history of hypersensitivity to mepolizumab or excipients in the formulation.

WARNINGS AND PRECAUTIONS

• Hypersensitivity reactions (e.g., anaphylaxis, angioedema, bronchospasm, hypotension, urticaria, rash) have occurred after administration of Nucala. Discontinue Nucala in the event of a hypersensitivity reaction.
• Do not use to treat acute bronchospasm or status asthmaticus.
• Herpes zoster infections have occurred in patients receiving Nucala. Consider vaccination if medically appropriate.
• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Nucala. Decrease corticosteroids gradually, if appropriate.
• Treat patients with pre-existing helminth infections before therapy with Nucala. If patients become infected while receiving treatment with Nucala and do not respond to anti-helminth treatment, discontinue Nucala until parasitic infection resolves.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥5%) in severe asthma clinical trials included headache, injection site reaction, back pain, and fatigue. Injection site reactions (eg, pain, erythema, swelling, itching, burning sensation) occurred in 8% of subjects treated with 100 mg of Nucala versus 3% treated with placebo.

In a clinical trial in patients with EGPA receiving 300 mg of Nucala, no additional adverse reactions were identified to those reported in severe asthma clinical trials. Injection site reactions (eg, pain, erythema, swelling) occurred in 15% of subjects treated with 300 mg of Nucala versus 13% treated with placebo.

In a clinical trial in patients with Hypereosinophilic Syndrome, no additional adverse reactions were identified to those reported in the severe asthma trials. Injection site reactions (e.g., burning, itching) occurred in 7% of subjects treated with 300 mg of Nucala versus 4% treated with placebo.

GSK's commitment to respiratory disease

For over 50 years, GSK has led the way in developing medicines that advance the management of asthma and COPD. From introducing the world's first selective short-acting beta agonist in 1969, to launching six treatments in five years to create today's industry-leading respiratory portfolio, we continue to innovate so we can reach the right patients, with the right treatment. Working together with the healthcare community, we apply world-class science to discover and understand the molecules that become the medicines of tomorrow. We won't stand still until the simple act of breathing is made easier for everyone.

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 Q2 Results and any impacts of the COVID-19 pandemic.

Registered in England & Wales:

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View source version on businesswire.com: https://www.businesswire.com/news/home/20200925005503/en/

– Largest-to-date analysis of serum samples from nearly 650 SARS-CoV-2-infected patients –

– High-resolution serology advances understanding of variations in natural antibody response to SARS-CoV-2 and paves the way for future development of vaccines/therapies –

– Manuscript highlights need for the rational design of vaccines and therapies that address the gaps in natural antibody response –

SAN FRANCISCO, Sept. 24, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the online publication of new research characterizing differences in antibody responses to SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus-2). This analysis, which is the largest to date, describes both the binding properties and kinetics of neutralizing antibodies, providing key insights that could be important to the development of new vaccines and therapies to address COVID-19. The results were published "online first" in the peer-reviewed journal Cell and will appear in the November 12, 2020, print edition of the journal.

Results of this study, based on blood samples from nearly 650 SARS-CoV-2 infected individuals in Switzerland, Italy and the United States, demonstrate that the magnitude of antibodies produced by an infected individual is proportional to disease severity (with hospitalized patients possessing higher antibody titers compared to non-hospitalized patients), and that those antibodies have a half-life of less than two months. Scientists also report that the receptor binding domain (RBD) of the virus is the main target of naturally occurring neutralizing antibodies, accounting for 90% of the neutralizing activity in serum.

"This study provides new information about the diverse individual antibody response to SARS-CoV-2 infection. The results establish a blueprint that could help guide future serology studies and inform vaccine and therapeutic design strategies," said Davide Corti, senior vice president of antibody research at Vir and study author. "Further, the rapid waning of the natural antibody response and the fact that approximately 60% of infected individuals do not produce antibodies that can block infection underscores the potential need for additional therapeutic approaches."

The manuscript also describes the structural characteristics of the interactions of six different neutralizing antibodies targeting the SARS-CoV-2 RBD, including S309. As described in the July 9, 2020 print edition of Nature, S309 was isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, and has been shown to be effective against SARS-CoV-2 infection in cells and in animal models. The findings published in Cell demonstrate that S309 has a high affinity for binding to a different part of the RBD compared to the other five monoclonal antibodies examined, and one that Vir believes may be less likely to mutate. S309 also promotes effector function, enhancing its ability to kill infected cells in addition to its potent neutralizing effect.

"Our high-resolution look at the binding characteristics of the six antibodies highlights nuanced differences that correlate with specific functional activity," said David Veesler, Ph.D., Associate Professor of Biochemistry at the University of Washington School of Medicine and study author. "This unique approach to analyzing antibody responses in infected individuals could be key to ensuring optimal characteristics in the design of future COVID-19 vaccines and therapeutics."

Vir, in collaboration with GlaxoSmithKline plc (NYSE:GSK), is advancing COVID-19 monoclonal antibodies based on the S309 antibody, including VIR-7831 (also known as GSK4182136) and VIR-7832. In August, the companies initiated a Phase 2/3 study, called COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early), which is evaluating VIR-7831 for the early treatment of COVID-19 in patients at high risk of hospitalization.

The research published in Cell was conducted by Vir's subsidiary Humabs BioMed SA in collaboration with the Institute for Research in Biomedicine (IRB), which is affiliated with the Università della Svizzera italiana in Bellinzona, Switzerland; the Ente Ospedaliero Cantonale (EOC) in Ticino, Switzerland; the Clinica Luganese Moncucco in Lugano, Switzerland; the Università della Svizzera italiana (USI); the Luigi Sacco University Hospital in Milan; and the University of Washington in Seattle.

Key contributors include Dr. Veesler; Paolo Ferrari, M.D., chief medical officer for EOC; Federica Sallusto, professor at ETH Zurich and director of the Center of Medical Immunology at the IRB affiliated with the Università della Svizzera italiana; Christian Garzoni, M.D., specialist in general internal medicine and infectious diseases for Clinica Luganese Moncucco; and Agostino Riva, M.D., attending physician at the Luigi Sacco University Hospital.

"We wish to thank our many collaborators and partners who dedicated substantial resources and attention to ensuring the collection, screening and preparation of thousands of samples in just a few weeks," said Herbert "Skip" Virgin, M.D., Ph.D., chief scientific officer of Vir. "Their efforts were important to advancing our understanding of how to combat this global health crisis. We are grateful for their collective focus and collaboration on this research, which represents a key step in the fight against COVID-19."

About VIR-7831 / GSK4182136

VIR-7831 (GSK4182136) is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7831/GSK4182136 has been engineered to enhance lung bioavailability and have an extended half-life.

About VIR-7832 

VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered to enhance lung bioavailability, have an extended half-life, and potentially function as a therapeutic and/or prophylactic T cell vaccine.

About the Vir and GSK Collaboration

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio. 

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "could," "expect," "plan," "anticipate," "believe," "estimate," "goal," "intend," "potential," "candidate," "continuing," "developing" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of commencement of clinical trials of the company's antibodies to treat and prevent COVID-19, the ability of the company's antibodies to neutralize the SARS-CoV-2 virus, the company's efforts to identify additional antibodies, the ability of S309 to cover the entire family of related coronaviruses or S309's ability to recruit the rest of the immune system to kill off already infected cells, as well as statements about the highly conserved nature of the epitope recognized by VIR-7831 and VIR-7832 making it more difficult for escape mutants to develop. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in neutralizing SARS-CoV-2, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

Contact:

Investors
Neera Ravindran, M.D.
VP, Head of Investor Relations & Strategic Communications

+1-415-506-5256

Media
Cara Miller
VP, Corporate Communications

+1-415-941-6746

LAVAL, QC, Sept. 23, 2020 /CNW/ - Today, ViiV Healthcare Canada announced stock availability of CABENUVA and VOCABRIA across the country. CABENUVA is the first and only once-monthly, complete long-acting injectable regimen indicated for the treatment of HIV-1 infection in adults to replace the current antiretroviral (ARV) regimen in patients who are virologically stable and suppressed (HIV-1 RNA less than 50 copies/mL). It combines the integrase strand transfer inhibitor (INSTI) cabotegravir with the non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine.¹ [VOCABRIA and CABENUVA PM p4A,26A]

Both CABENUVA and VOCABRIA received approval from Health Canada on March 18, 2020. VOCABRIA, oral cabotegravir, together with Janssen Pharmaceutical Companies of Johnson & Johnson's EDURANT, oral rilpivirine, is used for the short-term treatment of HIV-1 infection in adults who are virologically stable and suppressed prior to initiating CABENUVA.¹ [VOCABRIA and CABENUVA PM p4A]

Dacia Hibbert, General Manager of ViiV Healthcare Canada, said: "We are proud to make CABENUVA and VOCABRIA available to people living with HIV. CABENUVA will give people living with HIV the option of maintaining viral suppression with 12 treatments per year."

The approval of VOCABRIA and CABENUVA was based on the pivotal phase III ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) studies that included more than 1,100 participants from 16 countries, including Canada. Prior to initiating treatment with CABENUVA, oral dosing of VOCABRIA and EDURANT was administered for approximately one month to assess the tolerability of cabotegravir and rilpivirine. The studies demonstrated that CABENUVA, when injected intramuscularly in the buttocks, once a month, was effective in maintaining viral suppression throughout the 48-week study period.^1-3  [VOCABRIA and CABENUVA PM p35A,35B,37B,38A][Swindells 2020 p4A,5A][Orkin 2020 p4A,5A]

In both studies, the most common adverse reactions (Grades 1 to 4) observed in ≥2% of participants receiving CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, rash, and diarrhea. Over the 48-week study period, a total of 4% of participants discontinued CABENUVA due to adverse events.¹ [CABENUVA PM p.16A,16B]

Please consult the Product Monograph at www.viivhealthcare.ca for complete safety information. The Product Monograph is also available by calling 1-877-393-8448.

About HIV

At the end of 2016, there were an estimated 63,110 people living with HIV in Canada, representing a 5% increase from 2014. The HIV prevalence rate was 173 per 100,000 population with an estimated 14% of people unaware of their status. As treatments work to reduce HIV-related mortality, and new infections are outpacing the number of deaths, the number of Canadians living with HIV will likely continue to increase in the near future.⁴ [PHAC 2016 p8A,9A]

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 aim is 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 – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.ca.gsk.com.

References:

1. ViiV Healthcare ULC. VOCABRIA and CABENUVA Product Monograph. March 18, 2020.

2. Swindells S et al. N Engl J Med 2020;382:1112-23.

3. Orkin C et al. N Engl J Med 2020;382:1124-35. 

4. Public Health Agency of Canada. Summary: Estimates of HIV Incidence, Prevalence and Canada's Progress on Meeting the 90-90-90 HIV targets, 2016. Public Health Agency of Canada, 2018. Available at: https://www.canada.ca/content/dam/phac-aspc/documents/services/publications/diseases-conditions/summary-estimates-hiv-incidence-prevalence-canadas-progress-90-90-90/pub-eng.pdf. Accessed September 16, 2020.

SOURCE ViiV Healthcare

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/September2020/23/c6649.html

New asthma indication for Trelegy Ellipta introduces an important option for patients to the current treatment paradigm

GlaxoSmithKline plc (NYSE:GSK) and Innoviva, Inc. (NASDAQ:INVA) announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol ‘FF/UMEC/VI') for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease (COPD). Trelegy Ellipta is not indicated for relief of acute bronchospasm.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200909006117/en/

The FDA-approved strength for both COPD and asthma is fluticasone furoate / umeclidinium / vilanterol 100/62.5/25mcg. There is an additional strength for asthma alone which is fluticasone furoate / umeclidinium / vilanterol 200/62.5/25mcg.

The approval means Trelegy is the first single inhaler triple therapy approved for the maintenance treatment of both asthma and COPD and is the only single inhaler triple therapy available for patients in a convenient once-daily inhalation in the US. Today's announcement marks GSK's sixth major medicine approval in 2020 across areas of significant unmet medical need including cancer, HIV, respiratory and chronic kidney disease.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Millions of asthma patients in the US rely on multiple inhalers to help control their condition and manage their symptoms. Today's approval is an important advance for these patients as it allows them to benefit from triple therapy by using one inhaler, once-a-day."

Trelegy's approval for the maintenance treatment of asthma in patients aged 18 years and older introduces a new paradigm for managing the approximately 30% of adult asthma patients who still experience symptoms despite being adherent to inhaled corticosteroids/ long-acting beta agonist (ICS/LABA) combination therapy.

Tonya Winders, President, Global Allergy and Airways Patient Platform (GAAPP) commented: "In the US there are almost 20 million adultsⁱ living with asthma and we know that many of those continue to live with and adapt their lives around ongoing symptoms, despite taking medication as prescribed by their physician. We welcome the news that for appropriate patients, Trelegy Ellipta will now be available as a new treatment option."

Today's approval was based on a supplemental New Drug Application which included data from the CAPTAIN study showing that in patients uncontrolled on ICS/LABA, the additional bronchodilation provided by Trelegy demonstrated significant improvements in lung function compared with FF/VI, in a single daily dose in an easy-to-use inhaler. The results from CAPTAIN were presented at the European Respiratory Society (ERS) Congress this week, reinforcing the potential of once-daily single inhaler triple therapy in asthma management.

Pavel Raifeld, Chief Executive Officer of Innoviva, said: "In 2017, Trelegy Ellipta was approved in the US as the first once-daily single inhaler triple therapy for the treatment of COPD, and it remains the market leader with strong continued growth. Today's approval in asthma is another successful outcome for our long-standing partnership with GSK and a testament to our commitment to make innovative medicines accessible to patients with respiratory diseases."

About asthma

Asthma is a chronic lung disease that inflames and narrows the airways. Asthma affects 358 million people worldwide. Despite medical advances, more than half of patients continue to experience poor control and significant symptoms impacting their daily lives.

The causes of asthma are not completely understood but likely involve an interaction between a person's genetic make-up and the environment. Key risk factors are inhaled substances that provoke allergic reactions or irritate the airways.

About the CAPTAIN Study

CAPTAIN (Clinical study of Asthma Patients receiving Triple therapy through A single INhaler) was a randomised, double-blind, active controlled, six-arm parallel group, global multicentre study evaluating FF/UMEC/VI (100/62.5/25 mcg, 200/62.5/25 mcg, 100/31.25/25 mcg, and 200/31.25/25 mcg) versus FF/VI (100/25 mcg and 200/25 mcg) given once-daily to patients whose asthma was inadequately controlled despite treatment with ICS/LABA (>250 mcg/day fluticasone propionate, or equivalent) maintenance asthma medication.

About Trelegy Ellipta (FF/UMEC/VI) in the US

FF/UMEC/VI is a combination of three molecules in a single inhaler that only needs to be taken in a single inhalation, once a day. It contains fluticasone furoate, an inhaled corticosteroid, umeclidinium, a long-acting muscarinic antagonist; and vilanterol, a long-acting beta2-adrenergic agonist, delivered in GSK's Ellipta dry powder inhaler.

FF/UMEC/VI was approved in the US under the brand name Trelegy Ellipta in September 2017 for the long-term, once-daily maintenance treatment of patients with COPD. Trelegy Ellipta was approved in the US on 9 September 2020 for the maintenance treatment of asthma in patients aged 18 years and older. Trelegy Ellipta is not indicated for relief of acute bronchospasm.

US Prescribing Information for Trelegy Ellipta.

Important Safety Information (ISI) for Trelegy Ellipta

The following ISI is based on the Highlights section of the US Prescribing Information for Trelegy Ellipta. Please consult the full Prescribing Information for all the labelled safety information.

Trelegy Ellipta is NOT indicated for the relief of acute bronchospasm.

Trelegy Ellipta is contraindicated in primary treatment of status asthmaticus or acute episodes of asthma requiring intensive measures and in patients with severe hypersensitivity to milk proteins or any of the ingredients.

LABA monotherapy increases the risk of serious asthma-related events.

Trelegy Ellipta should not be initiated in patients experiencing episodes of acutely deteriorating COPD or asthma. Do not use Trelegy Ellipta to treat acute symptoms

Trelegy Ellipta should not be used in combination with other medicines containing LABA because of risk of overdose.

Candida albicans infection of the mouth and pharynx has occurred in patients treated with fluticasone furoate, a component of Trelegy Ellipta. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.

There is an increased risk of pneumonia in patients with COPD taking Trelegy Ellipta. Monitor patients for signs and symptoms of pneumonia.

Patients who use corticosteroids are at risk for potential worsening of infections (e.g. existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex). Use Trelegy Ellipta with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.

There is a risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Trelegy Ellipta.

Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage of Trelegy Ellipta in susceptible individuals. If such changes occur, discontinue Trelegy Ellipta slowly.

If paradoxical bronchospasm occurs, discontinue Trelegy Ellipta and institute alternative therapy.

Hypersensitivity reactions such as anaphylaxis, angioedema, rash, and urticaria may occur after administration of TRELEGY. Discontinue TRELEGY if such reactions occur.

Use Trelegy Ellipta with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.

Assess patients for decrease in bone mineral density initially and periodically thereafter after prescribing Trelegy Ellipta.

Consider referral to an ophthalmologist in patients who develop ocular symptoms or use TRELEGY ELLIPTA long term. Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma and instruct patients to contact a healthcare provider immediately if symptoms occur.

Worsening of urinary retention may occur in patients taking Trelegy Ellipta. Use with caution in patients with prostatic hyperplasia or bladder-neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur.

Use Trelegy Ellipta with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.

Be alert to hypokalemia and hyperglycemia in patients taking Trelegy Ellipta.

Orally inhaled corticosteroids may reduce growth velocity in children and adolescents. Trelegy Ellipta is not indicated for use in children and adolescents.

COPD: The most common adverse reactions reported for Trelegy Ellipta 100/62.5/25 mcg (incidence ≥1%) are upper respiratory tract infection, pneumonia, bronchitis, oral candidiasis, headache, back pain, arthralgia, influenza, sinusitis, pharyngitis, rhinitis, dysgeusia, constipation, urinary tract infection, diarrhoea, gastroenteritis, oropharyngeal pain, cough, and dysphonia.

Asthma: The most common adverse reactions (incidence ≥2%) are nasopharyngitis, upper respiratory tract infection, bronchitis, viral respiratory tract infection, sinusitis, urinary tract infection, rhinitis, influenza, headache, and back pain.

GSK's commitment to respiratory disease

For 50 years, GSK has led the way in developing medicines that advance the management of asthma and COPD. From introducing the world's first selective short-acting beta agonist in 1969, to launching six treatments in five years to create today's industry-leading respiratory portfolio, we continue to innovate so we can reach the right patients, with the right treatment. Working together with the healthcare community, we apply world-class science to discover and understand the molecules that become the medicines of tomorrow. We won't stand still until the simple act of breathing is made easier for everyone.

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.

Trade marks are owned by or licensed to the GSK group of companies.

Editor's Note: In addition to the FDA's approval of Trelegy Ellipta in asthma, GSK has received five major medicine approvals to date in 2020 for CABENUVA (cabotegravir and rilpivirine) in Canada, DUVROQ (daprodustat) in Japan, and ZEJULA (niraparib), RUKOBIA (fostemsavir) and BLENREP (belantamab mafodotin) in the US.

About Innoviva

Innoviva is focused on royalty management. Innoviva's portfolio is anchored by the respiratory assets partnered with Glaxo Group Limited (GSK), including RELVAR®/BREO® ELLIPTA®, ANORO® ELLIPTA® and TRELEGY® ELLIPTA®, which were jointly developed by Innoviva and GSK. Under the agreement with GSK, Innoviva is eligible to receive associated royalty revenues from RELVAR®/BREO® ELLIPTA® and ANORO® ELLIPTA®. In addition, Innoviva retains a 15 percent economic interest in future payments made by GSK for TRELEGY® ELLIPTA® and earlier-stage programs partnered with Theravance Biopharma, Inc. For more information, please visit Innoviva's website at www.inva.com.

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.

Innoviva forward-looking statements

This press release contains certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events, including the development, regulatory and commercial plans for closed triple combination therapy and the potential benefits and mechanisms of action of closed triple combination therapy. Innoviva intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks, uncertainties and assumptions. These statements are based on the current estimates and assumptions of the management of Innoviva as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Innoviva to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are described under the headings "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" contained in Innoviva's Annual Report on Form 10-K for the year ended December 31, 2018, which is on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at www.sec.gov. Additional factors are described in those sections of Innoviva's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019. In addition to the risks described above and in Innoviva's other filings with the SEC, other unknown or unpredictable factors also could affect Innoviva's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. The information in this press release is provided only as of the date hereof, and Innoviva assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

Registered in England & Wales:

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ⁱ https://www.cdc.gov/nchs/fastats/asthma.htm

View source version on businesswire.com: https://www.businesswire.com/news/home/20200909006117/en/

WARREN, N.J., Sept. 9, 2020 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced Advil, a leading OTC pain reliever worldwide, is teaming up with actress Angela Kinsey for the launch of Advil Dual Action, a first of-its-kind pain fighting formula and the biggest over-the-counter (OTC) innovation in the oral pain category within the U.S. in 25 years. Advil Dual Action is the first and only Food and Drug Administration (FDA) approved formula that combines two of the best-known pain relievers, ibuprofen and acetaminophen, to fight pain in two ways: ibuprofen works throughout the body, targeting pain at the source, while acetaminophen blocks pain signals to the brain.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8763651-advil-taps-angela-kinsey-for-launch-of-advil-dual-action/

To support the innovative launch, Advil is teaming up with actress Angela Kinsey, who has long relied on Advil to help combat everyday aches and pains. Kinsey, perhaps most recognized as her character Angela Martin on NBC's "The Office," has been playing the role of busy leading lady in every aspect of her active life: as a mom, actress on Netflix's "Tall Girl," professional podcaster, avid basketball player and roller skating enthusiast.

"Whether I'm working as an actress, keeping up with my kids, or playing my favorite sports, I don't like to sit on the sidelines. Like anyone, I experience everyday aches and pains, but I never let them hold me back," Kinsey said. "I've used Advil for a long time and am thrilled to work with them on their latest innovation, Advil Dual Action, which helps relieve my pain so I can keep doing the things I love!"

As part of the partnership, Kinsey stars in a new video series where fans can watch her stretching, diving, jumping and flipping, without letting pain – or self-doubt – get in her way, thanks to Advil Dual Action.

"I want to show people that aches and pains don't have to stop you doing the things you love," Kinsey said. "For me, that's jumping on the trampoline with my kids, strapping on my roller skates, or crafting for hours on end. I know I can rely on Advil Dual Action to alleviate my pain."

While Kinsey has found relief in new Advil Dual Action since she began using it this summer, other pain sufferers have not. A survey of 1,000 U.S. adults ages 25 to 65, conducted by Advil in partnership with Wakefield Research*, revealed that while 95% of people experience everyday aches and pains, 80% do not always find complete relief with existing OTC pain treatment options.

"It's clear consumers are looking for a new option to treat aches and pains," said Albert Shiue, Brand Manager at GSK. "We are excited to bring that to market in our newest innovation, Advil Dual Action, so people everywhere can find relief. Like Angela Kinsey, we want to encourage our consumers to live life to the fullest, pain free."

Fans can watch Angela Kinsey's content series over the coming months on Advil's Instagram (@advilrelief) and Facebook (@advil), as well as on Angela's social channels (@AngelaKinsey). Visit Advil.com to learn more about Advil Dual Action, now available online and on retail shelves nationwide.

About Advil Dual Action

Advil Dual Action is an exclusive pain-fighting formula, combining ibuprofen and acetaminophen to fight pain in two ways. Ibuprofen is a nonsteroidal anti-inflammatory (NSAID) that targets pain at the source, temporarily reducing the production of prostaglandins, which cause swelling and pain signals. Acetaminophen is a pain reliever that blocks the transmission of pain signals to the brain. Advil Dual Action will be available over-the-counter nationwide in 2020.

GSK's commitment to pain relief

We are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

Important safety information about Advil Dual Action

Before using the product, consumers should read the Advil Dual Action drug facts label.

About GSK

We are 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 GSK Consumer Healthcare

We are the world's largest Consumer Healthcare company following our new joint venture with Pfizer Consumer Healthcare. The new drug application for Advil Dual Action was approved under the Pfizer name. We develop and market a portfolio of consumer-preferred and expert-recommended brands including Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu.

^*Methodological Notes

The Advil Survey was conducted by Wakefield Research (www.wakefieldresearch.com) among 1,000 nationally representative US adults ages 25-65, between July 16^th and July 22nd, 2020, using an email invitation and an online survey. Quotas have been set to ensure reliable and accurate representation of the US adult population ages 25-65.

Results of any sample are subject to sampling variation. The magnitude of the variation is measurable and is affected by the number of interviews and the level of the percentages expressing the results. For the interviews conducted in this particular study, the chances are 95 in 100 that a survey result does not vary, plus or minus, by more than 3.1 percentage points from the result that would be obtained if interviews had been conducted with all persons in the universe represented by the sample.

View original content:http://www.prnewswire.com/news-releases/advil-taps-leading-lady-and-super-mom-angela-kinsey-for-the-launch-of-major-pain-innovation-advil-dual-action-301126381.html

SOURCE GSK Consumer Healthcare

WARREN, N.J., Sept. 8, 2020 /PRNewswire/ -- GSK Consumer Healthcare (LSE/NYSE: GSK) today announced the launch of new Advil Dual Action, an exclusive formula that combines two of the most powerful pain fighting ingredients: ibuprofen and acetaminophen. In February, the Food and Drug Administration (FDA) approved Advil Dual Action as the first and only over-the-counter medication that combines ibuprofen and acetaminophen. The widely used, effective ingredients help to manage pain in two ways: ibuprofen works through the body, targeting pain at the source, while acetaminophen blocks pain signals to the brain. The innovation takes these two powerful pain fighting ingredients and combines them into one tablet to offer fast, strong pain relief.

Physical pain is unique to each person who experiences it and it comes in many forms, yet, the ways we treat and even talk about pain can be outdated and insufficient. Advil surveyed 1,000 U.S. adults ages 25 to 65, in partnership with Wakefield Research*, to understand our relationship with pain: how we experience it, how frequently, how we treat it and even how we describe it to others. The results were clear: although 95% of people in America experience everyday aches and pains, there is no singular, universal experience surrounding pain.

"With the majority of people who experience body aches and pains unable to find full relief from just one medication, Advil recognized that there is so much more potential within the pain relief category, and it starts with gaining a comprehensive understanding of how people experience pain," said Albert Shiue, Brand Manager at GSK. "Driven by GSK's commitment to provide safe and effective pain relief options and our continued efforts to innovate within the pain category, we are excited to launch Advil Dual Action, the most innovative OTC oral pain relief product to hit the market in over 25 years, and provide people with the tools they need to understand and talk about their pain."

To explore findings, Advil is launching the new "Next Generation Pain Report" which offers a deep dive into unique, emerging trends that point to opportunities for us to understand, address and treat everyday pain. The report reveals:

• OTC Medications aren't getting the job done: 95% of people experience everyday aches and pains, but 80% do not always find complete relief with existing OTC pain treatment options.
• No Pain is the Same: Nearly three-quarters (72%) of U.S. adults experience what they would consider "multidimensional pain," getting different types of body pain at different times. In addition to the physical sensation of pain, psychological, social and cultural factors all contribute to an individual's pain experience.
• Age Is Just a Number: Younger people report experiencing just as much pain as older generations. One-third (34%) of Millennials report experiencing pain every day, nearly equal to that of Gen Xers (36%) and Boomers (35%).
• Over-The-Counter Pain Medications are Misunderstood: When presented with both true and false statements about the effects of ibuprofen and acetaminophen, the active ingredients in the most commonly-used, top recommended pain fighters, 81% answered at least one question incorrectly about the effects of these medications.
• A Loss for Words: 62% of U.S. adults feel they aren't able to effectively communicate the everyday pain they experience – to their friends, partners and even their doctors.

To help consumers better identify and address their own everyday aches and pains, Advil is introducing a more modern way to talk about it. No longer will a rigid sad-to-happy-face scale guide how we describe our pain. Instead, a modernized scale will expand our pain lexicon with the common symbols we already use every day: emojis.

Most adults favor putting a digital-era spin on the traditional graphic scale that was initially developed for use with children. More than half (53%) say an emoji chart with multiple types of pain depicted better represents the pain they feel from a body pain than a sad-to-happy face scale. With Advil's new pain scale, consumers will be better able to express their pain, and with Advil Dual Action, people everywhere have a new option for fast, powerful pain relief.

Advil Dual Action is now available online and on retail shelves nationwide.

About Advil Dual Action

Advil Dual Action is an exclusive pain-fighting formula, combining ibuprofen and acetaminophen to fight pain in two ways. Ibuprofen is a nonsteroidal anti-inflammatory (NSAID) that targets pain at the source, temporarily reducing the production of prostaglandins, which cause swelling and pain signals. Acetaminophen is a pain reliever that blocks the transmission of pain signals to the brain. Advil Dual Action will be available over-the-counter nationwide in 2020.

GSK's commitment to pain relief

We are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

Important safety information about Advil Dual Action

Before using the product, consumers should read the Advil Dual Action drug facts label.

About GSK

We are 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 GSK Consumer Healthcare

We are the world's largest Consumer Healthcare company following our new joint venture with Pfizer Consumer Healthcare. The new drug application for Advil Dual Action was approved under the Pfizer name. We develop and market a portfolio of consumer-preferred and expert-recommended brands including Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu.

*Methodological Notes

The Advil Survey was conducted by Wakefield Research (www.wakefieldresearch.com) among 1,000 nationally representative US adults ages 25-65, between July 16^th and July 22nd, 2020, using an email invitation and an online survey. Quotas have been set to ensure reliable and accurate representation of the US adult population ages 25-65.

Results of any sample are subject to sampling variation. The magnitude of the variation is measurable and is affected by the number of interviews and the level of the percentages expressing the results. For the interviews conducted in this particular study, the chances are 95 in 100 that a survey result does not vary, plus or minus, by more than 3.1 percentage points from the result that would be obtained if interviews had been conducted with all persons in the universe represented by the sample.

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SOURCE GSK Consumer Healthcare

• 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.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.

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

Colleen.

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

-- 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 source version on businesswire.com: https://www.businesswire.com/news/home/20200908005498/en/

-- 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 source version on businesswire.com: https://www.businesswire.com/news/home/20200908005282/en/

Tuebingen, Germany and Houston, TX, Sept. 03, 2020 (GLOBE NEWSWIRE) --

• Completed merger with ARYA Life Science Acquisition Corp. and subsequent NASDAQ listing with proceeds from the transaction totaling $253 million (€226 million¹) in July 2020.
• At the closing of the transaction, cash and cash equivalents amounted to $322 million (€288 million¹) enabling Immatics to fund operating expenses and capital expenditure requirements for at least 36 months.
• Expanded ACTengine® clinical programs into Europe with first patient treated with genetically engineered T cell product candidate IMA202 in August 2020; regulatory approval by Paul-Ehrlich-Institute to begin phase I clinical trial with product candidate IMA203 in Germany and to open additional clinical trial sites in the EU.
• Expanded leadership team with appointment of Cedrik Britten as Chief Medical Officer and new appointments made to Immatics' board of directors.
• Extended collaboration with The University of Texas Health Science Center at Houston (UTHealth) in August 2020 until end of 2024 to ensure continued clinical batch supply for all ongoing and upcoming Adoptive Cell Therapy (ACT) clinical trials in US and Europe.

Tuebingen, Germany and Houston, TX, September 3, 2020 – Immatics N.V. (NASDAQ:IMTX, "Immatics"))), a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, today reported financial results for the second quarter of 2020 and provided a corporate update.

"We have achieved a significant milestone as an organization in the last months with our successful listing on NASDAQ, securing the capital needed for Immatics to reach several critical inflection points in our mission to deliver the power of T cells to cancer patients," said Harpreet Singh, Ph.D., CEO of Immatics. "The second quarter is notable for the expansion of our clinical ACTengine programs in Europe as well as for bringing forward our preclinical and partnered programs. We have strengthened our internal leadership and our board, all of which places us in a strong position to achieve our clinical and operational goals for 2020 and 2021."

Second Quarter 2020 and Subsequent Company Progress

Adoptive Cell Therapy Programs

• IMA201 – The phase I dose-escalating clinical trial, IMA201-101, is actively recruiting patients in the US. The trial is designed to evaluate safety, tolerability and initial signs of clinical efficacy of Immatics' genetically engineered T cell ACTengine® product candidate, IMA201, that targets melanoma-associated antigen 4 or 8 ("MAGEA4/A8").
• IMA202 – The phase I dose-escalating trial, IMA202-101, is actively recruiting patients in the US and Europe. Recently, the first patient was dosed in the European part of the trial which is evaluating safety, tolerability and initial signs of clinical efficacy of Immatics' second ACTengine® product candidate, IMA202, that targets melanoma-associated antigen 1 ("MAGEA1").
• IMA203 – The phase I dose-escalating clinical trial, IMA203-101, is actively recruiting patients in the US. Recently, Immatics has been granted regulatory approval by the German regulatory agency, Paul-Ehrlich-Institute to commence the European part of the trial. The clinical trial is evaluating safety, tolerability and initial signs of clinical efficacy of Immatics' ACTengine® product candidate, IMA203, that targets preferentially expressed antigen in melanoma ("PRAME").
• Additional clinical trial centers have been opened in the US and in Germany for all ongoing ACTengine® clinical studies and Immatics expects to provide a combined initial data readout on all three studies in Q1 2021.
• IMA204 – Immatics expects to submit the IND for its fourth ACT program, IMA204, in 2021. The clinical trial will investigate a T cell receptor (TCR) directed against the tumor stroma target, COL6A3, which is highly prevalent in the tumor microenvironment in a broad range of tumor tissues including lung, pancreas, esophagus, breast, ovary, colon and stomach cancer. Immatics expects to provide a data update from the pre-clinical studies in Q3 2020. Non-engineered (endogenous) COL6A3-targeting T cells were infused as part of Immatics' IMA101-101 trial. Immatics expects to report updated clinical trial results from this trial in Q4 2020.

TCR Bispecifics Programs

• IMA401 – Significant progress has been made towards an IND for Immatics' first TCR Bispecifics product candidate, IMA401. Preparatory activities for GMP development have been initiated. Based on favorable pharmacokinetics and pharmacodynamics data in vitro and in vivo, the IND submission is expected in 2021.
• IMA402 – Lead candidate selection for the second TCR Bispecifics program, IMA402, is expected in 2020.

Next Generation Adoptive Cell Therapies

• IMA301 – Immatics' first ACTallo® therapeutic candidate, IMA301, is an allogeneic, off-the-shelf product candidate containing TCR-engineered gamma delta T cells. In in vitro preclinical studies, the T cells achieved large expansion rates and exhibited anti-tumor activity. A preclinical data update is expected to be presented in Q4 2020. IND-enabling studies are ongoing and Immatics expects to submit the IND in 2022.
• IMA101 – Immatics intends to report updated clinical trial results for its multi-target cell therapy pilot clinical trial, IMA101-101, in Q4 2020.
• Immatics continues to advance its next-generation ACT portfolio and manufacturing capabilities.

Business Update

COVID-19 Impact

• Immatics continues to monitor the impact of the COVID-19 pandemic on operations in the US and in Germany.
• Significant measures have been put in place to protect Immatics' employees, GMP manufacturing, biomarker testing, supply chain, operations and the execution of clinical trials.
• Immatics continues to expand its clinical programs with additional clinical trial sites opening in the US and in Europe. Patient screening in Germany has been ramping above expectation. Immatics currently expects to remain on track to meet the enrollment timelines set in its ACTengine® clinical programs.

Corporate Development

Transaction and NASDAQ Listing Summary

• On March 17, Immatics entered into a definitive business combination agreement with ARYA Sciences Acquisition Corp. (NASDAQ:ARYA, "ARYA"))), a special purpose acquisition company, sponsored by Perceptive Advisors. Under the terms of the agreement, the transaction was structured through Immatics B.V., a Dutch private limited liability company, which converted to Immatics N.V. in connection with the closing of the transaction. The transaction was completed on July 1 and Immatics N.V. commenced trading its shares on the NASDAQ under the symbol "IMTX" and its warrants under the symbol "IMTXW" on July 2. In connection with the agreement, Immatics N.V. raised an additional $104 million (€93 million¹) in equity proceeds through a private placement of ordinary shares with existing shareholders of Immatics and ARYA, as well as additional institutional investors. Total proceeds from the transaction, including marketable securities held in a trust account by ARYA and the private placement, were $253 million (€226 million¹). At the closing of the transaction, cash and cash equivalents amounted to $322 million (€288 million¹) enabling Immatics to fund operating expenses and capital expenditure requirements for at least 36 months. The funds at closing of the transaction include funds of Immatics Biotechnologies GmbH, ARYA Sciences Acquisition Corp., equity proceeds through a private placement and transaction costs.

Management and Board of Directors Updates

• On June 1, Cedrik Britten, MD, joined Immatics as Chief Medical Officer (CMO). Dr. Britten previously served as Vice President and Head of Oncology Cell Therapy Research Unit at GlaxoSmithKline plc (NYSE:GSK). He brings to Immatics more than a decade of experience in clinical development. He will be responsible for the management and global development of Immatics' clinical pipeline.
• In conjunction with the NASDAQ listing, Michael Atieh, Paul Carter, Heather Mason and Adam Stone joined Immatics' board as new members. Christof Hettich, L.L.D. remains a board member and Peter Chambré continues to serve as the Chairman of the board.

Partnerships and Alliances

• On August 6, Immatics extended its strategic alliance with UTHealth. The continued collaboration will provide Immatics exclusive access to three cGMP suites enabling manufacturing and supply of its ACT products for current and upcoming phase I clinical trials in Germany and in the US for an additional four years.
• Immatics remains fully committed to its partnered programs with Amgen, Genmab, BMS and GSK.

Second Quarter 2020 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2020 were €86.1 million ($96 million¹). Following the transaction with ARYA, cash and cash equivalents were €288 million ($322 million¹) based on net proceeds from the merger with ARYA and the PIPE financing.

Revenue: Total revenue, consisting of revenue from collaboration agreements, was €6.9 million ($7.7 million¹) for the three months ended June 30, 2020, compared to €5.4 million ($6.1 million¹) for the three months ended June 30, 2019.

Research and Development Expenses: R&D expenses were €16.6 million ($18.5 million¹) for the three months ended June 30, 2020, compared to €9.7 million ($10.9 million¹) for the three months ended June 30, 2019.

General and Administrative Expenses: G&A expenses were €10.0 million ($11.3 million¹) for the three months ended June 30, 2020, compared to €2.1 million ($2.4 million¹) for the three months ended June 30, 2019.

Net Loss: Net loss was €21.3 million ($23.9 million¹) for the three months ended June 30, 2020, compared to €6.7 million ($7.5 million¹) for the three months ended June 30, 2019. The increase was mainly driven by one-time expenses incurred as a result of the conversion of the former share-based employee compensation program and is covered both in R&D and G&A expenses.

Shares Outstanding: 62,908,617 (as of July 2, 2020). Based on the outstanding shares the net loss per share for the three months ended June 30, 2020 was €0.34 ($0.38¹).

Planned Investor and Analyst Activities

• Immatics presenting at 10th Annual Goldman Sachs Biotech Symposium – September 11, 2020
• Immatics presenting at Jefferies Cell Therapy Summit – October 5, 2020
• Immatics presenting at Chardan Virtual Genetic Medicines Conference – October 6, 2020
• Immatics presenting at Eigenkapitalforum – November 16, 2020, 4pm CET
• Immatics presenting at Jefferies London Healthcare Conference – November 17-19, 2020
  
  
  
  

To see the full list of events and presentations, visit www.investors.immatics.com/events-presentations.

Full financial statements can be found in the current report on Form 6-K filed with the Securities and Exchange Commission (SEC) and published on the SEC website under https://www.sec.gov/.

¹ All amounts translated using the exchange rate published by the European Central Bank in effect as of June 30, 2020 (1 EUR = 1.1198 USD).

About Immatics

Immatics combines the discovery of true targets for cancer immunotherapies with the development of the right T cell receptors with the goal of enabling a robust and specific T cell response against these targets. This deep know-how is the foundation for our pipeline of Adoptive Cell Therapies and TCR Bispecifics as well as our partnerships with global leaders in the pharmaceutical industry. We are committed to delivering the power of T cells and to unlocking new avenues for patients in their fight against cancer.

For regular updates about Immatics, visit www.immatics.com. You can also follow us on Twitter and LinkedIn.

Forward-Looking Statements

Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or Immatics' future financial or operating performance. For example, statements concerning the timing of product candidates and Immatics' focus on partnerships to advance its strategy are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "may", "should", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in filings with the SEC. Nothing in this presentation should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Immatics undertakes no duty to update these forward-looking statements.

Attachments

• Immatics_Q2 2020_EN
• Immatics_Q2 2020_GER

For more information, please contact:

For Media Inquiries
Gretchen Schweitzer or Jacob Verghese, PhD
Trophic Communications
Phone: +49 89 2388 7731 


Investor Relations Contact
John Graziano
Solebury Trout
Phone: +1 646 378 2942


Immatics N.V.
Anja Heuer
Corporate Communications
Phone: +49 89 540415-606 


Jordan Silverstein
Head of Strategy
Phone: +1 281 810 7545

• The Phase 3 study is evaluating the safety, tolerability and immunogenicity of GSK's MenABCWY vaccine candidate compared to BEXSERO and MENVEO in adolescents and young adults
• Study investigators to enrol 3,650 participants aged 10-25 years in Canada, the U.S., Europe, Turkey and Australia

MISSISSAUGA, ON, Aug. 31, 2020 /CNW/ - GlaxoSmithKline plc (LSE: GSK) (NYSE:GSK) announced that a multi-national phase III clinical program investigating its 5-in-1 meningitis (MenABCWY) vaccine candidate compared to licensed meningococcal vaccines, BEXSERO (meningococcal group B vaccine) and MENVEO (meningococcal groups A,C, Y, and W-135 vaccine) has begun globally, with patient dosing expected to commence in Canada in September 2020.

Emmanuel Hanon, Senior Vice President and Head of Vaccines R&D for GSK, said: "Entering the final stage of clinical trials with our 5-in-1, MenABCWY vaccine candidate is a major step toward GSK's goal of reducing meningococcal disease around the world.  This vaccine candidate builds on the heritage of BEXSERO and MENVEO and we would like to thank all the scientific researchers, medical partners, advocates and families around the world who also hope for a successful outcome."

The initial Phase 3 studies ^[1] (NCT04502693) will be conducted in individuals aged 10-25 years in Canada, the United States, Europe, Turkey and Australia and the study investigators will enrol 3,650 participants. The trial will evaluate safety, tolerability and immunogenicity of GSK's 5-in-1, MenABCWY vaccine candidate compared to licensed meningococcal vaccines, BEXSERO and MENVEO.

Five meningitis serogroups -- A, C, W, Y and B -- account for nearly all cases of invasive meningococcal disease (IMD) and there is no 5-in-1 combination vaccine currently available ^[2]. Meningitis caused by serogroup B (MenB) is responsible for the majority of cases of IMD in Canada ^[3].

The first vaccination of the multi-national Phase 3 trial's first participant is a pivotal milestone in GSK's leadership in meningitis vaccine research and development.  Since their first approvals in 2010 and 2013 respectively, GSK has distributed more than 58 million doses of MENVEO (meningococcal groups A, C, Y, and W-135 vaccine) and more than 52 million doses of BEXSERO (meningococcal group B vaccine) world-wide.

Lori Knox, Director, Clinical Development Vaccines, GSK Canada, said: "We're excited to reach this important milestone in the development of a 5-in-1, MenABCWY vaccine. It offers the potential to help protect against all 5 vaccine-preventable serogroups with one combined product."

As with all vaccines at this stage of development, safety and efficacy of GSK's MenABCWY vaccine are being evaluated and market authorization has not yet been obtained.

About Invasive Meningococcal Disease

Invasive Meningococcal Disease (IMD) is uncommon,^[4] with reported cases ranging from 0.1 to 2.4 cases per 100,000 population across multiple countries in 2017^[5]. However, this potentially serious and unpredictable disease can kill in as few as 24 hours ^[6] and is the leading cause of life-threatening bacterial meningitis in most of the industrialized world ^[7]. While meningococcal disease is uncommon, about one in 10 of those who contract the disease will die, even with appropriate treatment ^[8]. Additionally, around 20 percent of those who survive the disease may suffer a major physical or neurological disability (limb loss, hearing loss or seizures) ^[9].

Increased rates of meningitis could be due to risk factors including close contact with others, sharing drinks or eating utensils, kissing or coughing.^[10],^[11]. In adolescents and young adults, U.S. surveillance studies have shown that between 2014-2017, the relative risk of contracting MenB was 3.5 to 5 times higher in college students aged 18-24 years compared with peers not attending college.^**†

^*(95% confidence interval = 14.9%–19.9%).

^**0.17 cases in college students vs. 0.05 cases in peers not attending college per 100,000 population in 2014-2016 ^[10]

^†0.22 cases in college students vs. 0.04 cases in peers not attending college per 100,000 population in 2015-2017^[11]

About BEXSERO  

BEXSERO is licensed in more than 40 countries including Canada. BEXSERO is indicated for active immunization of individuals from 2 months through 25 years of age against invasive disease caused by N. meningitidis serogroup B strains.

Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

About MENVEO

MENVEO has been approved in 62 countries including Canada. MENVEO is indicated for active immunization of individuals 2 months through 55 years to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135.

Please consult the Product Monograph at www.gsk.ca for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

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 Q2 Results and any impacts of the COVID-19 pandemic. 

Trademarks are owned by or licensed to the GSK group of companies.

References

[1] https://clinicaltrials.gov/ct2/show/NCT04502693?term=205416&draw=2&rank=1 identifier NCT04502693

[2] World Health Organization (WHO), 2018. Meningococcal meningitis Fact sheet no 141. Available at: https://www.who.int/news-room/fact-sheets/detail/meningococcal-meningitis [Accessed March 2020]

[3] Vaccine Preventable Disease: Surveillance Report to December 31, 2015. Available at https://www.canada.ca/en/public-health/services/publications/healthy-living/vaccine-preventable-disease-surveillance-report-december-31-2015.html#a64 

[4] Pelton SI. Meningococcal disease awareness; Clinical and epidemiological factors affecting prevention and management in adolescents. J Adolesc Health. 2010;46:S9-S15

[5] European Centre for Disease prevention and Control (ECDC). Surveillance report: Invasive meningococcal disease – Annual Epidemiological Report for 2017. Available at: https://ecdc.europa.eu/en/publications-data/invasive-meningococcal-disease-annual-epidemiological-report-2017 [Accessed march 2020]

[6] Thompson MJ et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367:397-403

[7] Rappuoli R et al. Meningococcal B vaccine (4CMenB): the journey from research to real world experience. Expert Rev Vaccines. 2018;17(12):1111-1121

[8] World Health Organization (WHO), 2018. Meningococcal meningitis Fact sheet no 141. Available at: https://www.who.int/news-room/fact-sheets/detail/meningococcal-meningitis [Accessed March 2020

[9] World Health Organization (WHO), 2018. Meningococcal meningitis Fact sheet no 141. Available at: https://www.who.int/news-room/fact-sheets/detail/meningococcal-meningitis [Accessed March 2020]

[10] Walker TY, Elam-Evans LD, Yankey D, et al. National, Regional, State, and Selected Local Area Vaccination Coverage Among Adolescents Aged 13–17 Years — United States, 2018. MMWR Morb Mortal Wkly Rep 2019;68:718–723. DOI: http://dx.doi.org/10.15585/mmwr.mm6833a2external icon 

[11] Gary S Marshall, Amanda F Dempsey, Amit Srivastava, Raul E Isturiz, US College Students Are at Increased Risk for Serogroup B Meningococcal Disease, Journal of the Pediatric Infectious Diseases Society,piz024, https://doi.org/10.1093/jpids/piz024

SOURCE GlaxoSmithKline Inc.

View original content to download multimedia: http://www.newswire.ca/en/releases/archive/August2020/31/c0704.html

• Phase 2/3 COMET-ICE study will investigate the safety and efficacy of antibody treatment in preventing hospitalization due to COVID-19
  
   
• Potential for initial study results to be available before the end of 2020, with early access to the antibody treatment as soon as the first half of 2021

SAN FRANCISCO and LONDON, Aug. 31, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (NYSE:GSK) announced that the first patient was dosed last week in a Phase 2/3 study with VIR-7831 (also known as GSK4182136), a fully human anti-SARS-CoV-2 (Severe Acute Respiratory Syndrome coronavirus-2) monoclonal antibody, for the early treatment of COVID-19 in patients who are at high risk of hospitalization.

The aim of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study, which will enroll approximately 1,300 patients worldwide who have early symptomatic infection, is to assess whether VIR-7831, as a single-dose monoclonal antibody, can prevent hospitalization due to COVID-19. Initial results may be available before the end of this year, with complete results expected in the first quarter of 2021, and potentially early access to the antibody treatment as soon as the first half of 2021. Last week's initiation of the study follows the signing of a collaboration between the two companies in April 2020 to research and develop solutions for coronaviruses.

George Scangos, Ph.D., chief executive officer, Vir, said: "Treating those with early COVID-19 disease so that it doesn't become worse is critical both for the patients and for society. Hospital systems are overwhelmed worldwide, with new infections continuing to strain already limited resources. This study is designed to demonstrate whether VIR-7831 can significantly reduce the need for hospitalization in high-risk individuals, such as the elderly or those with pre-existing conditions such as lung or heart disease." 

Dr. Hal Barron, chief scientific officer and president R&D, GSK, said: "Monoclonal antibodies directed against the SARS-CoV-2 virus could provide an effective and immediate immune response to COVID-19, bypassing the need for our body to produce its own antibodies, which is particularly important in the absence of an effective vaccine. This study will assess the ability of VIR-7831 to prevent high-risk individuals from progressing to severe disease, and in future studies we will also test the antibody's ability to prevent infection in high-risk patients and to reduce disease severity in patients who are already hospitalized."

Monoclonal antibodies that neutralize SARS-CoV-2 infection, the virus that causes COVID-19, are being investigated as a potential therapeutic and prophylactic approach against the disease. They are produced, or cloned, from immune cells in a laboratory. Vir's antibody platform has identified unique antibodies from survivors that may work by blocking the virus from infecting new cells (neutralization) and by recruiting the immune system to eliminate infected cells (effector function).

A key feature of SARS-CoV-2 is the spike protein that covers the virus' outer surface. The virus uses these spike proteins to bind to and enter human cells, leading to infection. It is hypothesized that monoclonal antibodies directed against the spike proteins could represent a therapeutic approach against COVID-19. Pre-clinical studies with VIR-7831, which was identified through Vir's antibody platform, showed affinity for the SARS-CoV-2 spike protein and high potency in neutralizing SARS-CoV-2, suggesting a high barrier to resistance and an ability to recruit immune cells to kill already infected cells. In addition, VIR-7831 has been designed to enhance lung bioavailability.

The COMET-ICE multi-center, double-blind, placebo-controlled Phase 2/3 study investigating VIR-7831 in patients with mild or moderate COVID-19 who are at high risk of progression to severe disease comprises two parts. The first part (the Lead-In phase) will serve as the first-in-human assessment. The Lead-In phase will assess the safety and tolerability of a single 500 mg intravenous (IV) infusion of VIR-7831 or placebo over a 14-day period in non-hospitalized patients. It aims to recruit 20 patients across the United States. Following this initial safety assessment, the second part (the Expansion phase) will progress with the aim of reducing the need for hospitalization. The Expansion phase will assess the safety and efficacy of a single IV infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally. The primary efficacy endpoint is the proportion of patients with mild or moderate COVID-19 who worsen, as defined by the need for hospitalization or death, within 29 days of randomization.

The COMET clinical development program for VIR-7831 also includes two additional planned trials—one for the treatment of severely ill hospitalized patients and another for the prophylaxis of symptomatic infection.

Later this year, the companies expect to start a Phase 2 trial of their other investigational SARS-CoV-2 neutralizing antibody, VIR-7832, which shares the same characteristics as VIR-7831 but may also function as a therapeutic and/or prophylactic T cell vaccine.

About VIR-7831 / GSK4182136

VIR-7831 (GSK4182136) is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7831/GSK4182136 has been engineered to enhance lung bioavailability and have an extended half-life.

About VIR-7832 

VIR-7832 is a monoclonal antibody that has shown the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered to enhance lung bioavailability, have an extended half-life, and potentially function as a therapeutic and/or prophylactic T cell vaccine.

About the Vir and GSK Collaboration

In April 2020, Vir and GSK entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir's proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK's expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

About Vir Biotechnology

Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus, and tuberculosis. For more information, please visit www.vir.bio. 

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.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the potential benefits of Vir's collaboration with GSK, the expected timing of clinical study results for VIR-7831, Vir-7831's potential to treat COVID-19 and its expected clinical activity, clinical trials for VIR-7832, the ability of VIR-7832 to function as a therapeutic and/or prophylactic vaccine and its clinical activity, as well as Vir's ability to identify new anti-viral antibodies and its technologies, as well as Vir's ability to address the current COVID-19 pandemic and future outbreaks of the disease. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials, challenges in identifying new anti-viral antibodies, challenges in neutralizing SARS-CoV-2 or in identifying and inhibiting cellular targets, difficulties in obtaining regulatory approval, challenges in accessing manufacturing capacity, clinical site activation rates or clinical trial enrollment rates that are lower than expected, changes in expected or existing competition, delays in or disruptions to Vir's business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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. 

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New York, United States, Fri, 28 Aug 2020 05:45:42 / Comserve Inc. / -- This drug is not used to kill or cure this virus, but rather stop the growth of this virus.The antiretroviral drugs market is anticipated to record a CAGR of around 6% over the forecast period 2020-2028.

Research Nester has published a report titled "Antiretroviral Drugs Market: Global Demand Analysis & Opportunity Outlook 2028" which delivers detailed overview of the antiretroviral drugs market in terms of market segmentation by drug type and by region.

Further, for the in-depth analysis, the report encompasses the industry growth drivers, restraints, supply and demand risk, market attractiveness, BPS analysis and Porter's five force model.

The antiretroviral therapy is a medical prescription that treats HIV. This drug is not used to kill or cure this virus, but rather stop the growth of this virus.The antiretroviral drugs market is anticipated to record a CAGR of around 6% over the forecast period, i.e., 2020-2028. Based on drug type, the market is segmented into protease inhibitors, integrase inhibitors, multi-class combination products, nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs) and others, out of which, multi-class combination products segment is anticipated to hold the largest market share on the back of the better clinical outcome and replacing the conventional treatment method which involve multiple tablets. The increasing sale of this multi class combination tabletsare expected to give the fuel to the growth of this segment in the global antiretroviral drugs market.  

The antiretroviral drugs market is segmented into five major regions including North America, Europe, Asia Pacific, Latin America and Middle East & Africa region. The region of North America is estimated to hold the largest share of this market owing to the high ART coverage rate and growing R&D activity in this region is increasing the demand of this market and anticipated to hold the high CAGR during the forecast period. On the other hand, In Latin America it is anticipated to hold the second largest share in this drug market during the forecast period on the back of increasing number cases, which in turn increasing the demand of this market. In Asia pacific the market is growing at a tremendous rate on account of increasing cases among people of this region, especially in India and China.

Growing Investments for R&D in the Healthcare Industry

The increasing concern for the chronic diseases affecting individuals worldwide is raising the need amongst the healthcare operators to continuously put up their efforts for the development of advanced healthcare products that can help humanity to fight against the deadly diseases. As such, several governments of nations worldwide are increasingly spending on research and developments. Similar advancements are also observed for the manufacturing of medicines and treatments for HIV disease, which is also anticipated to drive the demand for antiretroviral drugs, and in turn the growth of the market. Get Sample PDF Copy of this Report

However, increasing portfolio of this drug is anticipated to hamper the market over the forecast period.

This report also provides the existing competitive scenario of some of the key players of the antiretroviral drugs market which includes company profiling of Roche Holding AG(SWX: RO), Gilead Sciences Inc.(NASDAQ:GILD), GlaxoSmithKline(NYSE:GSK), Bristol-Myers-Squibb(NYSE:BMY), Abbott Laboratories(NYSE:ABT), AstraZeneca plc(LON: AZN), Merck & Co.(NYSE:MRK), Johnson and Johnson(NYSE:JNJ) and Novartis international AG(SWX: NOVN). The profiling enfolds key information of the companies which encompasses business overview, products and services, key financials and recent news and developments. On the whole, the report depicts detailed overview of the antiretroviral drugs market that will help industry consultants, equipment manufacturers, existing players searching for expansion opportunities, new players searching possibilities and other stakeholders to align their market centric strategies according to the ongoing and expected trends in the future.

Research Nester is a one-stop service provider, leading in strategic market research and consulting with an unbiased and unparalleled approach towards helping global industrial players, conglomerates and executives to make wise decisions for their future investment and expansion by providing them qualitative market insights and strategies while avoiding future uncertainties. We believe in honesty and sheer hard work that we trust is reflected in our work ethics. Our vision is not just limited to gain the trust of our clients but also to be equally respected by our employees and being appreciated by the competitors.

For more information, please contact:

Research Nester
Email:
Tel: +1-6465869123

The post Antiretroviral Drugs Market Outlook- Increasing Investments for Research in Healthcare Industry to Drive The Global Antiretroviral Drugs Market By A CAGR Of Around 6% Throughout 2020-2028 appeared first on Comserveonline.

New York, United States, Fri, 28 Aug 2020 04:05:44 / Comserve Inc. / -- Dendritic Cell Therapy Market is anticipated to experience significant CAGR during the forecast period, i.e. 2020-2028.

Research Nester published a report titled "Dendritic Cell Therapy Market: Global Demand Analysis & Opportunity Outlook 2028" which delivers a detailed overview of the dendritic cell therapy market in terms of market segmentation by product type, by end- user, by application, and by region.

Further, for the in-depth analysis, the report encompasses the industry growth drivers, restraints, supply and demand risk, market attractiveness, BPS analysis, and Porter's five force model.

Dendritic cell therapy is used for the treatment of chronic diseases such as cancer, tumor, and others. The dendritic cell therapy presents an antigen cell to target the T- cells. This helps in boosting the immune system of the patient. The therapy has minimal or no side effects in the patient's body. As technological advancements are taking place and innovation is in focus, the therapy market is evolving and upgraded versions of the therapy are being tested.

"The Final Report will cover the impact analysis of COVID-19 on this industry (Global and Regional Market)."

The market is anticipated to experience significant CAGR during the forecast period, i.e. 2020-2028. A boost in the growth is evident during the forecast period as a result of increasing awareness among people along with increasing expenditure on healthcare by the patients. Further, the number of chronic disease sufferers is increasing. The market for dendritic cell therapy is segmented by product type, end- user, by application, and by region. On the basis of product, the market is further segmented into sipuleucel, creavax, and others. The segment sipuleucel is anticipated to hold the leading market share as a result of quick results shown by the drug in boosting the immune system to eliminate the unwanted cells.Request Sample Copy of Strategic Report

The market is anticipated to grow in North America and Europe as innovations are rapid along with highly advanced techniques and equipment to test the and treat the diseases.

Increasing Awareness among People and Government Initiatives to Drive the Market Growth

The increasing government initiatives and awareness campaigns are imparting knowledge in the minds of people about chronic diseases such as cancer, tumor, along with their treatments. This is projected to lead to an increase in demand for therapies and treatments that have minimum or no side effects. Further, the therapy is effective in treating the diseases. People are ready to spend on their health since several policies and health insurance are available in their geographical areas.  However, the dendritic cell therapy market is estimated to face restraints as well. The therapy market has to face strict regulations from the government. Further, constant innovation and research are required in this market. Download Sample

"The Final Report will cover the impact analysis of COVID-19 on this industry (Global and Regional Market)."

This report also provides the existing competitive scenario of some of the key players of the dendritic cell therapy market which includes company profiling of Kite Pharma- Gilead Sciences, Inc. (NASDAQ:GILD), Argos Therapeutics, Dendreon, GlaxoSmithKline plc (NYSE:GSK), Batavia Biosciences, ImmunoCellular Therapeutics Ltd. (OTC:IMUC), Elios Therapeutics, Merck & Co. Inc. (NYSE:MRK), Tella Inc. (TYO:2191). The profiling enfolds key information of the companies which encompasses business overview, products and services, key financials, and recent news and developments. On the whole, the report depicts a detailed overview of the dendritic cell therapy market that will help industry consultants, equipment manufacturers, existing players searching for expansion opportunities, new players searching possibilities and other stakeholders to align their market- centric strategies according to the ongoing and expected trends in the future.

Research Nester is a one-stop service provider, leading in strategic market research and consulting with an unbiased and unparalleled approach towards helping global industrial players, conglomerates and executives to make wise decisions for their future investment and expansion by providing them qualitative market insights and strategies while avoiding future uncertainties. We believe in honesty and sheer hard work that we trust is reflected in our work ethics. Our vision is not just limited to gain the trust of our clients but also to be equally respected by our employees and being appreciated by the competitors.

For more information, please contact:

Research Nester
Email:
Tel: +1-6465869123

The post Global Dendritic Cell Therapy Market 2020-2028 | Kite Pharma- Gilead Sciences, Inc., Argos Therapeutics, Dendreon, GlaxoSmithKline plc, Batavia Biosciences, ImmunoCellular Therapeutics Ltd. appeared first on Comserveonline.

Moderna, Inc., (NASDAQ:MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that John Lepore has joined Moderna as Senior Vice President, Government Engagement effective Monday, August 10, 2020. He will report to Chief Executive Officer, Stéphane Bancel.

"I am pleased to welcome John to Moderna as our Senior Vice President, Government Engagement. John is joining us at a pivotal time as we enroll the Phase 3 study of our COVID-19 vaccine and prepare for the start of the Phase 3 study of our CMV vaccine. Moderna has a large clinical pipeline of first-in-class vaccines," said Stéphane Bancel, Chief Executive Officer of Moderna. "John's experience in developing corporate strategy for vaccines at GSK along with his unique blend of government affairs, public policy, commercial and legal experience at the national, regional and global level will be an important asset as we transition Moderna into a global commercial stage enterprise."

Mr. Lepore joins Moderna from Mastercard (NYSE:MA), where he served as General Counsel, Policy and Advocacy since 2017. At Mastercard, he was responsible for global public policy, regulatory affairs and litigation and led a global team of more than 80 professionals based in North America, Latin America, Europe, Middle East, Africa, and Asia Pacific. Prior to Mastercard, Mr. Lepore was Head of Global Government Affairs at RELX (ReedElsevier LexisNexis) Group (NYSE:RELX).

Previously, Mr. Lepore spent 15 years with GlaxoSmithKline (NYSE:GSK) where he held a range of commercial and corporate leadership positions in the U.S., Europe and Asia. His most recent position was Vice President, Government Affairs for GSK Emerging Markets where he led government affairs, public policy and patient advocacy across all GSK's commercial divisions including the pharmaceutical, vaccines and consumer subdivisions. His prior roles at GSK included leading the CEO's Office and Corporate Strategy team, managing a vaccines business unit in China, and heading the company's Brussels office for EU government affairs. Before joining GSK, Mr. Lepore served as senior legal counsel in the U.S. Congress and practiced law at Akin, Gump in the firm's Washington and Brussels offices.

"Moderna is in a unique position to rapidly enter worldwide markets with the demonstrated progress of its mRNA platform," said Mr. Lepore. "I look forward to joining the Moderna team to build the global government engagement function and to help ensure that Moderna's mRNA medicines and vaccines are widely available."

Mr. Lepore received a Master of Public Health degree from Johns Hopkins University and Juris Doctorate from Georgetown University. He received his Bachelor of Arts degree from Boston College.

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. The company's platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna 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, and 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).  Moderna has been named a top biopharmaceutical employer by Science for the past five years. To learn more, visit www.modernatx.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200810005740/en/

• BLENREP is a first-in-class anti-BCMA (B-cell maturation antigen) therapy for patients whose disease has progressed despite prior treatment with an immunomodulatory agent, proteasome inhibitor and anti-CD38 antibody
• BLENREP is the fifth major medicine approval for GSK in 2020

GlaxoSmithKline plc (NYSE:GSK) announced the US Food and Drug Administration (FDA) has approved BLENREP (belantamab mafodotin-blmf) as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. BLENREP is the first anti-BCMA (B-cell maturation antigen) therapy approved anywhere in the world.ⁱ

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "As the second most common form of blood cancer in the US, multiple myeloma is an incurable and devastating disease. BLENREP is the first approved anti-BCMA therapy and has the potential to transform the treatment of patients with relapsed or refractory myeloma who have limited treatment options today.''

BLENREP is GSK's fifth major medicine approval in 2020 across areas of significant unmet medical need such as cancer, HIV and chronic kidney disease. This approval marks the second FDA approval for GSK's oncology portfolio in four months.

BLENREP employs a multi-faceted mechanism of action and is directed toward BCMA, a cell-surface protein that plays an important role in the survival of plasma cells and is expressed on multiple myeloma cells.ⁱⁱ The approval of BLENREP was based on six-month primary results from the pivotal DREAMM-2 study, which enrolled patients with relapsed or refractory multiple myeloma who had actively progressing disease that had worsened despite current standard of care.

Dr. Sagar Lonial, MD, Chief Medical Officer, Winship Cancer Institute of Emory University in Atlanta, Georgia, Chair of Emory Department of Hematology and Medical Oncology and Principal Investigator for DREAMM-2, said: "While treatable, refractory multiple myeloma is a significant clinical challenge with poor outcomes for patients whose disease has become resistant to the current standard of care. Due to the limited options currently available, these patients are often retreated with drugs from the same classes after they relapse, which is why the approval of BLENREP, the first anti-BCMA therapy, is significant for both patients and physicians alike."

In the DREAMM-2 study, treatment with single-agent BLENREP 2.5 mg/kg every three weeks demonstrated a clinically meaningful overall response rate (ORR) of 31% (97.5% CI; 21-43) in patients who had received a median of seven prior lines of treatment (n=97). The median duration of response (DoR) had not been reached at the six-month analysis, but 73% of responders had a DoR equal to or greater than six months. The most commonly reported adverse events (≥20%) were keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. Keratopathy is characterized as changes in the corneal epithelium as seen on eye examination, which can manifest with or without symptoms.

Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population and included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Corneal adverse events were monitored with eye exams prior to each dose, allowing for dose reductions or interruptions as appropriate. Patients also used preservative-free eye drops. Keratopathy leading to treatment discontinuation affected 2.1% of patients in the 2.5 mg/kg cohort.ⁱⁱⁱ

BLENREP is available through participation in the BLENREP Risk Evaluation and Mitigation Strategy (REMS), which was developed to ensure appropriate use of the medicine. The program requires education for all physicians prescribing BLENREP and their patients regarding the ocular risks associated with treatment as well as monitoring. Additional information about the BLENREP REMS can be found at www.blenreprems.com or 1-855-209-9188.

Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF), said: "The approval of BLENREP is an important advancement for patients with relapsed or refractory multiple myeloma, as it brings a much-needed new treatment to patients who face limited options due to their progressing disease. We are grateful for GSK's continued commitment to myeloma patients and their families."

In 2017, BLENREP was granted Breakthrough Therapy designation by the FDA, which is intended to facilitate the development of investigational medicines that have shown clinical promise for conditions where there is significant unmet need.

Making Our Products Affordable and Accessible

GSK is actively involved in creating solutions that allow patients to have access to new scientific breakthroughs. We remain committed to helping patients access GSK medications and have a long history of providing patient assistance programs. Patients and healthcare professionals can access more information about our oncology specific resources on insurance coverage and financial support at: www.TogetherwithGSKOncology.com or call: 1-844-4GSK-ONC (1-844-447-5662).

About Multiple Myeloma

Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.^iv In the US, more than 32,000 people are estimated to be diagnosed with multiple myeloma this year and nearly 13,000 people will die from the disease.^v Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.^vi

About BLENREP (belantamab mafodotin-blmf)

BLENREP is an antibody drug conjugate comprising a humanized anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

IMPORTANT SAFETY INFORMATION FOR BLENREP

WARNINGS AND PRECAUTIONS

Ocular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.

Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).

Visual Acuity Changes: A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).

Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS.

BLENREP REMS: BLENREP is available only through a restricted program under a REMS called the BLENREP REMS because of the risks of ocular toxicity. Notable requirements of the BLENREP REMS include the following:

• Prescribers must be certified with the program by enrolling and completing training in the BLENREP REMS.
• Prescribers must counsel patients receiving BLENREP about the risk of ocular toxicity and the need for ophthalmic examinations prior to each dose.
• Patients must be enrolled in the BLENREP REMS and comply with monitoring.
• Healthcare facilities must be certified with the program and verify that patients are authorized to receive BLENREP.
• Wholesalers and distributers must only distribute BLENREP to certified healthcare facilities.

Further information is available at www.BLENREPREMS.com and 1-855-209-9188.

Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity.

Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8%. Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.

Embryo-Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman because it contains a genotoxic compound (the microtubule inhibitor, monomethyl auristatin F [MMAF]) and it targets actively dividing cells. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose.

ADVERSE REACTIONS

The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder. Among the 218 patients, 24% were exposed for 6 months or longer.

The safety of BLENREP as a single agent was evaluated in DREAMM-2. Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Among these patients, 22% were exposed for 6 months or longer.

Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).

Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation.

Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%).

Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%). The most common adverse reactions (≥20%) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased (22%), platelets decreased (21%), hemoglobin decreased (18%), neutrophils decreased (9%), creatinine increased (5%), and gamma-glutamyl transferase increased (5%).

USE IN SPECIFIC POPULATIONS

Lactation: There is no data on the presence of belantamab mafodotin-blmf in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.

Females and Males of Reproductive Potential: BLENREP can cause fetal harm when administered to pregnant women. There are no available data on the use of BLENREP in pregnant women to evaluate for drug-associated risk. No animal reproduction studies were conducted with BLENREP.

Pregnancy Testing: Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP.

Infertility: Based on findings in animal studies, BLENREP may impair fertility in females and males. The effects were not reversible in male rats but were reversible in female rats.

Geriatric Use: Of the 218 patients who received BLENREP in DREAMM-2, 43% were aged 65 to less than 75 years and 17% were aged 75 years and older. Keratopathy occurred in 80% of patients aged less than 65 years and 73% of patients aged 65 years and older. Among the patients who received BLENREP at the 2.5-mg/kg dose in DREAMM-2 (n = 95), keratopathy occurred in 67% of patients aged less than 65 years and 73% of patients aged 65 years and older.

Renal Impairment: No dose adjustment is recommended for patients with mild or moderate renal impairment (estimated glomerular filtration rate [eGFR] 30 to 89 mL/min/1.73m² as estimated by the Modification of Diet in Renal Disease [MDRD] equation). The recommended dosage has not been established in patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m²) or end-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m² not on dialysis or requiring dialysis.

Hepatic Impairment: No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin ≤upper limit of normal [ULN] and aspartate aminotransferase (AST) >ULN or total bilirubin 1 to ≤1.5 × ULN and any AST). The recommended dosage of BLENREP has not been established in patients with moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST).

INDICATION 

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

The full Prescribing Information, including BOXED WARNING and Medication Guide, will be available here.

GSK in Oncology

GSK is focused on maximizing patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilizing modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

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.

Editor's Note: In addition to the FDA's approval of BLENREP, GSK has received four major medicine approvals to date in 2020 for CABENUVA (cabotegravir and rilpivirine) in Canada, DUVROQ (daprodustat) in Japan and ZEJULA (niraparib) and RUKOBIA (fostemsavir) in the 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 Q2 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

References

______________________

ⁱ NCI Drug Dictionary - Anti-BCMA Antibody-Drug Conjugate GSK2857916. National Cancer Institute. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-bcma-antibody-drug-conjugate-gsk2857916.

Accessed May 2020.

ⁱⁱ Trudel S, Lendvai N, Popat R, et al. Antibody–drug conjugate, GSK2857916, in relapsed/refractory multiple myeloma: an update on safety and efficacy from dose expansion phase I study. Blood Cancer Journal. 2019;9(4).

doi:10.1038/s41408-019-0196-6.

ⁱⁱⁱ Lonial, S, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020; 21(2):207–21.

^iv Estimated number of incident cases worldwide, both sexes, all ages. World Health Organization. https://gco.iarc.fr/ Published 2020. Accessed May 2020.

^v SEER Cancer Facts & Figures 2019. Available at: https://seer.cancer.gov/statfacts/html/mulmy.html. Accessed December 19, 2019.

^vi Nooka AK, Kastritis E, Dimopoulos MA. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015;125(20)

View source version on businesswire.com: https://www.businesswire.com/news/home/20200805006105/en/

BOSTON and LONDON, July 15, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (NASDAQ:ORTX), a global gene therapy leader, today announced that the company has entered into two worldwide royalty-bearing license agreements with GlaxoSmithKline plc (GSK) (NYSE:GSK) for use of their proprietary lentiviral stable cell line technology (LV-SCLT) for Orchard's investigational hematopoietic stem cell gene therapies for Wiskott Aldrich syndrome (OTL-103 for WAS) and transfusion-dependent beta thalassemia (OTL-300 for TDT).

"Utilization of a stable cell line provides an opportunity to generate lentiviral vector of consistently high titer and eliminates the need to purchase plasmids prior to the production of each viral vector batch, providing more efficient production processes and shorter lead times," said Bobby Gaspar, M.D., Ph.D., chief executive officer of Orchard. "By increasing the efficiency of the vector manufacturing process, this technology can provide a key competitive advantage and supports our focus on manufacturing innovations that enable commercial scalability."

The LV-SCLT permanently and stably enables all the lentiviral vector components to be introduced into a cell line in one step. Selection and expansion of a resulting clonal producer line in either suspension or adherent culture can deliver consistent levels of high titer lentiviral production comparable to those seen using conventional methods. An overview of this technology, co-authored by Orchard and GSK scientists, was presented at the European Society of Gene & Cell Therapy (ESGCT) Annual Congress in October 2019 using work done in the OTL-300 program for TDT^*. Under the licenses, GSK has granted patents and pending patent applications related to its LV-SCLT^**.

Gaspar continued, "We believe the work completed with OTL-300 utilizing a stable cell line can be leveraged and applied to future development plans in OTL-103 for WAS, which will be especially useful in a commercial setting given the large number of patients diagnosed and living with the disease."

Orchard plans to submit a biologics license application (BLA) and marketing authorization application (MAA) for OTL-103 for the treatment of WAS in the U.S. and EU, respectively, in 2021.

The terms of the license are not expected to have a material impact on Orchard's financial position or near-term cash needs.

About OTL-103 and WAS

OTL-103 is an ex vivo autologous hematopoietic stem cell gene therapy in development for the treatment of Wiskott Aldrich syndrome (WAS). WAS is a life-threatening inherited immune disorder that primarily affects males and is characterized by recurrent and severe infections, autoimmunity, eczema and severe bleeding episodes. It is caused by a mutation in the gene that produces the WAS protein, which results in abnormal function of white blood cells and low platelets. Without treatment, the median survival for children born with WAS is 14 years of age. The global incidence of WAS is estimated to be about one in every 100,000 male births per year^***.

About Orchard

Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSK's rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and the San Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit www.orchard-tx.com, and follow us on Twitter and LinkedIn.

Availability of Other Information About Orchard

Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchard's investor relations website and may include additional social media channels. The contents of Orchard's website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking Statements

This press release contains certain forward-looking statements about Orchard's strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include express or implied statements relating to, among other things, Orchard's business strategy and goals, the therapeutic potential of Orchard's product candidates, including the product candidate or candidates referred to in this release, Orchard's expectations regarding the timing of regulatory submissions for its product candidates, the size of the potential markets for Orchard's product candidates, and the effectiveness, efficiencies expected from and expected use of stable cell line technology. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchard's control, which could cause actual results to differ materially from those contemplated in these forward-looking statements.  In particular, these risks and uncertainties include, without limitation: the severity of the impact of the COVID-19 pandemic on Orchard's business, including on clinical development and commercial programs; the risk that any one or more of Orchard's product candidates, including the product candidate or candidates referred to in this release, will not be approved, successfully developed or commercialized; the risk of cessation or delay of any of Orchard's ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchard's product candidates; the delay of any of Orchard's regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchard's product candidates or the receipt of restricted marketing approvals; the risk of delays in Orchard's ability to commercialize its product candidates, if approved; the risk that the market opportunity for its product candidates may be lower than estimated; and the risk that stable cell line technology is less effective than anticipated or does not yield the expected manufacturing efficiencies. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchard's quarterly report on Form 10-Q for the quarter ended March 31, 2020, as filed with the U.S. Securities and Exchange Commission (SEC) on May 7, 2020, as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchard's views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

Investors

Renee Leck

Director, Investor Relations

+1 862-242-0764

Media

Molly Cameron

Manager, Corporate Communications

+1 978-339-3378

*Zeguer JL, Acors S, Rana B, et al. A BAC-cloning platform for development of stable producer cell lines for commercial scale lentiviral vector manufacture. Hum Gene Ther 2019; 30:11, P056

**PCT/EP2016/078336 and PCT/EP2016/078334

***Source: Malik MA, Masab M. Wiskott-Aldrich Syndrome. [Updated 2019 Jun 22]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2019 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK539838/

LONDON, July 14, 2020 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) today announced the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12-0 in favour of the demonstrated benefit of monotherapy treatment with belantamab mafodotin outweighing the risks for patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Two committee members could not participate in the final vote.

Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "We are pleased the committee recognised the potential for belantamab mafodotin to help patients who have relapsed or refractory multiple myeloma, an incurable disease with limited treatment options. We look forward to working with the FDA as they complete their review of our Biologics License Application."

The recommendation was based on data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme, including the pivotal DREAMM-2 study which enrolled heavily pre-treated patients who had actively progressing multiple myeloma that had worsened despite current standard of care.ⁱ The six-month primary results from the study were published in The Lancet Oncology in December 2019 and serve as the basis for the Biologics License Application (BLA).

The FDA will consider the recommendation of the committee but is not obligated to follow it. The FDA granted breakthrough therapy designation to belantamab mafodotin in 2017 and priority review designation for the BLA earlier this year. A Marketing Authorisation Application for belantamab mafodotin also is under accelerated assessment by the European Medicines Agency.

Belantamab mafodotin is not currently approved for use anywhere in the world.

About belantamab mafodotin (GSK2857916)

Belantamab mafodotin is an investigational antibody drug conjugate comprising a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

About DREAMM-2

DREAMM-2 is an open label study of belantamab mafodotin. Patients in the trial had actively progressing multiple myeloma that had worsened despite current standard of care and were randomised to two arms to receive either 2.5 mg/kg or 3.4 mg/kg belantamab mafodotin every three weeks. Overall, patients in DREAMM-2 had more advanced disease, poorer prognosis and performance status and also had a greater number of prior lines of therapy in comparison with patients in DREAMM-1, the first time in human study of belantamab mafodotin.

About multiple myeloma

Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable, but not curable.ⁱⁱ Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.ⁱⁱⁱ

About B-cell maturation antigen (BCMA)

The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.ⁱⁱⁱ 

GSK in Oncology

GSK is focused on maximising patient survival through transformational medicines. GSK's pipeline is focused on immuno-oncology, cell therapy, cancer epigenetics, and synthetic lethality. Our goal is to achieve a sustainable flow of new treatments based on a diversified portfolio of investigational medicines utilising modalities such as small molecules, antibodies, antibody drug conjugates and cells, either alone or in combination.

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 any impacts of the COVID-19 pandemic.

Registered in England & Wales:

No. 3888792

Registered Office:

980 Great West Road

Brentford, Middlesex

TW8 9GS

ⁱ Lonial, S, et al. Belantamab mafodotin for relapsed or refractory multiple myeloma (DREAMM-2): a two-arm, randomised, open-label, phase 2 study. Lancet Oncol. 2020; 21(2):207–21.

ⁱⁱ Kazandjian D. Multiple myeloma epidemiology and survival: A unique malignancy. Semin Oncol. 2016;43(6):676–681. doi:10.1053/j.seminoncol.2016.11.004.

ⁱⁱⁱ Nooka A, Kastritis E, Dimopoulos M, Lonial S. Treatment options for relapsed and refractory multiple myeloma. Blood. 2015;125(20):3085-3099. doi:10.1182/blood-2014-11-568923.

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SOURCE GlaxoSmithKline plc

WARREN, N.J., June 11, 2020 /PRNewswire/ -- GlaxoSmithKline (NYSE:GSK) announced that Voltaren Arthritis Pain Gel (diclofenac sodium topical gel, 1% (NSAID) arthritis pain reliever) recently became available over-the-counter (OTC) online and in stores nationwide, providing the over 30 million¹ osteoarthritis patients across the country broader access to a leading pain relief option.

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8731451-gsk-partners-with-paula-abdul-to-launch-voltaren-arthritis-pain-gel/

To launch the OTC offering, Voltaren is teaming up with music superstar Paula Abdul, who uses Voltaren for her arthritis pain. Staying active is important for arthritis patients everywhere, and together, Voltaren and Paula Abdul will inspire people to "rediscover the joy of movement".

"I'm excited to partner with Voltaren Arthritis Pain Gel to share my personal journey with arthritis and success using Voltaren," Paula said. "I've put my joints through a lot over the years. Dancing, jumping, flipping – it's my heart and soul, but I've been pushing my joints to the limit for decades as a result. When I was diagnosed with arthritis, my doctor prescribed Voltaren which made a huge difference in relieving my pain and helping me move with ease. I am so excited it's now available OTC at stores nationwide."

Joint pain due to arthritis symptoms is a daily reality for millions of people in the United States, and with many people across the country staying at home more often, finding arthritis pain relief is more important than ever. In a recent study of 1,000 U.S. adults aged 35+ suffering from joint pain* conducted by Voltaren in partnership with Wakefield Research, 82 percent of respondents said their physical activity has decreased as a result of more time at home, and 92 percent of respondents report that their joint pain is the same or more severe during this time.

"Stay-at-home orders led to a unique set of challenges for those with arthritis," said Jissan Cherian, Director, U.S. OTC Marketing at GSK Consumer Healthcare. "Now, more than ever, we need to offer solutions that help ease the challenge of joint pain and inspire arthritis patients to rediscover the joy of movement, even as we adapt to changing routines and a new way of life."

Additional results from the survey revealed:

• 78 percent of joint pain sufferers are finding ways to incorporate new ways of moving into their routine since the start of stay-at-home orders, including walking, stretching and stair climbing
• With many changing their daily routines to adjust to the new normal, 31 percent expressed they are unhappy about straying from their usual pain management routine
• 54 percent have felt more knee pain due to walking around on surfaces that offer less support
• 65 percent are looking for strategies to incorporate more exercise in their households, like using soup cans as dumbbells, or furniture as makeshift gym equipment
• More screen time on smartphones means increased finger pain –nearly three in five joint pain sufferers age 35-55 report an increase due to typing/holding devices while at home
• 51 percent are feeling joint pain due to new quarantine activities, including bread kneading, knitting, gardening, DIY projects, stretching and walking

Voltaren Gel, a doctor-prescribed arthritis treatment in the U.S. for over 10 years with a proven safety profile, was approved by the Food and Drug Administration (FDA) as an OTC treatment in February, making it the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC in the United States. As an alternative to pills, Voltaren treats joint pain by delivering medicine at the source, and is absorbed through the skin and not through the stomach like most oral medicines. Voltaren is applied directly to the site of pain, delivering powerful arthritis pain relief. It is indicated for the treatment of arthritis pain in the hand, wrist, elbow, foot, ankle or knee. To date, millions of patients around the world have relied on Voltaren as a powerful, well-tolerated and convenient therapeutic alternative for treating arthritis pain.

"As the world leader in pain relief, we have seen how Voltaren has helped people with osteoarthritis treat their pain and improve their quality of life" Cherian said. "The OTC availability of Voltaren Arthritis Pain helps to provide greater access to an effective topical treatment option for joint pain patients, so more people with osteoarthritis pain can find relief."

Voltaren Arthritis Pain Gel is now available online and at most major retailers nationwide.

About Voltaren Arthritis Pain Gel

The active ingredient in Voltaren Arthritis Pain Gel, diclofenac sodium, is an effective medicine that is clinically proven to relieve joint pain due to arthritis. Voltaren penetrates through the skin at the application site to deliver arthritis pain relief. Voltaren offers consumers who suffer from OA a well-tolerated alternative to oral analgesics.  For more information, visit https://www.VoltarenGel.com/.

About osteoarthritis

Osteoarthritis (OA) is the most common form of arthritis. OA occurs when the cartilage between joints begins to break down and wear away, resulting in joint pain and stiffness. OA occurs more frequently with age, and the pain can gradually worsen over time. The most common symptoms associated with OA include joint pain, stiffness, and decreased range of motion.

GSK's commitment to pain relief

We are the world leader in pain relief. With a portfolio of (systemic and topical) products to relieve pain, our range brings comfort and ease to millions. World-leading brands including Advil, Panadol and Voltaren; and beloved local brands like Excedrin in the US and Fenbid in China help people manage their symptoms so they can enjoy life to the fullest.

Important safety information about Voltaren Arthritis Pain

Before using the product, consumers should read the Voltaren Arthritis Pain Gel Drug Facts Label. 

* Methodological Notes

The GSK Voltaren Survey was conducted by Wakefield Research (www.wakefieldresearch.com) between May 7^th and May 15^th, 2020, among 1,000 US adults ages 35+ suffering from joint pain, plus an additional oversample of 500 joint pain sufferers in each of three states: Georgia, Oklahoma, Louisiana, using an email invitation and an online survey.

Results of any sample are subject to sampling variation. The magnitude of the variation is measurable and is affected by the number of interviews and the level of the percentages expressing the results. For the interviews conducted in this particular study, the chances are 95 in 100 that a survey result does not vary, plus or minus, by more than 3.1 percentage points from the result that would be obtained if the interviews had been conducted with all persons in the universe represented by the sample.

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 GSK Consumer Healthcare

We are the world's largest Consumer Healthcare company following our new joint venture with Pfizer Consumer Healthcare. We develop and market a portfolio of consumer-preferred and expert-recommended brands including Sensodyne, parodontax, Poligrip, Advil, Centrum and Theraflu.

¹ https://www.cdc.gov/arthritis/basics/osteoarthritis.htm

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SOURCE GSK Consumer Healthcare

LONDON and SONGDO, South Korea, May 21, 2020 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) and Samsung Biologics (207940.KS) have entered into a partnership to provide GSK with additional capacity to manufacture and supply GSK's innovative biopharmaceutical therapies.

Under the terms of the agreement, Samsung Biologics will provide GSK with additional capacity for large-scale biopharmaceutical product manufacturing. This capacity will be flexible depending on GSK's future needs and will supplement GSK's existing manufacturing network.

Regis Simard, President, Pharmaceuticals Supply Chain, GSK, said, "Today's agreement with Samsung Biologics complements and reinforces our existing world-class pharmaceutical manufacturing capability and will help ensure we can continue to deliver the transformative medicines that patients need."

"We are very proud and excited to announce this long-term agreement with GSK," said Dr. Tae Han Kim, CEO of Samsung Biologics. "Samsung Biologics entered the biopharma industry with the goal to help our clients bring valuable biological medicines to patients faster. We are thrilled to partner with GSK, a company who shares the vision."

The agreement is worth more than $231 million USD over the next eight years. It will initially cover commercial production of Benlysta (belimumab), with technology transfer starting in 2020 and first commercial supply expected in 2022. The intention is to expand to additional specialty-care products in the future.

About Samsung Biologics Co. Ltd.

Samsung Biologics is a fully integrated CDMO offering state-of-the-art contract development, manufacturing, and analytical testing services. With a proven regulatory approvals record, the largest capacity, and the fastest throughput, Samsung Biologics is an award-winning partner of choice and is uniquely able to support the development and manufacturing of biologics products at every stage of the process while meeting the evolving needs of biopharmaceutical companies worldwide. For more information, visit www.samsungbiologics.com.

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

Press Contact:
Samsung Biologics | Claire Kim
GSK | Tim Foley:

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SOURCE Samsung Biologics

• Human antibody potently neutralizes SARS-CoV-2 and related viruses, suggesting high barrier to resistance
   
• Clinical testing expected to begin this summer in collaboration with GSK

SAN FRANCISCO, May 18, 2020 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced the publication of research findings from the company's efforts to develop therapeutics for COVID-19 in the May 18, 2020 issue of the journal Nature. The paper, entitled "Cross-neutralization of SARS-CoV and SARS-CoV2 by a human monoclonal antibody" (Pinto, et al., Nature), details the identification and characterization of S309, an antibody isolated from a patient who recovered from severe acute respiratory syndrome (SARS) in 2003, which has been shown to prevent SARS-CoV-2 live virus infection of cells. Vir is advancing two clinical development candidates based on the S309 antibody as potential therapeutics for COVID-19, VIR-7831 and VIR-7832, in collaboration with GlaxoSmithKline plc (NYSE:GSK).

"Remarkably, we believe S309 likely covers the entire family of related coronaviruses, which suggests that, even as SARS-CoV-2 continues to evolve, it may be quite challenging for it to become resistant to the neutralizing activity of S309," said Herbert "Skip" Virgin, M.D., Ph.D., Chief Scientific Officer, Vir. "In addition, S309 exhibits potent effector function in vitro, potentially allowing the antibody to engage and recruit the rest of the immune system to kill off already infected cells. We have seen in animal models of other respiratory infections, such as influenza, that effector function significantly enhances the activity of antibodies that are already potently neutralizing."

"Potency, coupled with a high barrier to resistance, are hallmarks of a superior antiviral," said Phillip S. Pang, M.D., Ph.D., Chief Medical Officer, Vir. "We have seen this with mAb114, a single, potent monoclonal antibody that has been shown in a Phase 2/3 trial in the Democratic Republic of Congo to markedly reduce mortality from Ebola."

mAb114 is a monoclonal antibody that was isolated by Vir scientists in collaboration with the National Institutes of Health (NIH) and other government agencies using the same approach used to discover and develop S309. mAb114 is being developed by Ridgeback Biotherapeutics LP and the NIH.

The paper can be accessed on the Nature website here. To learn more about Vir's efforts to develop therapies for COVID-19, visit https://investors.vir.bio/press-releases.

About VIR-7831

VIR-7831 is a monoclonal antibody that has demonstrated the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7831 has been engineered to have an extended half-life.

About VIR-7832

VIR-7832 is a monoclonal antibody that has demonstrated the ability to neutralize SARS-CoV-2 live virus in vitro. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (also known as SARS), indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop. VIR-7832 has been engineered to have an extended half-life and to potentially function as a T cell vaccine.

About Vir's Antibody Platform
Vir has a robust method for capitalizing on unusually successful immune responses naturally occurring in people who are protected from, or have recovered from, infectious diseases. The platform is used to identify rare antibodies from survivors that have the potential to treat and prevent rapidly evolving and/or previously untreatable pathogens via direct pathogen neutralization and immune system stimulation. Vir engineers the fully human antibodies that it discovers to enhance their therapeutic potential. This platform has been used to identify and develop antibodies for pathogens including Ebola (mAb114, currently in use in the Democratic Republic of Congo), hepatitis B virus, influenza A, malaria, and others.

About Vir Biotechnology
Vir Biotechnology is a clinical-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting hepatitis B virus, influenza A, SARS-CoV-2, human immunodeficiency virus and tuberculosis. For more information, please visit www.vir.bio. 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "could," "expect," "plan," "anticipate," "believe," "estimate," "goal," "intend," "potential," "candidate," "continuing," "developing" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding the timing of commencement of clinical trials of the company's antibodies to treat and prevent COVID-19, the ability of the company's antibodies to neutralize the SARS-CoV-2 virus, the company's efforts to identify additional antibodies, the ability of S309 to cover the entire family of related coronaviruses or S309's ability to recruit the rest of the immune system to kill off already infected cells, as well as statements about the highly conserved nature of VIR-7831 and VIR-7832 making it more difficult for escape mutants to develop.  Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in neutralizing SARS-CoV-2, difficulty in collaborating with other companies or government agencies, and challenges in accessing manufacturing capacity. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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Vir Biotechnology, Inc.

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Neera Ravindran, MD
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+1-415-506-5256

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Lindy Devereux
Scient Public Relations

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LONDON, April 29, 2020 /PRNewswire/ -- GlaxoSmithKline plc (NYSE:GSK) today announced the US Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Zejula (niraparib), an oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor, as a monotherapy maintenance treatment for women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy, regardless of biomarker status. Until now, only 20% of women with ovarian cancer, those with a BRCA mutation (BRCAm), were eligible to be treated with a PARP inhibitor as monotherapy in the first-line maintenance setting.ⁱ

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Women with advanced ovarian cancer have a five-year survival rate of less than 50%. This expanded indication means that many more women with this devastating disease can receive earlier treatment with Zejula, which can extend the time it takes for their cancer to progress."

Zejula is the only once-daily PARP inhibitor approved in the US as monotherapy for women with advanced ovarian cancer beyond those with BRCAm disease in the first-line and recurrent maintenance treatment settings, as well as late-line primary treatment settings.

This new indication is supported by data from the phase III PRIMA study (ENGOT-OV26/GOG-3012), which enrolled patients with newly diagnosed advanced ovarian cancer following a complete or partial response to platinum-based chemotherapy regardless of biomarker status. The PRIMA study enrolled women who had higher risk of disease progression, a population with high unmet needs and limited treatment options. 

Dr. Bradley Monk, PRIMA investigator, US Oncology, University of Arizona College of Medicine, Phoenix Creighton University School of Medicine at St. Joseph's Hospital Phoenix, said: "PRIMA was designed for patients with ovarian cancer who have a high unmet need. The positive data observed regardless of biomarker status in this study is extremely encouraging and suggests benefit beyond the BRCAm population. This approval is an important step forward in the treatment of ovarian cancer. In my opinion, maintenance treatment with niraparib should be considered an option for appropriate patients who responded to first-line platinum-based chemotherapy versus active surveillance."

The primary endpoint in the PRIMA study was progression-free survival (PFS) analysed sequentially, first in the homologous recombination deficient (HRd) population, then in the overall population. The PRIMA study significantly improved PFS for patients treated with Zejula, regardless of biomarker status. In the HRd population, Zejula resulted in a 57% reduction in the risk of disease progression or death vs. placebo (HR 0.43; 95% CI, 0.31 to 0.59; p<0.0001), and a 38% reduction in the risk of disease progression or death vs. placebo in the overa