GSK and Vir Biotechnology Announce United States Government Agreement to Purchase Additional Supply of Sotrovimab, Authorized for the Early Treatment of COVID-19
– 600,000 additional doses to be supplied to the US government for distribution in Q1 2022, enabling further access to sotrovimab nationwide –
– Brings total number of doses secured to date through binding agreements to approximately 1.7 million globally –
– Preclinical data generated through both pseudo-virus and live virus testing demonstrate sotrovimab retains activity against all tested SARS-CoV-2 variants of concern including Delta and Omicron –
LONDON and SAN FRANCISCO, Jan. 11, 2022 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the US government will purchase an additional 600,000 doses of sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, enabling further nationwide access to sotrovimab for patients. The additional 600,000 doses will be delivered throughout the first quarter of 2022. This agreement is an amendment to earlier commitments announced with the US government in November 2021.
Including the commitments announced today, GSK and Vir have received binding agreements for the sale of approximately 1.7 million doses of sotrovimab worldwide. In addition, today’s agreement also includes the option for the US government to purchase further additional doses in the second quarter of 2022.
Sotrovimab, which was granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) in May 2021, is an investigational single-dose intravenous (IV) infusion SARS-CoV-2 monoclonal antibody. Under the EUA, sotrovimab can be used for the 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 progression to severe COVID-19, including hospitalization or death.
GSK and Vir expect to manufacture approximately 2 million doses globally in the first half of 2022 and additional doses in the second half of the year.
Maya Martinez-Davis, President, US Pharmaceuticals, GSK, said: “We are proud to continue to work with the US government to bring sotrovimab to patients who need it, especially as the Omicron variant continues to grow in prevalence across the country. We understand the role we can play in supporting the ongoing pandemic response, and our teams are working with urgency to explore options to expand our supply capacity so we can support more patients in 2022.”
George Scangos, Ph.D., Chief Executive Officer of Vir, said: “As the Omicron variant continues its rapid spread alongside the still prevalent Delta variant, we are pleased to once again work with the US government to provide more access to sotrovimab for people in the US at high risk of progression to severe COVID-19. Data from multiple pseudo-virus and live virus preclinical studies, generated by industry and academia, continue to demonstrate that sotrovimab retains activity against all tested variants of concern and interest. We are proud of our ongoing contributions to the fight against the COVID-19 pandemic here in the US and around the world.”
The Biomedical Advanced Research and Development Authority (BARDA), part of the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), collaborated with the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) and Army Contracting Command to purchase contract numbers W58P0521C0008 and W58P0522C0002.
In June 2021, GSK and Vir announced confirmatory full results for the COMET-ICE Phase 3 trial examining use of sotrovimab for early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults. The trial met the primary endpoint with a 79% reduction (adjusted relative risk reduction) (p<0.001) in all-cause hospitalizations for more than 24 hours or death due to any cause by Day 29 compared to placebo. In absolute numbers, 30 (6%) of the 529 patients in the placebo arm progressed, compared to six (1%) of the 528 patients receiving sotrovimab. In clinical trials conducted to date, sotrovimab has been well-tolerated. The most common adverse reactions are hypersensitivity and infusion-related reactions, seen in approximately 2% and 1% of cases, respectively.
GSK and Vir are committed to the ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve at different rates across the globe and new variants of concern and interest emerge. Preclinical pseudovirus data, published in bioRxiv, demonstrate that sotrovimab retains activity against all tested variants of concern and interest of the SARS-CoV-2 virus as defined by the World Health Organization, including, but not limited to, Omicron (B.1.1.529), Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu (B.1.621). Preclinical live virus testing has also been completed with data, recently published in bioRxiv, further demonstrating that sotrovimab retains activity against the Omicron variant.
About Global Access to Sotrovimab
Sotrovimab is supplied in several countries worldwide, including through national agreements in the US, UK, Japan, Australia, Canada, Singapore, Switzerland, and the United Arab Emirates. The companies are also supplying sotrovimab to participating Member States of the EU through a Joint Procurement Agreement with the European Commission. Additional agreements are yet to be disclosed due to confidentiality or regulatory requirements.
Sotrovimab in the United States
Sotrovimab has been authorized by the US FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use.
Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Limitations of Authorized Use
Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID-19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
Important Safety Information
WARNINGS AND PRECAUTIONS
Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions
Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of sotrovimab. 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 (eg, 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, vaso-vagal reactions (eg, pre-syncope, syncope), dizziness and diaphoresis.
Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.
Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.
Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration
Limitations of Benefit and Potential for Risk in Patients with Severe COVID-19
The most common treatment-emergent adverse events observed in the sotrovimab treatment group in COMET-ICE were rash (1%) and diarrhea (2%), all of which were Grade 1 (mild) or Grade 2 (moderate). No other treatment-emergent adverse events were reported at a higher rate with sotrovimab compared to placebo.
USE IN SPECIFIC POPULATIONS
About the GSK and Vir Collaboration
GSK Commitment to Tackling COVID-19
GSK is collaborating with several organisations on COVID-19 vaccines by providing access to its adjuvant technology. The Company is working with Sanofi SA, Medicago Inc. and SK bioscience Co., Ltd. to develop adjuvanted, protein-based vaccine candidates, and all are now in phase III clinical trials. 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 in need.
GSK is also working with mRNA specialist CureVac NV to jointly develop next-generation, optimised mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine.
GSK is also exploring treatments for COVID-19 patients, collaborating with Vir Biotechnology to investigate monoclonal antibodies that could be used as therapeutic or preventive options for COVID-19.
Vir’s Commitment to COVID-19
About Vir Biotechnology
GSK Cautionary Statement Regarding Forward-Looking Statements
Vir Forward-Looking Statements
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