GSK And Vir Biotechnology Announce United States Government Agreements To Purchase Sotrovimab, A COVID-19 Treatment

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) announced US government contracts totalling approximately $1 billion[1] (USD) to purchase sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, which the US Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) in May 2021. GSK will supply these doses to the US government by December 17, 2021, enabling further expanded nationwide access to sotrovimab for patients.

In addition to the doses that will be supplied this year, the US government will have the option to purchase additional doses through March 2022.

Including the contracts announced today, GSK and Vir have received binding agreements for the sale of more than 750,000 doses of sotrovimab worldwide, with additional doses reserved through other agreements including the previously announced Joint Procurement Agreement with the European Commission.

Sotrovimab is an FDA EUA authorised 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 paediatric patients (12 years of age and older weighing at least 40 kg) with positive test results for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalisation or death.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: "Given the large number of patients who continue to become ill with COVID-19 across many regions in the US, there is an ongoing need for access to effective treatments. We are proud to work with the US government to help make sotrovimab available for these patients."

George Scangos, Ph.D., Chief Executive Officer of Vir, said: "Monoclonal antibodies play an essential role in the treatment of certain patients with COVID-19, and we’re grateful that this agreement will allow more healthcare providers and patients who are at high risk for progression to severe COVID-19 to access sotrovimab. Given ongoing evidence, which demonstrates its ability to maintain activity against the tested circulating variants of concern, including Delta, we are confident sotrovimab will continue to be important in the fight against COVID-19."

The US government purchase was funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response through Department of Defense – contract numbers W58P0521C0008 and W58P0522C0002.

In June 2021, GSK and Vir announced confirmatory full results for the COMET-ICE Phase III trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p<0.001) in hospitalisations for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial.

The companies also recently announced headline data from the randomised, multi-centre, open-label COMET-TAIL Phase III trial, which achieved its primary endpoint, demonstrating intramuscular (IM) administration of sotrovimab was non-inferior to IV administration for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalised adults and adolescents (12 years of age and older). The companies plan to progress regulatory submissions globally.

GSK and Vir are committed to 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. Updated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against all current variants of concern and interest of the SARS-CoV-2 virus as defined by the World Health Organization, plus others, including, but not limited to, Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu (B.1.621).

About sotrovimab

Sotrovimab is an investigational SARS-CoV-2 neutralising monoclonal antibody. 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. Sotrovimab, which incorporates Xencor’s Xtend™ technology, has also 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 global access to sotrovimab

• Sotrovimab is authorised for emergency use in the United States and received a positive scientific opinion under Article 5(3) of Regulation 726/2004 from the Committee for Human Medicinal Products (CHMP) in the European Union (EU). Sotrovimab has been granted a provisional marketing authorisation in Australia and a conditional marketing authorisation in Saudi Arabia. In Japan, it has been approved via the Special Approval for Emergency Pathway. Temporary authorisations have been granted in Bahrain, Brazil, Canada, Egypt, Italy, Kuwait, Oman, Qatar, Singapore, Switzerland, Thailand and the United Arab Emirates (UAE).
• Sotrovimab is supplied in several countries around the world, including through national agreements in the United States, Japan, Australia, Canada, Singapore and the UAE. We have also signed a Joint Procurement Agreement with the European Commission to supply doses of sotrovimab. Additional agreements are yet to be announced due to confidentiality or regulatory requirements.