– US government contracts for approximately $1 billion1 (USD) now in place to purchase sotrovimab, further expanding access nationwide –
– This brings the total number of doses secured through binding agreements to more than 750,000 globally –
– Final data from the COMET-ICE Phase 3 trial showed sotrovimab reduces hospitalization and risk of death by 79% in adults with mild-to-moderate COVID-19 who are at high risk of progression to severe disease –
– In vitro data indicate sotrovimab maintains activity against the Delta variant of concern and other variants being monitored –
LONDON and SAN FRANCISCO, Nov. 17, 2021 (GLOBE NEWSWIRE) -- GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced US government contracts totaling approximately $1 billion1 (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-authorized 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 test results for COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization 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 3 trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p