July 7, 2020 -- Regeneron Pharmaceuticals was awarded a $450 million contract to manufacture and supply its REGN-COV2 antibody cocktail that is currently in phase II/III clinical trials for the treatment of COVID-19 patients and phase III for the prevention of COVID-19.
The award was granted as part of Operation Warp Speed, by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
The agreement supports Regeneron's continued manufacturing efforts to supply clinical trials and meet demand if the U.S. Food and Drug Administration grants Emergency Use Authorization or product approval. The contract specifies a fixed number of bulk lots that are intended to be completed in the fall of 2020, as well as fill/finish and storage of the drug. The ongoing clinical program for REGN-COV2 is evaluating the exact number of doses needed for treatment (estimated between 70,000 and 300,000) or prevention (estimated between 420,000 and 1,300,000). Manufactured doses may be ready as early as the end of the summer.
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