U.S. signs $450 million contract with Regeneron for coronavirus therapy
Topics: U.S. REGENERON
REGN-COV2 is Regeneron's investigational double antibody cocktail that is currently in two Phase 2/3 clinical trials for the treatment of coronavirus and in a Phase 3 trial for the prevention of coronavirus infection.
Regeneron began scaling up manufacturing of REGN-COV2 at business risk in spring of 2020.
This agreement supports continued manufacturing so that the product could be made available immediately in the United States if clinical trials are successful and the U.S. Food and Drug Administration (FDA) grants Emergency Use Authorization (EUA) or product approval.
The agreement covers a fixed number of bulk lots that are intended to be completed in the fall of 2020, as well as fill/finish and storage activities.
The ongoing REGN-COV2 clinical program is evaluating multiple dosages and will help establish the exact number of potential treatment doses (estimated range of 70,000 to 300,000) or prevention doses (estimated range of 420,000 to 1,300,000) available from these lots in total.
Initial doses may be ready as early as end of summer.
If EUA or product approval is granted, the government has committed to making doses from these lots available to the American people at no cost and would be responsible for their distribution. ■