CPhI Online

- Research & Development

Regeneron wins $450 million US government manufacturing agreement for anti-viral antibody cocktail

7 Jul 2020

The company began scaling up manufacturing of REGN-COV2 at business risk earlier this year to ensure the immediate availability of the product if clinical trials prove successful.

As part of Operation Warp Speed, the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense have awarded Regeneron a $450 million contract to manufacture and supply REGN-COV2.

REGN-COV2 is Regeneron's investigational double antibody cocktail that is currently in two Phase II/III clinical trials for the treatment of COVID-19 and in a Phase III trial for the prevention of COVID-19 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 US if clinical trials are successful and the 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 the 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.