Regeneron Pharmaceuticals said Tuesday that it received a contract worth $450 million from the US government to manufacture and supply its investigational double antibody cocktail REGN-COV2 for the treatment and prevention of COVID-19. The agreement was reached, as part of Operation Warp Speed, with the Biomedical Advanced Research and Development Authority (BARDA) and the US Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense.
"We made the decision early on to begin large-scale manufacturing [of REGN-COV2] at our own risk," commented Regeneron CEO Leonard Schleifer. He added that the manufacturing and supply agreement "could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic."
REGN-COV2, which combines two monoclonal antibodies that bind to the spike protein of the SARS-CoV-2 virus, is currently in two Phase II/III trials for the treatment of COVID-19 and in a Phase III study for the prevention of COVID-19 infection. Regeneron said the contract will assist with its plans to ramp-up production of REGN-COV2 so that the product could be made available immediately if clinical trials prove successful and the FDA grants emergency-use authorisation or approval.
Up to 300,000 treatment doses
Regeneron noted that the deal 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 clinical programme for REGN-COV2 is evaluating multiple dosages and will help establish the exact number of potential treatment doses, estimated to range from 70,000 to 300,000, or prevention doses, expected be between 420,000 and 1.3 million. According to the US Health and Human Services (HHS) department, if the FDA eventually authorises REGN-COV2 for emergency use, the government has committed to making doses from these lots available to Americans at no cost and would be responsible for their distribution.
"This agreement with Regeneron is the first of a number of Operation Warp Speed awards to support potential therapeutics all the way through to manufacturing, allowing faster distribution if trials are successful," said HHS Secretary Alex Azar. The US government-led initiative also aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.
Separately on Tuesday, Novavax was awarded $1.6 billion through Operation Warp Speed to progress development of NVX CoV2373 and potentially deliver 100 million doses of the COVID-19 vaccine as early as late 2020.
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