If testing and approval go well, the local pharma co. could supply Americans with an antibody cocktail as early as the end of summer.
Regeneron Pharmaceuticals recently announced that it has been awarded a $450 million contract to manufacture and supply an anti-viral antibody cocktail it has been developing for the treatment and prevention of COVID-19 infection.
The double antibody cocktail, called REGN-COV2, is currently in Phase 2 and 3 clinical trials for the treatment of COVID-19 and in Phase 3 trials for the prevention of the virus.
The Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense awarded this agreement to the biotechnology company as part of Operation Warp Speed, the program to fast track the nation’s coronavirus response.
Under the terms of the contract, REGN-COV2 will be made available immediately in the United States if clinical trials are successful and the U.S. Food and Drug Administration (FDA) grants either Emergency Use Authorization or full product approval.
Since early spring, Regeneron has been increasing manufacturing of the cocktail, a combination of two potent, non-competing and virus-neutralizing antibodies, using the same method it developed for rapid development of a highly-effective novel Ebola treatment last year.
Leonard S. Schleifer, M.D., Ph.D., Co-Founder, President and CEO of Regeneron, says the company’s thirty years of investment in this type of antibody discovery and development technology have enabled them to move quickly on the REGN-COV2 program.
“We made the decision early on to begin large-scale manufacturing at our own risk in order to ensure that product would be available immediately if our clinical trials prove successful and an Emergency Use Authorization is granted,” he says. “This manufacturing and supply agreement with BARDA and the Department of Defense could help REGN-COV2 reach many people quickly, hopefully helping to change the course of this deadly and still-raging pandemic.”
The contract covers a fixed number of bulk lots that may be completed in fall of 2020: Initially, between 70,000 and 300,000 potential treatment doses may be ready as early as the end of summer, as well as an additional 420,000 to 1.3 million preventative doses.
If the FDA approves the product or grants EUA, the government will be responsible for making doses from these lots available to Americans at no cost and would be responsible for distribution.
Co-Founder, President and Chief Scientific Officer of Regeneron, George Yancopoulos, M.D., Ph.D., says Regeneron is doing everything it can to make treatment and prevention possible.
“We are running simultaneous adaptive trials in order to move as quickly as possible to provide a potential solution to prevent and treat COVID-19 infections, even in the midst of an ongoing global pandemic,” he says.