A company that just entered its antiviral drug candidate for Covid-19 into late-stage clinical testing has a new, lucrative contract from the federal government.
Tarrytown, New York-based Regeneron Pharmaceuticals said Tuesday that it had received a contract worth $450 million from the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense. The contract was awarded under HHS’ Operation Warp Speed for the manufacture and supply of REGN-COV2, the two-antibody drug cocktail that Regeneron is developing both to treat and prevent Covid-19.
The news comes the day after Regeneron said it had started a Phase III study of REGN-COV2 to investigate whether the drug can prevent SARS-CoV-2 infection in people who have had exposure to patients with the disease, as well as starting the Phase II/III portions of its trials of the drug in patients already infected, including those who are hospitalized and those who are not.
Shares of Regeneron had been up 2% premarket on the Nasdaq before markets opened and were still up slightly shortly after markets opened.
“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,” Regeneron CEO Leonard Schleifer said in a statement. “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 company said it started scaling up manufacturing of the drug in the spring, and the new contract would enable it to be made available immediately if the Food and Drug Administration approves it or grants an EUA. It covers a fixed number of bulk lots intended for completion in the fall. The clinical trials will help establish the number of potential treatment doses – which is estimated to range from 70,000-300,000, or the number of prevention doses, estimated to range from 420,000 to 1.3 million, the company said.
Regeneron is one of numerous companies that has been developing drugs for Covid-19, including antivirals and anti-inflammatory drugs. However, last week it said its Phase III study of the autoimmune disease drug Kevzara (sarilumab), which it is developing for the disease’s inflammatory symptoms, had failed to meet its primary and key secondary endpoints. Other firms developing antivirals include Vir Biotechnology, while Gilead Sciences has secured an EUA for its drug, remdesivir.
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