Regeneron, which had $7.8 billion in 2019 sales, and pharmaceutical giant Roche, which is headquartered in Switzerland and had 2019 sales of $63.4 billion, have announced that they will collaborate on developing and manufacturing Regeneron’s antibody cocktail known as REGN-COV2.
The cocktail is needed to both protect against being infected by the Covid-19 virus and also provide a treatment should infection occur. The combination of antibodies was designed to interfere with the ability of protein spikes on the virus to invade and infect cells while also preventing mutant versions of the virus from having an effect.
REGN-COV2 is being studied in three separate clinical trials on humans after having produced positive results in hamsters and rhesus macaques, also known as rhesus monkeys. Two of the trials are designed to test the drug as a treatment while the third is designed to see whether it is effective to prevent infection.
The agreement calls for Regeneron to distribute REGN-COV2 in the U.S. while Roche will be responsible for distribution outside the U.S. if the drug is found to be safe and effective and receives regulatory approvals.
Roche will be primarily responsible for securing regulatory approvals outside the U.S., following the initial European Medicines Agency approval, and conducting any additional studies specifically required for approval by regulators outside the U.S.
“We are excited about the potential for one medicine to serve both as a treatment for those infected as well as protection for people exposed to the virus. REGN-COV2 could be a critical line of defense against the Covid-19 pandemic,” said Bill Anderson, CEO of Roche Pharmaceuticals. “We’re committing our manufacturing expertise and capacity, and our global distribution network, to bring Regeneron’s potential antibody combination to as many people around the world as we possibly can.”
Leonard S. Schleifer, president and CEO of Regeneron, said, “This major collaboration with Roche provides important scale and global expertise to bring REGN-COV2 to many more patients in the United States and around the globe.”
George D. Yancopoulos, co-founder, president and chief scientific officer at Regeneron had previously said, “The concept that drug cocktails can prevent viral escape (the ability of mutant viruses to escape treatment) has previously been demonstrated for traditional antiviral drugs used to treat HIV and other viruses. We now report the fundamental realization that this can also be true for antibody-based therapies, supporting our hope that our REGN-COV2 cocktail can be a potent weapon against Covid-19 while preventing the emergence of viral drug-resistance.”
In early July, Regeneron and the U.S. Department of Health and Human Services along with the Department of Defense signed a $450 million contract for the company to supply up to 300,000 treatment doses and up to 1,300,000 prevention doses of the drug if it proved to be safe and effective. It was part of the government’s “Operation Warp Speed” program.
