Regeneron will distribute a prospective therapy in the US and Roche will be responsible for it internationally.
Late last week, Regeneron and Roche announced they were going to collaborate in developing and manufacturing an antiviral antibody cocktail.
REGN-COV2 is an investigational treatment for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus.
REGN-COV2 is currently being studied in 2 phase 2/3 clinical trials for the treatment of COVID-19 and in a phase 3 trial for the prevention of COVID-19 in household contacts of infected individuals.
"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," Roche Pharmaceuticals CEO Bill Anderson, said. "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."
REGN-COV2 was designed specifically by Regeneron scientists to block infectivity of SARS-CoV-2. They evaluated thousands of fully-human antibodies produced by the company's proprietary VelocImmune mice, which have been genetically-modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The 2 virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the virus's spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.
Under the terms of the agreement, each company has committed to dedicate a certain manufacturing capacity to REGN-COV2 each year, and the collaborators have already begun the technology transfer process. Each company will bear its own distribution expenses in their designated territories.
The collaborators will jointly fund and execute the ongoing Phase 3 prevention and Phase 1 healthy volunteer safety studies, as well as any additional global studies to evaluate further the potential for REGN-COV2 in treating or preventing COVID-19. Roche will be primarily responsible for securing regulatory approvals outside the US, following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the US.
Regeneron will distribute REGN-COV2 in the US and Roche will be responsible for distribution internationally. "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," Regeneron President and CEO Leonard S. Schleifer, MD, PhD, said.