Roche Pharmaceuticals is teaming up with Regeneron to develop and distribute Regeneron’s COVID-19 investigational antiviral antibody combination.
The treatment, known as REGN-COV2, is being developed as a treatment option for people already experiencing symptoms of COVID-19. It also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic.
Through this collaboration, the companies are expected to increase the supply of REGN-COV2 to at least three and a half times the current capacity — with the potential for even further expansion.
REGN-COV2 is currently involved in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial for the prevention of COVID-19. If approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. while Roche will be responsible for distribution 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,” Bill Anderson, CEO of Roche Pharmaceuticals, 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.”
Under the terms of the agreement, each company has committed to dedicating a certain manufacturing capacity to REGN-COV2 each year. Further, 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 additional global studies. Roche will be primarily responsible for securing regulatory approvals outside the United States.
“Regeneron has progressed the REGN-COV2 research and development program at record speed and worked tirelessly to maximize our in-house manufacturing capacity,” 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.”
REGN-COV2 was designed to block infectivity of SARS-CoV-2, the virus that causes COVID-19. Its development, manufacturing, and clinical trials have been funded in part by the Biomedical Advanced Research and Development Authority (BARDA).
Roche is headquartered in Basel, Switzerland.