August 19, 2020 -- Regeneron Pharmaceuticals and Roche are joining forces to develop, manufacture, and distribute Regn-COV2, Regeneron's investigational antiviral antibody cocktail against COVID-19. The collaboration is expected to increase supply of the drug to 3.5 times the current capacity.
Regn-COV2 is currently being studied in phase II/III clinical trials for the treatment of COVID-19 and a phase III trial for the prevention of COVID-19 in healthy individuals who come into contact with infected individuals. Upon successful regulatory approval, Regeneron will distribute and sell Regn-COV2 in the U.S. while Roche will be responsible for distribution outside of the U.S.
Under the agreement, each company has committed to dedicate a certain manufacturing capacity to Regn-COV2 each year, made possible by technology transfer. Each company is responsible for its own distribution costs. The companies will collaborate to jointly fund and execute the ongoing phase III prevention trial and the phase I safety study, as well as any additional global studies. Roche will be primarily responsible for securing regulatory approvals outside of the U.S. following the initial European Medicines Agency approval, and conducting any additional studies specifically required for approval by regulators outside of the U.S.