Roche and Regeneron have partnered to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination, to people around the globe. REGN-COV2 could provide a much-needed treatment option for people already experiencing symptoms of COVID-19, and also has the potential to prevent infection in people exposed to the virus, thus slowing the spread of the global pandemic.
This collaboration aims to increase 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 being studied in two Phase 2/3 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. If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute and record sales for REGN-COV2 in the U.S. and Roche will be responsible for distribution outside the U.S.
Each company has committed to dedicate manufacturing capacity to REGN-COV2 each year, and the companies 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 volunteers safety studies as well as 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 U.S., following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the U.S.