Roche and Regeneron are collaborating to develop, manufacture and distribute REGN-COV2, Regeneron’s investigational antiviral antibody combination for the treatment of COVID-19, according to a press release.
Under this collaboration, the partners expect the overall capacity of REGN-COV2 to increase by at least three and a half times of what it would have been without the collaboration.
REGN-COV2 is currently being studied 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 in household contacts of infected individuals.
REGN-COV2 was designed by Regeneron scientists to block infectivity of SARS-CoV-2, the virus that causes COVID-19. The two 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.
If it proves safe and effective in clinical trials and regulatory approvals are granted, Regeneron will distribute REGN-COV2 in the United States and Roche will be responsible for distribution outside of the United States.
Under the terms of the agreement, each company will dedicate a specified amount 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.
Roche will be primarily responsible for securing regulatory approvals outside the United States, following the initial European Medicines Agency (EMA) approval, and conducting any additional studies specifically required for approval by regulators outside the United States. And the two companies will jointly fund and execute the ongoing Phase 3 study on the prevention of COVID-19 in household contacts of infected individuals as well as other future studies.
REGN-COV2's development, manufacturing and clinical trials also have been funded, in part, by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
