Roche and Regeneron have signed an manufacturing and distribution agreement on Regeneron’s Phase II therapeutic antibody for the treatment of COVID-19.
Roche AG and Regeneron Therapeutics Inc said their collaboration is aimed at increasing the global supply of REGN-COV2, an experimental antibody combination (REGN10987+REGN10933) designed to prevent severe course of the COVID-19 syndrome, by at least three and a half times. While Regeneron will be responsible for distribution in the US, Roche will take responsibility for supply of the rest of the world with the antibody therapeutic, which is directed against two different sites of the viral spike protein.
REGN-COV2 is currently being studied in two Phase IIb clinical trials as a therapeutic given to infected, hospitalised patients with COVID-19 and in a Phase III trial for passive immunisation in household contacts of infected individuals. The goal of the Phase IIb trials is to evaluate if the cocktail two anti-S-protein antibodies can prevent the severe immunological host reaction follwing viral replication in some patients, the Phase III study aims at demonstrating that passive immunisation with REGN-COV2 can protect non-infected people for a certain time.
“REGN-COV2 could be a critical line of defense against the COVID-19 pandemic,” said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. “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 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 III prevention and Phase I 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.
The two potent, 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
