On the morning of 19 August 2020, the Roche Group announced a new collaboration with the Regeneron Group for research against Covid-19. The two companies indeed published a press release in which they announced to join their forces for the development, the manufacture and the distribution of a treatment.
Roche and Regeneron are working together on REGN-COV2, an experimental combination of antiviral antibodies. This treatment candidate could thus prevent infection in people exposed to the virus in order to slow the spread of the global pandemic. This alliance could thus further increase the supply of REGN-COV2 to at least three and a half times current capacity with even greater potential for expansion.
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 this virus in household contacts of infected individuals. If the efficacy of this treatment is successful in clinical trials and after regulatory approvals are obtained, Regeneron could distribute and register sales of REGN-COV2 in the U.S. while Roche will handle distribution in other countries.
The CEO of Roche Pharmaceuticals said this morning: "We are excited about the potential of a drug to serve both as a treatment for those infected and as a protection for those exposed to the virus. REGN-COV2 could be a critical line of defence against the VIDOC-19 pandemic. We are committing our manufacturing expertise and capacity, as well as our global distribution network, to bring Regeneron's potential antibody combination to as many people around the world as possible".
Regeneron's President stated: "Regeneron has advanced the REGN-COV2 research and development program at record speed and has worked tirelessly to maximize our in-house manufacturing capacity. This major collaboration with Roche provides significant scale and global expertise to bring REGN-COV2 to many more patients in the U.S. and around the world".
The terms of this agreement specify that each of the two companies is committed to dedicate a certain production capacity to REGN-COV2 each year and the employees have already started the process of technology transfer. Companies will bear their own distribution costs in their designated territories. They will jointly fund and execute the ongoing Phase 3 and Phase 1 prevention studies on healthy volunteers and additional global studies to further evaluate the potential of REGN-COV2 in the treatment or prevention of coronavirus.
Roche will be responsible for obtaining regulatory approvals outside the United States, following initial EMA approval, as well as conducting any additional studies specifically required for regulatory approval outside the US.