Sanofi Gains Full U.S. Commercial Control of Nirsevimab
Sanofi has simplified its contractual arrangements for the development and commercialization of nirsevimab (Beyfortus) in the United States. The updated agreements grant Sanofi complete commercial authority within the U.S.
Paris, April 11, 2023 – Sanofi has streamlined its contractual ties concerning the development and commercialization of Beyfortus (nirsevimab) in the United States. Under the revised terms, Sobi will conclude its participation agreement with AstraZeneca. Concurrently, Sanofi and AstraZeneca will update their collaboration agreement, granting Sanofi full commercial control of nirsevimab within the U.S.
Sanofi has also entered into a direct royalty agreement with Sobi, establishing a revenue-sharing arrangement for a portion of nirsevimab's net sales in the U.S. These modifications are not expected to impact the registration and launch timelines for nirsevimab in the U.S. All parties remain committed to ensuring Beyfortus is available for all infants in time for the upcoming 2023/24 Respiratory Syncytial Virus (RSV) season.
For regions outside the United States, the existing collaboration agreement between AstraZeneca and Sanofi will continue to govern that relationship. Nirsevimab, marketed as Beyfortus, is an investigational long-acting antibody designed to protect infants from birth through their first RSV season with a single dose. It is co-developed by Sanofi and AstraZeneca.
The antibody is intended to provide direct protection against RSV-induced lower respiratory tract infections in newborns and infants. Unlike vaccines, monoclonal antibodies offer immediate protection without needing the immune system to be activated. Beyfortus has already received marketing authorization in the European Union for preventing RSV-related lower respiratory tract disease in neonates and infants during their initial RSV season.