The rearranged agreement will provide Sanofi increased flexibility to advance its early-stage immune-oncology pipeline independently, while still maintaining an active collaboration.
A spokesperson for Sanofi told us, “This restructuring was driven by the conclusions of a strategic analysis performed late 2018 considering the remaining time on the original agreement, the necessity to focus on the remaining collaboration efforts on BCMAxCD3 and MUC16xCD3 bi-specifics, and accelerate their advancement to proof of concept.”
Per the agreement, Sanofi secures the right to opt-in to certain bispecific programs, BCMAxCD3 and MUC16xCD3, when proof of concept is achieved or allocated funding is expended.
Post-opt-in, Sanofi will lead development and commercialization and fund development costs of BCMAxCD3. Regeneron will reimburse up to 50% out of its share of collaboration profits. Both companies will share global profits equally.
Regeneron will lead MUC16xCD3 bispecific development and commercialization in the US after the opt-in.
Post-opt-in, Regeneron will lead MUC16xCD3 bispecific development and lead commercialization in the U.S. The companies will share development costs and global profits equally. Sanofi will lead commercialization outside the US.
Sanofi will pay Regeneron $462m (€402m) representing the balance of payments due under the original immune-oncology agreement, covering the Sanofi share of the discovery program costs for the last quarter of 2018.
Additionally, Sanofi may pay up to $120m in development costs for two selected clinical-stage bispecific antibodies and a termination fee for the other programs under the original immune-oncology agreement.
The companies’ ongoing development collaboration of Libtayo (cemiplimab-rwlc), a PD-1 antibody, is unaffected by the amended agreement.
Libtayo, a human monoclonal antibody that targets the immune checkpoint receptor PD-1, was granted US Food and Drug Administration approval for the treatment of advanced cutaneous squamous cell carcinoma (CSCC).
This agreement is not the first between Regeneron and Sanofi, in 2007 the two companies entered into a discovery, and development agreement of monoclonal antibody treatments ended in 2017. The collaboration previously produced Praluent (alirocumab), Dupixent (dupliumab), and Kevzara (sarilumab).