Sanofi (Nasdaq:SNY) has agreed to sell Regeneron (Nasdaq:REGN) exclusive international rights of Libtayo (cemiplimab) for $900 million. Sanofi will also receive an 11% royalty on global sales of the drug.
Libtayo is a monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells.
Sanofi could also receive $100 million if the drug hits regulatory milestones in the next two years. The Paris-headquartered company could get an additional $100 million for meeting sales-related milestones in the same time window.
FDA approved the drug for advanced cutaneous squamous cell carcinoma in 2018. In 2021, Libtayo picked up indications for advanced basal cell carcinoma and first-line advanced non-small cell lung cancer with PD-L1 expression of at least 50%.
Sanofi and Regeneron entered into an international immuno-oncology alliance in 2015, agreeing then to split operating profits for Libtayo in the U.S. Sanofi agreed then to commercialize the drug in the rest of the world.
FDA has accepted the supplemental Biologics License Application for Libtayo for advanced non-small cell lung cancer when used with chemotherapy. The agency has set a target action date of September 19, 2022.
Regeneron sales of the drug in 2021 were $306 million while the drug earned Sanofi €129 million.
“Our diverse oncology portfolio doubled between 2019 and 2022 and now includes twelve compounds in clinical trials, each with a unique mechanism of action,” said Bill Sibold, executive vice president of specialty care and president of North America, Sanofi. “Our early steps with Libtayo in immuno-oncology provided a strong foundation for our revitalized oncology efforts,” Sibold added in a news release. “Now, we are focused on leveraging our internal capabilities and advancing a new generation of oncology medicines.”
Sanofi said that it would continue working with Regeneron in immunology.