Regeneron To Buy Sanofi’s Stake in Oncology Pact in $1.1-Bn DealBy
Sanofi and Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, have restructured their license and collaboration pact for Libtayo (cemiplimab), an immuno-oncology drug, under which Regeneron will acquire exclusive global development, commercialization, and manufacturing rights to Libtayo with Sanofi receiving $1.1 billion ($900 million upfront plus $200 million in potential milestone payments) as well as an 11% royalty on worldwide net sales of Libtayo.
Regeneron and Sanofi entered into the license and collaboration agreement for the drug in 2015. The companies now split Libtayo’s global operating profits equally and co-commercialize Libtayo in the US, with Sanofi solely responsible for commercialization outside the US. The drug is approved in more than two dozen countries, including in the US, as a monotherapy for certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma, and advanced non-small cell lung cancer (NSCLC). Regulatory reviews are also underway for Libtayo in combination with chemotherapy as a first-line treatment in advanced NSCLC in multiple markets, including the US and European Union. It is also currently being studied with 18 investigational agents in 22 clinical trials for a variety of difficult-to-treat cancers.
Under the new deal, Regeneron will gain exclusive global development, commercialization, and manufacturing rights to Libtayo. Upon closing of the transaction, Regeneron will make an upfront payment of $900 million to Sanofi, which will be entitled to receive an 11% royalty on global net sales of Libtayo. Sanofi will also be entitled to a $100-million regulatory milestone payment upon the first approval of Libtayo by either the US Food and Drug Administration or European Commission in combination with chemotherapy for the first-line treatment of certain patients with NSCLC as well as sales-related milestone payments of up to $100 million over the next two years (as reported on June 2, 2022).
The deal is subject to merger control clearance outside the US and is expected to close in the third quarter of 2022.
In addition, Regeneron will accelerate reimbursement of the development balance associated with Regeneron and Sanofi’s separate antibody collaboration. Regeneron will increase from 10% to 20% the share of its profits that are paid to Sanofi to reimburse Sanofi-funded development expenses until Regeneron’s share of the total cumulative development costs incurred under the collaboration has been reached.