NEW YORK – Regeneron Pharmaceuticals this week said it will buy out Sanofi's stake in the companies' collaboration agreement for Libtayo (cemiplimab) in order to obtain exclusive worldwide development, commercialization, and manufacturing rights to the PD-1 inhibitor.
The transaction, subject to merger control clearance outside the US, is slated to close in Q3 2022. Upon closing, Regeneron will record 100 percent of global net sales and expenses for Libtayo, which is approved in many countries for various cancer indications, including for advanced non-small cell lung cancer patients who have high PD-L1-expressing tumors.
Under a 2015 arrangement between Regeneron and Sanofi, the companies agreed to split Libtayo's worldwide profits equally and co-commercialize the drug in the US. Sanofi was in charge of ex-US marketing efforts.
To gain worldwide rights, Regeneron will make an upfront payment of $900 million upon closing of the transaction and Sanofi will be entitled to an additional 11 percent royalty on worldwide net sales as well as $100 million in regulatory milestones if the drug is approved in the US or Europe in combination with chemotherapy as a first-line treatment for advanced NSCLC regardless of PD-L1 status. The US Food and Drug Administration is expected to make a decision on this regulatory application in September.
Beyond this pending indication, Libtayo is currently being studied with more than a dozen investigational agents in 22 clinical trials in a range of cancer settings, including in combination with Regeneron's antibody targeting the LAG-3 checkpoint receptor.
Also as part of this week's deal, Sanofi is eligible to receive up to $100 million in sales-related milestones over the next two years. Regeneron also said in a statement that it will accelerate reimbursement to Sanofi for development costs associated with an antibody collaboration between the two firms. Regeneron will pay 20 percent, instead of 10 percent, of its share of the profits to reimburse Sanofi for its share of development expenses.