Sanofi to transfer 100 percent rights of Libtayo to Regeneron

Libtayo, which was invented using Regeneron's proprietary VelocImmune technology, is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T cells. It is currently approved by regulatory authorities in more than two dozen countries, including by theU.S. Food and Drug Administration (FDA) as cemiplimab-rwlc monotherapy treatment for certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC) and advanced non-small cell lung cancer (NSCLC). Libtayo is a first-in-class PD-1 inhibitor for the treatment of approved non-melanoma skin cancers and is considered a standard of care.

Regulatory reviews are also underway for Libtayo in combination with chemotherapy as a first-line treatment in advanced NSCLC in multiple markets, including the U.S. and European Union, where approvals would provide promising opportunities to extend the medicine's reach. It is also currently being studied with 18 investigational agents in 22 clinical trials for a variety of difficult-to-treat cancers. These combinations include numerous assets from Regeneron, including its antibody targeting the LAG-3 checkpoint receptor, and several assets from its collaborators.

"This strategic acquisition is a major step towards Regeneron's goal of becoming a global oncology leader, centered on Libtayo as an important choice in settings where PD-1 inhibitors can be used as monotherapy and, excitingly, in potential new combinations with our differentiated and diverse pipeline of oncology assets," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "In 2021, Libtayo was approved for two new monotherapy indications in the U.S. and EU and global net product sales increased 32% year-over-year, providing a strong foundation for our multi-faceted oncology strategy and helping to maximize the potential value of our pipeline."

Regeneron and Sanofi entered into the Immuno-oncology License and Collaboration Agreement in 2015. Pursuant to this agreement, the companies currently split Libtayo's worldwide operating profits equally and co-commercialize Libtayo in the U.S., with Sanofi solely responsible for commercialization outside the U.S.

Under the terms announced, Sanofi will transfer the rights to develop, commercialize and manufacture Libtayo entirely to Regeneron, on a worldwide basis, over the course of a defined transition period. 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 worldwide net sales of Libtayo. Sanofi will also be entitled to a $100 million regulatory milestone payment upon the first approval by either the FDA or European Commission of Libtayo in combination with chemotherapy for first-line treatment of certain patients with NSCLC, as well as sales-related milestone payments of up to $100 million in total over the next two years.

Pursuant to the agreement, 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.

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