Tarrytown-headquartered Regeneron Pharmaceuticals Inc. announced its intent to purchase Sanofi’s stake in the cancer medicine Libtayo (cemiplimab), created in collaboration by the companies.
Regeneron and Sanofi began collaborating on this medicine in 2015. Under the terms of the transaction, Sanofi will transfer the rights to develop, commercialize and manufacture Libtayo entirely to Regeneron on a worldwide basis. Upon closing of the transaction, Regeneron will make an upfront payment of $900 million to Sanofi, which will 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 U.S. or European Commission regulators, as well as sales-related milestone payments of up to $100 million in total over the next two years.
According to Regeneron, Libtayo 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 the U.S. Food and Drug Administration as cemiplimab-rwlc monotherapy treatment for certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
As a result of this purchase, Regeneron will gain the exclusive worldwide development, commercialization and manufacturing rights to the medicine. The transaction is subject to merger control clearance outside the U.S. and is expected to close in the third quarter of 2022.
“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, 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.”
