Regeneron Pharmaceuticals Inc came to an agreement to buy the drug from Sanofi for up to $1.1 billion.
The news of Sanofi selling the rights of pembrolizumab (Libtayo; Sanofi and Regeneron Pharmaceuticals, Inc) comes after a restructuring of an oncology collaboration agreement between the companies which was created in 2015. Under the amended and restated license and collaboration agreement, Regeneron will obtain worldwide exclusive license rights to Libtayo, according to the press release.
Before this, the companies split the profits from the worldwide operations equally co-commercialized pembrolizumab in the United States. Sanofi was responsible for commercialization across the rest of the globe by itself.
“Our diverse oncology portfolio doubled between 2019 and 2022 and now includes twelve compounds in clinical trials, each with a unique mechanism of action. Our early steps with Libtayo in immuno-oncology provided a strong foundation for our revitalized oncology efforts,” said Bill Sibold, the executive vice president of Specialty Care & president of North America for Sanofi in a press release. “Now, we are focused on leveraging our internal capabilities and advancing a new generation of oncology medicines. We continue to maintain a strong partnership with Regeneron in immunology, and will work closely with them on the seamless transition of Libtayo to ensure there is no impact for patients.”
In the terms of the amended and restated immuno-oncology license and collaboration agreement, Sanofi will transfer the rights to develop, commercialize, and manufacture pembrolizumab entirely to Regeneron, on a global scale. This transition over the course of a period which will be defined by the requirement of each government and their clearances needed worldwide.
Sanofi, in exchange for these rights, will receive an upfront payment of $900 million, and an 11% royalty on global net sales of pembrolizumab, according to the release. There will also be a payment of $100 million to Sanofi in the case of a regulatory milestone payment approval for pembrolizumab in combination with chemotherapy for first-line treatment of certain patients with non-small cell lung cancer treatment (NSCLC) by either the FDA or European Commission. In addition, there may be sales-related milestone payments of up to $100 million in total over the next 2 years. The transaction is subject to clearance under competition law and is expected to close in the third quarter of 2022.
Regeneron will also accelerate reimbursement of the development balance associated with Regeneron and Sanofi’s separate Antibody Collaboration, the press release continued. The company, Regeneron, will increase from its share of profits from 10% to 20 to Sanofi to reimburse Sanofi-funded development expenses. It will stay that way until Regeneron’s share of the total cumulative development costs incurred under the collaboration has been reached.
Regeneron buys Sanofi cancer drug for up to $1. 1 billion. Accessed June 2, 2022. https://finance.yahoo.com/news/regeneron-buys-sanofi-cancer-drug-134521034.html