US-based Regeneron Pharmaceuticals has obtained exclusive global license rights to Sanofi’s cancer drug Libtayo, as part of the amended license and collaboration agreement between the two companies.
The two companies initially entered into an immuno-oncology collaboration in 2015.
As per the previous collaboration, the two firms had equally shared the global operating profits and co-commercialised Libtayo in the US.
Sanofi was exclusively responsible for commercialisation in the territories outside the US.
Under the terms of the amended license and collaboration agreement, Sanofi will transfer the global rights to develop, commercialise, and manufacture Libtayo entirely to Regeneron.
In exchange, Sanofi will receive an upfront payment of $900m, along with an 11% royalty on worldwide net sales of Libtayo.
Sanofi will receive $100m in regulatory milestone payments, subject to receipt of first approval of Libtayo plus chemotherapy to treat NSCLC, either by the US FDA or European Commission (EC).
In addition, the company is also eligible to receive sales-related milestone payments of up to $100m over a period of two years.
The transaction is expected to complete in the third quarter of 2022, subject to approval from the competition law
Sanofi North America president and speciality care executive vice president Bill Sibold said: “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 revitalised oncology efforts. 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.”
Furthermore, Regeneron is expected to advance the reimbursement of the development balance related to its separate antibody collaboration with Sanofi.
The company would increase its share of profits paid to Sanofi as reimbursement, from 10% to 20%, until its share of the total cumulative development costs incurred.
