Regeneron and Sanofi have partnered on the drug since 2015, splitting profits equally. Regeneron will now gain the sole rights oncology monoclonal antibody: gaining global development, commercialization and manufacturing rights; and recording all net sales and expenses for the program.
Approved in the US and more than two dozen other countries, the drug has an extensive clinical program focused on difficult-to-treat cancers, either as a monotherapy or in combination with other therapeutic approaches for solid tumors and blood cancers.
The transaction is subject to merger control clearance outside the US and is expected to close in the third quarter of 2022.
Libtayo looks to NSCLC approvals in combination with chemotherapy
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 approved in a number of countries 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 leading and first-in-class PD-1 inhibitor for the treatment of approved non-melanoma skin cancers and is considered a standard of care," notes Regeneron.
Regulatory reviews are also underway for Libtayo in combination with chemotherapy as a first-line treatment in advanced NSCLC in multiple markets, including the US and EU, 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 assets from Regeneron, including its antibody targeting the LAG-3 checkpoint receptor, and other assets from collaborators.
The acquisition of Sanofi’s stake represents a ‘major step’ towards Regeneron’s goal of becoming a global oncology leader, 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 US 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. The companies currently split Libtayo's worldwide operating profits equally and co-commercialize Libtayo in the US, with Sanofi solely responsible for commercialization outside the US.
Sanofi will now transfer the rights to develop, commercialize and manufacture Libtayo entirely to Regeneron. Regeneron will make an upfront payment of $900m to Sanofi, who will be entitled to receive an 11% royalty on worldwide net sales of Libtayo. Sanofi will also be entitled to a $100m 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 $100m over the next two years.
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.
Bill Sibold, Executive Vice President of Specialty Care & President of North America at Sanofi, 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 revitalized 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.”