Summary
Regeneron Pharmaceuticals, Inc. (REGN) announced a significant restructuring of its Praluent® (alirocumab) collaboration with Sanofi, effective April 1, 2020. This filing details the entry into a Third Amendment to their existing License and Collaboration Agreement and a new Praluent Cross License & Commercialization Agreement. The core of this restructuring involves Regeneron taking sole responsibility and cost for the development and commercialization of Praluent within the United States, while Sanofi will assume the same for territories outside the U.S. This shift in responsibility will impact revenue sharing and operational control. Regeneron will no longer share profits and losses with Sanofi for Praluent from the first quarter of 2020 onwards, and Sanofi will pay Regeneron a 5% royalty on Praluent sales outside the U.S. until March 31, 2032. Regeneron will not owe royalties to Sanofi on U.S. sales. Both companies will also assume sole responsibility for Praluent-related litigation in their respective territories for activities occurring on or after April 1, 2020.
Key Highlights
- 1Regeneron and Sanofi have restructured their Praluent® (alirocumab) antibody collaboration, effective April 1, 2020.
- 2Regeneron now has sole responsibility and cost for Praluent development and commercialization in the United States.
- 3Sanofi will have sole responsibility and cost for Praluent development and commercialization outside the United States.
- 4Regeneron will receive a 5% royalty on Sanofi's net product sales of Praluent outside the U.S. until March 31, 2032.
- 5Regeneron will not owe royalties to Sanofi on Praluent sales within the United States.
- 6Profit and loss sharing for Praluent between Regeneron and Sanofi ceased as of the quarter ended March 31, 2020.
- 7Both parties will be solely responsible for Praluent-related litigation in their respective territories for post-April 1, 2020 activities.