Sanofi and Regeneron Pharmaceuticals, Inc. have expanded their long-standing antibody collaboration by adding several next-generation, long-acting antibodies to the Alliance that jointly established Dupixent (dupilumab) as the global standard of care for type 2 inflammation-related diseases. The expanded partnership builds on the companies’ more than 20-year collaboration and broadens the scope of their immunology alliance. More than 1.5 million people are currently receiving Dupixent in nine indications, making it one of the most widely used antibody therapies in the world.
“This is a deliberate first step to reignite Sanofi’s innovation engine. Our long-standing alliance with Regeneron has transformed the therapeutic landscape for millions of patients with type 2 inflammation-related diseases and created one of the world’s leading immunology businesses,” said Belén Garijo , CEO of Sanofi.
Four Long-Acting Antibodies Added to Collaboration
Under the expanded licensing and collaboration agreement, Sanofi and Regeneron will co-develop and co-commercialize four novel long-acting antibodies invented by Regeneron. The programs target interleukin-13 (IL-13), the bispecific IL-4xIL-13, interleukin-4 (IL-4), and the interleukin-4 receptor alpha (IL-4Rα). The anti-IL-13 antibody REGN20423 is currently in a Phase 1 clinical trial in atopic dermatitis, while the three other antibodies are expected to enter clinical trials in 2027. Regeneron will also have the option to bring Sanofi’s Phase 2/3 investigational Nanobody VHH bispecific therapy targeting TSLP and IL-13 into the collaboration. This option can be exercised after completion of its Phase 3 studies in chronic obstructive pulmonary disease.
“The Regeneron-Sanofi Alliance has been one of the most productive in the history of biopharmaceuticals. This agreement builds on that foundation to bring the next generation of immunotherapy medicines to patients even faster,” said Leonard S. Schleifer , MD, Ph.D., Co-Chairman of the Board, President and CEO of Regeneron. “By expanding our Alliance, we are positioning promising new long-acting antibodies for rapid global impact of the kind our joint work on Dupixent has already achieved.”
$1 Billion Upfront Payment and Global Development Structure
Under the terms of the agreement, Regeneron will receive an upfront payment of $1 billion from Sanofi. The deal also includes potential milestone payments related to development, regulatory approvals, and commercialization of up to an additional $7 billion. Sanofi and Regeneron will share development and commercialization costs for the new programs and will split future profits from potential products globally on a 50/50 basis. Regeneron will lead research and development activities, while Sanofi will lead global commercial efforts. The existing profit-sharing agreement for Dupixent will remain unchanged.
“The clinical and commercial alliance between the two companies dates back to 2003 and has resulted in several approved medicines to date, including Dupixent, which has redefined the standard of care for people with type 2 inflammatory diseases and is now one of the most widely used commercial antibodies for any disease, with more than 1.5 million active patients worldwide,” said George D. Yancopoulos , MD, Ph.D., Co-Chairman of the Board, President and Chief Scientific Officer of Regeneron, and lead inventor of Dupixent.
“By combining Regeneron’s world-class expertise in scientific discovery and antibody development with Sanofi’s global capabilities and reach, we hope to once again deliver the next wave of innovation in immunology,” he added.
