Sanofi and Regeneron Pharmaceuticals have expanded their longstanding global immunology alliance to include four next-generation, long-acting antibodies targeting inflammatory diseases, with Regeneron receiving $1 billion upfront and potentially up to an additional $7 billion in development, regulatory and commercial milestone payments.
The expanded collaboration builds on a relationship spanning more than 20 years that produced Dupixent, which is currently used by more than 1.5 million patients across nine indications. The companies said the new agreement is intended to accelerate development of another generation of therapies for immune-mediated diseases.
Under the agreement, Sanofi and Regeneron will co-develop and co-commercialize four Regeneron-invented antibodies targeting IL-13, IL-4xIL-13, IL-4 and IL-4 receptor alpha.
The most advanced program is REGN20423, a long-acting IL-13 monoclonal antibody currently in a Phase 1 clinical study for atopic dermatitis. The three additional antibodies include a long-acting IL-4xIL-13 bispecific and antibodies targeting IL-4 and IL-4Rα, which are expected to enter clinical development in 2027.
Regeneron will also receive an option to bring Sanofi’s lunsekimig into the collaboration following completion of its Phase 3 studies in chronic obstructive pulmonary disease. Lunsekimig is an investigational bispecific Nanobody VHH therapy targeting TSLP and IL-13.
Regeneron will lead research and development activities for the newly added programs, while Sanofi will lead global commercialization. The companies will share development and commercialization costs and split any future profits from the products equally on a worldwide basis.
The expanded agreement does not change the companies’ existing profit-sharing arrangement for Dupixent. Sanofi and Regeneron also said they have settled their previous collaboration-related litigation.
Dupixent inhibits IL-4 and IL-13 signaling and has been approved in more than 60 countries for one or more indications. Depending on the market and patient population, those indications include atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic spontaneous urticaria, chronic obstructive pulmonary disease, bullous pemphigoid and allergic fungal rhinosinusitis.
The expanded alliance is intended to apply the scientific, clinical development and global commercialization infrastructure created around Dupixent to additional long-acting antibody therapies.
KEY QUOTES:
“This is a deliberate first step in igniting Sanofi’s innovation engine. Our longstanding Alliance with Regeneron has transformed the treatment landscape for millions of patients living with diseases driven by type 2 inflammation and created one of the world’s leading immunology businesses. By deepening our collaboration, we will make rapid progress in creating the next generation of meaningful therapies for patients with immune-mediated diseases, while contributing to Sanofi’s long-term future.”
Belén Garijo, Chief Executive Officer of Sanofi
“The Regeneron-Sanofi Alliance has been one of the most productive in biopharma history. This agreement builds on that foundation to bring the next generation of immunology medicines to patients even faster. By expanding our Alliance, we are positioning promising new long-acting antibodies for the kind of rapid, global impact that our shared work on Dupixent has already achieved.”
Leonard S. Schleifer, M.D., Ph.D., Board Co-Chair, President and Chief Executive Officer of Regeneron
“The companies’ clinical and commercial Alliance dates to 2003 and has resulted in multiple 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 antibodies for any disease, with over 1.5 million active patients worldwide. By combining Regeneron’s world-class scientific discovery and antibody development expertise with Sanofi’s global capabilities and reach, we hope to once again deliver the next wave of innovation in immunology.”
George D. Yancopoulos, M.D., Ph.D., Board Co-Chair, President and Chief Scientific Officer of Regeneron
