WASHINGTON—Covington advised Regeneron Pharmaceuticals, Inc. in the expansion of its longstanding antibody collaboration with Sanofi, adding multiple next-generation, long-acting antibodies to the alliance that has jointly established Dupixent® (dupilumab) as the world-leading treatment for diseases driven by type 2 inflammation. The agreement builds on the companies' more than 20-year collaboration, through which more than 1.5 million people are currently receiving Dupixent across nine indications, making it one of the most widely used antibody medicines in the world.
Under the terms of the expanded license and collaboration agreement, Regeneron will receive an upfront payment of $1 billion from Sanofi, with the potential for development, regulatory and commercial milestone payments of up to an additional $7 billion. The companies will share development and commercialization costs for the new programs and will split future profits from these potential products 50:50 on a global basis. Regeneron will lead research and development activities, and Sanofi will lead global commercial efforts.
Under the agreement, Regeneron and Sanofi will co-develop and co-commercialize four new long-acting, Regeneron-invented antibodies targeting interleukin-13 (IL-13), IL-4xIL-13 bispecific, interleukin-4 (IL-4) and interleukin-4 receptor alpha (IL-4Rα). IL-13 antibody REGN20423 is currently in a phase 1 clinical study for atopic dermatitis, and the other three antibodies are expected to enter clinical studies in 2027. Regeneron will also have the option to include in the collaboration Sanofi’s lunsekimig, an investigational bispecific Nanobody® VHH therapy targeting TSLP and IL-13, exercisable upon completion of its phase 3 clinical studies for chronic obstructive pulmonary disease (COPD).
The companies have settled their prior collaboration-related litigation.
Dupixent, which was invented using Regeneron’s proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the IL-4 and IL-13 pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in phase 3 clinical studies, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.
The Covington team included John Hurvitz, Lauren Rakitin, Katrina Alfano, and Robert Kim (life sciences transactions), James Dean, Christian Ahlborn, Sibel Yilmaz, Leire Garagorri Eguidazu, and Nicolas Jung (antitrust), Matthew Franker (corporate), and Krista Carver, Kristie Gurley, Michael Stern, Victoria Corke, and Guillaume Julian (regulatory).