Sanofi and Glenmark Pharmaceuticals Sign License Agreement on Novel Monoclonal Antibody for Crohn's Disease and Other Chronic Autoimmune Disorders
Paris, France - May 16, 2011 - Sanofi (EURONEXT: SAN and NYSE: SNY) announced today that it has entered into a license agreement with Glenmark Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), for the development and commercialization of GBR500, a novel monoclonal antibody to treat Crohn's Disease and other chronic autoimmune disorders. The closing of the transaction is subject to customary conditions, including the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
GBR500 is an antagonist of the VLA-2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders. GBR500 has completed a Phase I dosing study in the US and has been well tolerated with a good pharmacokinetic profile.
Under the terms of the agreement, Glenmark will receive an upfront payment of US$ 50 million, of which US$ 25 million will be paid upon closing of the transaction and US$ 25 million, which is contingent upon Sanofi's positive assessment of certain data to be provided by Glenmark. In addition, Glenmark could receive potential success-based development, regulatory and commercial milestone payments. In addition, Glenmark is eligible to receive double-digit royalties on net sales of products commercialized under the license. Sanofi will have exclusive marketing rights in North America, Europe, Japan, Mexico, Argentina, Chile and Uruguay, and co-marketing or co-promotion rights in Brazil, Russia, Australia and New Zealand. Glenmark will retain exclusive marketing rights in India and the rest of the world.
"There continues to be a strong medical need for safer and more efficacious products for the treatment of Inflammatory Diseases," said Elias Zerhouni, M.D., President, Global Research & Development, Sanofi. "GBR500 brings an innovative approach to Sanofi's Immuno-Inflammation portfolio, which we believe may address a significant gap in treating Inflammatory Diseases which would be of huge benefit to patients".
According to Glenn Saldanha, M.D., Chief Executive Officer of GPL, "This collaboration on a novel first-in-class monoclonal antibody validates Glenmark's world-class innovative R&D capabilities in the drug discovery area. We are pleased to have this second licensing collaboration with Sanofi, one of the largest pharmaceutical companies in the world and the first one from Glenmark in the field of novel biologics."
About the GBR500 program
VLA-2 (alpha2 beta1) integrin is a receptor that plays a role in lymphocyte adhesion at inflammation sites and in the downstream release of inflammatory cytokines. By targeting VLA-2, GBR500 can play a selective and critical role in treating inflammatory conditions. The goal of the partnership will be to advance GBR500 with the hope of providing to patients better medicines for chronic inflammatory disorders.
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. It is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has eight molecules in various stages of clinical development and is primarily focused in the areas of Inflammation, Metabolic Disorders and Pain. The company has a significant presence in branded generics markets across emerging economies including India. GPL along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centers.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, rare diseases, consumer healthcare, emerging markets and animal health. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).