Glenmark Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals, has entered into an agreement with Sanofi to grant a license for the development and commercialization of GBR 500, a novel monoclonal antibody for the treatment of Crohn's disease and other inflammatory conditions. With this announcement, the Glenmark scrip moved up by over 13 per cent in the morning session today on BSE and touched to Rs. 310.75 from its earlier day close of Rs. 274.20.
Under the terms of 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 $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. The total of these payments could reach $613 million. In addition, Glenmark is eligible to receive tiered double-digit royalties on sales of products commercialized under the license.
Sanofi will have exclusive marketing rights for North America, Europe, Japan, Argentina, Chile an Uruguay. Sanofi and Glenmark will co-market in Russia, Brazil, Australia and New Zealand, and Glenmark will retain exclusive marketing rights in India and other countries in the rest of the world.
The transaction is expected to close in the coming month subject to customary closing conditions, including the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.
GBR 500 is an antagonist of the VLA-2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody and has established proof of concept in animal models across a range of anti-inflammatory conditions. Glenmark has completed phase I dosing of GBR 500 in the US and the drug has been well tolerated with a good pharmacokinetic profile. Plans are in place to initiate clinical proof of concept studies in Crohn's disease. Sanofi has licensed the rights to all therapeutic indications.
Elias Zerhouni, M.D., president, global research & development, Sanofi, said, “There continues to be a strong medical need for safer and more efficacious products for her treatment of inflammatory diseases. 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.”
Glenn Saldanha, managing director and CEO of Glenmark Pharmaceuticals, said, “This collaboration on a novel firs-in-class monoclonal antibody validates Glenmark's world-class innovative R&D capabilities in the drug discovery arena. 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.”
Dr Michael Buschle, president biologics for Glenmark commented, “ The focus for the Switzerland biologics R&D centre has been to discover and develop exciting novel monoclonal antibodies for the potential treatment of inflammatory and oncology conditions. This deal is a testimony to the strong biologics platform that Glenmark has established in relatively short frame of time.”