Sanofi (previously sanofi-aventis) is paying India’s Glenmark Pharmaceuticals $50 million up front for a license to develop and commercialize the latter’s Phase I-stage monoclonal antibody candidate GBR 500, which is currently in development for the treatment of Crohn disease and other inflammatory conditions. Under terms of the deal Glenmark could receive up to an additional $613 million in development, regulatory, and commercialization milestones, plus double-digit sales royalties. Half of the $50 million initial payment will be dependent on Sanofi’s assessment of data to be provided by its partner.
Sanofi’s license extends to all therapeutic indications for GBR 500. The agreement with Glenmark gives the French firm exclusive marketing rights to the drug in North America, Europe, Japan, and certain South American countries. Sanofi and Glenmark will co-market the drug in Russia, Brazil, Australia, and New Zealand. Glenmark retains exclusive marketing rights in India and other global territories. The firms have an existing licensing deal for the development of Glenmark’s TRPV-3 antagonist, GRC 15300, which is in Phase I trials as a potential treatment for osteoarthritis pain, neuropathic pain, and skin disorders.
GBR 500 is a VLA-2 (alpha2-beta1) integrin inhibitor for which Phase I dosing trials have been completed in the U.S. Glenmark claims GBR 500 is the first molecule owned by an Indian company to enter clinical trials. Plans are now progressing to initiate clinical proof-of-concept trials in Crohn disease.
Glenmark has a pipeline of eight small molecule and biologic candidates in clinical development. Focused primarily on inflammatory disorders and pain, the firm’s lead antidiarrheal candidate, Crofelemer, has been licensed from Napo Pharmaceuticals, and has completed Phase III trials. Under terms of its license Glenmark has exclusive rights to develop, commercialize, and distribute the CFTR inhibitor in 140 emerging countries for acute adult and peadiatric diarroea as well as HIV-related diarrhea. The most recent Crofelemer trial data, from a multicenter study in adults, were reported by Glenmark, Napo, and Salix Pharmaceuticals in February.
Glenmark operates three drug discovery R&D centers. NCE research is conducted at the R&D center in Navi Mumbai in India. Biologics research is carried out at the firm’s site in Switzerland, and clinical R&D is conducted at a facility in Oxford, U.K. In March Glenmark reported the initiation of IND-enabling studies for an anti-CD19 monoclonal antibody, designated GBR 401, which was discovered and is in development in-house as a potential treatment for lymphomas and B cell leukemias.