In May this year Glenmark Pharma has outlicenced its novel monoclonal antibody, GBR 500, to French drug-maker Sanofi for as much as $613 million. The deal has got the clearance from the US antitrust improvement group.
After the approval from the antitrust law overseeing Federal Trade Commission, the deal has now become effective. The Hart-Scott-Rodino Act provides the Federal Trade Commission and the Department of Justice with information about large mergers and acquisitions before they occur.
Glenmark will also get sales royalties if the drug clears all clinical trials and regulatory hurdles. It's the first novel biologic out-licensing deal coming from any Indian company.
Glenmark has completed the phase-I testing of the molecule in the US and global phase-II trials are expected to begin soon. Glenmark had bought the antibody - GBR500 from Canadian company Chromos in 2007.
GBR 500 is currently undergoing early-stage human trials as a treatment for Crohn's disease (a form of inflammatory bowel disease), but is considered to have potential for treatment of other inflammatory conditions, such as multiple sclerosis and ulcerative colitis.
Glenmark had out-licensed its GRC15300 molecule - used in the treatment of osteoarthritis pain to Sanofi last year, while it had in-licensed anti-diarrheal drug Crofelemer from U.S.-based Napo Pharmaceuticals.