Glenmark Pharmaceuticals Announces the Initiation of Phase II Study for GBR 500 for Ulcerative Colitis

MUMBAI, September 13, 2012 /PRNewswire/ --

Glenmark Pharmaceuticals S.A. (GPSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Limited (GPL), announced today that GBR 500 has entered Phase II clinical development. This Phase II clinical trial is part of a strategic global collaboration between Glenmark and Sanofi to investigate GBR 500 for the treatment of chronic inflammatory disorders.

This study is a randomized, double-blind, placebo-controlled, multi-center study designed to investigate the efficacy and safety of GBR 500 in patients with moderate to severe ulcerative colitis (UC). The trial will be conducted at multiple clinical sites in North America and Europe, and is expected to include approximately 84 patients. Individuals participating in the study will receive multiple doses of either GBR 500 or placebo, administered over a period of several weeks.

"Despite treatment advances in recent years, UC remains a debilitating condition for many individuals, and represents an area of substantial unmet medical need," said Dr. Michael Buschle, Chief Scientific Officer, Glenmark Pharmaceuticals Ltd. "We're pleased with the continued progress of our partnership with Sanofi and excited about the commencement of this trial."

GBR 500 is an antagonist of the VLA2 (alpha2-beta1) integrin. It is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders. Glenmark has completed Phase I of GBR 500 in the US. Sanofi has licensed the rights to all therapeutic indications and is conducting the clinical development program including this trial.

About Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company and ranked among the top 100 Pharma & Biotech companies of the world in terms of revenues. Glenmark is a leading player in the discovery of new molecules both NCEs and NBEs. Glenmark has several molecules in various stages of clinical development and primarily focused in the areas of inflammation, pain and oncology. The company has significant presence in branded formulations across emerging economies including India. Its subsidiary, Glenmark Generics Limited, services the requirements of the US and Western Europe markets.

Primary Media Contact: Corporate Communications, [email protected], 91-22-40189999