Glenmark Announces a New Discovery and the Initiation of IND Enabling Studies of a Novel Monoclonal Antibody Targeting OX40

MUMBAI, February 4, 2013 /PRNewswire/ --

- GBR 830 is the First Antagonistic Antibody Targeting OX40 and is a Potential Global First-in-class Molecule

- OX40, Also Known as CD134, Plays a Key Role in T-cell Mediated Autoimmune Disorders

Glenmark Pharmaceuticals S.A. (GPSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announces the discovery and initiation of IND enabling studies of a novel clinical development candidate, GBR 830, an anti-OX40 monoclonal antibody. GBR 830 has been discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland. GBR 830, an anti-OX40 monoclonal antibody is a potential Global First-in-class molecule.

OX40 is a well-known target and the development of OX40 antagonists has been very challenging. Glenmark has achieved a significant milestone with the successful generation of an antagonistic OX40 monoclonal antibody coupled with generation of data validating the role of OX40 in autoimmune diseases.

GBR 830 shows great promise to emerge as a valuable therapeutic option to treat patients suffering from immune pathologies such as autoimmune diseases like Rheumatoid Arthritis (RA) and Inflammatory Bowel Disease (IBD).

Commenting on this milestone, Dr. Michael Buschle, Chief Scientific Officer & President - Biologics, Glenmark Pharmaceuticals mentioned, "GBR 830 is a tremendous achievement for us. No antagonistic antibodies targeting OX40 are currently in clinical stage of development. We are confident that the antibody expertise and product development capabilities of the Switzerland Biologics Research Centre will continue to enrich the Glenmark discovery pipeline."

About OX40

OX40 (CD134) is a member of the TNFR/TNF super family and is mainly expressed on activated CD4 and CD8 T cells as well as a number of other lymphoid and non-lymphoid cells. Costimulatory signals from OX40 to an activated T cell promote division and survival, augmenting the clonal expansion of effector and memory populations. OX40 mediated costimulatory signaling plays a central role in the development of multiple inflammatory and autoimmune diseases. Inhibiting these interactions can be used to treat these conditions. Conversely, agents that activate OX40 are being developed to activate T-cells to target cancer cells. No OX40 antagonistic antibodies are currently in clinical stage of development.

Glenmark's Novel Biologics Entity pipeline

With the addition of GBR 830 to the pipeline, Glenmark will now have three monoclonal antibodies in the Novel Biologics Entity (NBE) pipeline. First, GBR 500, a monoclonal antibody represents a first-in-class opportunity indicated for the treatment of Inflammatory Bowel Disease (IBD) and Multiple Sclerosis (MS). GBR 500 has been licensed to Sanofi and is in Phase II trials in the US. The second monoclonal antibody, GBR 900 targets the TrkA receptor for pain. This project is developed under license from Lay Line Genomics S.p.A., an Italian based Company. Monoclonal antibodies specific for TrkA represent a first-in-class opportunity for the treatment of chronic pain, which has a high level of unmet need. GBR 900 is in the pre-clinical stage of development and will be developed further by Glenmark Biologics Research Centre in Switzerland.

About Glenmark

Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company. It is a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity). Glenmark has a number of molecules in various stages of clinical development and is primarily focused in the areas of Inflammation (asthma/COPD, rheumatoid arthritis etc.) and Pain (neuropathic pain and inflammatory pain). The company has a significant presence in branded generics markets across emerging economies including India. Through its subsidiary, Glenmark Generics Limited it has a significant present in the US and is among the leading generics organization in the country.

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