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Last updated on May 18, 2013 at 21:20 EDT

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

February 4, 2013

MUMBAI, India, 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.

SOURCE Glenmark Pharmaceuticals Ltd


Source: PR Newswire