Glenmark Announces the Discovery and Initiation of IND Enabling Studies of a Novel Biologics Entity, GBR 401, Targeting Lymphomas and Leukemia’s of B-Cell Origin

March 31, 2011
    - Glenmark's first novel molecule for an oncology indication

    - GBR 401 is a monoclonal antibody targeting CD19. The
      antibody is implicated in treatment of B cell malignancies and
      inflammatory disorders mediated by B lymphocytes

    - CD19 is expressed earlier and more broadly in B-cell
      development than CD20 and represents a promising treatment approach

    - GBR401 has been developed using an advanced technology
      platform that greatly enhances the efficacy of the antibody and has
      been developed completely in-house by Glenmark

    - Glenmark will file for Phase I trials in Q4 FY 2011-12

Glenmark Pharmaceuticals announces the discovery and initiation of IND
enabling studies of a Novel Biological Entity (NBE) lead candidate, GBR 401,
an anti-CD19 monoclonal antibody. GBR 401 is developed completely in-house by
Glenmark’s Biologics Research Centre located in Switzerland.

The disease areas primarily targeted by GBR 401 are lymphomas and
leukemia’s of B-cell origin. Lymphomas are cancers originating from the
lymphatic system. Non-Hodgkin’s lymphoma (NHL), a type of B cell lymphoma, is
the most common form of blood cancer. Leukemia is a cancer of the white blood
cells. In addition the CD19 target holds potential for treatment of
inflammatory disorders such as rheumatoid arthritis.

GBR 401 shows great promise to emerge as a valuable therapeutic option to
treat patients affected with B-cell malignancies. GBR 401 has demonstrated
strong anti-tumour potency and anti-proliferative apoptotic activity in
several in-vitro and in-vivo studies. CD19 is known to be expressed earlier
and more broadly in B-cell development than CD20, the latter being the target
of the worlds second largest selling anti-cancer biotech product rituximab
(Rituxan(R) / MabThera(R)) whose annual 2010 sales were in excess of US$6

Mr. Glenn Saldanha, CEO & MD, Glenmark Pharmaceuticals mentioned “We are
excited to announce GBR 401, which has been developed completely in-house
leveraging our biologics antibody know-how. We are confident that the
antibody expertise and product development capabilities of the Switzerland
Biologics Research Centre will continue to enrich the Glenmark discovery

“Targeting CD19 is a promising approach to treat B-cell malignancies.
Further, GBR 401 has been developed using a technologically advanced platform
that greatly enhances the efficacy of the antibody” said Dr. Michael Buschle,
President-Biologics, Glenmark Pharmaceuticals S.A., Switzerland.

    For further information, please contact:

    Jason D'Souza
    Glenmark, Mumbai, India; Tel: [+91-22]-40189919 / 40189993
    e-mail : media@glenmarkpharma.com

SOURCE Glenmark Pharmaceuticals Ltd.

Source: newswire

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