Glenmark Pharmaceuticals discover GBR 401 an anti-CD19 monoclonal antibody

Glenmark Pharmaceuticals announces GBR 401, an anti-CD19 monoclonal antibody. GBR 401 is developed completely in-house by Glenmark's Biologics Research Centre located in Switzerland. End Quote

(1888PressRelease) April 02, 2011 - 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 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 acancer of the white blood cells. Within the seven major markets comprising of US, Europe Top 5markets and Japan, new cases of NHL and leukemia's of B cell origin were estimated at 126,000and 34,000 respectively. In addition the CD19 target holds potential for treatment of inflammatorydisorders 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 antiproliferativeapoptotic 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 ofthe worlds second largest selling anti-cancer biotech product rituximab (Rituxan® / Mab Thera®)whose annual 2010 sales were in excess of US$6 billion. Glenmark will pursue furtherdevelopment of GBR 401 to accelerate its entry into clinical trials.

Commenting on this milestone, Mr. Glenn Saldanha, CEO & MD, Glenmark Pharmaceuticalsmentioned "We are excited to announce GBR 401, which has been developed completely inhouse leveraging our biologics antibody know-how. We are confident that the antibody expertiseand product development capabilities of the Switzerland Biologics Research Centre will continue to enrich the Glenmark discovery pipeline.

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

About CD19 Target

Antibody inhibitors or cytotoxic antibodies against CD19 have the potential to treat a plethora of Bcell or antibody-mediated diseases including malignancies and autoimmune diseases. CD19 formspart of the B cell co-receptor in conjunction with CD81 and CD21. It has no known ligand and is acritical signal transduction molecule that regulates B lymphocyte development, activation, anddifferentiation. It is present on B cells from the earliest recognizable B-lineage cells duringdevelopment within the bone marrow to B-cell blasts but is lost on maturation to plasma cells.CD19 is used as the primary marker for the identification of B cell malignancies so its use as atarget is understandable and as the B cell is also the producer of autoimmune antibodies in diseases such as systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) then the removal ofthese cells will also benefit sufferers.

Glenmark's Novel Biologics Entity pipeline

With the addition of GBR 401 to the pipeline, Glenmark will now have four 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 completed Phase I trials in the US and is the first novel monoclonal antibody developed by an Indian Company in the US. The second monoclonal antibody product, GBR 600, is a highly specific platelet inhibitor for the prevention of von Willebrand Factor (vWF) mediated diseases. GBR 600 has received approval for initiation ofPhase I trials in Europe. Further, in Sept 2010 Glenmark received the exclusive license to themonoclonal antibody BXL1H5 i.e. GBR 900 including the exclusive target license to commercialize monoclonal antibodies against TrkA receptor for pain from Lay Line Genomics, an Italian based Company. TrkA is a promising target and 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 Swiss R&D center.

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