Glenmark Pharmaceuticals Ltd. (India) has filed its molecule GBR 500 for phase-I trials with the US FDA. The filing of this crucial IND (Investigational New Drug Application) signifies the successful completion of a substantial number of pre-clinical studies for its humanized biologic molecule. GBR 500, a monoclonal antibody, is an antagonist of the VLA-2 (Alpha2 ?eta1) integrin.

Since VLA - 2 mediates interaction of cells relevant for the inflammatory process with the extracellular matrix, it has the potential to be a broadly applicable anti-inflammatory compound. Glenmark intends to initially develop GBR 500 for MS (Multiple Sclerosis).

Glenmark expects to complete phase-I trials for GBR 500 in this financial year immediately followed by several proof of concept phase-IIA studies in patients with multiple sclerosis and another common human inflammatory disease. In addition to the essential safety, tolerability and pharmacokinetics testing in phase-I, this study will also evaluate a number of relevant pharmacodynamic inflammatory parameters. These include validated models of inflammatory response in blood and skin, particularly involving T-lymphocytes and neutrophils which are relevant to a number of common inflammatory disorders

Glenn Saldanha, managing director & CEO, commented, "This is a significant development for the organization. We are excited about the progress made by GBR 500 and glad to have completed all requirements for filing the IND for phase-I trials. The first molecule is always the toughest and it has been a tremendous learning experience for the organization. We would now be able to implement relevant learnings to our other biologic molecule which should hasten the discovery process for biologics in the pre-clinical stage."

Dr Michael Buschle, president-Biologics, Glenmark Switzerland said, "We are excited about the progress we have made with this antibody. We have now a complete preclinical data package at hand to present to the FDA. We are very much looking forward to bringing this molecule into the clinic."

GBR 500, a monoclonal antibody, is a potential first in class compound being initially developed for MS (Multiple Sclerosis). It is an antagonist of the VLA-2 (?2ß1) integrin. VLA-2 mediates interactions of cells with the extracellular matrix. Integrin-mediated cell migration is required for the recruitment of immune cells to sites of inflammation, and Glenmark intends to develop GBR 500 as a modulator of inflammation. The market for MS alone is around USD 7 billion

Glenmark's other biologic molecule, GBR 600, which is in the pre-clinical stage of development is also a monoclonal antibody directed against a validated key target in the thrombus-forming cascade. GBR 600 is under development at Glenmark's Biologics Research Centre in Switzerland. GBR 600 is being developed for the treatment of acute coronary syndrome and cerebral thrombosis.

Monoclonal antibody (mAbs) products generated global revenues in excess of USD $ 23 billion in 2007 representing the fastest-growing segment within the global pharmaceutical industry. The future outlook for mAbs is very strong with global sales of the class projected to reach ~$40 billion by 2012. The major advantage of mAbs over other therapeutics is their exquisite specificity. They are ideal drugs as they bind only to specific targets and therefore have great potential for high efficacy with favourable side effect profiles. No therapeutic areas illustrate this better than oncology and inflammatory disorders: mAbs have revolutionized treatment of certain cancers, which in the past could not be effectively treated using conventional small molecule therapies. In addition, patients suffering from inflammatory disorders such as rheumatoid arthritis, ankylosing spondylitis, Crohns disease, psoriasis, IBD (Inflammatory Bowel Disease) and psoriatic arthritis have greatly benefited from use of mAb therapies.