Glenmark Pharmaceuticals Ltd (India) has filed its molecule GBR 500 for Phase I trials with the US Food and Drug Administration (FDA), making it the first Indian company to have a novel biologic molecule that will be tested on humans. The filing of this IND (investigational new drug application) signifies successful completion of a substantial number of pre-clinical studies for its humanised biologic molecule, the company said in a media release. GBR 500 is a monoclonal antibody and Glenmark plans to initially develop it to treat MS (multiple sclerosis).
Monoclonal antibody products generated global revenues in excess of $23 billion in 2007, representing the fastest-growing segment within the global pharmaceutical industry. Global sales of the class are projected to reach around $40 billion by 2012. Glenmark expects to complete Phase I trials during this fiscal; they will be followed by Phase IIA studies on patients with multiple sclerosis and another common human inflammatory disease. Trials will involve evaluation of relevant pharmacodynamic inflammatory parameters.