Glenmark's diabetes drug completes Phase I study

Glenmark Pharmaceuticals SA, the wholly-owned Swiss subsidiary of Glenmark Pharmaceuticals, today announced the completion of Phase-I study of its lead DPP-IV inhibitor candidate for diabetes - GRC 8200.

The study, conducted by UK-based clinical research organisation Parexel,  has been filed with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

GRC 8200 has now entered Phase II testing with trials beginning in South Africa at an USFDA approved clnicial research organisation. The company is also planning to file a US investigational new drug (IND) application for GRC 8200 by May 2006 for further Phase II clinical testing, and is expecting to complete all Phase II trials by March 2007.

Glenn Saldanha, managing director and CEO of Glenmark Pharma, said: "With our aggressive timeline, we hope to be the fourth to market with GRC 8200 in the DPP-IV class. We maintain our guidance for launching GRC 8200 in the US markets in 2010."