GLENMARK FILES APPLICATION FOR GRC 8200 IN UK

Glenmark Pharmaceuticals has filed for Phase I clinical trials for its leading DPP-IV inhibitor compound, GRC 8200, with the Medicines and Healthcare Products Regulatory Agency in the UK.

The Phase I study is expected to be completed in February 2006, and will be conducted using single and multiple oral doses in healthy volunteers. The objective of this study is to assess the safety and bio-availability of GRC 8200 in humans.

Preclinical studies have demonstrated GRC 8200 to be more potent than competing DPP-IV inhibitors. The compound is highly bio-available and safe, displaying significant reduction in glucose excursion on oral glucose challenge. Preclinical studies have also demonstrated that GRC 8200 has the potential of being a long-acting compound, with high selectivity to the DPP-IV target over DPP-II, VIII and IX.