Glenmark Pharmaceuticals files PhaseI application for anti-diabetic drug in the UK

Glenmark Pharmaceuticals in Switzerland, a subsidiary of Glenmark Pharmaceuticals of Mumbai, India, has filed for Phase I clinical trials for its DPP-IV inhibitor compound, GRC 8200, with the UK's Medicines and Healthcare Products Regulatory Agency (MHRA). DPP-IV inhibitors are one of several new classes of antidiabetic medications in development for type 2 diabetes.

The Phase I study will be conducted by global contract research group Parexel UK and is expected to be completed in February 2006. It will assess the safety and bioavailability of GRC 8200 in humans.

Pre-clinical studies have demonstrated this drug to be more potent than competitors' DPP-IV inhibitors. It also has the potential to be a long-acting compound.

No DPP-IV inhibitor has been approved for marketing to date, but such drugs are predicted to be the therapy of choice, once approved. Several leading multinational companies are known to have lead molecules in early to late stage clinical trials.

Glenmark hopes its aggressive clinical development plan for GRC 8200 will reduce the gap between its drug and some of these competing molecules in early clinical trials. Along with Phase I trials, it plans to initiate a Proof of Concept Phase IIA study in South Africa in January 2006 on diabetic patients. It also expects to file an IND with the US FDA between April-June 2006 in order to commence Phase II.

Glenn Saldanha, md and CEO of Glenmark, said: 'We have a very aggressive timeline and hope to be the fourth to market with GRC 8200 in the DPP-IV class. We expect GRC 8200 to be launched on the US market in 2010.'