Glenmark's Swiss unit moves UK body for clinical trials

Glenmark Pharmaceuticals SA (Switzerland), a wholly-owned subsidiary of Glenmark Pharmaceuticals Ltd, has filed for phase I clinical trials for GRC 8200, its leading DPP-IV inhibitor compound, with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK.

The phase I study will be conducted by Parexel UK, a leading global clinical research organisation (CRO). The study is expected to be completed in February 2006 and will be conducted using single and multiple oral doses on healthy volunteers. The objective of this study is to assess the safety and bio-availability of GRC 8200 in humans.

"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 in the US market in 2010," said Glenn Saldanha, managing director and CEO, Glenmark Pharma.

The company has commenced initial discussions with potential partners in the regulated markets to collaborate on the clinical development, filing and marketing of the product.

This is in line with its policy of partnering its new chemical entities (NCEs) with strong development and marketing partners for North America, Europe and Japan.