Glenmark Pharmaceuticals S.A [Switzerland], a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd. [Glenmark], has filed for Phase I clinical trials for GRC 8200, its leading DPP-IV inhibitor compound, with the MHRA in the UK.
The Phase I study, which is expected to be completed in February 2006, will be conducted by Parexel UK. The objective of this study is to assess the safety and bioavailability of GRC 8200 in humans. Pre-clinical 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.
Along with Phase I trials, the company plans to initiate a Proof Of Concept [Phase IIA] study in South Africa in January 2006 on diabetic patients. Further, the company has already commenced various other non-clinical studies and expects to file an IND with the US FDA between April-June 2006 in order to commence Phase II, according to a company release.
Glenn Saldanha, Managing Director and CEO of Glenmark, stated, "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."
Glenmark has commenced early discussions with potential partners in the regulated markets to collaborate on the clinical development, filing and marketing of this product. This is in line with its policy of partnering its NCEs with strong development and marketing partners for North America, Europe and Japan. Glenn Saldanha confirmed this by adding, "The timing for concluding any licensing deal will depend on the value offered by potential partners. In the meantime, we are aggressively moving ahead with the clinical development and have already commenced discussions with CROs for confirmative Phase II trials."
The company in also engaged in research in discovering new molecules and runs discovery projects in the areas of Asthma, COPD, Diabetes, Obesity, etc. It had licensed its first Asthma, COPD molecule to Forest Labs and Teijin Pharma for the North American and Japanese markets, respectively. This compound has subsequently completed Phase I clinical trials successfully, added the release.