Glenmark’s Novel Molecule For Neuropathic Pain, Osteoarthritis To Enter Phase I Trials

MUMBAI - Indian drug maker Glenmark Pharmaceuticals' lead molecule for neuropathic pain, osteoarthritis and other inflammatory pain will enter Phase I trials shortly, the company announced, after filing for Phase I approval with European regulatory authorities.

The company expects to complete phase I trials for the molecule GRC 10693 by March 2009 and initiate phase II later next year.

GRC 10693 is a cannabinoid-2 receptor agonist, and Glenmark said the molecule is likely to be among the first in this class of compounds to hit the market. Glenmark has set a target launch date of 2014. "There has been significant scientific interest and commercial attention devoted to the cannabinoid receptors as potential pain targets with several pharma majors having active CB-2 programs. However, only a few molecules have progressed through to the clinical testing stages," Glenmark CEO Glenn Saldanha said.

According to the company, the molecule has completed the battery of preclinical studies and has demonstrated favorable results, a good safety profile and also exhibited superior efficacy in in-vivo models of neuropathic and inflammatory pain.

The neuropathic pain market is estimated at around $5 billion with over 40 million patients worldwide while the osteoarthritis market is valued at over $4 billion with over 20 million patients. There is a large unmet medical need and the recent concerns around the safety of cox-2 inhibitors should propel sales of safer products, the company said.

This is Glenmark's fifth molecule to enter clinical development from its pipeline of thirteen new chemical entities and new biological entities. Saldanha added that this development is an affirmation of Glenmark's research capabilities and focused approach towards drug discovery.

Glenmark is among the few Indian pharmaceutical companies with an active drug discovery program. The company's research activities focus on inflammation, including asthma and chronic obstructive pulmonary disease, dermatology and metabolic disorders, such as diabetes and obesity.

The company is in the process of creating marketing front-ends for the launch of its proprietary products in the future. Glenmark's first asthma/COPD molecule, oglemilast (GRC 3886), was licensed out to Forest Laboratories and Teijin Pharma Limited for the North American and Japanese markets, respectively. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211, a lead molecule for metabolic disorders, is undergoing phase II clinical trials in Europe and has been out-licensed to Eli Lilly along with other molecules for an upfront fee of $45 million (Also see "Anti-Pain Drugs Licensed To Lilly Boost Glenmark Earnings" - Scrip, 23 Jan, 2008.).

Glenmark is still looking for a partner for its DPP-IV inhibitor melogliptin type 2 diabetes treatment after Merck Serono terminated their agreement (Also see "Glenmark Continues Search For New Partners As Merck Diabetes Agreement Ends, Reports Strong Q4 Earnings" - Scrip, 30 Apr, 2008.).

- Jeetha D'Silva ([email protected])