|
Glenmark Pharmaceuticals Ltd. (GPL) today announced that its candidate for Neuropathic Pain, Osteoarthritis and other Inflammatory Pain – GRC 10693 is entering Phase I trials
Mumbai, India | July 15, 2008 | Glenmark Pharmaceuticals Ltd. (GPL) today announced that its candidate for Neuropathic Pain, Osteoarthritis and other Inflammatory Pain – GRC 10693 is entering Phase I trials. The company intends to develop GRC 10693, a cannabinoid-2 [CB-2] receptor agonist, in neuropathic pain as the primary indication. The molecule has been filed for Phase 1 approval with European regulatory authorities. Glenmark expects to complete Phase I trials for GRC 10693 and initiate Phase II before the end of FY 09.
Speaking on this development, Mr. Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals Ltd. (GPL) said, “We are happy to take GRC 10693 forward into Phase I trials. This is Glenmark’s fifth molecule to enter the clinics from our pipeline of thirteen NCEs and NBEs, and is an affirmation of Glenmark’s research capabilities and focused approach towards drug discovery. This development reiterates Glenmark’s commitment towards setting new benchmarks in speed, efficacy and demonstrates the company’s steady progress in the drug discovery space.” He further added “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. In this context, we are glad to have a Phase I ready molecule that could present a potential opportunity as it matures. We see this as further validation of the strength and speed of our discovery program.”
Note on the Molecule
GRC 10693 is potentially a first-in-class molecule and is likely to be an early launcher in this class of compounds with a target launch date of 2014 The molecule is a novel, potent and selective human cannabinoid (CB-2) receptor agonist, with over 4700-fold selectivity over the CB-1 receptor and good bioavailability across species tested. The molecule has completed the battery of pre-clinical studies and has demonstrated favorable results, a good safety margin and also exhibited superior efficacy in in-vivo models of neuropathic & inflammatory pain.
Note on the addressable market
There is a large un-met medical need and the recent concerns around the safety of cox-2 inhibitors should propel sales of safer products. The neuropathic pain market is estimated at around USD 5 billion with over 40 million patients worldwide while the Osteoarthritis market is valued at over USD 4 billion with over 20 million patients.
About Glenmark Pharmaceuticals Ltd
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company headquartered at Mumbai, India. Its shares are listed on India’s two large stock exchanges, the Bombay Stock Exchange (BSE) and the National Stock Exchange (NSE). It employs over 5000 people across its global operations over 85 countries. The Company is a leader in India in the discovery of new molecules and is focused in the areas of inflammation [Asthma/COPD, etc.], dermatology and metabolic disorders [Diabetes, Obesity, etc.]. 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, in two landmark deals. Oglemilast is presently undergoing Phase II clinical trials in the US. GRC 6211, undergoing Phase II clinical trials in Europe, has been outlicensed to Eli Lilly & company. Glenmark’s API and generics business interests span over the highly regulated markets of USA, Latin America and Europe, and are managed by its subsidiary Glenmark Generics Limited. For more information on GPL, log on to www.glenmarkpharma.com
SOURCE: Glenmark Pharmaceuticals Limited |
