Company Watch

Glenmark investing robust amounts in R&D

Usha Sharma - Mumbai

Glenmark Pharmaceuti-cal is investing huge amount on research and development activity. Currently, its four new molecules are in pre-clinical trial and five are in different stages of completion for different therapeutic area. Its pre clinical candidates are expected to enter into phase I trials in another one and half years. GPL is targeting that five of its molecules, at different stages of research, will complete their studies and will be in market by 2014. The company's candidates, namely, GRC 9332, GRC 17173, GBR 500 and GBR 600 are designed for obesity dyslipitemia, neurop-athic pain, osteoarthritis, multiple sclerosis and acute stone chronic syndrome, respectively. All its pre-clinical molecules are different from its existing or ongoing trial candidates.

Recently, its candidate for neuropathic pain, osteoarth-ritis and other inflammatory pain—GRC 10693—has entered into phase I trial. 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 I approval with European regulatory authorities. And it is expecting to complete phase I trials for GRC 10693 and initiate phase II before the end of FY 09.

Speaking on the latest GRC 10693 development, Glenn Saldanha, MD and CEO, Glenmark, 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 New Chemical Entitties (NCEs) and new Biological Entities (NBEs), and is an affirmation of Glenmark's research capabilities and focused approach towards drug discovery. This develop-ment reiterates Glenmark's commitment towards setting new benchmarks in speed, efficacy and demonstrates the company's steady progress in the drug discovery space."

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 bioavaila-bility across species tested. The molecule has completed a battery of pre-clinical studies and has demonst-rated favourable results, a good safety margin and also exhibited superior efficacy in in-vivo models of neuropathic and inflammatory pain.

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 programmes. 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 programme."

The company's GRC 3886, GRC 6211 and GRC 68200 are for asthma COPD, neuropathic pain, osteoarthritis and diabetes, respectively in phase II trials and in few months will be entering into phase III. Its GRC 4039 for rheumatology osteoarthritis candidate is currently in phase I and will be shortly moving to the next phase.

usha.sharma@expressindia.com