The Hindu Business Line : Glenmark starting phase II trials on pain drug molecule

Mumbai May 28 Glenmark Pharmaceuticals Ltd is set to initiate the second phase of clinical trials on its prospective pain-related drug molecule, GRC 6211. The Mumbai-based drug company is also in talks with other companies to license out the drug to help develop it further till commercialisation, a Glenmark note said.

The company said that it would commence Phase IIA proof of concept study for dental pain in Europe and expected to complete the study by December this year. In phase II studies, the prospective drug molecule is targeted at about 100 to 500-odd people with the disease.

Glenmark's Swiss subsidiary, Glenmark Pharmaceuticals SA (GPSA), has completed Phase I clinical trials for GRC 6211 in Europe. The prospective drug molecule is its lead compound for a range of pain indications such as neuropathic pain, osteoarthritis and urinary incontinence, a note from the company said.

Non-clinical studies

On completion of the dental pain study, Glenmark plans to initiate a large Phase IIB study in the first quarter of 2008 for neuropathic pain and osteoarthritis. To ensure that Phase IIB trials start by early 2008, various non-clinical studies are currently under way, the note said.

Mr Glenn Saldhana, Managing Director and Chief Executive Officer of the company, said that the company now has three molecules in Phase II and expected another three to enter clinical testing over the next six months. Pain management is a large unmet need around the world and GRC 6211 presents an excellent opportunity to capture this large market, he added. It aims to be an early launcher in this class and targets launching the molecule in 2011.

Competition in the same category comes from Merck's lead molecule (a molecule in -licensed from Neutrogena, at present in Phase II), GlaxoSmithKline's lead molecule (also in Phase II) and Pfizer's lead molecule (a molecule in-licensed from Renovis, at present undergoing pre-clinical trials).

Out-licensing

Glenmark is in discussions with potential partners for licensing this compound, the note added. The timing of licensing would depend on the terms of the deal and the ability to get co-promotion rights for some of the regulated markets, according to the company.

Out-licensing a prospective drug molecule to help develop it up to the time it can be launched in the market is a strategy adopted by Glenmark. It has licensed out its prospective asthma drug molecule (Oglemilast GRC 3886) to Forest Laboratories for North America and Teijin Pharma Limited in the Japanese markets.

Oglemilast is currently undergoing Phase II clinical trials in the US. The company's second lead GRC 8200, for Type II Diabetes was recently out-licensed to Merck KGaA, Germany for the North American, European and Japanese markets.

Glenmark has six New Chemical Entities at various stages of development. The company has three other programmes across obesity, inflammation and pain management at pre-clinical stages, all of which should enter the clinics by the first half of fiscal 2008, a note from the company said.

Glenmark shares were marginally up at Rs 700.45 on the BSE.

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