Business Daily from THE HINDU group of publications
Thursday, Aug 20, 2009
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Business Daily from THE HINDU group of publications Thursday, Aug 20, 2009 ePaper | Mobile/PDA Version | Audio | Blogs |
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Research & Development Web Extras - Health Glenmark’s first out-licensed molecule shelved Our Bureau Mumbai, Aug. 19 Glenmark Pharmaceuticals’ first prospective drug molecule Oglemilast that was out-licensed for further development to Forest Laboratories has been shelved for Chronic Obstructive Pulmonary Disease (COPD), one of the disease areas that it targeted. Forest Laboratories Inc and GPL’s Switzerland subsidiary, Glenmark Pharmaceuticals SA, said that Phase IIb dose range studies on Oglemilast in patients with COPD were not successful. Glenmark’s shares on the Bombay Stock Exchange plummeted over 17 per cent on the development, closing at Rs 223, down close to 15 per cent from Wednesday. In September 2004, Glenmark had forged a $190 million outlicensing deal with Forest Labs, for further development of Oglemilast in the COPD and asthma segments. Glenmark has received $35 million in milestone payments. The Mumbai-based drug-maker also has a similar agreement on Oglemilast with Teijin Pharma Ltd for the Japanese market. There is little clarity on this deal, given that COPD was the primary indication for this study as well. Studies for asthma onGlenmark’s Chief Executive and Managing Director, Mr Glenn Saldanha, clarified in an e-mail response that “Oglemilast is still being studied for the treatment of asthma, with results expected during the first calendar quarter of 2010. The phase II trials for asthma is ongoing at 27 sites across the country. Regarding the COPD trials, we are considering together with Forest what action would be useful or appropriate.” Giving details on the development, a Glenmark statement said: “Once-daily treatment with Oglemilast did not show a statistically meaningful increase from baseline compared to placebo in the primary endpoint trough FEV1, a measure of pulmonary function that is lower in patients with COPD. Oglemilast was well-tolerated at all doses studied.” Other prospective molecules outlicensed by Glenmark earlier had also faced rough weather. Glenmark’s prospective diabetes molecule outlicensed to Merck in 2006 had returned to its stable after Merck opted out of this segment last year, as part of its restructuring. Glenmark’s deal with Eli Lilly for its prospective pain molecule also ran aground last year. “When we outlicensed Oglemilast in 2004, we had only one molecule in clinical trials. Today we still have six molecules in human trials. We have been successful in receiving over $115 million (over Rs 500 crore) in upfront and milestone payments and have ploughed back these funds back into the discovery programme,” Mr Saldanha said. “Our strategy will continue to look for partners to outlicense our other candidates in clinical trials. Even for Oglemilast we received $35 million (around Rs 150 crore) in the past from upfront and milestone payments, which we get to keep,” he said. “The focus for Glenmark will be to continuously discover best-in-class or first-in-class molecules, take them to clinical trials and then look at outlicensing these molecules. We presently have atleast three more outlicensing candidates.GRC 10693, GBR 500 and GRC 15300,” he added. SmithKline files patent case against Glenmark More Stories on : Research & Development | Pharmaceuticals | Health
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