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BW Businessworld

Spotting Potential

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Swiss drug maker Nycomed has applied for marketing approval for Daxas, a once-a-day tablet for Chronic Obstructive Pulmonary Disorder (COPD), with the US Food and Drug Administration. This is seen as good news by Mumbai's Glenmark Pharmaceuticals, whose oglemilast — a drug in the same class known as PDE4 inhibitors — is in advanced trials. No drug in the class has found the right balance between safety and efficacy yet. "Progress of roflumilast to pre-registration augurs well for the class since this is the first one crossing the hurdles of clinical development after initial failures," says Glenn Saldanha, managing director of Glenmark. "Any improvement in efficacy or safety of the second-in-class drug can build on the base established by the first entrant." Glenmark, whose oglemilast is licensed to US firm Forest Laboratories, says Daxas is the only PDE4 inhibitor ahead of oglemilast.

Daxas has had a chequered history. Pfizer, which had tied up with Altana (the company that Nycomed bought) for taking it through trials, walked out some years ago. This is its second attempt to seek marketing approval in a western country. Daxas's potential has yet to be proven beyond doubt. A recent note by research firm Datamonitor expressed "cautious optimism" about its commercial potential, but observed that it did not address the greatest unmet medical need in COPD, which is halting the progressive loss of lung function or reversing the course of the disease.  Glenmark's oglemilast has also fallen behind original schedules for crossing certain milestones that made it eligible to receive bullet payments from Forest Laboratories.

(This story was published in Businessworld Issue Dated 17-08-2009)