Glenmark may well have lost it on its much talked aboutnew molecule — oglemilast.
The molecule, targeted at chronic obstructive pulmonary disease (COPD), a progressive and irreversible lung disease resulting in difficulty in breathing, was outlicensed to US-based Forest Laboratories in 2004 for further development.
To the company’s disappointment, results from a phase IIb trial showed that
patients taking the molecule didn’t show any “statistically meaningful” improvement in lung function compared with a placebo.
Glenn Saldanha, CEO and MD, Glenmark, said studies are still being conducted for oglemilast to be used as a treatment for asthma, and the results should be ready in the March quarter of 2010.
“Regarding the COPD trials, we are considering what further action would be useful or appropriate,” he said.
COPD is a high potential area, with the WHOdata suggesting some 80 million affected people worldwide at present. Healthcare data and consulting services company IMS Health estimates gross sales of $9 billion for the segment by 2010.
Going by Sanjeev Mehta, chest physician, Lilavati Hospital in Mumbai, COPD is a critical area in India as well. “Though there aren’t exact estimates, COPD is said to affect 3-7% of people in India, which is a huge number. The disease mainly affects smokers, as also those in contact with biofuels,” he said.
Understandably, had the trials gone its way, oglemilast would have been a multi-bagger for Glenmark. The company has so far received milestone and upfront payments of $15 million and $20 million, respectively, from Forest.
However, according to research analyst Bhavin Shah of brokerage Dolat Capital Market, milestone payments of at least $60 million, which were to be received from Forest in the event of positive data from phase IIb, have now been postponed to the June quarter of 2010.
Saldanha pointed out that Glenmark has so far received over $115 million in upfront and milestone payments from licensing deals, and these funds have been ploughed back into the discovery programme.
“Our focus will be to build a world class pipeline and we will continue to look at out-licensing partners for the molecules which are in the clinic,” he said.
Analysts, however, said it’s a huge setback.
“It is a very big setback for the company even though it is not a complete failure. This was a very potent molecule and we had assigned a valuation of Rs 50 per share to it,” NW18 quoted Sharekhan analyst Sapna Jawahar as saying.
Reflecting the disappointment, Glenmark’s stock fell nearly 15% on Wednesday.
The company’s hopes now hinge on two more molecules it has in advanced stages of development - Melogliptin, which is an oral anti-diabetic molecule, and Crofelemer, a first-in-class innovative drug for multiple indications including HIV-associated diarrhoea.
On its part, the orally administered oglemilast belongs to the category of phosphodiesterase-4 (PDE-4) inhibitors, a class of drugs known to be hard to develop, which have side effects like nausea and diarrhoea.
Prashant Chhajed, director of pulmonology, Fortis Hiranandani Hospital, Navi Mumbai, however, plays down the drug’s importance. PDE-4 inhibitors can at best be given as ‘add-on therapy’, he said, adding, “The best medicines for COPD are a combination of anti-cholinergics, steroids, and long acting beta-2 agonists in inhaled form. PDE-4 inhibitors are a very new class and can’t be given alone.”
Incidentally, Forest has an agreement for another COPD molecule from the PDE-4 inhibitor class, roflumilast (brand name Daxas), with Swiss pharma company Nycomed. Roflumilast, like oglemilast, is orally administered, but has demonstrated “statistically significant improvements” compared to a placebo, in phase III, according to statements from Forest.
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