Glenmark Pharmaceuticals is unwilling to let go of the first molecule discovered by it despite receiving setbacks in the trial phase and thumbs-down from the market.
Oglemilast, the much-hyped novel molecule may have failed to show effectiveness in treating chronic obstructive pulmonary disease (COPD), a segment estimated to touch $9 billion in sales by 2010, according to IMS Health, but Glenmark’s MD & CEO Glenn Saldanha says that it still has a key shot left at asthma, the other indication for which trials are currently on.
“Trial data for asthma will come out in December-January, and if that goes well, development will continue for asthma and we will continue getting milestone payments and royalty,” Saldanha told DNA.
Results from a phase IIb trial for oglemilast (for COPD) last month, disappointed heavily and showed that patients taking the molecule didn’t show any “statistically meaningful” improvement in lung function compared with a placebo.Reflecting this, Glenmark’s stock fell nearly 15%.But Saldanha feels that there’s still a lot left with oglemilast.
“The markets have not fully understood the oglemilast announcement,” he said (commenting on the stock plummeting), adding, the company today has the best pipeline in its history with six to seven molecules in various stages of development and having billion-dollar sales potential.
According to an analyst with an equity firm, the industry would have to wait and watch with respect to oglemilast. “We have to see the data from the asthma trials whenever it is out, and then only can the industry get a complete picture.”
The molecule belongs to the category of phosphodiesterase -4 (PDE-4) inhibitors, a new class of drugs known to be hard to develop, and which have side effects such as nausea and diarrhoea.
Oglemilast, which had the scope to be a money spinner, was outlicensed to US-based Forest Laboratories in 2004 for further development, and Glenmark has till date received milestone and upfront payments of $15 million and $20 million respectively from Forest.
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According to research analyst Bhavin Shah from the brokerage firm 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.
The molecule was also outlicensed to Japanese player Teijin Pharma, and the Mumbai based Glenmark has received about $6 million as upfront payment. “We can’t get too specific about the Teijin trials right now, but we continue to enjoy our partnership with that company. We will continue to receive milestone,” says Saldanha.
Known as ‘smoker’s cough’, COPD is a progressive and irreversible lung disease resulting in difficulty in breathing, and is a high potential area with World Health Organisation data suggesting that some 80 million people have been affected with worldwide.
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