Setback to domestic pharma industry’s hopes for a breakthrough
The Indian drug industry’s attempts to develop an original new chemical entity (NCE) received a setback as Glenmark Pharmaceutical’s flagship drug under development, Oglemilast, was declared today to have failed in clinical trials for chronic obstructive pulmonary disease (COPD) or smoking-induced acute bronchitis.
Stock markets reacted sharply to the development and shares of research-driven Glenmark fell 14.4 per cent on the Bombay Stock Exchange (BSE) today to close at Rs 223.85.
US-based Forest Laboratories, which in-licensed the drug candidate from Glenmark for further development in September 2004, announced today that results from a 12-week advanced second phase clinical trial on a dose range-finding study in patients with COPD did not yield positive results.
“We are, of course, disappointed that Oglemilast has not been successful in this study,” said Howard Solomon, chairman and chief executive officer of Forest Laboratories.
“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 are going on at 27 sites across the country. Regarding the COPD trials, we are considering together with Forest what further action would be useful or appropriate,” said Glenn Saldanha, chief executive and managing director, Glenmark.
Glenmark had out-licensed the North American rights of this drug to Forest Labs and Japanese rights to Teijin Pharma in a combined deal size of $240 million in 2004-05 period.
The COPD and asthma market is estimated at $28 billion worldwide, with nearly 75 million people suffering from the disease. Glenmark, which was planning to launch the drug by 2012-13, was expecting a peak sales opportunity of $3 billion worldwide.
Oglemilast, code named GRC 3886, was stuck in the second phase of trials for more than two years, as the US Food and Drug Administration had sought additional safety data on this drug.
Indian companies such as Dr Reddy’s, Glenmark, Lupin and Piramal Healthcare are working on about 50-70 drug candidates to become the first Indian drug maker to come out with at least one original molecule in the commercial stage before 2010-11. New drug development is a complex process and for a single product to make it to market, many hundreds or thousands of compounds have to be tested, and the preclinical and clinical failure rates are high, in a process involving 10-12 years.
Glenmark has six molecules under development and is now banking on Crofelemer, an antidiarrheal molecule under development. The drug is now in the third phase of clinical trials and data on final lap of clinical trials are expected soon. Glenmark hopes to launch Crofelmer in developing countries by next year. Merck, which was developing a diabetes drug of Glenmark, had returned the molecule last year, citing its disinterest in pursuing diabetes drug research. Eli Lilly, which had inlicensed an osteoarthritis and pain molecule from Glenmark, also suspended further development in October last year.
“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. Presently we have at least three more outlicensing candidates,” said Glenn Saldanha.
