Firm plans to start selling anti-diarrhoea drug in H12010.
Glenmark Pharmaceuticals, India’s 11th biggest drug maker by sales, may beat bigger rivals, including Ranbaxy, Dr Reddy’s and Nicholas Piramal, in selling an original drug, or novel chemical entity (NCE), by 2010.
Glenmark plans to start selling its anti-diarrhoea drug, Crofelemer, by the first-half of 2010 across the globe, except in North America, Europe, Japan and China, the company said. The confidence to sell the drug ahead of its rivals comes as the Crofelemer's original developer, Napo Pharmaceutical Inc, recently entered into a tie-up with a US-based drug maker, Salyx, for selling the drug in the US market, paving the way for Glenmark to sell it in the rest of the world.
If successful, Glenmark will become the first Indian company to sell an NCE, which came through global standards of clinical drug development.
Glenmark's Crofelemer has the potential to earn revenue of at least $80 million from sales to patients afflicted with HIV-related diarrhea.
India is yet to discover and commercialise a new pharmaceutical drug, which involves a discovery process of 10-15 years and involves over a billion dollar of investment.
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At least half a dozen molecules under development - such as Dr Reddy's Laboratories' Balaglitazone, Glenmark's three molecules - Oglemilast (GRC 3886), Melogliptin (GRC 8200) and GRC 6211 for osteoarthritis and neuropathic pain, Ranbaxy's malaria drug Arterolane and Nicholas Piramal's oncology drug P276 and an oral herbal drug for inflammation- are still under development. Experts estimate that these drugs may reach the markets between 2010 and 2013.
The anti-diarrhoea drug, Crofelemer, originally was developed by the US-based Napo Pharmaceuticals Inc. The compound was in-licensed by Glenmark in July 2006 and it conducted the second phase of its clinical trials in India.
"Technically we cannot call Crofelemer an Indian drug as it was invented by a US company. Nevertheless, its Indian connections are strong since Glenmark in-licensed it early and has a key role in its development. Glenmark has licence to sell the drug in 140 countries and will also manufacture the key active pharmeceutical ingredient(API)," said an industry analyst.
Further, the drug discoverer, Napo, has Indian scientists at the top management and has an Indian office.
Napo, which also had a drug discovery alliance with Nicholas Piramal for screening biotech compounds, partnered with Glenmark following its financial trouble and paucity of funds to take forward the drug to the commercialisation stage. The future of the drug was uncertain, but a few weeks ago Napo could rope in Salyx pharmaceuticals as partner for the US. Currently, the drug is undergoing Phase III trials in the US among a patient population of 350 people. The drug has fast track status from the US drug authorities, which will help in an early launch in the US market.
"This is an exciting development for Glenmark. We are optimistic about the opportunity that Crofelemer presents," said Glenn Saldanha, managing director and chief executive, Glenmark Pharmaceuticals.
However, Glenmark’s effort to develop other NCE’s is languishing. Progress of its lead molecule Oglemilast (GRC 3886) for asthma and chronic obstructive pulmonary disease is yet to reach the final stage of clinical trials as the US FDA demanded additional data on the drug from the out-licensing partner, Forest Laboratories.
In February this year, Merck Serono, a division of Merck KGaA, returned Glenmark's drug candidate for the treatment for Type 2 diabetes in Phase II of clinical development Melogliptin (GRC 8200), as the company decided not to pursue diabetes research.
Two months ago, Eli Lilly and Company and Glenmark together announced to suspend further clinical development for GRC 6211, another Glenmark molecule in second stage of clinical trials. Glenmark is yet to find new partners for these two drugs.
While commercialisation of Dr Reddy's flagship diabetes drug Balaglitazone (DRF 2593) may be delayed due to financial trouble for its Danish partner Rheoscience, Ranbaxy's anti-malaria drug Arterolane (RBx 11160) has also delayed due to partner issues.
Lupin has a pipeline of four investigational new drugs (IND) under development in the clinical trial stage and its lead drug LL 2011, a herbal formulation to treat psoriasis and named as ''Desoris,' is currently undergoing advanced phase II clinical trials in India. Nicholas Piramal's oncology drug P276 is undergoing third phase trials in India and Canada and may take at least 1-2 years for commercialisation.