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BW Businessworld

So Near, Yet So Far

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The coming months will be crucial for Indian pharmaceutical companies striving to develop a new chemical entity (NCE). On 5 September, the US Food and Drug Administration (FDA) will decide whether Glenmark's US partner Salix Pharmaceuticals can launch Crofelemer, a drug for HIV-related diarrhoea, in the US. Salix has filed an application with the FDA to sell 125 mg tablets of the drug under the trade name Provir. Another drug from Glenmark, Revamilast, is currently undergoing advanced phase-II trials in Europe and Asia, for indications such as asthma, chronic obstructive pulmonary disease and rheumatoid arthritis.

In April, Ranbaxy Laboratories launched Synriam (for malaria) in India. The company claims it is the first new drug developed in India, with trials held in India, Thailand and Bangladesh.

More recently, on 20 July, Piramal Healthcare said that the Drug Controller General of India had given it the go-ahead for phase-II trials of its drug for head and neck cancer in India. The drug is already in the final stages of phase-II trials in the US, Australia and New Zealand. Piramal Healthcare's chairman Ajay Piramal, in an earlier interview to BW, had said that his company would take the drug to the market on its own instead of partnering with other multinational companies.

In Glenmark's case, the firm has the rights to sell Crofelemer — in-licensed from US-based Napo Pharmaceuticals — in 140 countries. Glenmark will produce the API (active pharmaceutical ingredient) for this drug at its new plant at Aurangabad in Maharashtra.
Napo, which developed the drug and licensed it to Salix and Glenmark, in November 2011 terminated a pact it had signed in 2005 with Glenmark to develop and commercialise the drug in 140 countries. Glenmark approached a US arbitration panel and got an interim order. A Glenmark spokesperson declined to comment on Crofelemer citing legal issues.

These developments have put the spotlight back on new drug discovery in India after repeated failures in the past. Three years ago, after pursuing NCE research for 15 years, Dr Reddy's Laboratories closed its drug discovery facilities in the US and converted the facilities in Hyderabad to develop proprietary products. Ranbaxy merged its new drug discovery team with parent Daiichi Sankyo and now pursues only innovative generic products. Lupin, another player, revamped its entire new drug research plans after its efforts to develop NCEs failed.

Glenmark, which has six out-licensing deals with multinational companies, has also had its share of setbacks. Its main drug for asthma failed in the final phase of trials and two other out-licensed molecules were returned by Eli Lilly and Merck.
Why do pharma firms fail in drug discovery? One reason could be that the discovery process involves time, cost and risks. It costs $800 million to take a drug to the market.

According to a research by the Tufts Center for the Study of Drug Development, only 21.5 per cent of drugs that start phase-I trials are eventually approved for marketing. In 2011, the FDA approved only 35 drugs. Most of the promising drugs fail in the final stages; examples from India include Glenmark's Oglemilast for asthma and Biocon's oral insulin. So, it needs to be seen how the promising molecules of Glenmark, Piramal Healthcare and other drug makers fare in the final stages of development. For now, the search for new drugs continues.

(This story was published in Businessworld Issue Dated 06-08-2012)