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Piramal Life developing drug to tackle Glivec resistance

Phase II studies on dosage safety completed


Drug discovery

A clear picture on the drug is expected to emerge in six months, when the efficacy data is in

Reports suggest about 20 per cent patients taking Glivec could develop resistance

Though the drug is being developed from a plant source, it is being developed in the same way as a chemical entity


P.T. Jyothi Datta

Mumbai, June 16 A plant extract could hold the key to tackling the resistance seen in some patients against Novartis’ blood cancer drug Glivec, indicates research being done by Piramal Life Sciences Ltd — the research arm of drug-maker Piramal Healthcare, or erstwhile Nicholas Piramal India Ltd.

The company expects to have efficacy data in another three to six months on the drug being developed to address the resistance seen in some patients using Glivec, said Dr Somesh Sharma, its Chief Executive Officer.

The drug is from a plant extract, as described in Ayurveda, and Phase II studies relating to safe dosages, have been completed in the country, he told Business Line. A clear picture on the drug is expected to emerge in six months, when the efficacy data is in, he said. Put simply, the prospective drug seeks to inhibit the excessive growth of white blood cells seen in chronic myeloid leukaemia (CML) cases, he explained.

The research is in collaboration with Kolkata’s Indian Institute of Chemical Biology (IICB) — a unit of the Council of Scientific and Industrial Research — and the company has filed a patent on the research, where the rights will be with Piramal Life Sciences and IICB would get payments as the drug gets developed and achieves different milestones.

IICB provided the preliminary observations, and Piramal Life Sciences took it forward doing the toxicology tests and studies for further development of the drug, with the aim to commercialise it, he explained.

Glivec resistance

The drug is exciting from a patient point of view, he said, as reports suggest about 20 per cent patients taking it could develop resistance. The company is laying the ground for approval of the prospective new drug in different markets, he said, adding that the goal would be to commercialise it first in India.

Though the drug is being developed from an alternate (plant) source, it is being developed in the same way as a chemical entity, in terms of clinical studies etc, he said.

Resistance to Glivec is seen in some cases as the disease progresses, concurred Dr Purvish Parikh, principal investigator conducting the clinical study.

Human trials on the prospective drug are being conducted in different centres across the country, he said.

Novartis’ Glivec is a path-breaking cancer drug, and in India it has been mired in patent-related litigation. Pricing is also a concern in the domestic market, as Glivec is priced at over a lakh of rupees to the patient, while local companies make similar versions of the drug at about Rs 10,000.

Given the pricing concerns in the country, Dr Sharma said that differential pricing, where a product is priced less in markets that may not be able to afford the drug, is a reality with the pharma industry.

About 10 companies, including Novartis, were looking at the drugs to tackle Glivec resistance, he said.

Piramal Life Sciences, the demerged research entity of Piramal Healthcare, got listed over a fortnight ago. The new company has 14 prospective drug molecules in its kitty, in varying stages of clinical development.

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