The Hindu Business Line : Roche bringing cancer drug to India

The drug, from Swiss drug-maker Roche, is priced at Rs 22,000 per vial that will be administered after every chemotherapy cycle, explained Dr G.L. Telang, Managing Director of Roche Scientific Company (India) Ltd.

The drug is given as a single fixed dose per chemotherapy cycle and is indicated for decreasing the incidence of fever associated with the drop in infection-fighting white blood cells or febrile neutropenia.

Neulastim is the brand-name for pegfilgrastim and the once-per-chemotherapy dosing offers convenience over filgrastim, also used in a similar application but that had to be given in 12 injections.

Dr Telang said that the drug was a pre-1995 product and so the company did not apply for a patent in India. The drug was priced less than its counterpart overseas sold at an estimated Rs 35,000 per vial, he said. It would be imported from Switzerland and since it was temperature sensitive (requiring storage temperatures between two and eight degrees), it would be distributed through C&F agents, he said.

Roche did not have to undertake specific trials in India on this drug, as there was globally established safety data, a company official said. However, it would be watching all adverse events that would be reported to the parent company and the local regulator in the country, he said.

Roche is undertaking five clinical trial projects in India, Dr Telang said. They include Phase III trials on Mabthera, used in treating Non-Hodgkin's Lymphoma and similar trials on breast-cancer drug Herceptin, where it is being tested for an alternative indication in gastric cancer. Two expanded access programmes are also on the cards with regard to colorectal cancer drug Avastin and non-small cell lung cancer drug Tarceva, a company official said.

Dr Telang also indicated that the parent company was increasingly sourcing from India. However, more research would come this way only when there was more clarity on data exclusivity and issues such as patentability of incremental developments on drug molecules.

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