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P.T. Jyothi Datta

New Delhi , Nov. 11

THE Indian-arm of Swiss-pharma major Roche is set to formalise an agreement with an Andhra Pradesh-based pharma company to source active pharmaceutical ingredients and intermediaries. This comes, even as Roche formally parts ways this month with Nicholas Piramal India Ltd (NPIL), with regard to the distribution of biotechnology drugs.

Dr G.L. Telang, Managing Director, Roche Scientific Company (India) Pvt Ltd, told Business Line that the process of evaluation of the facilities had been completed and a formal decision could come as early as January 2004.

Elaborating on Roche's India plans for the biotech, pharmaceutical and diagnostic segments, he said that these segments would see an increased activity in terms of research and clinical trials. The company was also in talks with local contract research organisations for this purpose.

Company officials, however, said that though NPIL's decade-long agreement with F. Hoffman-La Roche (FHLR) on biotech drugs came to an end on November 3, 2003, Roche continued to have agreements with NPIL on other chemical drugs till 2018.

"The time period varies with the agreement for different drugs, but NPIL has the first right of refusal for new Roche drugs in India," they pointed out. With the ending of the biotech distribution agreement, NPIL would stop distributing six products — Cymevene, CellCept, Zenapax, Mabthera, Xeloda & Herceptin - worth about Rs 35 crore, said the NPIL top-brass. However, a clutch of other biotech drugs, such as Neupogen would continue to be with NPIL till 2008.

All this action comes even as Roche has appointed Taksal Pharma Pvt Ltd as its new importer and distributor of products from the parent company. But on the research front, Roche is bullish, with the company taking up research for known biotech drugs in new application areas.

Dr Telang cited the example of oncology drug Mabthera, which is being researched for its application in rheumatoid arthritis. Company officials said that it would undergo phase III trials in the new application area, in India. Similarly, CellCept, a biotech kidney transplant drug, was being researched further in the auto-immune disease segment.

The company was also undertaking a study on the prevalence of multi-drug resistance for anti-retrovirals (ARVs) or anti-AIDS drugs. This would be a precursor to the use of Roche's anti-AIDS drug Fuzeon, which was used in cases where resistance was seen to ARVs, he said.

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