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Roche outsources some stages of Tamiflu production

Drug NewsOct 13, 05

Roche Holding AG, the Swiss company that produces the most effective antiviral drug available for avian flu, is outsourcing some stages of its production but would not surrender patents on it.

The Swiss firm is under pressure to increase production of the antiviral treatment Tamiflu amid fears of a shortage in the event of a bird flu pandemic.

Roche said on Wednesday that it had already outsourced some stages in the 10-step production process for the drug.

However, the Basel-based firm said it would not relinquish the patents that protect the treatment and it had no plans to farm out the entire production process to other companies, not least because of its complexity.

“We are already collaborating with several specialist companies on the production process for Tamiflu,” a spokesman for Roche said. “This has nothing to do with the patent.”

Roche said that it needed to enlist the help of other specialised companies in order to ramp up certain stages in the Tamiflu production process.

Antiviral drugs, and Tamiflu in particular, are viewed by scientists as the best option for holding pandemic flu at bay—and Roche has come under pressure from some medical experts to allow production of cheap generic versions of the medicine.

Kofi Annan, the secretary general of the United Nations, said last week he did not want to see intellectual property obstructing the supply of flu drugs to the poor, although he stopped short of calling on Roche to surrender its patents.

Concerns about Roche’s exclusive rights to manufacture Tamiflu are reminiscent of the pressure on Bayer AG in 2001 to slash the price of its Cipro drug after anthrax was found in the U.S. mail system.

DOUBLING PRODUCTION

Roche plans to double Tamiflu production by the end of this year over 2004 levels and to double it again by mid-2006, as governments follow the advice of the World Health Organisation (WHO) and place bulk orders for stockpiles of the drug.

“Roche has the expertise to scale up production and, together with a significant number of partners, will continue to look at ways to increase capacity,” the spokesman said.

Industry analysts expect the sudden demand for Tamiflu to generate windfall profits for Roche, although the company is also donating 3 million packs of Tamiflu to the WHO for use anywhere in the world.

This week, avian flu was discovered in birds in Turkey and has been suspected in Romania. The H5N1 avian influenza virus has killed millions of birds across Asia and infected 116 people, killing more than 60 of them.

Scientists fear that the virus, known to pass to humans from birds, could mutate and start to spread easily from person to person.

Scientists say a vaccine is the best way to prevent millions of deaths should avian flu “go human” in this way but current global manufacturing capacity, at around 300 million regular flu doses a year, is insufficient to meet world needs.

David Nabarro, U.N. coordinator for global readiness against an outbreak, said on Tuesday it could take six months to manufacture adequate vaccine stocks.



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