- The Washington Times - Wednesday, November 9, 2005

BASEL, Switzerland (AP) — Swiss drug maker Roche Holding AG, seeking to reassure governments concerned about bird flu, said yesterday it is producing enough of its antiviral drug Tamiflu to treat 55 million people this year.

David Reddy, the company’s influenza-pandemic task force leader, said production will be nearly tripled next year — to 150 million treatments — and doubled again the next year.

“In 2007, Roche will be in a position to make 300 million treatments” of Tamiflu, said Jan van Koeveringe, technical head of Roche Pharmaceutical.

Experts consider Tamiflu, or oseltamivir, to be the most efficient treatment in case of an outbreak of human influenza caused by a mutation of the bird-flu virus H5N1. The virus has caused a deadly epidemic among birds.

Roche’s production of Tamiflu has risen swiftly, from 5.5 million treatments in 1999 to 18 million in 2003 and 27 million last year, Mr. Reddy said. But Roche has come under international pressure to ease its control on the manufacture of the drug as governments and companies stockpile it out of fear of a global influenza pandemic.

About 150 companies have offered to join in the production of Tamiflu. Roche is in talks with eight companies and is reviewing completed questionnaires submitted by others. Roche would not reveal the names of its potential partners.

The Base, Switzerland, company hopes to have a short list by the end of November of companies capable of producing the drug — either in part or in whole — and meeting the required standards to be granted a sub-license, said William M. Burns, chief executive of the pharmaceutical division.

Mr. Burns said Roche will do everything necessary to ensure that governments around the world have access to the drug for pandemic stockpiles without violating the company’s patent.

“We are not on a course or a collision course with any government anywhere in the world,” he said during a daylong news briefing on Tamiflu.

However, he made it clear that Roche would protect its intellectual property from those who might try to take advantage of the current frenzy attached to Tamiflu.

“We will also try hard not to allow pirates to enter the fray for commercial endeavor, rather than as a serious contribution to what we’re trying to do here,” Mr. Burns said.

Roche denied assertions by Vietnamese officials that it had given permission for that country to produce Tamiflu.

A Ministry of Health official in Vietnam, which has been hit hard by bird flu, said yesterday that the country had reached an agreement with Roche to allow Vietnam to produce the drug starting early next year.

The company said it expects Tamiflu sales to range between $1.1 billion and $1.2 billion this year.

Roche officials declined to say how much they were investing in production, but did say they were being driven partly by governments stockpiling the drug. About 50 companies around the world have bought or ordered supplies of Tamiflu for pandemic stockpiles, Roche executives said.

So far, the company has no firm orders for 2007, Mr. Burns said.

“How prepared the governments want to be is the $64,000 question,” he said.

Mr. Burns also said Roche expects its dispute with Foster City, Calif., company Gilead Sciences Inc., which developed the drug and wants the licensing rights back, to be resolved before the matter goes to court. Gilead says Roche violated a 1996 licensing agreement by failing to adequately promote and manufacture the drug. Roche rejects the claims.

“Even though we have entered into arbitration, we expect to solve this before it enters the courtrooms,” he said.

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