Roche agrees to generic version of Tamiflu drug


WASHINGTON -- The maker of the antiviral pill Tamiflu has agreed to help U.S. generic manufacturers increase production of the drug, which is in short supply because of fears of a worldwide bird flu epidemic, lawmakers said yesterday.

Sens. Charles E. Schumer, a New York Democrat, and Lindsey Graham, a South Carolina Republican, said the Swiss company Hoffman-La Roche Inc. has agreed to enter into negotiations with generic manufacturers to significantly expand U.S. production.

Tamiflu is not a vaccine, but if administered early, it can reduce the severity of the illness and help prevent its spread.

The government has stockpiled enough Tamiflu to treat nearly 4 million people. But 67 million Americans could become infected in an outbreak. Tamiflu would be a last line of defense because vaccines for a new and virulent flu strain could take months to develop.

"The bottleneck on Tamiflu has basically been broken, and there will be production," Schumer said after he and Graham met with Roche Chief Executive George Abercrombie. "The problem was never cost."

The Bush administration is trying to finish work on a flu pandemic preparedness plan that could require billions of dollars in new government spending and unprecedented public health efforts on the part of state and local officials.

Some Democrats are criticizing the administration for what they see as a lack of attention to the threat and drawing comparisons to the weak response to Hurricane Katrina.

Medical experts are concerned that an aggressive flu that has infected birds in Asia and is now showing up in Europe could mutate and become easily transmissible among humans. Because people do not have immunity to the relatively new H5N1 strain, the consequences could be dire. But no one can predict when a pandemic might break out, and government scientists say it is not likely to happen this flu season.

The senators said that Roche has agreed to meet with four major U.S. generic manufacturers and to license them to produce Tamiflu. Roche would receive fees from the generic firms, and the government would stockpile the medications.

The four companies are Teva Pharmaceuticals, Barr Laboratories, Mylan Laboratories and Ranbaxy Laboratories. Schumer said all have expressed an interest in producing Tamiflu.

Abercrombie left the meeting without talking to reporters, but later said in a statement that Roche wants to do "whatever is needed to prepare for a pandemic."

He said Roche wants to be sure that other companies can produce "substantial amounts of Tamiflu for pandemic use in a timely manner in accordance with appropriate quality specifications, safety and regulatory guidelines."

Even with generic drug makers pitching in, it could take a year to ramp up U.S. production, said Kim Elliott, deputy director of the Trust for America's Health, a nonprofit public health organization.

"It's not something that you can just turn on, and Tamiflu pills will start popping out," said Elliott.

Dozens of ingredients are involved and the manufacturing process is slow and complicated, she said. Financially, it would only be worth the effort for a company that has the ability to make a large quantity of the medication, she said.

Tamiflu has been on the market several years as a treatment for the garden variety flu. Sales have soared since some lab tests found that it is effective against H5N1. However, other studies have shown that the virus can build up a resistance to the medication.

The federal government has set a goal of stockpiling enough of the drug to treat 20 million people. But Washington moved slowly to order the drug from Roche and now faces worldwide competition for a scarce supply.

Abercrombie also met with Health and Human Services Secretary Michael Leavitt. Christina Pearson, Leavitt's spokeswoman, said the senators' efforts complemented what the administration is trying to do to increase supplies of Tamiflu.

Ricardo Alonso-Zaldivar writes for the Los Angeles Times.

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