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Spokane, Washington  Est. May 19, 1883

Tamiflu maker agrees to help boost production

Ricardo Alonso-Zaldivar Los Angeles Times

WASHINGTON – Faced with the possibility of a worldwide epidemic of bird flu, the maker of the antiviral pill Tamiflu has agreed to help generic pharmaceutical manufacturers increase production of the drug, which is in short supply, lawmakers said Thursday.

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

Sens. Charles Schumer, D-N.Y., and Lindsey Graham, R-S.C., said Hoffman-La Roche Inc., the U.S. unit of Swiss-based drug giant Roche, has agreed to enter into negotiations with generic manufacturers to increase U.S. production of the drug significantly.

The government has stockpiled enough Tamiflu to treat just over 4 million people. But a massive outbreak of the disease could infect as many as 67 million Americans. And Tamiflu would be a last line of defense, since vaccines for new strains of flu can 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 George Abercrombie, CEO of Roche’s North American operations.

Roche has faced increasing pressure in recent weeks to boost production of Tamiflu. Last week Cipla, an India-based drug maker, said it would market an inexpensive generic version of Tamiflu by early next year without the company’s permission.

The Capitol Hill meeting came as the Bush administration was trying to finish work on a flu pandemic preparedness plan that could require billions of dollars in new government spending.

The concern about Tamiflu supplies and the possibility of a pandemic arose from the fact that medical experts have been concerned that an aggressive strain of flu plaguing birds in Asia and now Europe could mutate in a way that would make it easily transmissible among humans. Since people do not have immunity to the relatively new strain, known as H5N1, the consequences could be dire.

No one can predict when, if ever, a pandemic might break out, though government scientists say it is not likely to happen this flu season.

The senators said Roche has agreed to meet with four major generic manufacturers and license them to produce Tamiflu, provided the companies are capable of turning out large quantities of the drug. Roche would receive fees from the generic companies, and the government would stockpile the medications.

The four companies are Israel-based Teva Pharmaceutical Industries, Barr Pharmaceuticals Inc. of Woodcliff Lake, N.J., Mylan Laboratories Inc. of Canonsburg, Pa., and Ranbaxy Laboratories of India.

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.”

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.