Sens. Charles Schumer, D-N.Y., and Lindsey Graham, R-S.C., said they had received assurances from Roche that it would meet with Teva Pharmaceuticals, Barr Laboratories, Mylan Laboratories and Ranbaxy Pharmaceuticals in the coming days to determine how to boost production of Tamiflu, which is in high demand as a potential treatment to prevent infection by the avian-flu virus.

Roche has agreed to issue manufacturing sub-licenses for the companies, "who demonstrate appropriate capabilities to manufacture Tamiflu in order to accelerate product supply," Schumer and Graham said in a news release issued prior to a meeting with reporters on Capitol Hill.

The Food and Drug Administration still must approve all U.S. production standards, they said. The Department of Health and Human Services also will be involved.

"The purpose here is not to break the patent on Tamiflu, but rather to meet an emergency need for quantities of this drug that Roche itself simply cannot do alone," Schumer said.

Schumer had been pressuring the company to permit other manufacturers to produce Tamiflu and met with George Abercrombie, Roche's chief executive officer, before the news briefing, although Abercrombie did not attend.

"I can't believe what we have been able to accomplish in the past 48 hours," Graham said. "It's breathtaking."

So far, 40 countries worldwide have rushed to place Tamiflu orders with Roche because of rising public concern over the spread of the virus, which has been detected in Turkey, Greece and Romania and along the eastern edge of Africa.

"We are all worried about a pandemic," Schumer said. "The experts say this pandemic is not an 'if,' but a 'when.'"

He said the expanded supplies should begin reaching the market in about a month.

H5N1, as this avian-flu virus strain is known, first began infecting humans in 1997 in Southeast Asia. Since then it has infected 120 people, most of whom have had close contact with birds.

At present, there is no immunization available against the virus, and various strains can become resistant to anti-viral drugs such as Tamiflu over time.

Roche holds the patent on the drug until 2016.

--

Lizzie Wozobski is an intern for UPI. E-mail: healthbiz@upi.com

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