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Manufacturer Greenlights Generic Tamiflu

Roche Pledges to Allow Generic Production by Able Companies
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WebMD Health News
Reviewed by Louise Chang, MD

Oct. 20, 2005 -- The manufacturer of the antiviral drug Tamiflu agreed Thursday to negotiate with generic pharmaceutical makers after facing an effort to boost the government stockpiles against bird flu.

Roche -- Tamiflu's sole manufacturer -- agreed to hold talks with four U.S. generic companies after U.S. lawmakers and other officials pressured it to allow expanded production of the drug.

Tamiflu is the only drug known to offer at least some influenza protection caused by H5N1, the virus responsible for more than 120 bird flu cases and at least 61 deaths in Southeast Asia. A worldwide rush to stockpile the drug has led to a run on Roche's supplies, putting the United States far short of the number of treatments that it would need in the event of a human pandemic.

The Bush administration has stockpiled some 2.3 million Tamiflu courses, enough to treat less than 1% of the population, if properly administered. A deal to boost U.S. stockpiles to 20 million doses is expected to take Roche well over one year to fill.

The Pressure Is On

Shortages in the U.S. and other countries led to pressure on Roche to speed production by licensing the drug to generic manufacturers. The company resisted, arguing that Tamiflu's production process is too complex for other companies to complete quickly.

But Sen. Charles Schumer (D-N.Y.), who this week threatened to push legislation forcing Roche to relent, today announced that the company had agreed to meet and negotiate with generic drugmakers.

The companies include Teva Pharmaceuticals, Barr Laboratories, Mylan Laboratories, and Ranbaxy Laboratories, according to a statement released by Schumer's office. Roche agreed to license Tamiflu to any of the companies that showed they could properly manufacture the drug quickly, the statement says.

Another company, Cipla, headquartered in India, said last week that it would start manufacturing a Tamiflu copy whether or not Roche granted it a license to do so.

"Roche has come a great distance in the best interests of the global public health," Schumer said following a meeting with George Abercrombie, the company's CEO.

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