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Manufacturer Greenlights Generic Tamiflu

Roche Pledges to Allow Generic Production by Able Companies
By
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.

The company says it is determining whether other companies can quickly produce oseltamivir, the generic name for Tamiflu.

"We want to be sure that they can produce substantial amounts of Tamiflu for pandemic use in a timely manner in accordance with appropriate quality specifications, safety, and regulatory guidelines," Abercrombie says. "We continue to take the steps necessary to protect the health of people on a worldwide basis, and to make Tamiflu available wherever it is needed for both seasonal influenza and pandemic stockpiling."

Questions of Effectiveness

Tamiflu is not a cure for the flu, but it can lessen the flu's severity or cut the chances of spreading the disease if taken before symptoms develop.

Even still, despite the rush to stockpile the drug, some experts warn that uncertainty remains around how effective it will be in a real-world bird flu pandemic.

H5N1 infects more quickly and enters a broader range of lung cells than do other more common flu strains, Michael Osterholm, MD, an infectious disease expert and Department of Homeland Security official, cautioned earlier this week. The infection causes the body to release a rush chemicals that attack the immune system, and there is little evidence showing how well Tamiflu can stop or lessen the release, he told reporters.

"Frankly we just don't know," Osterholm said.

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