Roche to allow generic versions of Tamiflu

Updated: 4:40 p.m. ET Oct. 20, 2005
Roche to allow generic versions of Tamiflu

WASHINGTON - Swiss drug maker Roche AG has agreed to meet with four
generic manufacturers willing to increase production of Roche’s antiviral drug Tamiflu to prepare for the possibility of a bird flu pandemic, Sen. Charles
Schumer said Thursday.

The companies are Teva Pharmaceutical Industries Ltd., Barr
Pharmaceuticals Inc., Mylan Laboratories Inc. and Ranbaxy Laboratories Ltd..

“Roche has agreed to meet with these companies as soon as possible, as
early as next week, and to meet with additional companies who might also be interested in making Tamiflu,” the New York Democrat said after meeting with George Abercrombie, chief executive of Roche North American Pharmaceuticals.

Roche said it would sublicense Tamiflu production to any company that
can produce it in sufficient quantities, Schumer said.

“Within a few months, we will have much more Tamiflu available than if
Roche produced it itself,” he said.

Tamiflu, known generically as oseltamivir, is considered the first line
of defense against the H5N1 avian flu virus that experts fear could spark a deadly, worldwide outbreak in people.

Governments are rushing to stockpile the treatment. Forty countries
have placed orders with Roche, and the company has been under pressure to allow others to produce Tamiflu so demand can be met quickly.

Some countries, such as Argentina, have said they will produce their
own version of Tamiflu.

Roche said in a statement it was “assessing the ability of other
companies and partners to either produce or provide capabilities in Tamiflu production.”

“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,” the company said.

Some experts have cautioned that it will be difficult for generic
companies to manufacture Tamiflu.

The four generic makers, however, believe they could be producing the
drug within a month with Roche’s cooperation, Schumer said.

The decision on which companies get the licenses will be made in
consultation with the U.S. government, he said.

Barr spokeswoman Carol Cox said it was premature to say how many doses
the company could make or how long it would take.

“We need to meet with (Roche). We need to see their manufacturing
process,” she said.

Roche has donated 3 million courses of the drug to the World Health
Organization, and a small amount to Romania, one of the countries where
bird flu has been detected.

Sixty-seven people in Asia are known to have been killed by the H5N1
virus. Experts fear it will mutate into a form that can pass easily from person to person, sparking a worldwide pandemic.

Tamiflu is not a cure for the flu, but it can lessen symptoms if taken
shortly after they first appear. Researchers warned last week that they
have seen signs the avian flu virus is becoming resistant to the drug.

Roche is locked in a legal dispute with Gilead Sciences Inc., the
company that invented Tamiflu, over the rights to the drug. Gilead is seeking to regain the rights to Tamiflu, which it sold to Roche, saying the Swiss company has failed to adequately promote the drug.