Roche Will Meet With Generic Drugmakers on Tamiflu
(Reuters)-- 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.
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Oct. 20 (Bloomberg) -- Roche Holding AG agreed to meet with four generic drugmakers to discuss rights for making Tamiflu pills, the treatment countries are stockpiling for a feared worldwide outbreak of lethal avian flu.
Roche will consider licensing the drug to Teva Pharmaceutical Industries Ltd., Barr Pharmaceuticals Inc., Mylan Laboratories Inc. and Ranbaxy Laboratories Ltd., said U.S. Senators Charles Schumer, a New York Democrat, and Lindsey Graham, a South Carolina Republican, in a statement today.
George Abercrombie, chief executive of Roche's North American operations, met with Schumer and Graham at the U.S. Capitol today to discuss the agreement. Schumer earlier this week urged Roche to license the drug to generic producers and said he would introduce legislation to mandate cooperation if the company didn't act voluntarily.
"Roche is doing the right thing, and at the same time, they're going to make a little money,'' Schumer told reporters at a press conference at the U.S. Capitol."The purpose isn't to break the patent. It's to meet an emergency need.''
The strain of influenza that is causing concern, H5N1, erupted in Southeast Asia, where more than 140 million birds have died or been destroyed. About 120 people have been infected through birds, resulting in 60 deaths, according to the World Health Organization, a branch of United Nations.
A moderate to severe outbreak in the U.S. may kill as many as 500,000 Americans and sicken 2 million, according to the Trust for America's Health, a nonprofit public health advocacy group in Washington.
`Interest in Participating'
Roche sells Tamiflu under a 1996 licensing agreement with Foster City, California-based Gilead Sciences Inc., which invented the drug. Roche will assess the ability of other manufacturers to either produce or help with Tamiflu production, the company said in an e-mailed statement today.
``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 statement said.
Barr hasn't yet set up a meeting with Roche, said Carol Cox, a spokeswoman, for the Woodcliff Lake, New Jersey, company.
``We've just shown an interest in participating,'' she said. ``We're willing to help manufacture the product if Roche would choose to license the product.''
Mylan Chief Executive Robert Coury told CNBC he expected Roche to contact his company soon. Mylan has a current capacity to make 18 billion tablets and capsules, he told the network.
Ranbaxy spokesman Charles Caprariello and Teva spokesman Kevin Mannix didn't immediately return telephone calls and emails seeking comment. Mylan is based in Canonsburg, Pennsylvania. Teva is based in Petah Tikva, Israel, and Ranbaxy in Gurgaon, India.
Roche approached Schumer after he called on the company to license Tamiflu, and asked him to find companies that would be willing to make the drug, Schumer said. The senator called the generic companies, who estimated that they could begin making the drug within a month as long as Roche provided raw materials and details of the manufacturing process. Without that cooperation, it would take the generic companies three months to make Tamiflu, Schumer said.
Under the terms of today's agreement, Roche will begin meeting with generic companies as early as next week, in consultation with U.S. health officials, who may recommend additional manufacturers. Roche also consented to license the production of Tamiflu to any company that can produce it in quantities large enough to help meet demand in case of a flu outbreak. Roche will offer ``equitable terms'' on licensing.
``There's no guarantee that they'll reach an agreement, but the odds are very high,'' Schumer said. Schumer expects Roche to work with the generic companies until the manufacturing ``bottleneck'' is relieved.
Roche's Abercrombie met today with Health and Human Services Secretary Michael Leavitt and other HHS officials to discuss flu preparedness, Roche spokesman Terry Hurley said. HHS spokeswoman Christina Pearson said she didn't have an immediate comment on the meeting.
The Bush administration plans to stockpile as many as 20 million doses of Tamiflu and has 2.3 million doses already, U.S. officials told reporters Oct. 7 in a briefing. The Tamiflu the U.S. has now would be enough to protect only 1 percent of population, Schumer said Oct. 18.
The World Health Organization has recommended that Tamiflu be available for the treatment of suspected infections in farm workers involved in the mass culling of poultry. Tamiflu sales have jumped as countries including the U.S., the U.K. and Japan placed orders of more than $1.4 billion to fight bird flu.
The U.S. is catching up with countries that leapt into the Tamiflu market earlier. Italy, with a population of 58 million, has ordered 2 million doses, almost as much as the U.S. New Zealand's government has ordered 800,000 doses, enough for 20 percent of its population.
More than 12 sites are now making the medicine after Basel, Switzerland-based Roche won U.S. Food and Drug Administration approval of a new facility.
Roche's agreement mirrors one that German drugmaker Bayer AG made in 2001 under pressure from U.S. officials to lower the price of its Cipro antibiotic for treating anthrax. Tommy Thompson, then the U.S. Health and Human Services secretary, threatened to override Bayer's patent after anthrax spread through the U.S. mail and infected 11 people. A day later, Bayer agreed to cut its Cipro price roughly in half. Ultimately, five Americans died of anthrax in 2001 and hundreds more were exposed to the bacteria.
"Roche is exhibiting good corporate citizenry at this point,'' Thompson said in an interview today."If in fact there's an epidemic of avian flu, we do not have a vaccine. The only thing out there that's known to do anything to protect people is Tamiflu. Roche can't ramp up fast enough.''
Last Updated: October 20, 2005 15:48 EDT