European Union ministers declare bird flu a global threat

Wednesday, October 19, 2005

LUXEMBOURG -- European Union foreign ministers Tuesday declared the spread of bird flu from Asia to Europe a global threat, as the Swiss manufacturer of one of the only available anti-flu drugs announced it was building a new U.S. plant to increase production amid fears of a major outbreak.

Also Tuesday, an Indian drug company said it was seeking a license from the pharmaceutical giant Roche to produce a generic version of the drug Tamiflu to make it more widely available.

The European ministers urged international cooperation to contain the virus and called on the EU Executive Commission to accelerate steps to draft stronger rules against bird flu, which in recent days has been discovered in Greece, Romania and Turkey, leading to bans on poultry from those countries.

In the latest case, Romanian announced Tuesday that a swan with bird flu antibodies was discovered near the Ukrainian border. It was not immediately clear, however, if the swan was infected with deadly H5N1 bird flu strain that has swept poultry populations in large swaths of Asia since 2003, jumping to humans and killing 60 people and resulting in the deaths of tens of millions of birds.

The flu's spread westward by migrating wild fowl has intensified fears the virus may mutate into one that can be easily transmitted among humans, a development experts fear could provoke a global epidemic that puts millions of lives at risk.

In India, pharmaceutical firm Cipla Ltd. announced it was seeking a license from Roche to manufacture a generic version of Tamiflu.

The firm, which said last week it already has developed a generic version, plans to approach Roche for a license shortly, Joint Managing Director Amar Lulla said.

Roche has been under growing pressure from governments and U.N. Secretary-General Kofi Annan to license generic versions of Tamiflu, believed to be effective in treating a flu pandemic. The drug is already in limited supply.

Sen. Charles Schumer, D-N.Y., will call on Roche to license Tamiflu production to five U.S. companies within 30 days, he said in a statement Tuesday. Schumer has said that if Roche does not allow the additional production voluntarily, he will introduce legislation to force the move.

Earlier Tuesday, Roche said it plans to build a new plant in the United States to produce more of the drug. While the firm has ruled out relinquishing the patent on the drug, which is protected until 2016, it also has said it was seeking other companies to help speed production due to the increased demand.

"For Tamiflu, the key need today is the rapid expansion of production capacity," said William M. Burns, chief executive of Roche's pharmaceuticals division. "We are prepared to discuss all available options, including granting sub-licenses, with any government or private company who approach us to manufacture Tamiflu or collaborate with us in its manufacturing."

Roche said it could go ahead with its plans to expand production in the United States because it had received approval from the Food and Drug Administration for the new plant, which it said would be one of more than a dozen production facilities worldwide. It did not disclose the location of the new manufacturing site.

By the middle of next year, the company says, it will have boosted production tenfold in comparison with 2003. There is no human vaccine for the current strain of bird flu, but scientists believe Tamiflu and the drug Relenza may help humans fend off the virus.

Lulla told The Associated Press that any possible agreement with Roche likely would limit where the generic version could be sold, implying the Indian company could sell in mostly developing nations in Asia and Africa.

Roche previously said making Tamiflu involves a complex process and that a company given a license to make a generic copy would need at least two to three years to ramp up production.

But Cipla said last week its scientists already have developed the generic version, oseltamivir, and the company would be able to bring it into the market early next year.

The company has not said how much a generic version would cost, but insists it would be cheaper that Tamiflu, which costs up to $60 for a strip of 10 tablets -- expensive for people in Asia, where millions earn less than $1 a day. Patients are advised to take a tablet daily for at least a week, and the dosage could extend up to six weeks for people living in epidemic-infested areas.

The EU ministers were to issue a statement saying they recognize bird flu poses a serious, global health threat if it shifts from birds to people and would require a coordinated international response.

While the bloc stepped up biosecurity measures and installed early detection systems along the migratory paths of birds to prevent contamination of domestic flocks, there are concerns that Europe lacks sufficient stockpiles of vaccines and anti-virals.

Spain's health ministry said Tuesday it will order 6 million to 11 million doses of anti-viral medicines, giving it enough medication to treat between 15 percent and 25 percent of its people. The World Health Organization recommends governments keep enough anti-viral drugs and regular human flu vaccines to inoculate at least 25 percent of their populations.

European officials say the 25 nations in the EU, as well as Iceland, Norway and Liechtenstein, have only 10 million doses for an area with 500 million people. That's just 1 percent of the population.

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