- The Washington Times - Tuesday, October 18, 2005

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

Also yesterday, an Indian drug company said it was seeking a license from 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’s 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, Romania announced yesterday that a swan with bird-flu antibodies was discovered near the Ukrainian border. It was not immediately clear, however, whether the swan was infected with the deadly H5N1 bird flu strain that has swept poultry populations in large swaths of Asia since 2003, jumping to humans and killing 60 persons and resulting in the deaths of tens of millions of birds.

The flu’s spread westward by migrating wild fowl has intensified fears that 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, which is thought to be effective in treating a flu pandemic. The drug is already in limited supply.

Sen. Charles E. Schumer, New York Democrat, said he will call on Roche to license Tamiflu production to five U.S. companies within 30 days. Mr. Schumer has said that if Roche does not allow the additional production voluntarily, he will introduce legislation to force compliance.

Earlier yesterday, 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 up production to meet the increased demand.

Roche said it could go ahead with its plans to expand production in the United States because it already has received approval from the Food and Drug Administration for the new plant. It did not say where the plant will be located.

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