Indian company asks to license generic versions of bird flu drug

A major Indian pharmaceutical company said Tuesday it would seek a license from Roche of Switzerland to manufacture a generic version of the anti-influenza drug Tamiflu, a move that could increase availability of the drug in the event of a major bird flu outbreak. Cipla Ltd., which said last week that it has developed a generic copy of the flu drug, plans to approach Roche Holding AG 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, the only available drug that is effective in treating people infected with bird flu. The drug is already in short supply.

Earlier Tuesday, Roche said it plans to build a new plant in the United States to produce more Tamiflu, and senior Roche executive told the Dow Jones Newswires separately that the company would also consider any request for a license to make the generic version.

"We would welcome any company that made such a request to produce Tamiflu under license," David Reddy, who leads the company's influenza task force, told Dow Jones.

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

Roche had previously said that making Tamiflu involves a very 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 that its scientists have already developed the generic version, oseltamivir, and that the company would be able to bring it into the market early next year, the AP reports.

The company has not said how much a generic version would cost, but insists it would be cheaper that Tamiflu, which costs up to US$60 for strip of 10 tablets, a lot of money for people in Asia where millions earn less than a dollar 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.

Lulla said Cipla's offering would carry "a humanitarian price" tag, which would also depend on the fee charged by Roche if it decides to provide a license.

Without a license, generic manufacturers cannot legally sell the patented drug in the West and in many countries in Asia, including India, which recently tightened its patent laws. But the laws in many of these countries also allow governments to invalidate patents during emergencies and permit the sale of generics.

T.E.