Indian Firm Plans Generic Flu Drug

Despite patent concerns, Indian pharmaceutical giant Cipla Ltd. plans to bring a generic version of the anti-influenza drug Tamiflu to market amid critical shortages ahead of possible bird flu epidemic, company officials said Friday.

Cipla has already developed a generic version, oseltamivir, which would be much cheaper than Tamiflu, the only available drug effective in treating avian flu, company chairman Dr. Yusuf K. Hamied said.

"We have been able to synthesize it," Hamied said in a telephone interview from Spain, where he was attending an AIDS symposium. "Once the lab work is done, things don't take too long."

Although the drug is in short supply, Tamiflu's maker, the Swiss drug company Roche Holding AG, has refused to license generic versions despite pressure from several countries and U.N Secretary-General Kofi Annan.

"We fully intend to remain the sole manufacturer of Tamiflu, together with our partners," Roche spokesman Daniel Piller said.

Generic manufacturers cannot legally sell the patented drug in the West and parts of Asia, including India, which recently tightened its patent laws. But the laws in many of these countries allow governments to invalidate patents during emergencies.

The H5N1 strain of avian flu has been sweeping through poultry populations in Asia since 2003, killing at least 65 people, mostly poultry workers. The virus does not pass from person to person easily, but experts fear it could mutate.

The 1918 influenza pandemic killed more than 40 million people. Subsequent pandemics in 1957 and 1968 had lower death rates, but caused extreme disruption.

World Health Organization spokesman Dick Thompson declined to comment specifically on Cipla's plans, but he said WHO supported the line taken by Annan at a visit to the Geneva-based agency two weeks ago.

"We will take the measures to make sure poor and rich have access to the medications and the vaccines required," Annan said at the time.

Scientists in Taiwan have recently said they, too, can produce generic Tamiflu, if patent issues are resolved.

Cipla's Hamied did not disclose the drug's cost, but said the company will make it available at "a humanitarian price."

A strip of 10 Tamiflu tablets cost about $60. 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.

Hamied didn't say how and where he plans to sell his product, but insisted he won't "break the law."

"Anyone who wants the drug can purchase it from us," he said. "Maybe people in America and Europe would want to buy it from us, but they are governed by their own patents."