San Francisco Chronicle - October 19, 2005
Sabin Russell, srussell@sfchronicle.com.

Tamiflu, also known as oseltamivir, is considered the first line of defense against a global pandemic if the bird flu, currently spreading from Asia to Europe, mutates into a form that transmits easily among humans.

"We are prepared to discuss all available options, including granting sublicenses," said William Burns, chief executive of the Roche Pharma Division in Basel, Switzerland.

The stance appears to be an about-face for Roche in response to a growing international clamor for the company to permit others to make the potentially lifesaving drug. Last week, Roche declared that it "fully intends to remain the sole manufacturer of Tamiflu."

Roche is currently the only supplier of Tamiflu, an influenza treatment originally developed by Gilead Sciences Inc. of Foster City and licensed to the Swiss company in 1996. Tamiflu's effectiveness against the H5N1 strain has only been proven in laboratory tests with mice, but governments around the globe are now frantically stockpiling supplies of it as a precaution against a pandemic.

The United States government expects to stockpile enough Tamiflu to treat 4.3 million people by year's end, but one government proposal under consideration calls for stashing away enough antiviral medicine to treat nearly 90 million Americans were a pandemic to occur.

Roche said Tuesday that a U.S. plant -- at a location kept secret for security reasons -- has been licensed to begin production of Tamiflu in the United States. "We're starting production of Tamiflu in the U.S. for the first time, right away," said Roche spokesman Terry Hurley.

Worldwide concern over bird flu heightened this month after the disease that has ravaged flocks in Southeast Asia turned up in Turkey and Romania. Scientists fear that the virus, which is largely confined to birds, could mutate into a form that could spread easily among humans -- triggering a pandemic on the scale of the 1918 Spanish flu, which killed an estimated 50 million people.

Roche has expanded production of Tamiflu eightfold in two years, but the World Health Organization estimates it would take the company 10 years to make enough of it to cover 20 percent of the world's population.

Roche's change of heart comes just days after Indian drugmaker Cipla claimed to have mastered production of the drug. The Bombay-based company was the first to defy international patents on AIDS drugs and produce low-cost generic copies, sparking a global movement to bring such drugs to the developing world.

"We have been able to make oseltamivir and are in the process of scaling up," said Cipla managing director Amar Lulla, from company headquarters in Bombay. "We plan to be in commercial production by year end."

Roche contends that Tamiflu is an extraordinarily difficult drug to make. Production, the company says, requires at least one year and 10 steps -- one of which has the potential to cause an explosion -- and relies on hard-to-find raw materials.

"We think Cipla is vastly underestimating the enormous task of rapidly producing quality Tamiflu on a commercial scale," Hurley said.

Although there have been no contacts between Roche and Cipla, Hurley would not rule out a dialogue. "We would be willing to talk to them or any company who has the capacity to manufacture Tamiflu," he said.

Hurley said Roche has not been approached by any private company about a sublicense, but the company has begun talks with "a Far East" government about its interest in a license. He declined to identify the country, but health officials in both Thailand and Taiwan have said they could manufacture oseltamivir on their own.

Roche's announcement drew a skeptical response from activists who have battled drug companies for years over the right to bring low-cost generic AIDS drugs to Africa. "They are trying to get favorable publicity to get some of the pressure off," said Brook Baker, a policy analyst for the Health Gap Coalition.

Baker said that any licensing deal by Roche probably would not help poor countries defend against a pandemic. "You can imagine rich countries lining up to get preferred quantities," he said.

AIDS activists worked for years to establish the right of countries to issue "compulsory licenses" for drugs needed to meet health emergencies. Under a compulsory license, generic copies of a patented drug could be produced without permission of the patent holder -- although that company would be paid a royalty on sales of the generic drug.

The pharmaceutical industry has strong objections to the practice. In response to the controversy over Tamiflu, the Pharmaceutical Research and Manufacturers of America President Billy Tauzin said Monday that imposing compulsory licenses would "take away incentives for other companies to undertake the difficult and costly work of searching for new antivirals and vaccines for this possible health crisis."

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