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Roche may allow others to make Tamiflu

Swiss drug maker Roche, under pressure to increase output of its antiviral drug Tamiflu as avian flu reaches Europe, said it would consider granting other firms licenses to make the drug.
/ Source: Reuters

Swiss drug maker Roche, under pressure to increase output of its antiviral drug Tamiflu as avian flu reaches Europe, said on Tuesday it would consider granting other firms licenses to make the drug.

In a move that echoes schemes to make expensive HIV/AIDS treatments available in Africa, Roche said it would consider allowing companies and governments in developing nations to produce the drug in preparation for a feared bird flu pandemic.

“If a company believes that they have the ability to do this from start to finish we would discuss that with them,” David Reddy, head of the Swiss firm’s production and sales of Tamiflu, told Reuters in a telephone interview.

Reddy said the firm had not received any approaches by companies, and just one approach by an Asian government. He added, however, that Roche would be willing to discuss production with Indian generics maker Cipla which has said it wants to make a copy-cat version of Tamiflu.

“We have not yet been approached by Cipla. We would welcome if a company believes that it has the competencies then we would like an open discussion with them and therefore we are open to being approached,” Reddy said.

“What we would be looking at is companies such as Cipla which -- at least they announced in the media -- has the ability to produce for the lower income countries,” he said.

Thailand also said earlier it would bypass Roche to make its own version of Tamiflu by next October.

“Every country is queuing up to buy Tamiflu from Roche and we are afraid we won’t be able to get enough drug when we need it. So we have to produce it ourselves,” Thawat Suntarjarn, head of Thailand’s department of Disease Control, told Reuters.

Removing barriers
Tamiflu, known generically as oseltamivir, is the most effective antiviral drug currently available for avian flu and is one of a class of treatments recommended by the World Health Organization for use in the event of a flu pandemic.

Roche has come under pressure in recent weeks to loosen its grasp on the patents that protect the treatment, with calls from the United Nations to sweep away the commercial barriers to producing the drug.

Mike Ryan, WHO director for epidemic and pandemic alert, said on Monday supplies were clearly insufficient to face up to a potential bird flu pandemic if the steadily spreading avian virus jumps to humans.

“Public health must overcome all obstacles in the trade and licensing area,” Ryan said, echoing recent comments by U.N. Secretary General Kofi Annan.

Reddy said that companies could collaborate in the Tamiflu manufacturing process in order to help lift overall output, or the firm would discuss granting rival companies or governments a license to produce the drug from scratch.

Deadly strain
Governments are rushing to build stocks of the treatment, with 40 nations having placed bulk orders with the Swiss drug maker so far, including Turkey which reported cases of bird flu last week.

A strain of bird flu was detected in a bird in Greece on Monday, amplifying concerns that the deadly H5N1 virus could be spreading into Europe from Asia, where it has claimed 60 lives since first being detected in 1997.

Roche has donated 3 million courses of the drug to the WHO to be used as and when the world health body sees fit, and on Monday it gave a small amount of the drug to Romania, where a bird flu outbreak has also been detected.

In a sign that it is working to increase capacity, Roche said the U.S. Food and Drug Administration had approved a manufacturing plant in the United States, one of 12 production sites worldwide, to be used to make the drug.

Researchers at the University of Wisconsin-Madison last week said the virus might be showing signs of resistance to Tamiflu.

But Roche allayed concerns the drug could become less effective over time, saying it had only rarely seen resistance to the drug develop in Japan, where Tamiflu is popular.

The antiviral drug, first discovered by U.S. firm Gilead, is not a cure for the virus but it can lessen the symptoms of flu if taken shortly after they first appear.

Roche is locked in a legal dispute with Gilead over the rights to the drug, with the U.S. firm claiming that Roche has not done enough to market and produce the treatment.