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Roche says could allow others to produce Tamiflu
  Tue Oct 18, 2005 9:49 AM ET
By Tom Armitage
ZURICH (Reuters) - Swiss drugmaker 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.
The company said in a statement it was willing to discuss all options to increase output of the treatment, including granting sub-licenses to produce Tamiflu for emergency pandemic use to governments and other companies.
A Roche executive told Reuters the company would be willing to enter discussions with governments in Asia and with companies that believe they could make the drug on their own.
"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.
One Indian generic drugs maker, Cipla, has said it wants to start supplying governments which are building stockpiles of the drug.
"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.
Thailand also said earlier it would bypass Roche's patent to make its own version of Tamiflu by next October.
Reddy told Reuters the firm had not been approached by the Thai government, but it had received a letter from another Asian government and would start negotiations with them.
Thawat Suntarjarn, head of Thailand's department of Disease Control, said a version of the drug could be put on sale before October if serious outbreaks hit the country.
"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 told Reuters.
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 and the WHO 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.
Governments are rushing to build stocks of the treatment, with 40 nations having placed bulk orders with the Swiss drugmaker 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 moved to allay concerns the drug could become less effective over time, saying it had only rarely seen resistance to the drug develop in Japan, where the drug has been prescribed as a popular flu remedy.
Roche certificates, the company's most widely traded form of equity, had risen 2.0 percent to 191.70 francs by 1010 GMT. The stock has gained more than 43 percent so far this year.
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.
(Additional reporting by Richard Waddington in Geneva and Nopporn Wong-Anan in Bangkok)
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