GENEVA (AP):
Swiss pharmaceutical company Roche Holding AG said Wednesday it is counting on other manufacturers to help produce the only drug that experts believe can treat human cases of bird flu.
However, the Roche said there was no question of completely outsourcing production or relinquishing the patent for the antiviral oseltamivir, known commercially as Tamiflu.
PRODUCTION METHOD
"There are 10 complex steps to make Tamiflu. And we have a network of partner companies and suppliers who handle some of those steps," said Roche spokesman Daniel Piller, dismissing reports the company was ready to discuss about allowing other companies to produce the drug. "But this has been so since 1999. Nothing has changed."
"There is no discussion of completely outsourcing produc-tion," he said. "We would discuss it if it made sense. But it doesn't make sense."
Piller said it would be unrealistic to outsource production, as companies would need a minimum of three years to set up production as well as gain the capacity and know-how.
For security reasons, Roche said it would not disclose the names of the companies it worked with to make the Tamiflu drug, said Alexander Klauser, another spokesman at the Basel, Switzerland, company.
"We've agreed with our manufacturing partners not to disclose any names to guarantee the security of the production process," Klauser said.
Tamiflu is made from an acid produced from the Chinese star anise plant, which is in limited supply because it is grown in only four provinces in China and is harvested between March and May.
However, in the past year, Roche discovered a way to make the acid, called Shikimic acid, without the plant.
In most markets, sales of Roche's Tamiflu, launched in 1999, were for many years well below the company's expectations.
But that changed last year, when the World Health Organisation recommended governments stockpile antiviral drugs, such as Tamiflu.
Consequently, sales of Tamiflu from January to June 30, 2005, were nearly double the number in 2004. Experts expect revenue from the drug to reach at least 800 million Swiss francs (US$620 million; euro517 million) this year.
Piller said WHO has never asked it to outsource production.
"But we are in close discussions with WHO to find ways to scale up production," he said, confirming that Roche will have increased production up to tenfold by mid-2006 from 2003.
In a visit to WHO headquarters in Geneva last week, U.N. Secretary-General Kofi Annan said the U.N. will not let intellectual property rights stand in the way of access to flu treatments and vaccines in case of a pandemic.
Roche has donated three million doses of Tamiflu to the WHO, which has asked Roche to increase production of Tamiflu as rapidly as possible, including by working with other companies.
Health experts collect chickens to cull to fight an outbreak of avian flu in Kiziksa village, near Manyas in northwestern Turkey, on Tuesday. Turkey and Romania culled thousands of birds and imposed quarantine zones on Sunday to try to stop the spread of avian flu as scientists worked to discover if the outbreaks could be the deadly H5N1 strain.