November 7, 2005

 

Thailand to make generic bird flu drug 2006

 

 

Thailand could begin distributing its own generic version of the anti-viral drug used to treat bird flu as early as February next year, the head of the country's state drug production company said Friday.

 

The Government Pharmaceutical Organization said it plans to begin distributing 1 million tablets of the drug Oseltamivir for 100,000 people by October 2006. The drug-which is taken immediately after flu infection is suspected-would be set aside for health workers and other people with higher than normal exposure to the virus.

 

But the agency said that it could rush Oseltamivir, better known by the trademarked name Tamiflu, into distribution by February next year if the country was hit by a pandemic.

 

"We are prepared to produce 1 million tablets for 100,000 medical personnel who have the high risk of becoming infected with bird flu and to the elderly who have weak immune systems," said Dr. Mongkhon Chirasantikan, chief of the Government Pharmaceutical Organization at a news conference.

 

Production of the drug is slated to start in January, but would be made available through hospitals and clinics only in October after passing drug tests approved by Thailand's Food and Drug Administration.

 

At least 62 people in Asia have been killed by the H5N1 bird flu virus since 2003, with the deaths linked to direct contact with infected birds. Most of the victims have been in Vietnam, but 20 people in Thailand also became infected, 13 of them fatally.

Health experts fear that the virus could mutate into a form easily passed between humans, possibly causing a global pandemic. Many countries are trying to stockpile Oseltamivir, which is considered to be the most effective anti-viral drug to treat flu infections, but is in short supply worldwide.

 

The Swiss pharmaceutical company Roche developed Oseltamivir, and markets it under the name Tamiflu, but cannot keep up with demand.

 

Dr. Thawat Suntrajarn, director general of Thailand's Department of Communicable Disease Control, said last month that Roche had not patented Tamiflu in Thailand, so the Public Health Ministry decided to proceed with production of the drug without seeking a license.

 

Thailand will purchase the raw active ingredient for the drug from an Indian pharmaceutical company.

 

In a statement sent to The Associated Press, the general manager of Roche Thailand, Rob Mitchell, confirmed that Tamiflu is not patented in Thailand.

 

He said the company advised the Thai government that it was "therefore free to manufacture Tamiflu at its discretion and without paying compensation to Roche".

 

The statement added that "Roche remains willing to openly discuss the technical aspects of the manufacturing of Tamiflu with the government of Thailand in view of our expertise and experience in the manufacturing of this important therapy and as a responsible company interested in ensuring the best possible global preparedness for a potential pandemic threat."

 

Wanchai Subhachaturus, the deputy chief of the Government Pharmaceutical Organization, said Roche had contacted Thai authorities with an offer to sell the drug to Thailand in powdered form, but that Thai experts found it would be more difficult to distribute than its own generic version.