November 28, 2005

 

Roche considers Indonesia's request to make Tamiflu

 

 

Swiss pharmaceutical company Roche will reply within days to the Indonesian government's request for a local production license for the H5N1 bird flu treatment drug Tamiflu, the company's local unit said Friday.

 

"Roche has received on Nov 22, 2005 a letter from the Ministry of Health with a request to Roche to 'consider the provision of voluntary licensing to Indonesia' for local (Tamiflu) production," a PT Roche Indonesia statement said.

 

"The request has been the same day transmitted to Switzerland and Roche's reply is expected anytime today or early next week."

 

Tamiflu-also known as oseltamivir-has shown promise in treatment of human infections of H5N1 avian influenza.

 

Indonesia joins a growing list of third parties, including the governments of Taiwan and Vietnam, petitioning Roche to allow local production of the drug amid fears of a possible worldwide pandemic.

 

Indonesia's government formally requested that the company grant the country a local Tamiflu production license and a presidential decree authorising that production is pending, Minister of Health Siti Fadilah Supari said late Thursday.

 

Supari said that the government had already appointed 90-percent state-owned Kimia Farma as Indonesia's domestic Tamiflu producer.

 

The government's request for local manufacturing of Tamiflu reflects escalating government concern about the country's ongoing H5N1 outbreak.

 

Indonesia has recorded a total of eight human H5N1 fatalities and 12 confirmed infections, Supari said. That figure compares to a WHO tally of 11 cases and 7 deaths since July. H5N1 has killed more than 60 people in Asia since late 2003.

 

Indonesia's President Susilo Bambang Yudhoyono said last week that domestic Tamiflu production was needed because Indonesia's current inventory of 75,000 Tamiflu doses was insufficient to meet potential local demand.

 

But Roche indicated the firm is not enthusiastic about Indonesia's request for licensing to produce Tamiflu domestically.

 

"The manufacturing process for Tamiflu is complex and lengthy and can take up to 12 months," the company statement said.

 

"Our assumption is that it would take a generic company three years to gear up (for Tamiflu production); thus, it doesn't make sense to out-license manufacturing."

 

However, Kimia Farma's managing director Gunawan Pranoto said that the company could produce a local version of Tamiflu within five months of the licensing agreement.