The company expects to have the capacity to produce up to 400 million treatments annually by the end of 2006 – an addition of 100 million treatments. Tamiflu will be manufactured at several Roche sites and more than 15 external contractors located in nine different countries around the world.
These production partners have been selected primarily on the basis of their ability to produce substantial quantities of intermediates and finished materials in accordance with Roche’s quality standards in a relatively short time frame.
Roche is in the final stages of negotiations for a sublicense with a company in China. Roche is also evaluating sharing of expertise in order to enable production in Africa. This is in addition to sub-licenses for the complete production of oseltamivir that were granted to Hetero and Shanghai Pharmaceuticals last year.
Company representatives said Roche was committed to expanding knowledge of the H5N1 virus and the Tamiflu vaccine, but that it needed to partner third parties to do this as efficiently as possible.
“The H5N1 virus is continually changing. We know that the 1997 Hong Kong virus is different to the Vietnam virus and this in turn is different to the recent Turkey virus. For H5N1 to be the next pandemic strain it must change again and extensive research needs to be carried out in this area so we have as much information as possible about the virus and Tamiflu to help us fight the pandemic threat when it fully emerges,” said David Reddy, Roche’s pandemic task force leader.