Making Tamiflu

Roche has signed agreements with more than 15 external contractors to help it expand production of oseltamivir, the active ingredient in Tamiflu, an antiviral being stockpiled by governments around the world as a defense against the H5N1 avian flu virus. With the use of intermediates and finished materials from these contractors, Roche says it will be able to produce 400 million flu treatments annually by the end of 2006, up from 300 million currently.

The 13 firms so far revealed to be on the contractor list are a who's who of the global fine chemicals industry: Albemarle, Ampac Fine Chemicals, API Corp., Clariant, DSM, FIS, Martek Biosciences, Novasep/Dynamit Nobel, PHT International, PPG Industries, Sanofi-Aventis, Shaanxi Jiahe Phytochem, and Siegfried.

Martek and Sanofi both say they will produce Tamiflu's starting material, shikimic acid, via fermentation-Martek in Kingstree, S.C., and Sanofi in Saint-Aubin-lÈs-Elbeuf, France. Roche has been obtaining shikimic acid largely via extraction from Chinese star anise fruit, but supplies from this source are limited. Clariant will produce a shikimic acid derivative known as epoxide at a U.S. plant, and Novasep will produce a downstream azide intermediate in Germany.

Roche earlier signed sublicenses for complete oseltamivir production with India's Hetero and China's Shanghai Pharmaceuticals. It now says it is negotiating a production sublicense with another Chinese company and that it is evaluating sharing expertise to enable production in Africa.

In addition, Roche says it has launched research initiatives to answer questions about the use of Tamiflu against the evolving H5N1 virus. According to Roche Pharma CEO William M. Burns, the company is "committed to further expanding the knowledge base regarding Tamiflu and the H5N1 virus, but we cannot do this alone, and we need to collaborate with third parties moving forward."