FDAnews Drug Daily Bulletin


March 27, 2006

Roche will boost production of its influenza drug Tamiflu to 400 million treatments annually -- a capacity that currently exceeds demand from governments stockpiling the drug for a possible H5N1 flu virus pandemic.

Roche will have the capacity to produce an additional 100 million treatment courses Tamiflu (oseltamivir phosphate) annually by the end of 2006 through the addition of manufacturing partners, the company said recently.

The rate at which that capacity is used will depend on future orders from governments around the world, said William Burns, CEO of Roche's pharma division.

"We are now ahead of demand in meeting the manufacturing challenge, but as a research-based company, our role goes beyond this," he said. "We are 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," Burns added.

The company announced various research initiatives into H5N1 that involve predicting the optimum dose and duration of Tamiflu against different H5N1 subtypes and monitoring for resistance of the H5N1 virus to Tamiflu.