Roche ready to make Tamiflu in US

Sep 20, 2006 (CIDRAP News) – Roche announced last week that its United States supply chain for oseltamivir (Tamiflu), used to treat avian influenza and seasonal flu patients, is fully operational, meaning all aspects of its production are based on US soil.

The company said it now has the capability to produce 80 million treatment courses of the drug annually in the United States, which is stockpiling oseltamivir as part of efforts to prepare for a flu pandemic.

The US Department of Health and Human Services (HHS) had asked Roche to establish a system that involves US sources for all phases of osteltamivir production, from synthesizing shikimic acid, the starting material, to packaging the medication, the company said in a news release.

"The ability to produce Tamiflu from start to finish on US soil is a significant milestone that will help ensure access to Tamiflu when and where it is needed," said George Abercrombie, president and chief executive officer for Hoffman-La Roche, Inc., the company's US pharmaceutical division.

The company said HHS has ordered 21.3 million treatment courses of oseltamivir for the Strategic National Stockpile, all of which will be delivered by the end of this year. Marc Wolfson, a spokesman for the HHS Office of Public Health Emergency Preparedness in Washington, DC, verified that information for CIDRAP News.

The long-term goal for the stockpile is 81 million courses by the end of 2008, according to Wolfson and Roche. Of that total, HHS says it will buy 50 million courses and will provide a 25% subsidy for states to purchase another 31 million courses.

Roche says that with its own manufacturing network and 16 external contractors, it has more than enough capacity to meet the osteltamivir orders from 75 countries that are stockpiling the drug. Global annual production capacity will reach 400 million treatment courses by the end of this year, the company said.

Approved for prevention and treatment of influenza in adults and children 1 year and older, osteltamivir is intended to treat influenza viruses in all clinical settings. It has been shown to be active against the H5N1 virus in the laboratory and in animals that are infected with an H5N1 avian flu strain taken from humans, according to Roche.

See also:

Sep 14 Roche press release
http://www.roche.com/med-cor-2006-09-14

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