Roche announced this thursday that a Tamiflu® (oseltamivir phosphate) supply chain is now fully operational in the U.S., with an annual production capacity of 80 million treatment courses.

According to PRNewswire, the U.S. supply chain is part of Roche's global production network, which will be capable of producing 400 million treatment courses of Tamiflu annually by the end of 2006, a more than ten-fold increase since 2004. Established by Roche at the request of the U.S. Department of Health & Human Services (HHS), the U.S. supply chain, which includes Roche sites as well as external contractors, encompasses all aspects of Tamiflu production, from synthesis of the initial starting material (shikimic acid) through all major steps of manufacturing to finished packs.

"The ability to produce Tamiflu from start to finish on U.S. soil is a significant milestone that will help ensure access to Tamiflu when and where it is needed," said George abercrombie, President and CEO, Hoffmann-La Roche Inc. "This most recent expansion further demonstrates Roche's long term commitment to serving as a responsible and collaborative partner with the U.S. government on pandemic preparedness and response."

Tamiflu is approved for the prevention and treatment of influenza in adults and children one year and older. Tamiflu is designed to be active against all clinically relevant influenza viruses, including the H5N1 virus, and has been shown to be active against the H5N1 virus in the laboratory and in animals infected with the H5N1 strain taken from humans.

To date, HHS has ordered 21.3 million courses of Tamiflu for the U.S. Strategic National Stockpile, which will be delivered in full this year. The total targeted U.S. stockpile is 81 million antiviral treatment courses by the end of 2008; HHS plans to purchase 50 million treatment courses and subsidize by 25 percent the states' purchases of 31 million courses.

The initial starting material for Tamiflu, shikimic acid, is extracted in one of two ways: from the pods of the star anise or via a fermentation process. The majority of shikimic acid used in Tamiflu today is derived by fermentation, reducing reliance on scarce natural sources.

"U.S.-based sources for key steps in the manufacturing process have been qualified, and have demonstrated the ability to produce at targeted rates for both the U.S. and globally," explains Jan van Koeveringe, head of global technical operations at Roche.