U.S.-Based Supply Chain For Tamiflu Fully Operational

Main Category: Bird Flu / Avian Flu
Article Date: 15 Sep 2006 - 0:00 PST

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

Comprehensive Global Production Network

Roche's global manufacturing network includes several Roche sites and more than 16 external contractors located in ten different countries. Roche has received and is filling on schedule orders from more than 75 countries to-date for stockpiling Tamiflu, and its capacity currently outstrips demand.

Roche has granted sub-licenses to Shanghai Pharmaceutical Group and to HEC Group for the overall production of oseltamivir for pandemic use in China, as well as to India's Hetero Drugs to make oseltamivir for India and developing countries. Roche has also reached an agreement with Aspen for providing oseltamivir for pandemic use to further help to address the needs of governments and other not for profit organizations in the African sub-continent. Additionally, Roche has donated a total of 5.1 million Tamiflu treatment courses to the World Health Organization (WHO) for use as rapid stockpiles and regional stockpiles to respond to bird flu outbreaks.

About Tamiflu

Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City, CA, is a systemic treatment for the most common strains of influenza (types A and B). Tamiflu is indicated for the treatment of uncomplicated acute influenza caused by virus types A and B in patients one year and older who have been symptomatic for no more than two days. Tamiflu is also indicated for the prophylaxis of influenza in patients one year and older.

In treatment studies in adult patients, the most frequently reported adverse events (incidence >1%) were nausea and vomiting. Other events reported numerically more frequently in patients taking Tamiflu compared with placebo were bronchitis, insomnia and vertigo. In treatment studies in patients one to 12 years old, the most frequently reported adverse event (incidence >1%) was vomiting. Other events reported more frequently in patients taking Tamiflu compared with placebo included abdominal pain, epistaxis, ear disorder and conjunctivitis.

In prophylaxis studies in adult patients, adverse events were similar to those seen in the treatment studies. Events reported more frequently in patients taking Tamiflu compared with placebo (incidence >1%) were nausea, vomiting, diarrhea, abdominal pain, dizziness, headache and insomnia. In a household prophylaxis trial that included patients one to 12 years old, adverse events were consistent with those observed in pediatric treatment studies, with GI events being the most frequently observed.

Treatment efficacy in subjects with chronic cardiac and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population. Safety and efficacy of repeated treatment or prophylaxis courses have not been studied.

In post-marketing experience, rare cases of anaphylaxis and serious skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema multiforme, have been reported with Tamiflu.

Vaccination is considered the first line of defense against influenza. Tamiflu is available for the treatment of influenza in more than 80 countries worldwide.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years, the Roche Group has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America, one of the Top 20 Employers (Science magazine), ranked as the No. 3 Best Company to Work For in NJ (NJ Biz magazine), the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers. For additional information about the U.S. pharmaceuticals business, visit our websites: http://www.rocheusa.com or http://www.roche.us.

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