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

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:
rocheusa or roche.us.


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