Investor Update
Basel, 15 December 2005
Tamiflu
gains positive opinion in Europe and Switzerland for prevention of influenza in children 1 to 12 years
Roche
announced today that its anti-influenza medicine Tamiflu (oseltamivir) has received a positive opinion
from the European and Swiss authorities for the prevention of influenza (prophylaxis use) in children
aged one to 12 years. A filing for the same indication was submitted in the United States in April this
year and an approval is expected early next year.
Tamiflu is already
indicated for the treatment of influenza in adults and children aged 1 year and above and for the prevention
of influenza in adults and adolescents 13 years and older. Tamiflu is a highly effective influenza drug
that works by blocking an enzyme on the surface of the virus which prevents it infecting other cells
in the body.
Eduard Holdener, Head of Global Pharma Development in Roche’s
Pharmaceutical Division commented: “After approval by the European Commission and Swissmedic, Roche
plans to make Tamiflu available to prevent influenza in very young children who are particularly vulnerable
during an outbreak of the disease. This is particularly helpful in the family setting when one member
of the family catches influenza - using Tamiflu for prevention will stop the spread of the disease to
other family members.”
The application is based on results from a subset
of paediatric patients in a clinical study where Tamiflu was used for the management of influenza in
households. The study showed that treatment of flu patients with Tamiflu combined with post- exposure
prophylaxis of other household members is more effective in preventing secondary spread of influenza
infection in the household than treating the patient alone. The protective efficacy of Tamiflu was the
same in children aged one to 12 as in the whole population.
Flu's
Impact on Children
Influenza is particularly dangerous for the most vulnerable
in society and this includes young children and infants. Children younger than two years old are as
likely as those over age 65 to be hospitalized because of influenza. It is estimated that children are
three times more likely to get sick with the flu – on average, one in 10 adults is affected by influenza
annually, compared with one in three children. Therefore, prevention of influenza in children can have
a significant impact on the spread of influenza in the household and the whole community.
About
Tamiflu
Tamiflu delivers:
• 38 percent reduction in the severity
of symptoms
• 67 percent reduction in secondary complications such as bronchitis, pneumonia
and sinusitis in otherwise healthy individuals
• 37 percent reduction in the duration
of influenza illness
• Tamiflu is shown to provide up to 89 percent overall protective
efficacy against clinical influenza in adults and adolescents who had been in close contact with influenza-infected
patients
In children, treatment with Tamiflu delivers:
•
36 percent reduction in the severity and duration of influenza symptoms
• 44 percent
reduced incidence of associated otitis media as compared to standard care
Tamiflu
was discovered by Gilead and developed jointly by Gilead and
Roche. Roche has exclusive world-wide rights for the manufacturing and marketing of Tamiflu and continues
to work in partnership with Gilead.
About
Roche
Headquartered in Basel, Switzerland, Roche is one of the world’s leading
research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of
innovative products and services for the early detection, prevention, diagnosis and treatment of disease,
the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche
is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and
a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled
21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs.
Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances
with numerous partners, including majority ownership interests in Genentech and Chugai. Additional
information about the Roche Group is available on the Internet (www.roche.com).
All trademarks used or mentioned in this release are legally protected.