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Basel, 2 October 2006
Tamiflu readily available
for 2006/2007 influenza season
Production expansion ensures supply
for both seasonal use and pandemic stockpiling
Roche announces that its
antiviral medication Tamiflu (oseltamivir) is readily available for the forthcoming 2006-2007 influenza
season for the treatment and prevention of influenza. Seasonal influenza is a debilitating and disruptive
illness that affects millions of people each year and can lead to complications and death if not treated.
Roche can also confirm that any government and corporate orders for stockpiling for an influenza pandemic
are being progressed.
“During the past year, Roche has been gearing up
its production capacity and we will be in a position to produce 400 million treatment courses by the
end of this year”, said William M. Burns, CEO Division Roche Pharma. “Physicians can be confident that
Tamiflu will be readily and widely available to patients who need it this season for flu treatment and
post-exposure prevention. The measures taken also enable us to schedule any additional orders from governments
and corporations who are stockpiling Tamiflu in preparation for an influenza pandemic. Of course, the
rate at which this capacity is utilized will depend in large part on the future order flow and the severity
of this year’s influenza season”.
During the 2005 -2006 season Roche
had to restrict distribution of Tamiflu to wholesalers in many markets to ensure availability during
an influenza outbreak, whilst the production capacity was being expanded. This led to the perception
that Tamiflu was in short supply. Based on the available manufacturing capacities, the supply shortage
no longer exits.
Manufacturing Capacity
The
broad availability of Tamiflu for both seasonal and pandemic use is due to expanded global production
capacity, which will reach the rate of 400 million treatment courses annually by the end of 2006, a
more than 10-fold increase since 2004. Roche's global network for the manufacture of Tamiflu includes
several Roche sites and more than 15 external contractors located in 10 different countries around the
world. The expansion includes a fully functioning European supply chain and a North American supply
chain for Tamiflu with an annual capacity of 80 million treatment courses. In addition, Roche has further
extended global availability by offering sublicenses to Hetero Pharmaceuticals and the HEC Group in
India and Shanghai Pharmaceuticals in China. Roche has also finalised an agreement on sharing technical
know-how with the South African company Aspen, allowing them to supply for pandemic use in the African
continent.
About influenza
Influenza,
commonly called the ‘flu’, is a serious disease and annual outbreaks and epidemics are caused by influenza
A and B viruses. Influenza is a highly contagious viral illness and is characterised by a sudden onset
of debilitating clinical symptoms which affect the entire body. Up to 500 million people are infected
by influenza and up to 500,000 deaths are attributed to influenza each year. Influenza complications
occur in all patient groups and include bronchitis, sinusitis, otitis media, and pneumonia.
About
Tamiflu
Tamiflu is designed to be active against all clinically relevant influenza
viruses and works by blocking the action of the neuraminidase (NAI) enzyme on the surface of the virus.
When neuraminidase is inhibited, the virus is not able to spread to and infect other cells in the body.
It
is licensed for the treatment and prophylaxis of influenza in children aged one year and above and in
adults.
Roche’s efforts to support government pandemic
stockpiling
The World Health Organization (WHO) advises that stockpiling antivirals
in advance is presently the only way to ensure that sufficient supplies are available in the event of
a pandemic. Roche has been working closely with WHO and national governments to ensure governments are
aware of the importance of stockpiling antivirals in the event of a pandemic situation. Roche has received
and fulfilled pandemic orders for Tamiflu from more than 75 countries worldwide. The magnitude of these
orders varies with some countries, France, Finland, Iceland, Ireland, Luxembourg, Netherlands, New Zealand,
Norway, Switzerland and UK stockpiling or intending to stockpile adequate Tamiflu to cover 20-40% of
their population. Roche has also donated 5.125 million courses of Tamiflu treatment to the WHO for international
rapid response and regional response to a pandemic influenza strain.
Roche
and Gilead
Tamiflu was invented by Gilead Sciences and licensed to Roche in 1996.
Roche and Gilead partnered on clinical development, with Roche leading efforts to produce, register
and bring the product to the markets. Under the terms of the companies’ agreement, amended in November
2005, Gilead participates with Roche in the consideration of sub-licenses for the pandemic supply of
oseltamivir. To ensure broader access to Tamiflu for all patients in need, Gilead has agreed to waive
its right to full royalty payments for product sold under these sub-licenses.
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 2005 sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the
Diagnostics Division posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 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.
Additional
information
- Roche Health Kiosk, Influenza
-
About Tamiflu
- About influenza
-
WHO: Global influenza programme
- WHO: Avian flu |
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Tamiflu blister-packing line at the packaging facility in Kaiseraugst
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