Updated WHO Bird Flu (H5N1) Management Guidance Reinforces Tamiflu as First Line Treatment

Basel, Switzerland (ots/PRNewswire) - The World Health
Organization (WHO) has reinforced that Tamiflu (oseltamivir) is the
primary recommended antiviral of choice in managing patients infected
with H5N1 in updated guidance published on the WHO website today.
Experts believe that a human influenza pandemic is imminent and could
be triggered by the highly pathogenic H5N1 strain, which to date has
infected 321 humans causing 194 deaths worldwide (as of Aug 16 2007).

"Experiences clearly show that to reduce mortality patients should
receive treatment with oseltamivir as early as possible, but
treatment remains effective even when patients present late,"
commented Professor John Oxford, Professor of Virology at St
Bartholomew's and the Royal London Hospital, "H5N1 has proven to be
an extremely virulent virus in humans and in some countries we have
seen the need to use higher and longer doses of oseltamivir to gain
maximum benefit."

The latest advice is based on evidence presented to the WHO by
experts in countries that have reported human cases of bird flu.
Tamiflu is the only neuraminidase inhibitor to have been used in the
management of human cases of H5N1 and is the only antiviral strongly
recommended for treatment of H5N1 infected patients by the WHO.

With this latest evidence WHO recommends:

- Standardising care and promptly sharing clinical and
treatment information to improve understanding of the disease and
identify appropriate therapy

- Tamiflu remaining the primary antiviral treatment both early and
late in the infection as there is evidence of prolonged replication
with H5N1

- Modified Tamiflu treatment regimens - higher and longer dosing
may be necessary given the virulence of some forms of H5N1 seen
recently

- Possible combination therapy with adamantanes (case by case
basis), particularly in patients with pneumonia or progressive
disease

The guidance also states that inhaled zanamivir has not been
studied in human H5N1 illness and that the adequacy of inhaled
zanamivir delivery in patients with serious lower respiratory tract
or extra pulmonary disease is a major concern. Ongoing modifications
will be made to the WHO guidance based on continual research
findings.

During the clinical development programme Roche carried out
studies looking at higher doses of Tamiflu. The safety profile at
these higher doses was supportive of further investigation A high
versus standard dosage study has recently started in patients with
severe influenza, both H5N1 and seasonal , in conjunction with the
National Institutes of Health (NIH), to determine which is the most
effective dose in severe disease.

WHO coordinates the global response to human cases of H5N1 avian
influenza and tracks the corresponding threat of an influenza
pandemic, providing access to both technical guidelines and
information useful for the general public.

Tamiflu is an oral neuraminidase inhibitor that is active against
all strains of influenza A and B tested. More than 80 governments
worldwide are now stockpiling Tamiflu in preparation for a pandemic
and many global businesses are in discussions with Roche and are now
stockpiling for their employees and their families in line with local
laws and regulations.

Notes to Editors:

About the guidance http://www.who.int/csr/disease/avian_influenza/
guidelines/clinicalmanage07/en/index.html

About pandemic influenza

An influenza pandemic occurs when a new strain of influenza A
virus appears, against which the human population has no immunity
resulting in several, simultaneous epidemics worldwide with enormous
numbers of deaths and illness. The most severe influenza pandemics to
date include: 'Spanish flu' A (H1N1): 1918 caused in excess of 50
million deaths worldwide, 'Asian flu' A (H2N2): 1958 caused 1 million
deaths worldwide, 'Hong Kong flu' A (H3N2): 1968 caused 800,000
deaths worldwide in six weeks. The WHO believes that we are as close
to the next pandemic as we have been any time in the past 37 years,
with two of the three widely-recognised prerequisites for a human
pandemic met to date in the avian influenza outbreak in East Asia.
Firstly, a new influenza virus strain has emerged (H5N1), and
secondly, the virus has spread to humans. The final barrier will be
effective transmission of the virus from human to human.

About Tamiflu

Tamiflu is designed to be active against all clinically relevant
influenza viruses and works by blocking the action of the
neuraminidase (NA) enzyme on the surface of the virus. When
neuraminidase is inhibited, the spread of the virus to other cells in
the body is inhibited. It is licensed for the treatment and
prophylaxis of influenza in children aged one year and above and in
adults.

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 Tamiflu in resource-limited
countries. 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 the world's biggest biotech
company and an innovator of products and services for the early
detection, prevention, diagnosis and treatment of diseases, the Group
contributes on a broad range of fronts to improving people's health
and quality of life. Roche is the world leader in in-vitro
diagnostics and drugs for cancer and transplantation, a market leader
in virology and active in other major therapeutic areas such as
autoimmune diseases, inflammation, metabolism and central nervous
system.

Additional information

- Roche Health Kiosk, Influenza:
http://www.health-kiosk.ch/start_grip.htm

- About Tamiflu:
http://www.roche.com/med_mbtamiflu05e.pdf

- About influenza:
http://www.roche.com/med_mbinfluenza05e.pdf

- WHO: Global influenza programme:
http://www.who.int/csr/disease/influenza/en/

- WHO: Avian flu:
http://www.who.int/mediacentre/factsheets/avian_influenza/en/

ots Originaltext: Roche Pharmaceuticals
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Contact:
Helen Walicka, International Communications Manager, Tel.
+41(0)79-263-9701