Roche Pharmaceuticals

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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