2007-08-22

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


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

"Experiences clearly show that to reduce mortality patients shouldreceive treatment with oseltamivir as early as possible, buttreatment remains effective even when patients present late,"commented Professor John Oxford, Professor of Virology at StBartholomew's and the Royal London Hospital, "H5N1 has proven to bean extremely virulent virus in humans and in some countries we haveseen the need to use higher and longer doses of oseltamivir to gainmaximum benefit."

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

With this latest evidence WHO recommends:

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

- Tamiflu remaining the primary antiviral treatment both early andlate in the infection as there is evidence of prolonged replicationwith H5N1

- Modified Tamiflu treatment regimens - higher and longer dosingmay be necessary given the virulence of some forms of H5N1 seenrecently

- Possible combination therapy with adamantanes (case by casebasis), particularly in patients with pneumonia or progressivedisease

The guidance also states that inhaled zanamivir has not beenstudied in human H5N1 illness and that the adequacy of inhaledzanamivir delivery in patients with serious lower respiratory tractor extra pulmonary disease is a major concern. Ongoing modificationswill be made to the WHO guidance based on continual researchfindings.

During the clinical development programme Roche carried outstudies looking at higher doses of Tamiflu. The safety profile atthese higher doses was supportive of further investigation A highversus standard dosage study has recently started in patients withsevere influenza, both H5N1 and seasonal , in conjunction with theNational Institutes of Health (NIH), to determine which is the mosteffective dose in severe disease.

WHO coordinates the global response to human cases of H5N1 avianinfluenza and tracks the corresponding threat of an influenzapandemic, providing access to both technical guidelines andinformation useful for the general public.

Tamiflu is an oral neuraminidase inhibitor that is active againstall strains of influenza A and B tested. More than 80 governmentsworldwide are now stockpiling Tamiflu in preparation for a pandemicand many global businesses are in discussions with Roche and are nowstockpiling for their employees and their families in line with locallaws 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 Avirus appears, against which the human population has no immunityresulting in several, simultaneous epidemics worldwide with enormousnumbers of deaths and illness. The most severe influenza pandemics todate include: 'Spanish flu' A (H1N1): 1918 caused in excess of 50million deaths worldwide, 'Asian flu' A (H2N2): 1958 caused 1 milliondeaths worldwide, 'Hong Kong flu' A (H3N2): 1968 caused 800,000deaths worldwide in six weeks. The WHO believes that we are as closeto the next pandemic as we have been any time in the past 37 years,with two of the three widely-recognised prerequisites for a humanpandemic met to date in the avian influenza outbreak in East Asia.Firstly, a new influenza virus strain has emerged (H5N1), andsecondly, the virus has spread to humans. The final barrier will beeffective transmission of the virus from human to human.

About Tamiflu

Tamiflu is designed to be active against all clinically relevantinfluenza viruses and works by blocking the action of theneuraminidase (NA) enzyme on the surface of the virus. Whenneuraminidase is inhibited, the spread of the virus to other cells inthe body is inhibited. It is licensed for the treatment andprophylaxis of influenza in children aged one year and above and inadults.

Roche and Gilead

Tamiflu was invented by Gilead Sciences and licensed to Roche in1996. Roche and Gilead partnered on clinical development, with Rocheleading efforts to produce, register and bring the product to themarkets. Under the terms of the companies' agreement, amended inNovember 2005, Gilead participates with Roche in the consideration ofsub-licenses for the pandemic supply of Tamiflu in resource-limitedcountries. To ensure broader access to Tamiflu for all patients inneed, Gilead has agreed to waive its right to full royalty paymentsfor product sold under these sub-licenses.

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world'sleading research-focused healthcare groups in the fields ofpharmaceuticals and diagnostics. As the world's biggest biotechcompany and an innovator of products and services for the earlydetection, prevention, diagnosis and treatment of diseases, the Groupcontributes on a broad range of fronts to improving people's healthand quality of life. Roche is the world leader in in-vitrodiagnostics and drugs for cancer and transplantation, a market leaderin virology and active in other major therapeutic areas such asautoimmune diseases, inflammation, metabolism and central nervoussystem.

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 PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de

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

Roche Pharmaceuticals

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

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