Media Release

Basel, 17 January 2006

Roche donates a further 2 million treatment courses of antiviral Tamiflu to the WHO for regional stockpiling

Roche announced today that it will donate another 2 million treatment courses, or 20 million doses, of the antiviral Tamiflu (oseltamivir) to the World Health Organization (WHO). This is addition to previous donations made by Roche in 2004 and in August 2005, and will result in a total of 5.125 million treatment courses being available to the WHO to help people affected by a potential pandemic.

Whilst the donation made last year is stored centrally, these additional 2 million treatment courses will be stored as regional stockpiles in locations to be determined by WHO to serve the needs of developing countries. The regional stockpiles of Tamiflu will be used to reduce morbidity and mortality in the case of an outbreak of avian influenza in humans and prevent the further spread of such an outbreak, in the interest of public health.

“Roche is working as a collaborative and responsible partner with governments and the WHO to assist in pandemic planning, including the stockpiling of Tamiflu. We are pleased to be able to further increase our donation to the WHO and help establish regional stockpiles of Tamiflu”, commented William M. Burns, CEO Division Roche Pharma.

“By establishing regional stockpiles of antivirals, developing countries most likely to be affected by avian influenza in humans will be better prepared to rapidly manage outbreaks in the interest of global public health. It is important to emphasize that this and the previous donation(s) do not replace the need for countries to consider the establishment of national antiviral stockpiles as one of a number of measures of national pandemic preparedness consistent with the national priorities of each country”, commented Lee Jong-Wook, the Director-General of the World Health Organization.

In contrast to the regional stockpiles of Tamiflu, the “rapid response stockpile” of 3 million courses of Tamiflu treatment donated by Roche to the WHO in August 2005, will be used exclusively at the site of outbreak of a pandemic in an attempt to contain or slow its spread.

A comprehensive production network
In order to increase the availability of Tamiflu to meet the growing demand as pandemic planning continues, Roche has taken significant steps to increase manufacturing capacity, doubling production capacity in 2004 and 2005 and will have the capacity to produce over 300 million treatments of Tamiflu annually by 2007 - more than a ten fold increase over the capacity in 2004. Roche has established close relationships with 50 external suppliers and the supply chain in place exceeds our current orders from Governments. Roche is now in a position to have a back-up supply in case of emergency and companies identified to take the capacity further will allow Roche’s supply network to respond to future demands from governments. Furthermore Roche has granted sublicenses to manufacture oseltamivir to a Chinese and an Indian pharmaceutical manufacturer.

About pandemics and H5N1
Influenza pandemics occur approximately every 40 years, and experts caution that it is a case of when, not if, the next pandemic will strike. The H5N1 avian influenza strain originating in Asia is considered by experts to be the most likely source of the next pandemic. Tamiflu is designed to be active against all clinically relevant influenza viruses, including H5N1, and data suggest it could be effective against any mutating strain of the virus– the key to a pandemic. An orally administered treatment, Tamiflu is systemically active, and can protect against the virus at all sites in the body.

About Tamiflu (oseltamivir)
Tamiflu is designed to be active against all clinically relevant influenza viruses and key international research groups have demonstrated, using animal models of influenza that Tamiflu is effective against the avian H5N1 strain circulating in the Far East.

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It 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.

Tamiflu delivers:
• 38 percent reduction in the severity of symptoms

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• 67 percent reduction in secondary complications such as bronchitis, pneumonia and sinusitis in otherwise healthy individuals

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• 37 percent reduction in the duration of influenza illness

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• Tamiflu was 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

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In children, Tamiflu delivers:
• 36 percent reduction in the severity and duration of influenza symptoms

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• 44 percent reduced incidence of associated otitis media as compared to standard care

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As with any antiviral, a theoretical potential exists for an influenza virus to emerge with decreased sensitivity to a drug. Extensive monitoring, by Roche and the independently established Neuraminidase Inhibitor Susceptibility Network (NISN) measured the incidence of resistance to NAIs. From around 4000 patients treated with Tamiflu resistance was encountered in 0.4 per cent in adults and 4 per cent in children aged one to 12. This resistant virus was found to be less virulent than the wild type virus and did not affect the course of the illness.

The greatest use of Tamiflu today is in Japan. To illustrate this, there were an estimated 16 million influenza infections in Japan over the 2004/2005 influenza season. Roche estimates that around 6 million of those individuals infected with the influenza virus received Tamiflu. Even with this degree of usage, resistance appears very infrequent.

Avian Influenza and Pandemics
Most avian influenza viruses are not infectious to humans, but, should an avian and a human influenza virus co-infect a human or a pig, the virus strains can join, mutate and create a completely new virus, which may be transmissible from animals to humans, and from humans to humans. Such a strain would be entirely new in composition, so vaccines developed and administered to date to protect humans during seasonal epidemics, would be ineffective against this new strain, leaving the population vulnerable to infection. Experts believe the next influenza pandemic could result from such a mutation of virus strains.

World Health Organisation
One of WHO's recommendations as part of its Pandemic Preparedness Plan is that countries establish stockpiles of antiviral treatments, which are effective against all strains of the influenza virus. The Pandemic Preparedness Plan, along with details of the countries that have implemented national plans, can be viewed on the Internet.

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. 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.

Additional information
- Roche Health Kiosk, Influenza
- About Tamiflu
- About influenza
- WHO: Global influenza programme
- WHO: Avian flu

1  Treanor JJ et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized, controlled trial. JAMA 2000;283: 1016–24
2  Kaiser et al. Impact of Oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalisations. Arch Intern Med. 163:1667-1672 (2003)
3  Nicholson KG et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Lancet 2000; 355:1845–1850
4  Welliver R. W. et al. Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. JAMA, 2001 Feb 14; 285(6): 748-754
5  Whitely RJ, Hayden FG et al; Oral oseltamivir treatment of influenza in children, Pediatr Infect Dis J 2000; 20: 122-133
6  Roche data on file, 2003