Roche confirms ability to supply pandemic Tamiflu to the people of Taiwan

Basel, 25 November 2005, Fallback on compulsory license will be unnecessary as agreed delivery timelines will be met by Roche

Roche received the announcement that the Taiwanese government would issue a compulsory license for use only if Roche could not meet the requested delivery timelines for the pandemic order with surprise. Roche met with the Taiwanese government earlier this week and committed to supply the required Tamiflu order according to mutually agreed delivery timelines.

Roche confirms it will provide Taiwan with an additional 1.3 million treatments of Tamiflu (oseltamivir) next year, taking the total treatments of Tamiflu ordered for pandemic use in the country to 2.3 million treatments. This will be used to safeguard the public health of citizens in Taiwan in the event of an influenza pandemic. Roche’s ability to meet the needs of Taiwan has been made possible due to a global scale-up effort that has been underway at Roche since 2004, resulting in a production output by the end of 2006 of 300 million treatments a year.

In addition, during a recent visit to Taiwan, members of Roche reviewed the manufacturing capabilities of a local company with a view to issuing a voluntary license to produce Tamiflu for local pandemic use. As a result of this review, it was clear that the local company could not produce the drug more rapidly or at lower cost than Roche.

“We are confident that we will be in a position to deliver the quantities of Tamiflu requested by the Taiwanese Government in the required timelines. Therefore, the possibility of a compulsory license being invoked is unnecessary”, commented David Reddy, Roche Pandemic Task Force Leader.

About pandemic planning
Roche has been working with many governments over the last few years to determine their needs for stockpiling of Tamiflu and has received and/or fulfilled orders from around 50 countries.
Roche has also pledged to donate 3 million treatments to the WHO for use where an influenza pandemic may start. This amount, based on mathematical modeling, could contain or stop the spread of a potential pandemic at the source of the outbreak.

Potential licensing terms
Roche is looking to identify companies who can contribute to manufacturing scale-up to increase global availability for pandemic use without negatively affecting Roche’s own production capability.
These are:
- Companies that can contribute to critical manufacturing steps such as bio- fermentation, azide chemistry, and combined alcohol granulation/capsule filling. These companies could become potential toll manufacturers.
- Companies that believe they can fully produce Tamiflu in substantial quantities. Such companies would become either contract manufacturers and be able to produce Tamiflu via the approved Roche process with the help of technology transfer or will be issued with sub-licenses or de-blocking licenses.
Commercial terms regarding these agreements have not currently been finalized but are of secondary importance to ensuring adequate and timely supply of Tamiflu for pandemic use.

About Tamiflu (oseltamivir)
Tamiflu, which was originated by Gilead Sciences, California, 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.3

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 symptoms1
• 67 percent reduction in secondary complications such as bronchitis, pneumonia and sinusitis in otherwise healthy individuals2
• 37 percent reduction in the duration of influenza illness5,3
• 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 patients4

In children, Tamiflu delivers:
• 36 percent reduction in the severity and duration of influenza symptoms5
• 44 percent reduced incidence of associated otitis media as compared to standard care6

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
The WHO has recommended as part of its Pandemic Preparedness Plan that countries establish stockpiles of antiviral treatments such as Tamiflu, 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. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. 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.

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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

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