Media Release

Basel, 18 October, 2005

Further expansion of Tamiflu manufacturing capacity

Roche reiterates willingness to enter discussions with governments and other manufacturers on the production of Tamiflu for emergency pandemic use.

Roche announced today that the Food and Drug Administration (FDA) has granted approval of an additional capsule manufacturing site in the US for the supply of the influenza antiviral Tamiflu (oseltamivir), expanding its already significantly increased worldwide production capacity.
This facility is part of a network of more than a dozen production sites for Tamiflu worldwide, more than half of which are with third party manufacturers.

William M. Burns, CEO Roche Pharma Division, commented: "For Tamiflu, the key need today is the rapid expansion of production capacity. Patients' needs in case of a pandemic remain our top priority. We have already significantly expanded production capacity internally and by working in close collaboration with other companies, and we will continue to do so. In addition, we are prepared to discuss all available options, including granting sub-licenses, with any government or private company who approach us to manufacture Tamiflu or collaborate with us in its manufacturing. In support of the global effort to fight a potential pandemic, we would be prepared to discuss such sub-licenses to increase the manufacturing of Tamiflu, provided such groups can realistically produce substantial amounts of the medicine for emergency pandemic use, in accordance with appropriate quality specifications, safety and regulatory guidelines".

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. As a result, more governments are stockpiling Tamiflu therefore Roche is expanding a collaborative production network to meet the increasing demand. The manufacturing process for Tamiflu is complex and lengthy.

Roche has been working with many governments over the last few months to determine their needs for stockpiling of Tamiflu and has received and/or fulfilled orders from around 40 countries.

About Tamiflu (oseltamivir)
Tamiflu is designed to be active against all clinically relevant influenza viruses.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 15 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.

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