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Investor Update

Basel, 19. November 2005

FDA Advisory Committee Affirms Safety of Tamiflu in Children

The Pediatric Advisory Committee of the U.S. Food and Drug Administration (FDA) has confirmed the safety of Tamiflu (oseltamivir phosphate) in children following a scheduled comprehensive review of data about the use of Tamiflu in children. According to Dr. Robert M. Nelson, chairman of the committee, there is “no concern at all” that Tamiflu played a role in the reported deaths of children with influenza. Dr. Nelson is an associate professor in the department of anaesthesia and critical care at The Children’s Hospital of Philadelphia.

The FDA indicated that it intends to continue normal monitoring of the safety of Tamiflu for use in children, but found no basis for changing the labeling of the product for neuropsychiatric issues. Roche intends to work with the FDA to change the drug’s labeling based on adverse skin events that have occurred in a small number of patients, mostly in Japan. The FDA said it would report back to the committee in two years.

“We welcome the outcome of the FDA advisory committee and look forward to working with the FDA and other health authorities to continue to monitor the use of Tamiflu and its safety profile. The positive role of Tamiflu remains unchanged,” commented William M. Burns, CEO Roche Pharma Division.

About the meeting
The meeting of the Pediatric Advisory Committee on November 18th was a scheduled one at which adverse events for eight medicines used in children were reviewed. Tamiflu was among the drugs reviewed because it was granted pediatric exclusivity in March 2004.  Pediatric exclusivity is granted as an incentive to industry to study the use of medicines in children. The committee heard several presentations on Tamiflu including adverse event reports, a literature review and analysis of clinical trials data.

Facts and Figures
• To date, Tamiflu has been used by around 33 million patients worldwide
• In Japan, 24.5 million patients have used Tamiflu, 11.6 million of whom were children
• 12 deaths in children aged 1 to 16 years occurred; this number of reported deaths placed into the context of overall usage would provide a rate of 1 death per million patients treated. This is in close accordance with or lower than published rates of mortality in children infected with influenza (2 per million pediatric patients )
• Safety reporting based on clinical trials and routine use from around 33 million patients worldwide; of these, approximately 13 million were children

About Tamiflu
Tamiflu (oseltamivir) 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 illness3
  • 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


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.

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