Investor Update

Basel, 22 December 2005

U.S. Food and Drug Administration extends prophylaxis indication for Tamiflu to patients between 1 to 12 years of age

Roche announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) extending the prophylaxis (prevention) indication for Tamiflu (oseltamivir phosphate) to include children ages one through 12.  The leading prescription antiviral medication for prevention and treatment of influenza, Tamiflu was previously approved for prophylaxis in adolescents (age 13 years and older) and adults. Tamiflu is also the only antiviral medication indicated for the treatment of influenza type A or type B infection in patients one year and older, and is available in both tablet and liquid suspension formulations.

William M. Burns, CEO Division Roche Pharma, said: “Very young children are particularly vulnerable during an outbreak of the disease. The approval of Tamiflu in this indication enables doctors to have a safe and effective medicine at hand to help prevent young children from getting influenza. The data which the submission was based on confirms the importance of Tamiflu in the management of influenza”.

When administered within 48 hours of exposure, clinical data show that prophylaxis with Tamiflu reduced the incidence of flu from 17 percent (18/106) in the group not receiving Tamiflu to 3 percent (3/95) in the group receiving prophylaxis.  The dosing for the new indication is 30 mg to 60 mg once daily (dependant on body weight) for a duration of 10 days. Therapy should begin within two days of exposure, following close contact with an infected individual.

Tamiflu received a positive opinion in Europe and Switzerland for prevention of influenza in children 1 to 12 years last week.

About the study
The sNDA was filed based on results from a subset of pediatric patients in a clinical study where Tamiflu was used for the management of influenza in households.  The study, which included more than 1,000 patients (including adults and children), showed that post-exposure prophylaxis is effective in preventing secondary spread of influenza infection and illness in households and that the protective efficacy of Tamiflu was the same in children aged one through 12 as the whole population.   

The FDA Pediatric Advisory Committee last month confirmed the safety of Tamiflu in children, following a standard data review. As part of the Post Approval Commitment (PAC) for the new indication, Roche will provide the FDA with safety information on 40 to 50 patients between one and 12 years of age using the approved prophylaxis dosing for up to six weeks.

In clinical studies, gastrointestinal events, particularly vomiting, were the most frequently reported adverse events in pediatric patients. The updated Tamiflu label will also include a precaution related to anaphylaxis and serious skin reactions in children, based on adverse skin events that have occurred in a small number of patients. To date, Tamiflu has been used by about 33 million patients worldwide, 13 million of whom are children.

Flu's Impact on Children
Influenza is particularly dangerous for the most vulnerable in society and this includes young children and infants. Children younger than two years old are as likely as those over age 65 to be hospitalized because of influenza. It is estimated that children are three times more likely to get sick with the flu – on average, one in 10 adults is affected by influenza annually, compared with one in three children. Therefore, prevention of influenza in children can have a significant impact on the spread of influenza in the household and the whole community.

About Tamiflu
Tamiflu delivers:
• 38 percent reduction in the severity of symptoms
• 67 percent reduction in secondary complications such as bronchitis, pneumonia and sinusitis in otherwise healthy individuals
• 37 percent reduction in the duration of influenza illness
• Tamiflu is 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

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

Tamiflu was invented by Gilead Sciences and licensed to Roche in 1996. Roche and Gilead partnered on clinical development, with Roche leading efforts to produce, register and bring the product to the markets. Under the terms of the companies’ agreement, amended in November 2005, Gilead participates with Roche in the consideration of sub-licenses for the pandemic supply of Tamiflu in resource-limited countries. To ensure broader access to Tamiflu for all patients in need, Gilead has agreed to waive its right to full royalty payments for product sold under these sub-licenses.

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).

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