Basel, 23 July 2007

30mg and 45mg capsules are convenient alternative to suspension for management of seasonal and pandemic influenza in children

Roche announced today that it has received a positive opinion in Europe from the Committee of Human Medicinal Products (CHMP) recommending marketing authorization for Tamiflu (oseltamivir) capsules of 30 mg and 45 mg doses. Until now, Tamiflu was only available in capsules containing a 75 mg dose of oseltamivir and as a powder for oral suspension. The lower dose capsules provide a convenient alternative for the treatment and prevention of influenza types A and B in patients one year and older. Since the capsules have a longer shelf life than the suspension formulation currently used for children (five years vs. two years), they also offer an improved option for government pandemic stockpiling.

Tamiflu for the treatment of influenza

An approval for lower dose capsules was recently granted by the U.S. Food and Drug Administration (FDA).
The application for lower dose capsules was filed in February 2007 based on data already available for the 75 mg capsule. The method of manufacturing will remain the same and the only change will be the size of the capsule and the amount of the active ingredient, oseltamivir, filled into the capsule. The small capsules have longer stability and require considerably less storage space than the currently available paediatric dry suspension. This is critical given the volumes of drug that must be stored and will also facilitate easier distribution in the event of a pandemic.

About Tamiflu
Tamiflu, an oral neuraminidase inhibitor, is designed to be active against all clinically relevant influenza viruses. It works by blocking the action of the neuraminidase 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 is the only member of the neuraminidase class of drugs approved for use in treatment and prevention of influenza in children 1 to 5 years of age.

Flu's Impact on Children
Influenza is particularly dangerous for the most vulnerable 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. There is a high need for influenza treatments for children as they are more severely affected by seasonal influenza compared to adults.

About Tamiflu (oseltamivir)
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 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
• In children, 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

Roche’s efforts to support government pandemic stockpiling
The World Health Organization (WHO) advises that stockpiling antivirals in advance is presently the only way to ensure that sufficient supplies are available in the event of a pandemic. Roche has been working closely with WHO and national governments to ensure governments are aware of the importance of stockpiling antivirals in the event of a pandemic situation. Roche has received and fulfilled pandemic orders for Tamiflu totalling 215million treatments from more than 80 countries worldwide. The magnitude of these orders varies with some countries, France, Finland, Iceland, Ireland, Luxembourg, Netherlands, New Zealand, Norway, Switzerland and UK stockpiling or intending to stockpile adequate Tamiflu to cover 20-40% of their population. Few governments to date have stockpiled paediatric antiviral formulations. Roche has also donated 5.125 million courses of Tamiflu treatment to the WHO for international rapid response and regional response to a pandemic influenza strain.

Roche and Gilead
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 oseltamivir. 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 the world’s biggest biotech company and an innovator of products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolism and central nervous system. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 worldwide 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 at www.roche.com.

All trademarks used or mentioned in this release are legally protected.

Further information
- Roche Health Kiosk on Influenza
- More information about Tamiflu
- More about the flu
- Information from WHO on influenza
- Information from WHO on avian flu