New formulations provide more convenient dosing

Tamiflu (oseltamivir) significantly reduces illness severity and duration in children one year and older, particularly if given within 24 hours of symptom onset, according to new data presented at the World Society for Pediatric Infectious Disease (WISPID) meeting in Bangkok 15-18 November. The antiviral Tamiflu was also shown to reduce the incidence of respiratory tract infections, ear infections and antibiotic use. In addition this season smaller child sized Tamiflu (oseltamivir) capsules of 30 mg and 45 mg doses will be available to provide easier and more convenient dosing by parents.

"Children tend to be major vectors of influenza as they have limited pre-existing immunity, often spend time in groups and share germs easily. Its reassuring that oseltamivir can be used for the management of influenza in children as young as one year old," commented Dr Keith Reisinger, Primary Physicians Research, Pittsburgh, Philadelphia, USA. "There was a particularly severe influenza season in Australia this year which resulted in 6 deaths in children and we are monitoring whether the predominant strain circulating in Australia in 2007 A(H3) will have the same effect in the Northern Hemisphere when influenza strikes."

Tamiflu was shown to reduce influenza severity by almost a third (29%) and illness duration by a quarter (26%) compared to placebo when initiated within 48 hours of onset1. New data presented showed that if taken within 24 hours of symptom onset the influenza severity was halved (52%) and illness duration reduced by a third (34%) compared to placebo2. In addition there was a 55% reduction in severe ear infections (otitis media) in the Tamiflu group compared to placebo if treatment was started within 24 hours2. Tamiflu given as prevention reduced the incidence of secondary influenza infections3 by 55%. In studies Tamiflu was shown to be well tolerated and did not increase the risk for neurophsychiatric adverse events4.

The new lower dose capsules which will be available in the US and Europe this season provide a convenient alternative for the treatment and prevention of influenza types A and B in children one year and older. Furthermore, since the smaller capsules have a longer shelf life than the suspension formulation (five years vs. two years), they also offer an improved option for government pandemic stockpiling.

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.

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.

In addition the WHO has recently updated their guidance on the clinical management of human infection with H5N1 virus with Tamiflu as the only antiviral strongly recommended for treatment of H5N1 infected patients.

Ketchum