Roche Files Supplemental New Drug Application With U.S. Food & Drug Administration For Tamiflu(R) 30 Mg And 45 Mg Capsules

Roche has filed a supplemental
new drug application (sNDA) with the U.S. Food and Drug Administration
(FDA) to market Tamiflu (oseltamivir phosphate) capsules in pediatric doses
of 30 mg and 45 mg. Tamiflu, which is indicated for the prevention and
treatment of influenza types A and B in patients one year and older, is
currently available in a 75 mg capsule for adults as well as liquid
suspension formulation for children. With a longer shelf life than the
liquid suspension formulation (five years vs. 24 months), Tamiflu pediatric
capsules provide a better option for government pandemic stockpiling and
can be administered to children for seasonal influenza.



The application was filed based on information already available for
the 75 mg capsule. The method of manufacturing will remain the same; the
only change will be the size of the capsule and the amount of the active
ingredient, oseltamivir phosphate, filled into the capsule. Roche is
optimistic that the FDA will complete its review of the sNDA by mid-2007.



Flu's Impact on Children



Research indicates that children are especially vulnerable to influenza
and its complications. On average, one in three children in the U.S. is
affected by influenza annually.(1) Children are also two to three times
more likely than adults to get sick with the flu, according to the National
Institute for Allergies and Infectious Diseases (NIAID).(2)



Additionally, children represent a population that is both
vulnerable to influenza infection and one of the most important links in
its transmission.(3) Experts believe that compared with adults, children do
not have as much natural immunity to influenza, because they have had less
lifetime exposure. Close contact with each other in school, home and
daycare settings increases children's risk of getting and spreading the
virus.



The Centers for Disease Control and Prevention (CDC) recommends three
steps to protect against influenza: vaccination, good health/hygiene
habits, and antiviral medications. When taken within 12-48 hours of symptom
onset, antiviral medications like Tamiflu can help reduce the duration of
symptoms. Tamiflu can be used preventively to help avoid the flu
altogether. Clinical trials have shown Tamiflu to be up to 89 percent
effective in preventing influenza illness when taken within 48 hours of
exposure, which can help control spread in the workplace and other crowded
settings.



Roche's Efforts to Support 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 from more than
75 countries worldwide.
















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.



About Tamiflu



Tamiflu, co-developed by Gilead Sciences, Inc., based in Foster City,
CA, is a systemic treatment for the most common strains of influenza (types
A and B). Tamiflu is indicated for the treatment of uncomplicated influenza
caused by viruses types A and B in patients one year and older who have had
flu symptoms for no more than two days. Tamiflu is also indicated for the
prevention of influenza in patients one year and older. Tamiflu is not a
substitute for annual early vaccination as recommended by the Centers for
Disease Control and Prevention.



Tamiflu has not been shown to be effective against any illness other
than that caused by influenza types A and B. Efficacy of treatment in
patients with chronic cardiac and/or respiratory disease has not been
established. No difference in the incidence of complications was seen
between the treatment and placebo groups in this population. No information
is available regarding treatment of influenza in patients at imminent risk
of requiring hospitalization. Efficacy of TAMIFLU has not been established
in immunocompromised patients.



Safety and efficacy of repeated treatment or prophylaxis courses have
not been studied. In post-marketing experience, rare cases of anaphylaxis
and serious skin reactions, including toxic epidermal necrolysis,
Stevens-Johnson syndrome and erythema multiforme, have been reported.



There have been postmarketing reports (mostly from Japan) of
self-injury and delirium with the use of Tamiflu in patients with
influenza. The reports were primarily among children.



The relative contribution of the drug to these events is not known.
Patients with influenza should be closely monitored for signs of abnormal
behavior throughout the treatment period.



In treatment studies in adult patients, the most frequently reported
adverse events (incidence greater than or equal to 1%) were nausea and
vomiting. Other events reported numerically more frequently in patients
taking Tamiflu compared with placebo were bronchitis, insomnia and vertigo.
In treatment studies in patients one to 12 years old, the most frequently
reported adverse event (incidence greater than or equal to 1%) was vomiting
(15%). Other events reported more frequently in patients taking Tamiflu
compared with placebo included abdominal pain (5% vs 4%), nosebleed (3% vs
3%), ear disorder (2% vs 1%) and pink eye (1% vs