Genentech Announces FDA Approval of Tamiflu for the Treatment of Influenza in Infants

  Genentech Announces FDA Approval of Tamiflu for the Treatment of Influenza
  in Infants

-- First Medicine Approved to Treat Influenza in Infants Two Weeks of Age and
                                   Older --

Business Wire

SOUTH SAN FRANCISCO, Calif. -- December 21, 2012

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today
announced that the U.S. Food and Drug Administration (FDA) has extended the
approval of Tamiflu^® (oseltamivir phosphate) for the treatment of acute,
uncomplicated influenza to include infants two weeks of age and older.^i
Tamiflu is prescribed by doctors to help lessen the duration and severity of
influenza by blocking the virus’ ability to replicate in the body.

The approval makes Tamiflu the only prescription oral antiviral medicine
approved to treat people of all ages, from infants two weeks of age to elderly
people. Tamiflu was first approved in the United States over 13 years ago.^i
Approximately 30 million children worldwide over the age of one, including an
estimated 6.9 million children in the United States, have received a
prescription for Tamiflu.^ii

“We are very pleased that this approval providesparents witha medicine for
children as young as two weeks old, particularly becausethe CDC advises
against vaccinatinginfants less than six monthsof age,” said Hal Barron,
M.D., chief medical officer and head, Global Product Development.

The FDA approval is based on two open label safety and pharmacokinetic studies
conducted in 136 infants less than one year of age infected with influenza,
which assessed how Tamiflu was absorbed and distributed in the body and how
well it was tolerated in this group.^i Based on these studies, a 3 mg/kg dose
of Tamiflu given twice daily for five days to infants is expected to have a
similar safety and efficacy profile to that observed in older children and
adults. The clinical trials showed that the safety profile in infants less
than one year of age was consistent with other populations.

About Tamiflu

Tamiflu, co-developed by Gilead Sciences Inc, works by blocking the action of
the neuraminidase enzyme on the surface of the influenza virus. When
neuraminidase is inhibited, the virus is restrained from spreading to other
cells in the body.

Tamiflu is indicated for the treatment of acute, uncomplicated illness due to
influenza infection in people two weeks of age and older who have been
symptomatic for no more than two days. Tamiflu is also indicated for
preventing influenza in patients one year and older. Tamiflu is not indicated
for preventing influenza in children younger than one year of age. Tamiflu is
not a substitute for the annual influenza vaccination.

Important Safety Information

Before taking Tamiflu, patients should tell their doctor if they are pregnant
or nursing, or if they have kidney disease, heart disease, respiratory
disease, or other serious health conditions. Also, patients should let their
doctor know if they are taking any other medications or if they have received
nasally administered influenza virus vaccine during the past two weeks.

If patients develop an allergic reaction or a severe rash, they should stop
taking Tamiflu and contact their healthcare professional immediately, as it
may be very serious. People with the flu, particularly children and
adolescents, may be at an increased risk of seizures, confusion, or abnormal
behavior early during their illness. These events may occur shortly after
beginning Tamiflu or may occur when flu is not treated. These events are
uncommon but may result in accidental injury to the patient. Therefore,
patients should be observed for signs of unusual behavior and a healthcare
professional should be contacted immediately if the patient shows any signs of
unusual behavior.

The most common side effects of TAMIFLU when used for treatment of influenza
include nausea and vomiting.

The most common side effects of TAMIFLU when used for prevention of influenza
include nausea, vomiting, diarrhea, and stomach (abdomen) pain.

Report side effects to the FDA at (800) FDA-1088 or

Patients and caregivers may also report side effects to Genentech at (888)

For additional important safety information, please visit

About Genentech

Founded more than 30 years ago, Genentech is a leading biotechnology company
that discovers, develops, manufactures and commercializes medicines to treat
patients with serious or life-threatening medical conditions. The company, a
member of the Roche Group, has headquarters in South San Francisco,
California. For additional information about the company, please visit


^i Tamiflu® (oseltamivir phosphate) Prescribing Information. December 21, 2012
^ii Roche Data on File


Media Contact:
Tara Iannuccillo, 650-467-6800
Investor Relations:
Thomas Kudsk Larsen, 650-467-2016
Karl Mahler, 011 41 61 687 8503
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