The first and only fusion inhibitor for the treatment of HIV

Roche and Trimeris, Inc. today announced that the U.S. Food and Drug
Administration (FDA) has granted traditional approval to FUZEON(R)
(enfuvirtide), the first and only fusion inhibitor for the treatment of HIV.

The FDA granted accelerated approval to FUZEON on the basis of 24-week data in
March 2003; accelerated approval is a special regulatory status designed to
expedite the approval of therapies for serious or life-threatening illnesses
which provide meaningful benefit to patients over existing treatments.

The
traditional approval of FUZEON was based on results from Phase III clinical
trials over 48 weeks which confirmed the durable efficacy and safety of
FUZEON-based regimens.
"The 48-week data confirm that enfuvirtide-based regimens substantially
improve virologic and immunologic outcomes in treatment experienced patients
after approximately one year of therapy. Forty-six percent of patients on
enfuvirtide-based regimens achieved a significant reduction in HIV levels,
compared to 18 percent of patients taking previous standard of care
regimens.(1) These strong results establish enfuvirtide as an invaluable
component of therapy for triple-class experienced patients who require a
change in regimen," said Joel Gallant, M.D., M.P.H., Associate Professor of
Medicine and Epidemiology, Division of Infectious Diseases, The Johns Hopkins
University School of Medicine, Baltimore, Maryland.
"The traditional approval of FUZEON further confirms its importance as a
crucial option for treatment-experienced HIV patients," said Steven D.
Skolsky, CEO, Trimeris. "Together with our partner Roche, Trimeris is proud
to reach this important milestone for FUZEON. The significance of this
milestone is further reinforced by data recently presented at the XV
International AIDS Conference (IAC), which show that FUZEON is not only
potent, but durable over 96 weeks."
FUZEON in combination with other antiretroviral agents is indicated for
the treatment of HIV-1 infection in treatment-experienced patients with
evidence of HIV-1 replication despite ongoing antiretroviral therapy. This
indication is based on results from two controlled studies of 48 weeks
duration. Subjects enrolled were treatment-experienced adults; many had
advanced disease. There are no studies of FUZEON in antiretroviral naove
patients.
Injection site reactions are the most common adverse event associated with
FUZEON use. Other common side effects occurring in patients taking FUZEON arediarrhea (32%), nausea (23%), and fatigue (20%). A safety analysis at 48weeks showed that the incidence of these three common side effects was lessfrequent in patients taking FUZEON-based regimens compared to those who didnot receive FUZEON.