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 are
diarrhea (32%), nausea (23%), and fatigue (20%).  A safety analysis at 48
weeks showed that the incidence of these three common side effects was less
frequent in patients taking FUZEON-based regimens compared to those who did
not receive FUZEON. 

  FUZEON Receives International Recognition for Innovation
  This FUZEON approval milestone reflects a long history of Roche innovation
in the field of HIV.  Most recently, FUZEON has received the 2004
International Prix Galien award for the most innovative new medicine.  The
award recognizes significant advances in pharmaceutical research, identifying
the most important drugs introduced into the market and the most significant
research team in the pharmaceutical field.  FUZEON was selected out of 12
major new drugs from all therapeutic areas, each of which had won national
awards throughout Europe.  The very first International Prix Galien award was
granted in 1998 to Invirase(R) (saquinavir), Roche’s HIV protease inhibitor,
and Roche is the first company to be honored with this prestigious awarded
twice in the field of HIV.
  “This distinguished award is another testament to Roche’s commitment to
innovation and development of truly novel medicines.  It brings great pride
and motivation to everyone at Roche,” said George B. Abercrombie, president
and CEO, Hoffmann-La Roche.

  Facts About FUZEON

  FUZEON, co-developed by Roche and Trimeris (Nasdaq: TRMS) is also approved
in the European Union, Switzerland and Canada.  Unlike other HIV drugs that
work after HIV has entered the human immune cell, FUZEON works outside the CD4
cell, blocking HIV from entering the cell.  For this reason, FUZEON is
effective in treatment-experienced patients who have developed resistance to
other anti-HIV drugs, though patients may still develop resistance to FUZEON.

  TORO Study Design
  TORO 1 [T-20 (FUZEON) vs. Optimized Regimen Only] and TORO 2 were
randomized, open-label trials that enrolled approximately 1,000 HIV-1 infected
patients at 112 centers internationally.  Patients were treatment-experienced
and/or had documented resistance to each of the other three classes of
anti-HIV drugs.  At entry, resistance testing and patient treatment history
were used together to aid in the selection of an individualized regimen of
three to five anti-HIV drugs for each patient.  After selection of the
regimen, patients were randomized 2:1 to receive either the regimen in
combination with FUZEON (FUZEON arm) or the individualized regimen alone
(control arm).  At baseline, patients had a median HIV RNA level of more than
5.0 log(10) copies/mL, a median CD4 cell count of less than 100 cells/mm(3),
and had been treated with anti-HIV drugs for an average of seven years.

  Injection Site Reactions (ISRs):  ISRs are the most common adverse events
associated with FUZEON.  ISRs occurred in 98% of patients studied and 4%
discontinued FUZEON due to ISRs.  Signs/symptoms may include pain and
discomfort, hardened skin, redness, bumps, itching and swelling.  Eleven
percent of patients had local reactions that required analgesics or limited
usual activities.

  Pneumonia:  An increased rate of bacterial pneumonia was observed in
subjects treated with FUZEON in the Phase III clinical trials compared to the
control arm.  It is unclear if the increased incidence of pneumonia is related
to FUZEON use.  Patients with HIV infection should be carefully monitored for
signs and symptoms of pneumonia.  Risk factors for pneumonia included low
initial CD4 cell count, high initial viral load, intravenous drug use, smoking
and a prior history of lung disease.

  Hypersensitivity Reactions:  Systemic hypersensitivity reactions have been
associated with FUZEON therapy and may recur on rechallenge.  Hypersensitivity
reactions have included individually and in combination: rash, fever, nausea
and vomiting, chills, rigors, hypotension and elevated serum liver
transaminases.  Other adverse events that may be immune mediated and have been
reported in subjects receiving FUZEON include primary immune complex reaction,
respiratory distress, glomerulonephritis and Guillain-Barre syndrome.

  Other Adverse Events:  The events most frequently reported in patients
receiving FUZEON plus an optimized background regimen were diarrhea (32%),
nausea (23%) and fatigue (20%).  These events were seen at a lower incidence
in patients taking a FUZEON-based regimen compared to those receiving an
optimized background regimen without FUZEON when taking into account the
uneven number of patients in each arm and the length of time they are in that
arm.  As measured in number per 100 patient-years, the incidence was:
diarrhea (38 per 100 patient-years in subjects receiving FUZEON-based regimens
vs. 73 per 100 patient-years in patients who did not receive FUZEON), nausea
(27 vs. 50, respectively) and fatigue (24 vs. 38, respectively).

  Roche in HIV
  Roche is at the forefront of efforts to combat HIV infection and AIDS,
committed for 15 years to groundbreaking research and development of new drugs
and diagnostic technology.  The objective is to provide tailored treatment
solutions and an improved standard of care worldwide for those people living
with HIV.