Exhibit 99.1
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TRIMERIS ROCHE
FOR IMMEDIATE RELEASE
Contact: Heather Van Ness
Roche
Phone: (973) 562-2203
Contact: Robin Fastenau
Trimeris, Inc.
Phone: (919) 419-6050
Contact: Mike Nelson
Manning Selvage & Lee
Phone: (212) 213-7620
U.S. FDA Approves FUZEON(TM); First Drug to Block Entry of HIV into Immune Cells
FUZEON leads first new class of anti-HIV drugs since 1996
NUTLEY, N.J., and DURHAM, N.C. (March 13, 2003) - Roche and Trimeris, Inc.
(Nasdaq: TRMS) announced today that FUZEON(TM) (enfuvirtide), a novel treatment
for HIV-1, has been granted accelerated approval by the U.S. Food and Drug
Administration (FDA) following a six-month priority review. 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
analyses of plasma HIV-1 RNA levels and CD4 cell counts in controlled studies of
FUZEON of 24 weeks' duration. Subjects enrolled were treatment-experienced
adults; many had advanced disease. There are no studies of
FUZEON in antiretroviral naive patients. There are no results from controlled
trials evaluating the effect of FUZEON on clinical progression of HIV-1. This
indication is reflective of a policy shift within the anti-viral division at FDA
designed to ensure that indications more closely reflect the patient populations
studied.
FUZEON is the first fusion inhibitor, representing the first new class of
anti-HIV treatments in seven years. Unlike all currently approved anti-HIV
drugs, FUZEON blocks HIV's ability to infect healthy immune (CD4) cells. When
used with other anti-HIV medicines, FUZEON can reduce the amount of HIV in the
blood and increase the number of CD4 cells, which has been shown to slow HIV
progression in patients who have developed resistance to currently available
medications.
"This new fusion inhibitor is a significant breakthrough and its approval
is a milestone event in the HIV epidemic," said Dr. Michael Saag, Director, AIDS
Outpatient Clinic, University of Alabama at Birmingham. "Patients are becoming
resistant to our best therapies and they need new options. This drug attacks the
virus in a new way, so it can work for patients whose virus is resistant to
other therapies." As with any anti-HIV drug, patients can also develop
resistance to FUZEON.
"Almost one million people in the United States are living with HIV/AIDS,
and over 28,000 of those people are living here in New Jersey. Today, thanks to
Roche, whose U.S. headquarters is located right here in Nutley, New Jersey,
there is new hope for these patients [treatment experienced patients with
advanced disease]. Today, the FDA approved FUZEON, the first in a new-class of
HIV drugs called fusion inhibitors. I am extremely proud that Roche, and its
3,000 employees who live and work in New
Jersey, together with their partner Trimeris Inc., are responsible for this
incredible breakthrough in the treatment for HIV/AIDS," said Rep. Bill Pascrell
(D-New Jersey). "New Jersey's AIDS Drug Assistance Program helps provide these
life-sustaining HIV treatments to approximately 3,400 uninsured and underinsured
individuals. In Congress, I've worked and will continue to work towards greater
funding for this important program."
Pivotal Data
The regulatory submission for FUZEON was based on data from two 24-week
Phase III pivotal studies of approximately 1,000 patients, TORO (T-20/FUZEON vs.
Optimized Regimen Only) 1, conducted in North America and Brazil, and TORO 2,
conducted in Europe and Australia. These studies showed that
treatment-experienced patients receiving FUZEON as a part of an optimized
background regimen (individualized combination of anti-HIV drugs) experienced
greater immunologic improvements and were twice as likely to achieve
undetectable plasma levels of HIV (HIV-1 RNA of *400 copies/mL) compared to
patients receiving an individualized regimen alone. In addition, those patients
with two or more active drugs in their background regimen were more likely to
achieve undetectable levels of HIV.
Because of the public health implications, The New England Journal of
Medicine (NEJM) will post the clinical results from the FUZEON TORO 1 study on
its web site, www.nejm.org in advance of publishing the data in an upcoming
issue.
"With FUZEON, what we've essentially done is to take a piece of the virus
and turn it against itself. The safety and efficacy of this new molecule were
demonstrated through two rigorously-designed pivotal studies conducted in a
population of patients
* Less than.
with diverse treatment histories," said Dr. Dani Bolognesi, Chief Executive
Officer, Trimeris. "Together with our partner Roche, Trimeris is proud to bring
this innovative new therapy to the growing number of people with HIV who are in
need of new treatment options."
"FUZEON is yet another example of Roche's long-standing commitment to
advancing the treatment of HIV," said George B. Abercrombie, President and Chief
Executive Officer, North American Pharmaceuticals Operations, Roche. "FUZEON
also represents a major advancement in the large-scale chemical synthesis of
peptides. This cutting edge process has been successfully implemented at the
Roche manufacturing facility in Boulder, Colorado. FUZEON adds an important
dimension to our growing HIV product portfolio and opens the door for a new
treatment paradigm in HIV."
Supply and Distribution of FUZEON
Roche and Trimeris have committed to make FUZEON available for distribution
before the end of March. Because initial demand for FUZEON may exceed supply
following commercial availability, Roche and Trimeris have developed and are now
finalizing a US Progressive Distribution Plan to provide FUZEON to patients and
to ensure uninterrupted supply to patients once they begin therapy. The details
of this US Progressive Distribution Plan will be announced in the near future.
More About FUZEON
FUZEON is administered as a twice-daily subcutaneous injection. Local
injection site reactions were the most frequent adverse events associated with
the use of FUZEON. In Phase III clinical studies, 98 percent of patients had at
least one local injection site reaction. Manifestations of injection site
reactions may include pain and discomfort,
induration, erthyema, nodules and cysts, prurities, and ecchymosis.
There was less than five percent difference in the most common adverse
events seen between FUZEON plus an individualized regimen of antiretroviral
drugs and individualized regimen alone. The events most frequently reported in
subjects receiving FUZEON plus an individualized regimen were diarrhea (26.8%),
nausea (20.1%), and fatigue (16.1%). All these events were seen at a lower
incidence than in subjects that received background regimen alone: diarrhea
(33.5%), nausea (23.7%), and fatigue (17.4%). The most common adverse events
seen more frequently in patients receiving FUZEON plus an individualized regimen
than in patients who received treatment without FUZEON include headache (11.8%),
peripheral neuropathy (8.9%), dizziness (6.6%), insomnia (11.3%), depression
(8.6%), decreased appetite (6.3%), asthenia (5.7%), myalgia (5.0%), constipation
(3.9%) and pancreatitis (2.4%). The majority of adverse events were of mild or
moderate intensity. Hypersensitivity reactions have been associated with FUZEON
therapy (***1 percent) and have recurred on rechallenge. Symptoms of an allergic
reaction may include rash, fever, nausea and vomiting, chills, rigors,
hypotension, and elevated serum transaminases. In addition, an increased rate of
bacterial pneumonia was observed in patients 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.
FUZEON does not cure HIV infection or AIDS. FUZEON does not reduce the risk
of transmission of HIV to others through sexual contact or blood contamination.
Patients should continue to practice safer sex by using latex or polyurethane
condoms or other barrier methods. Never use or share dirty needles. Patients
taking FUZEON may
*** Less than or equal to.
acquire opportunistic infections or other conditions that are associated with
HIV infection. The list of side effects is not complete at this time because
FUZEON is still being studied.
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. Roche's objective is to provide tailored treatment
solutions and an improved standard of care worldwide for people living with HIV.
About Roche
Hoffmann-La Roche (Roche), based in Nutley, N.J., is the U.S. prescription
drug unit of the Roche Group, a leading research-based health care enterprise
that ranks among the world's leaders in pharmaceuticals, diagnostics and
vitamins. Roche discovers, develops, manufactures and markets numerous important
prescription drugs that enhance people's health, well being and quality of life.
Among the company's areas of therapeutic interest are: dermatology;
genitourinary disease; infectious diseases, including influenza; inflammation,
including arthritis and osteoporosis; metabolic diseases, including obesity and
diabetes; neurology; oncology; transplantation; vascular diseases; and virology,
including HIV/AIDS and hepatitis C.
For more information on the Roche pharmaceuticals business in the United
States, visit the company's Web site at: http://www.rocheusa.com.
-more-
About Trimeris, Inc.
Trimeris, Inc. (Nasdaq: TRMS) is a biopharmaceutical company engaged in the
discovery, development and commercialization of novel therapeutic agents for the
treatment of viral disease. The core technology platform of fusion inhibition is
based on blocking viral entry into host cells. FUZEON(TM), just approved by the
FDA, is the first in a new class of anti-HIV drugs called fusion inhibitors. A
Marketing Authorisation Application (MAA) has also been submitted for FUZEON in
the European Union. Trimeris' second fusion inhibitor product candidate, T-1249,
has received fast track status from the FDA and is in Phase I/II clinical
testing. Trimeris is developing FUZEON and T-1249 in collaboration with F.
Hoffmann-La Roche Ltd. For more information about Trimeris, please visit the
company's website at www.trimeris.com.
Trimeris Safe Harbor Statement
This document and any attachments may contain forward-looking information about
the Company's financial results and business prospects that involve substantial
risks and uncertainties. These statements can be identified by the fact that
they use words such as "expect," "project," "intend," "plan," "believe" and
other words and terms of similar meaning. Among the factors that could cause
actual results to differ materially are the following: there is uncertainty
regarding the success of research and development activities, regulatory
authorizations and product commercializations; the results of our previous
clinical trials are not necessarily indicative of future clinical trials; and,
our drug candidates are based upon novel technology, are difficult and expensive
to manufacture and may cause unexpected side effects. For a detailed description
of these factors, see Trimeris' Form S-3 filed with the Securities and Exchange
Commission on September 27, 2002 and its periodic reports filed with the SEC.
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