Exhibit 99.1
[TRIMERIS LOGO APPEARS HERE] [ROCHE LOGO APPEARS HERE]
Contacts:
Maureen Byrne
Roche
Office: 973-562-2203
In Bangkok: 973-980-8140
Maureen.Byrne@roche.com
Bethany Greer
Trimeris, Inc.
(919) 419-6050
bgreer@trimeris.com
Mike Nelson
Manning Selvage & Lee
Office: 212-468-3674
In Bangkok: 917-568-4450
Mike.Nelson@mslpr.com
New Data Finds Fuzeon-Based Therapy Provides Significant Long-Term Benefit
- AIDS Survivor Demonstrates Benefits of HIV Fusion Inhibitor -
BANGKOK, THAILAND (July 12, 2004) - Fuzeon (enfuvirtide), the first and only
fusion inhibitor for the treatment of HIV, durably suppresses HIV and provides
continuous increases in immune (CD4) cells over a period of 96 weeks, according
to new data presented today at the XV International AIDS Conference (IAC). In
another key study finding, more than half of treatment-experienced patients (56
percent) who began using Fuzeon at the outset of the study were successful in
completing 96 weeks of treatment. Additionally, investigators reported no
late-emerging safety issues associated with the long-term use of Fuzeon.
"The new data show that the significant virological and immunological benefits
of Fuzeon seen in earlier analyses are extended to 96 weeks, an especially
notable achievement given the extensive prior drug exposure of patients enrolled
in the TORO studies," said Corklin Steinhart M.D., Senior Attending Physician,
Mercy Hospital, Miami, FL. "It is particularly exciting that more than half of
patients who began treatment with Fuzeon continued on the drug for 96 weeks.
This news, coupled with the positive 96-week safety analysis, should be
encouraging to patients who are considering Fuzeon as a long-term treatment
option."
The high prevalence of HIV drug resistance among patients in the U.S. highlights
the need for newer HIV drugs, like Fuzeon, that are active against
drug-resistant virus. Data recently presented at the XII International Drug
Resistance Workshop, from a large cohort of HIV-infected individuals prescribed
antiretroviral therapy from 2001-2003, showed that four out of five of those
tested had resistance to at least one anti-HIV drug.1 Thirty-nine percent were
found to have resistance to a drug in two classes, and 18 percent had resistance
to a drug in three classes. These data are consistent with previous findings
from a different study recently published in AIDS by Dr. Douglas Richman, which
showed that 76 percent of US patients with measurable viral load in 1996-1998
carried a strain of the virus that is resistant to at least one drug.2
Fuzeon Patient Treated for Three Years Helps Demonstrate Long-Term Efficacy
Richard Apodaca - a 62 year-old AIDS survivor who had exhausted most of his
treatment options and was beginning to lose hope before enrolling in a clinical
trial for Fuzeon more than three years ago - provides evidence that patients can
continue to experience significant long-term benefits from Fuzeon. Richard's
immune cells had dropped into the single digits and his viral load soared into
the millions. A participant in an earlier trial for Fuzeon, Richard began to see
these numbers improve shortly after initiating combination therapy with Fuzeon.
"Four years ago, HIV had decimated my immune system. After beginning treatment
with Fuzeon and other anti-HIV drugs, my viral load became undetectable, and my
CD4 count increased dramatically. Currently my viral load is undetectable and I
have a CD4 count of over 350," said Richard.
Today Richard is leading a full and healthy life. He is an HIV/AIDS advocate who
is involved with the Names Project and collects HIV medications for patients in
developing countries. He has also adopted two African children suffering from
AIDS. Richard is an avid runner who has participated in 13 marathons throughout
the world, including those in New York City, Prague, and Hawaii, all while
continuing to adhere to his Fuzeon-based regimen.
Delayed Initiation of Fuzeon May Compromise Response
The data presented at IAC were from a 96-week analysis of the TORO studies, two
randomized, open-label trials that together enrolled approximately 1,000 HIV
infected patients who had previously been treated with an average of 12
antiretrovirals. Patients were randomized to receive a regimen of anti-HIV drugs
with or without Fuzeon. Patients randomized not to receive Fuzeon were allowed
to add Fuzeon to their regimens after week eight if they met virological failure
criteria or at the 48 week timepoint.
Patients who were randomized to receive a Fuzeon-based regimen had significantly
lower levels of the virus and higher CD4 counts at 96 weeks compared with those
randomized to a regimen without Fuzeon. Patients originally in the non-Fuzeon
control arm who were later switched to Fuzeon (after virological failure) showed
a mean reduction in viral load at week 96 of 1.1 log10copies/mL, compared to a
2.1 log10 copies/mL mean reduction for patients randomized to the Fuzeon arm -
thereby highlighting the potential consequences of delaying the initiation of
treatment with Fuzeon.
Patients in the Fuzeon arm saw continuous improvements in CD4 cells over the
study period,
with the mean CD4 increase from baseline of 166 cells/mm3 at week 96. In
contrast, patients who used Fuzeon after switching from a non-Fuzeon regimen,
experienced a mean increase of 116 cells/mm3 from baseline at week 96.
96-Week Safety
No new safety issues were identified in the 96-week analysis, and there was no
evidence of long-term or cumulative toxicities. Rather, patients in the Fuzeon
arm experienced less diarrhea, nausea and fatigue, side effects often associated
with antiretroviral therapy. Injection site reactions, which were found to not
increase in severity over 96 weeks, are the most common adverse event associated
with use of Fuzeon.
Adherence to Fuzeon-Based Regimens at 48 Weeks
In a separate poster presentation at IAC, adherence to Fuzeon-based regimens was
found to be high, and similar to adherence rates among patients taking a regimen
of oral drugs only. Furthermore, adherence to Fuzeon-based regimens was not
influenced by baseline disease status, treatment history or prior intravenous
drug use.
For more information on Fuzeon, patients and physicians can visit www.Fuzeon.com
or call 1-877-4FUZEON.
Facts About FUZEON
Fuzeon was granted accelerated approval on the basis of 24-week data by the U.S.
Food and Drug Administration in March 2003, and is also approved in the European
Union, Switzerland and Canada. Fuzeon leads the first class of anti-HIV drugs
with a unique mechanism of action to be introduced in seven years. 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.
Fuzeon (enfuvirtide) 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.
Injection Site Reactions (ISRs): ISRs are the most common adverse events
associated with Fuzeon. In two controlled Phase III studies at 24 weeks, TORO 1
and TORO 2, 98 percent of patients had at least one local injection site
reaction. Signs/symptoms may include pain and discomfort, induration, erythema,
nodules and cysts, pruritus, and ecchymosis. Nine 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: 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 (26.8%), nausea
(20.1%) and fatigue (16.1%). These events were seen at a lower incidence than in
patients receiving an optimized background regimen without Fuzeon: diarrhea
(33.5%), nausea (23.7%) and fatigue (17.4%). This list of side effects is not
complete 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. The objective is to provide tailored treatment solutions
and an improved standard of care worldwide for those people living with HIV.
Roche and Trimeris are working together to discover, develop and commercialize
the next generation of HIV fusion inhibitors.
About Roche
Hoffmann-La Roche Inc. (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 and diagnostics. 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.
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, approved in the U.S.,
Canada and European Union, is the first in a new class of anti-HIV drugs called
fusion inhibitors. Trimeris is developing Fuzeon and future generations of
peptide fusion inhibitors in collaboration with F. Hoffmann-La Roche Ltd. For
more information about Trimeris, please visit the Company's website at
http://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," "anticipate", "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 10-K filed with the
Securities and Exchange Commission on March 12, 2004 and its periodic reports
filed with the SEC.
1 Smith, A.J., et. al. "Prevalence of Mutations Associated with
Antiretroviral Drug Resistance in a Cohort of Treated Individuals in Four
Cities." Antiviral Therapy 2004; 9S112.
2 Richman,D. et. al. "The Prevalence of Antiretroviral Drug Resistance in
the United States." AIDS Vol. 18, July 2004: 1393-1401.
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