|
NUTLEY, N.J., and MORRISVILLE, N.C., Nov. 23 /PRNewswire-FirstCall/ --
Roche and Trimeris (Nasdaq: TRMS) announced that today the companies have
received an approvable letter from the U.S. Food and Drug Administration
(FDA), in response to their request for inclusion of information about the
Biojector(R) 2000 (B2000) needle-free injection device in the FUZEON(R)
(enfuvirtide) labeling. In the approvable letter, FDA has requested additional
information from the ongoing ENF-404 or WAND (With A Needle-Free Device)
study, a randomized, open-label, two-way, cross-over study assessing the
tolerability of the B2000 device for administration of FUZEON.
The B2000, made by Bioject Medical Technologies Inc., is a needle-free,
CO2-powered injector that disperses liquid medication beneath the skin.
FUZEON is the first and only entry inhibitor available for the treatment of
HIV and is currently approved for administration with a needle and syringe.
Roche and Trimeris filed a supplemental New Drug Application (sNDA) in May
2005 based on data from the T20-405 study, a single-dose pharmacokinetic study
of FUZEON administered by a nurse via the B2000 needle-free device, compared
to standard needle-syringe administration. In August 2005, Roche and Trimeris
announced the initiation of the FUZEON WAND (With A Needle-Free Device, or
ENF-404) study, an eight-week trial designed to assess patient acceptance and
experience of FUZEON administration via the B2000 needle-free device compared
to the standard needle and syringe. The primary endpoints of this study are
tolerability and injection site reactions. This trial is currently enrolling
and final data are expected in the second half of 2006.
Healthcare providers and patients can call Roche/Trimeris at 877-4FUZEON
(877-438-9366) or visit http://www.clinicaltrials.gov for details regarding
participation in the FUZEON WAND study.
Facts About FUZEON
FUZEON is the first and only fusion inhibitor for the treatment of HIV.
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 was granted accelerated approval by the
U.S. Food and Drug Administration (FDA) in March 2003 on the basis of 24-week
data, and was granted traditional (full) approval on Oct. 15, 2004 on the
basis of long-term 48-week data.
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. Roche and Trimeris are working together to discover, develop
and commercialize the next generation of HIV fusion inhibitors.
About Roche - More Than a Century in the U.S. and the World
Founded in 1896 and headquartered in Basel, Switzerland, Roche is one of
the worlds leading innovation-driven healthcare groups. Its core businesses
are pharmaceuticals and diagnostics. Roche is one of the worlds leaders in
diagnostics, the leading supplier of pharmaceuticals for cancer, as well as a
leader in virology and transplantation. As a supplier of products and
services for the prevention, diagnosis and treatment of disease, the Group
contributes on many fronts to improve peoples health and quality of life.
Roche employs roughly 65,000 people in 150 countries, including approximately
15,000 in the United States.
Roches U.S. operations celebrate their American Centennial in 2005. In
another milestone this year, Roche was named in January to Fortune magazines
list of Best Companies to Work for in America. One of an increasingly rare
breed of major healthcare companies that still bear their original name, Roche
today has more than a dozen U.S. sites located in California, Colorado,
Indiana, New Jersey and South Carolina, as well as in Puerto Rico. Roche has
alliances and research and development agreements with numerous partners,
including majority ownership interests in Genentech and Chugai. Roches
Pharmaceuticals Division offers a portfolio of leading medicines in
therapeutic areas including cancer, HIV/AIDS, hepatitis C, transplantation,
dermatology and influenza. Roches Diagnostics Division supplies a wide array
of innovative testing products and services to researchers, physicians,
patients, hospitals and laboratories world-wide. For further information,
please visit our worldwide and U.S. Web sites (Global: http://www.roche.com
and U.S.: http://www.roche.us). For more information on the Roche
pharmaceuticals business in the United States, visit the companys 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 companys
Web site at http://www.trimeris.com.
Trimeris Safe Harbor Statement
This document and any attachments may contain forward-looking information
about the Companys 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 10-K filed with the
Securities and Exchange Commission on March 11, 2005 and its periodic reports
filed with the SEC.
About Bioject Medical Technologies Inc.
Bioject Medical Technologies Inc., based in Bedminster, New Jersey, and
Portland, Oregon, is an innovative developer and manufacturer of needle-free
drug delivery systems. Needle-free injection works by forcing medication at
high speed through a tiny orifice held against the skin. This creates a fine
stream of high-pressure fluid penetrating the skin and depositing medication
in the tissue beneath. The Company is focused on developing mutually
beneficial agreements with leading pharmaceutical, biotechnology, and
veterinary companies.
|
|
