Basel, 28 May 2003
European Commission approves Fuzeon, first HIV-fusion
inhibitor, for use in the fight against HIV Go-ahead for Fuzeon in
Europe following the recent FDA approval
Roche and Trimeris announce today that the European Commission has
approved the groundbreaking anti-HIV drug Fuzeon (enfuvirtide, formerly
known as T-20) for use in the European Union. Fuzeon is the first in a new
class of anti-HIV medication, known as ‘fusion inhibitors’; this is the
first new class of HIV therapy to be approved since 1996. Fuzeon has been
developed jointly by Roche and Trimeris Inc.
Fuzeon attacks HIV in a totally different way compared to existing HIV
medications. Fuzeon blocks the fusion of HIV with human cells while
existing drugs act once the cell is infected. As a result of the very
different mechanism of action, Fuzeon is active against HIV strains that
have become resistant to current therapies.
"It was twenty years ago this year that HIV was identified as the
causative agent of AIDS" said Mr. William Burns, Head of Roche
Pharmaceuticals. "Over the last two decades there have been significant
advances in the treatment of HIV, however the virus continues to try to
outsmart us. The approval of Fuzeon by the European Medicines Evaluation
Agency today represents a landmark advance in the fight against HIV,
bringing with it new hope for HIV-infected people living in Europe."
"For me and my colleagues at Trimeris, who have seen Fuzeon from its
discovery to becoming a therapeutic option, today's announcement of the
European approval is a moment of great excitement" said Dr. Dani
Bolognesi, CEO of Trimeris Inc. "The rapid European approval demonstrates
the clinical benefit and favorable safety profile of Fuzeon shown in the
two pivotal phase III studies as well as the compelling need for this new
therapy."
Clinical 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. Optimised 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 optimised
background regimen (individualised 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 individualised regimen alone. In
addition, those patients with less advanced disease and two or more active
drugs in their background regimen were more likely to achieve undetectable
levels of HIV. Preliminary 48-week data was also provided to the European
Authorities in support of the approval of Fuzeon. The final 48-week data
will be presented at an international AIDS conference later this year.
“When I was diagnosed with HIV I thought that my life had come to an
end. I was the first patient in the UK to be enrolled in a Fuzeon study,
at a time when my treatment options had become limited. I now feel
extremely positive about my future and I am pleased, following today’s
announcement, that other HIV positive patients across Europe are now able
to benefit from this new class of drugs”, said James Locke, a HIV-patient
who was first diagnosed in 1984.
Fuzeon indication The indication for Fuzeon in the European
Union is for “use in combination with other antiretroviral medicinal
products for the treatment of HIV-1 infected patients who have received
treatment with and failed on regimens containing at least one medicinal
product from each of the following antiretroviral classes, protease
inhibitors, non-nucleoside reverse transcriptase inhibitors and nucleoside
reverse transcriptase inhibitors, or who have intolerance to previous
antiretroviral regimens. In deciding on a new regimen for patients who
have failed an antiretroviral regimen, careful consideration should be
given to the treatment history of the individual patient and the patterns
of mutations associated with different medicinal products. Where
available, resistance testing may be appropriate.” The European Union
approval announcement follows the granting of a positive opinion in March
by the Committee for Proprietary Medicinal Products. The Food and Drug
Administration (FDA) approved Fuzeon in March in the United States and the
approval in Switzerland, which was announced last week. Submissions for
marketing authorisations have also been made in Australia and Canada.
Safety of 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 the TORO
studies, 98 percent of patients had at least one local injection site
reaction. In this treatment-experienced patient population, 3 percent of
patients at 24 weeks discontinued treatment with Fuzeon as a result of
injection site reactions. An increased rate of some bacterial
infections, primarily pneumonia, was seen in patients treated with Fuzeon.
It is unclear if this increased incidence is related to Fuzeon use. The
addition of Fuzeon to background antiretroviral therapy generally did not
increase the frequency or the severity of the majority of adverse
reactions. The majority of adverse reactions were of mild or moderate
intensity. Hypersensitivity reactions have occasionally been associated
with Fuzeon therapy and in rare cases have recurred on re-challenge.
Fuzeon – Supply and Access There is a significant and growing
need for new antiretrovirals that are active against strains of HIV that
are resistant to the currently available medications. As Fuzeon represents
the first new class of HIV therapy to be introduced since 1996, there is
likely to be a considerable demand for the drug which may exceed initial
supplies. In view of the potential for demand to exceed supply, Roche and
Trimeris will carefully manage available drug to ensure that people who
initiate therapy have uninterrupted supply. Increased access to Fuzeon
will be in step with increased supply output. Significant investments have
been made and will be further committed to increase capacity for Fuzeon
production, which is expected to be fully realized early in 2004. Roche
undertake to work diligently with local reimbursement bodies and health
care providers to ensure the widest possible access for patients with drug
resistant HIV. Fuzeon is expected to be launched in individual countries
across Europe over the next few months.
Notes:
Resistance to HIV drugs It is estimated that in a single
untreated person the virus can mutate to form around a billion new and
potentially different versions of HIV every day. The incidence of drug
resistant HIV among already treated patients is increasing at a disturbing
rate. It was recently reported in one study that up to 50 percent of
patients in North America are infected with a strain of the virus that has
developed resistance to one or more anti-HIV drug.
Roche in HIV Roche is at the forefront of efforts to combat
HIV infection and AIDS, committed since 1986 to groundbreaking research
and development of innovative new drugs and diagnostic technology.
Saquinavir was the first Protease Inhibitor (PI) and was first introduced
by Roche in 1995 in the US.
As a consequence of Roche's continuous research and development, the
combination of boosted saquinavir with ritonavir (1000/100 mg twice daily)
has shown encouraging results in the MaxCmin 1 trial with high efficacy
and an excellent safety and tolerability profile. Saquinavir/r was
approved in the EU in August 2002. Viracept (nelfinavir), a leading PI is
supplied by Roche outside the US and Canada. In first-line HIV therapy,
Viracept delivers consistent long-term efficacy and safety. When used
first line, Viracept also allows the subsequent use of both NNRTIs and
other PIs for most patients due to its unique resistance pattern. Fuzeon
and T-1249 are being co-developed by Roche and Trimeris.
The viral load measurements in the clinical trials for Fuzeon were
performed using the AMPLICOR HIV-1 MONITOR® TEST, version 1.5. This test
from Roche Diagnostics is considered to be a highly sensitive measurement
of the amount of HIV circulating in a patient’s blood (“viral load”). With
a limited number of treatment regimens available, the accurate monitoring
of viral load levels is essential to establish and monitor the
effectiveness of therapeutic regimens and assess the potential onset of
drug resistance.
Roche is a committed partner of the Accelerating Access Initiative to
increase access to HIV care in sub-Saharan Africa and the world's Least
Developed Countries. For more information on Roche policy and pricing of
HIV protease inhibitors for these regions and research in HIV, visit http://www.roche-hiv.com/.
About Roche Headquartered in Basel, Switzerland, Roche is one
of the world’s leading innovation-driven healthcare groups. Its core
businesses are pharmaceuticals and diagnostics. Roche is number one in the
global diagnostics market and is the leading supplier of pharmaceuticals
for cancer and 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 a broad range of fronts to improving
people’s health and quality of life. Roche employs roughly 62,000 people
in 150 countries. The Group has alliances and research and development
agreements with numerous partners, including majority ownership interests
in Genentech and Chugai.
All trademarks used or mentioned in this release are
legally protected.
About Trimeris Trimeris, Inc. (Nasdaq: TRMS) is a
biopharmaceutical company engaged in the discovery, development and
commercialisation 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, recently approved by the FDA
and now in the European Union, is the first in a new class of anti-HIV
drugs called fusion inhibitors. 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 Roche. For more information about Trimeris, please
visit the company’s website.
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 authorisations and product commercialisations; 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 27, 2003
and its periodic reports filed with the SEC.
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