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Fuzeon (T-20) Distribution Program and New T-20 Information
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This paper contains two Press Releases from Roche and Trimeris announcing
new
48 week preliminary data fron T-20 studies, the T-20 distribution program
(how patients will get T-20), and manufacturing and pricing information
regarding T-20. At the end of this report, after the Press Releases, you
will
find instructions intended for doctors on how they can get T-20 for their
patients. The drug will be supplied on a first come first served basis for
now due to supply and manufacturing limits. Forms can be filled out and sent
by doctors to Roche. This process and how to get the forms are explained
below.
Roche Press Releases
Roche and Trimeris Announce U.S. FUZEON (enfuvirtide)
Progressive Distribution and Support Programs
NUTLEY, N.J., and DURHAM, N.C. (March 20, 2003) - Roche and Trimeris, Inc.
(Nasdaq: TRMS) today announced details of the U.S. FUZEON (enfuvirtide)
Progressive Distribution Program (PDP). Although significant progress has
been made in manufacturing FUZEON, the most complex pharmaceutical molecule
ever manufactured on a large scale, production is still not at full
capacity.
It is expected that demand will exceed the initial available supply. The
PDP is designed to make FUZEON available to as many patients as possible,
and
to ensure uninterrupted access to the drug during this period of limited
supply.
Essential components of the PDP include: single-source distribution of
FUZEON via Chronimed/StatScript Pharmacy; a Reimbursement Assistance Program
to help patients access funding support, and the FUZEON Patient Assistance
Program.
Roche and Trimeris anticipate being able to provide FUZEON progressively
throughout the year. During this time of limited availability, Roche and
Trimeris have placed the highest priority on providing FUZEON to the
greatest number of patients quickly and equitably. As supplies of FUZEON
increase in 2004 and beyond, the PDP will transition into a more
conventional
method of distribution.
"I am proud to have the Roche facility in my District manufacturing this
breakthrough treatment for HIV/AIDS. This remarkable facility is working 24
hours per day, 7 days a week to produce Fuzeon," stated Congressman Mark
Udall (CO, 2nd District). "With over 8,700 Colorado residents among the
800,000 to 900,000 people living with HIV, this effort to manufacture a
highly complex drug offers real hope and opportunity for treatment
progress."
"FUZEON marks another important step forward in treatment of HIV/AIDS,
bringing hope to treatment experienced people fighting this disease," said
Congressman David Price. "I'm proud that the 4th Congressional District of
North Carolina is home to Trimeris, the company that discovered this
important new therapy, and I'm optimistic that we will continue to work
together to make the latest medical technology available to everyone who
needs it."
Progressive Distribution Program (PDP)
The FUZEON PDP will function as the single-source of distribution for FUZEON
during the initial period of limited supply. The FUZEON PDP will receive
FUZEON prescriptions from physicians via telephone, mail and fax and will
ship drug to patients or prescribing physicians, including those affiliated
with federal and state drug assistance programs. Prescriptions will be
processed on a first-come, first-served basis as they are received from
physicians. All aspects of distribution of FUZEON will be managed in
accordance with federal law. Roche and Trimeris will have no access to
confidential patient information. For more information about FUZEON or the
FUZEON PDP, physicians can call 1-866-694-6670 or visit www.fuzeon.com.
Pricing
The Roche Wholesale Acquisition Cost (WAC) for FUZEON will be just under
$20,000 for a one year's supply (12 kits).
PDP Support Programs
Reimbursement support will be an important part of providing FUZEON to those
in need. Therefore, Roche and Trimeris are implementing several support
programs for patients and healthcare providers. For example, a
Reimbursement Assistance Program will be staffed by specialists who guide
patients through the reimbursement process. In addition, patients may be
considered for reimbursement through the FUZEON Patient Assistance Program.
Roche and Trimeris will also work with other private and public payors,
including U.S. AIDS Drug Assistance Programs (ADAPs), to obtain formulary
inclusion and reimbursement for FUZEON.
To assist patients and healthcare providers with patient education,
adherence
counseling and support programs, a wide variety of services are available.
Included are a Nursing Hotline 1-877-4-FUZEON (1-877-438-9366), which is
available 24 hours a day, seven days a week, and educational materials in
English and Spanish.
For more information on FUZEON, please see accompanying Fact Sheet (see
below).
Preliminary 48-Week Results Show Longer Term Response in HIV Patients
Treated
With FUZEON' (enfuvirtide), First Fusion Inhibitor
EU Regulatory Authority Issues Positive Opinion on FUZEON
NUTLEY, N.J., and DURHAM, N.C. (March 20, 2003) - Roche and Trimeris, Inc.
(Nasdaq: TRMS) today announced top-line details of preliminary 48-week data
from the combined Phase III studies of FUZEON' (enfuvirtide) referred to in
a positive opinion adopted by the European Committee for Proprietary Medicinal
Products (CPMP) recommending marketing authorization for FUZEON in the EU.
With the CPMP's positive opinion, FUZEON will now be considered for approval
by the European Commission. FUZEON was approved by the U.S. Food and Drug
Administration (FDA) last week. Submissions for marketing authorization
have
also been made in Australia, Canada and Switzerland.
At the request of Health Authorities a preliminary analysis of the combined
TORO 1 and 2 studies has been conducted at week 48 to determine the
durability of response to FUZEON. The preliminary 48 week analysis shows
that patients taking FUZEON in combination with an individualized regimen of
anti-HIV drugs continue to show a significantly greater reduction in HIV to
below detection of less than 400 copies/ml (30 percent) compared to the
individualized regimen only control arm (12 percent). In addition, 80
percent of patients in the FUZEON-containing arm who achieved a reduction in
HIV to below detection at 24 weeks maintained this response at 48 weeks.
Significantly fewer patients on the control arm achieved a reduction in HIV
to below detection by week 24, and of these 68 percent maintained this
response at week 48. These longer-term results build upon the positive
24-week results that were presented at the International AIDS Conference in
July 2002.
"This preliminary data is encouraging. There is a tremendous need for new
HIV therapies to combat the virus in new ways," said Dr. Joseph Eron,
Associate Professor of Medicine, University of North Carolina, Chapel Hill.
Roche and Trimeris are planning to present the full and final 48-week
results
at an upcoming international HIV conference. While it is possible that
there
may be some differences between these preliminary results and the final
analysis of the full 48-week data, these preliminary results appear to
confirm the 24-week results.
Study Design
TORO 1 (T-20 vs. Optimised Regimen Only) and TORO 2 are randomized,
open-label trials that enrolled approximately 1,000 patients at 112 centers
internationally. Patients in the trials were treatment-experienced and/or
had
documented resistance to each of the three classes of currently available
antiretrovirals. In addition, each patient was required to have a HIV level
of greater than 5,000 copies/mL.
At entry, genotypic and phenotypic resistance testing was used to aid in the
selection of an antiretroviral regimen, consisting of three to five drugs,
including if appropriate, up to two newly approved or investigational drugs.
After selection of the regimen, patients were randomized 2:1 to receive
either the regimen in combination with FUZEON or the regimen alone.
Patients
randomized to FUZEON receive FUZEON administered as one 90 mg subcutaneous
self-injection twice-daily.
More About FUZEON
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.
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,
erythema, nodules and cysts, pruritus, 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 (less
than or equal to 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 contami
nation. 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 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 company
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; in
flammation, 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, just
approved by the FDA, is the first in a new class of anti-HIV drugs called
fusion inhibitors. A Marketing Authorization 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.
The Fuzeon (T-20) Distribution Program
This letter is being distributed by Roche and Trimeris to doctors.
Roche and Trimeris are pleased to announce the recent approval of FUZEON
(enfuvirtide) by the US Food and Drug Administration (FDA) and details of
the
FUZEON Progressive Distribution Program. The FUZEON Progressive Distribution
Program is designed to make FUZEON available to as many patients as possible
and to ensure uninterrupted access to the drug during a potential period of
limited supply. FUZEON, requiring more than 100 steps in its production
process, is one of the most challenging and complex molecules ever
chemically
manufactured at commercial scale. FUZEON'S complex manufacturing process and
the anticipated limited supply have prompted the decision to allocate a
safety supply of FUZEON for patients who initiate therapy to help ensure
continuous treatment. Roche and Trimeris anticipate being able to provide
FUZEON progressively through the year, expanding the available supply in
2004
and beyond.
How FUZEON Will Be Distributed
To maximize patient access to FUZEON and manage the supply efficiently while
it is limited, the FUZEON Progressive Distribution Program will serve as a
single point of access for FUZEON. Allocation of FUZEON will be made on a
first-come, first-served basis. The FUZEON Progressive Distribution Program
can receive prescriptions from physicians via fax and will ship FUZEON to
the patient's or the prescribing physician's delivery point of choice. To
enroll a patient in the FUZEON Progressive Distribution Program-simply
complete the attached patient enrollment form and fax it to 1-877-428-9520.*
The form is available through your doctor
1. Physicians interested in prescribing FUZEON (enfuvirtide, a/k/a T-20) for
their patients or who would like more information about FUZEON or the FUZEON
Progressive Distribution Program can call 1-866-694-6670 or visit
www.FUZEON.com. If you have any additional questions, please contact your
FUZEON Sales Specialist 1-866-694-6670.
2. The prescribing physician faxes the patient's prescription enrollment
form
to the FUZEON Progressive Distribution Program at 1-877-428-9520
3. The prescription enrollment form is processed as it is received
4. A 30-day supply of FUZEON and injection supplies is shipped in a
convenience pack to the patient's home, their physician's office or a local
StatScript pharmacy
If you or your office staff have questions, or for more information about
FUZEON, please contact your FUZEON Sales Specialist or call 1-866-694-6670.
* For information about obtaining FUZEON for patients cared for in the
Department of Veterans Affairs/VA medical system, please see
http://vaww.vhaco.va.gov/phshcg/ or contact your VA facility's clinician or
coordinator.
If you wish to have your fax number removed from the AMA's Physician Fax
Database call 1-800-621-8335.
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