AMEVIVE is the first biologic treatment approved for psoriasis
CAMBRIDGE, Mass., Jan. 31 /PRNewswire-FirstCall/--
Biogen, Inc. (Nasdaq: BGEN) today announced that the U.S. Food and Drug
Administration (FDA) has approved AMEVIVE(R) (alefacept) for the treatment of
adult patients with moderate-to-severe chronic plaque psoriasis who are
candidates for systemic therapy or phototherapy.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
http://www.newscom.com/cgi-bin/prnh/20030131/NEF007 )
Psoriasis is an autoimmune skin disease in which skin cells multiply 10
times faster than the normal rate. The excess cells pile up on the skin's
surface, forming red, raised, scaly plaques that can be painful and
disfiguring. Psoriasis affects about 80 million people worldwide and 4.5
million U.S. adults. Approximately 1.5 million U.S. psoriasis patients suffer
from moderate-to-severe disease. According to a survey conducted by the
National Psoriasis Foundation (NPF), one-third of these patients reported they
were dissatisfied with current therapies.
Kenneth Gordon, M.D., Department of Dermatology, Northwestern University,
and AMEVIVE clinical investigator, said, "AMEVIVE is unique because it seems
to have a long-lasting effect. In our clinical trials, patients took the
medication for 12 weeks and then stopped treatment for several months. During
this time off treatment, many of our patients had prolonged remission of their
disease. A number of my patients have told me that AMEVIVE has made a real
difference in their lives, giving them more confidence and allowing them to
enjoy their favorite activities again."
James C. Mullen, Biogen's Chairman and Chief Executive Officer, said, "The
availability of AMEVIVE is important because it offers a unique treatment
option with the potential to provide patients with months free from both
psoriasis and its treatment. For the last 15 years, Biogen has committed
itself to the research and development of AMEVIVE. We are proud to offer new
hope for people with moderate-to-severe psoriasis."
Gail M. Zimmerman, President and CEO of the National Psoriasis Foundation
said, "Many people in the public mistakenly think that psoriasis is a mild
disease, a dandruff problem. It is far from that for many people. It can be
emotionally and physically debilitating. AMEVIVE represents a new class of
drugs that probably represents one of the biggest advances for psoriasis in 20
years. This is exciting news for people with psoriasis."
AMEVIVE must be administered under the supervision of a physician.
AMEVIVE induces dose-dependent reductions in CD4+ and CD8+ T-lymphocyte
counts. CD4+ T-lymphocyte counts should be monitored weekly during the 12-
week dosing period and used to guide dosing. AMEVIVE is an immunosuppressive
agent and could increase the risk of malignancies or infections. Adverse
events commonly observed in the first course of placebo-controlled clinical
trials with at least 2 percent or higher incidence in patients treated with
AMEVIVE compared to those treated with placebo were: pharyngitis, dizziness,
increased cough, nausea, pruritus, myalgia, chills, injection site pain,
injection site inflammation and accidental injury.
People with mild psoriasis can often control their disease with topical
agents, but more than one million patients with moderate-to-severe psoriasis
worldwide require ultraviolet or systemic therapies. AMEVIVE is a systemic
therapy that works by helping to rebalance the overactive cells in the immune
system that cause psoriasis. These cells, called T cells are the "messengers"
of disease in psoriasis and other autoimmune disorders. AMEVIVE is designed
to reduce the number of these disease-causing cells. As measured in the Phase
III clinical trials, PASI score improvement correlated with a reduction in T
cells, confirming the importance of targeting them to control the disease.
More than 1,000 patients at 100 sites in the United States, Europe and
Canada were enrolled in the Phase III clinical trials, which were conducted as
double-blind, placebo-controlled studies. Patients in the trials were aged
16-84 years with chronic plaque psoriasis that covered at least 10 percent of
their total body surface area.
AMEVIVE will be available on Monday, February 3, 2003 via two distribution
options: direct distribution to a physician's office or a specialty pharmacy.
Both options can be reached through the toll free number 1-866-AMEVIVE.
Physicians will administer AMEVIVE to patients in their office as a 12-week
course of IM or IV formulations. AMEVIVE for intramuscular injection contains
15mg alefacept per 0.5 mL of reconstituted solution. AMEVIVE for intravenous
injection contains 7.5 mg alefacept per 0.5 mL of reconstituted solution.
Acquisition price will range from approximately $7,000-$10,000 per course
depending on dosing. Average Wholesale Price (AWP) will be set by Redbook and
First Data Bank and should be available next week. AMEVIVE may be reimbursed
as a medical or a pharmacy benefit depending upon a patient's insurer.
Physicians will be able to obtain delivery of AMEVIVE directly to their
offices regardless of a patient's insurance coverage profile.
Information about AMEVIVE, including prescribing information, and its
comprehensive support services, will be available through a single toll-free
number (1-866-AMEVIVE), and via http://www.amevive.com. Services for AMEVIVE include
patient and healthcare provider support; reimbursement support; logistics; and
the award-winning website http://www.psoriasissupport.com.
About Biogen
Biogen is the world's oldest independent biotechnology company and a
leader in biologics research, development and manufacturing. A pioneer in
leading edge research in immunology, neurobiology and oncology, Biogen brings
novel therapies to improve patients' lives around the world through its global
marketing capabilities. For press releases and additional information about
the company, please visit http://www.biogen.com.
Safe Harbor
This press release contains forward-looking statements regarding the
potential for AMEVIVE. These statements are based on the Company's current
beliefs and expectations, and are subject to risks and uncertainties that
could cause actual results to differ materially. There is no assurance, for
example, that all experiences with AMEVIVE will be the same or that AMEVIVE
will not be affected by unexpected new data or technical issues or by
intellectual property disputes. With respect to patents, the Company believes
it has broad patent protection covering AMEVIVE, including composition of
matter, method and use claims. The Company is aware of certain patents
relating to immunoadheson technology, has had discussions with Genentech
regarding licensing, and is evaluating the patents to determine next steps.
The potential for AMEVIVE may also be influenced by reimbursement and pricing
decisions and the introduction of competitive products. For more detailed
information on risks and uncertainties associated with AMEVIVE and the
Company's activities see the Outlook section in MD&A of the Company's Annual
Report on Form 10-K and quarterly reports on Form 10-Q filed with the
Securities and Exchange Commission. The Company does not undertake any
obligation to publicly update any forward-looking statements.
Conference Call And Webcast
The company will host a call for investors at 8:30 a.m. EST on January 31,
2003, and will be accessible through the investor relations section of
Biogen's homepage, http://www.biogen.com.
Video News Release
Satellite feed for the Video News Release will be available Friday,
January 31, 2003 at the following times and coordinates:
10:00 AM - 10:15 AM EST 1:00 PM - 1:15 PM EST
Telstar 5 (C-BAND) Telstar 5 (C-BAND)
Transponder 8 Transponder 6
Downlink 3860 H Downlink 3820 H
Audio 6.2/6.8 Audio 6.2/6.8
Media Contact:
Amy McKnight
Associate Director, Public Affairs
Biogen, Inc.
Tel: (617) 914-6524
Investment Community Contact:
Elizabeth Woo
Senior Director, Investor Relations
Biogen, Inc.
Tel: (617) 679-2812
SOURCE Biogen, Inc.
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Related links:
http://www.biogen.com
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
http://www.newscom.com/cgi-bin/prnh/20030131/NEF007
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
Company News On-Call:
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CONTACT:
Media, Amy McKnight, Associate Director,
Public Affairs of Biogen, Inc., +1-617-914-6524; or Investment
Community, Elizabeth Woo, Senior Director, Investor Relations,
+1-617-679-2812, both of Biogen, Inc.
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