No Difference Seen Between Two Doses At Four Years
CAMBRIDGE, Mass., April 18 /PRNewswire-FirstCall/ --
Biogen, Inc. (Nasdaq: BGEN) announced that new four year data from its AVONEX
dose comparison study were presented today at the Annual Meeting of the
American Academy of Neurology (AAN) in Denver, Colorado. This study was
designed to see if doubling the approved 30 mcg weekly dose of AVONEX to 60
mcg weekly would produce additional clinical benefit in patients with
relapsing forms of multiple sclerosis (MS).
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
Commenting on his presentation of the four year data, Dr. Ernst-Wilhelm
Radue of the Institute for Diagnostic Radiology in Basel, Switzerland said,
"These data add significantly to our understanding of AVONEX in the long term
treatment of this life-long chronic disease."
After four years of treatment, there was no difference between the 30 mcg
and 60 mcg treatment groups in the cumulative rate of sustained disability
progression on the expanded Disability Status Scale (EDSS), decrease in mean
relapse rate from baseline, or percentage of relapse-free patients.
"The results are consistent with the pivotal Phase III study and further
support the approved 30 mcg dose," Dr. Radue said, adding, "Physicians and
patients can be assured by this study that, when treating relapsing MS, more
AVONEX is not better. The 30-mcg dose administered by intramuscular (IM)
injection once a week slows the progression of physical disability and reduces
the relapses associated with this disease."
The results presented by Dr. Radue were from an extension of the three-
year European Interferon Beta-1a Dose-Comparison Study. Three-year results
were reported at last year's meeting of the European Neurological Society
(ENS). This randomized, double-blind trial included 802 patients with
relapsing MS at 38 centers in ten countries in Europe; 491 of these patients
elected to continue through a fourth year of the study.
About AVONEX(R) (Interferon-beta 1a)
The most common side effects associated with AVONEX treatment are flu-like
symptoms, muscle ache, fever, and chills. Other common side effects seen, but
not statistically different between AVONEX and control groups, were headache,
pain and asthenia (weakness). These side effects usually go away within a day
after the injection and occur less often as the treatment continues. AVONEX
should be used with caution in people with depression and people with seizure
disorders. AVONEX should not be used by pregnant women. People with cardiac
disease should be closely monitored. Routine periodic blood chemistry and
hematology tests are recommended during treatment with AVONEX. Please see
complete prescribing information available at http://www.avonex.com.
AVONEX is the leading treatment for multiple sclerosis worldwide, with
more than 118,000 patients on therapy. It was launched in the U.S. in 1996
and later in Europe for the treatment of relapsing forms of MS to slow the
progression of disability and reduce relapses. AVONEX is marketed
internationally in more than 65 countries.
About Biogen
Biogen, Inc., winner of the U.S. National Medal of Technology, is a
biopharmaceutical company principally engaged in discovering and developing
drugs for human healthcare through genetic engineering. Headquartered in
Cambridge, MA, the Company's revenues are generated from U.S. and worldwide
sales of AVONEX(R) (Interferon beta-1a) for treatment of relapsing forms of
multiple sclerosis, and from the worldwide sales by licensees of a number of
products, including alpha interferon and hepatitis B vaccines and diagnostic
products. Biogen's research and development activities are focused on novel
products to treat inflammatory and autoimmune diseases, neurological diseases,
cancer, fibrosis and congestive heart failure. The Company maintains active
clinical research programs in protein therapeutics, small molecules, genomics
and gene therapy. For copies of press releases and additional information
about the Company, please consult Biogen's Homepage on the World Wide Web at
http://www.biogen.com.
Media Contact:
Kathleen O'Donnell
Associate Director, Public Affairs
Biogen, Inc.
(617) 679-2837
Media Contact Europe:
Nicholas Hicks
Manager International Communications
Biogen France
33 141377051
Investment Community Contact:
Elizabeth Woo
Director, Investor Relations
Biogen, Inc.
(617) 679-2812
SOURCE Biogen, Inc.
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CONTACT:
Media Contact: Kathleen O'Donnell, Associate
Director, Public Affairs of Biogen, Inc., +1-617-679-2837; or
Media Contact Europe: Nicholas Hicks, Manager International
Communications of Biogen France, 33 141377051; or Investment
Community Contact: Elizabeth Woo, Director, Investor Relations of
Biogen, Inc., +1-617-679-2812
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