CAMBRIDGE, Mass., Nov. 14 /PRNewswire-FirstCall/--
Biogen, Inc. (Nasdaq: BGEN) announced today that the U.S. Food and Drug
Administration (FDA) has approved a label change for AVONEX, lowering the rate
of occurrence of neutralizing antibodies to 5 percent from the original label
rate of 24 percent.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
Recent studies with multiple sclerosis patients given AVONEX for at least
1 year showed the presence of neutralizing antibodies at the rate of 5 percent
(13 of 261 patients). The clinical significance of neutralizing antibodies to
AVONEX is unknown.
"Biogen is pleased the FDA has reviewed these new clinical data and
determined that the neutralizing antibody rate with AVONEX is notably lower
than the rate reported from our first Phase III clinical trial," said Burt
Adelman, M.D., Biogen's Executive Vice President, Research and Development.
"The manufacturing of biologics is extremely complex," Dr. Adelman
continued. "Since AVONEX was approved in 1996, we've taken important steps to
improve our manufacturing processes. We believe these modifications result in
a lower percentage of AVONEX-treated patients developing neutralizing
antibodies."
All therapeutic proteins have the potential to cause an immune response in
the human body, such as the production of specific antibodies. A subset of
these antibodies, called neutralizing antibodies, can attach to proteins and
inhibit their biologic activity.
About AVONEX
AVONEX is the leading treatment for relapsing forms of multiple sclerosis
worldwide, with more than 120,000 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. 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.
About Biogen
Biogen, Inc., winner of the U.S. National Medal of Technology, is a
biotechnology 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 worldwide sales of AVONEX for
treatment of relapsing forms of multiple sclerosis, and from the sales by
licensees of a number of products. (Please see full prescribing information at
http://www.avonex.com.) 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.
SOURCE Biogen, Inc.
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http://www.biogen.com
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CONTACT:
Tim Hunt, Director, Public Affairs,
+1-617-914-6524; or Christina Dillon, Manager, Investor
Relations, +1-617-679-2812, both of Biogen, Inc.
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