Only Once-a-Week Multiple Sclerosis Therapy Now Even More Convenient
CAMBRIDGE, Mass., May 29 /PRNewswire-FirstCall/ --
Biogen, Inc. (Nasdaq: BGEN) today announced the U.S. Food and Drug
Administration (FDA) has approved a new prefilled syringe for AVONEX(R)
(Interferon beta-1a), designed to make treatment even more convenient for
people with multiple sclerosis (MS).
(LOGO: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
AVONEX, the only once-a-week treatment for MS, is now approved in a
convenient, prefilled syringe that makes it even easier to administer. Biogen
expects the prefilled syringe to be available in August and replace the
currently available form of AVONEX. As with the current form of AVONEX, the
new formulation will be indicated to slow the progression of disability and
reduce the frequency of relapses in relapsing forms of MS, including people
who have experienced a first clinical episode and who have brain scans
consistent with MS.
Burt Adelman, M.D., Biogen's Executive Vice President, Research and
Development, said, "Biogen is pleased to provide patients with an AVONEX
prefilled syringe. This formulation offers greater convenience for patients
and, as with the existing formulation, has a neutralizing antibody rate of 5
percent."
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 inhibit the biologic
activity of the therapeutic protein. The clinical significance of
neutralizing antibodies to AVONEX is unknown.
The most common side effects associated with AVONEX treatment are flu-like
symptoms, myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain
and asthenia.
Avonex, which is administered by intramuscular injection, should be used
with caution in patients with depression or other mood disorders and in
patients with seizure disorders. AVONEX should not be used by pregnant women.
Patients with cardiac disease should be closely monitored. Patients should
also be monitored for signs of hepatic injury. Routine periodic blood
chemistry and hematology tests are recommended during treatment with AVONEX.
Rare cases of anaphylaxis have been reported. Please see complete prescribing
information available at http://www.AVONEX.com.
Multiple Sclerosis
MS is a chronic disease of the central nervous system that affects
approximately 400,000 people in North America and approximately 1 million
people worldwide. It is a disease of young adults, mostly women, with onset
typically between 20 and 40 years of age. Symptoms of MS may include vision
problems, loss of balance, numbness, difficulty walking and paralysis.
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.
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
availability of the prefilled syringe and the prefilled syringe replacing the
currently available form of AVONEX. 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 the availability of the prefilled syringe will
not be affected by unexpected technical or manufacturing issues. For more
detailed information on risks and uncertainties associated with 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.
Media Contact:
Amy Brockelman
Manager, Public Affairs
Biogen, Inc.
(617) 914-6524
Investment Community Contact:
Christina Dillon
Manager, Investor Relations
Biogen, Inc.
(617) 679-2812
SOURCE Biogen, Inc.
 back to top
Related links:
http://www.biogen.com
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
Company News On-Call:
http://www.prnewswire.com/comp/101550.html
CONTACT:
Amy Brockelman, Manager, Public Affairs,
+1-617-914-6524, or Christina Dillon, Manager, Investor
Relations, +1-617-679-2812 both of Biogen, Inc.
|
