CAMBRIDGE, Mass., Sept. 12 /PRNewswire-FirstCall/ --
Biogen, Inc. (Nasdaq: BGEN) today announced that the Food and Drug
Administration (FDA) has committed to complete the review of its AMEVIVE(R)
(alefacept) application within six months. After review of the information
Biogen submitted to reply to FDA's Complete Response Letter, FDA determined it
was a class 2 resubmission. Under FDA guidelines, this commits the Agency to
complete the review within six months. Biogen is now one step closer toward
the approval of AMEVIVE for the treatment of moderate-to-severe chronic plaque
psoriasis.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
Psoriasis is a T-cell mediated inflammatory disorder of the skin that can
cause considerable discomfort. It is a disease for which there is no cure,
affecting people of all ages. According to the American Academy of
Dermatology, psoriasis affects 3-5 million people in the United States and
about another 100 million people worldwide. Although individuals with mild
psoriasis can often control their disease with topical agents, more than one
million patients worldwide require ultraviolet or systemic immunosuppressive
therapy. According to the National Psoriasis Foundation, the disease impacts
a person's psychological well being and social functioning as well as their
physical functioning.
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 U.S. and European sales of
AVONEX(R) (Interferon beta-1a) for treatment of relapsing forms of multiple
sclerosis, (Please see full prescribing information at
http://www.avonex.com.), 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.
Safe Harbor
This press release contains forward-looking statements regarding the
potential for approval of 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. Approval
of AMEVIVE is subject to the Company's ability to work with FDA to adequately
address the questions and provide the clarification and information requested
by the FDA during the review process. Approval is also subject to the other
risks and uncertainties inherent in drug development, including the risk of
unexpected new data or information. Even if approved, there is no assurance
that AMEVIVE will be free from technical issues affecting commercialization or
manufacturing or intellectual property disputes or that it will achieve its
market potential. For more detailed information on the 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.
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
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/101550.html
CONTACT:
Media Contact: Amy McKnight, Associate
Director, Public Affairs, +1-617-679-2723, or Investment
Community Contact: Elizabeth Woo, Director, Investor Relations,
+1-617-679-2822, both of Biogen, Inc.
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