CAMBRIDGE, Mass., June 13 /PRNewswire-FirstCall/ --
Biogen, Inc. (Nasdaq: BGEN) today announced that it has received a Complete
Response Letter from the U.S. Food and Drug Administration (FDA). The letter
is the next step forward in FDA's review of Biogen's application for approval
to market AMEVIVE(R) (alefacept) in the United States as a treatment for
moderate-to-severe chronic plaque psoriasis. FDA is requesting clarification
and information related to data Biogen previously submitted. No new clinical
trials were requested prior to approval. The Agency proposed post-marketing
clinical studies to further define the safety and effectiveness of AMEVIVE.
The Company said it will work closely with FDA to address the questions raised
and move forward rapidly in the approval process.
(Photo: http://www.newscom.com/cgi-bin/prnh/19990824/BIOLOGO )
Last month, a Dermatologic & Ophthalmic Advisory Committee convened by FDA
voted to recommend AMEVIVE for market approval.
Burt Adelman, M.D., Biogen's Executive Vice President-Research and
Development, said, "The FDA Advisory Committee vote last month was a clear
indication of the importance the physician and patient communities place on
AMEVIVE as a potential new therapy for psoriasis. This FDA letter brings
Biogen another step closer to meeting those unmet needs."
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(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 sales by licensees of a number of 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.
Safe Harbor Statement
This press release contains forward-looking statements regarding the
potential for approval and marketing 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 in the Complete Response Letter. 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, 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.
Media Contact:
Amy McKnight
Associate Director, Public Affairs
Biogen, Inc.
Ph: (617) 679-2723
Investor Contact:
Elizabeth Woo
Director, Investor Relations
Biogen, Inc.
Ph: (617) 679-2812
SOURCE Biogen, Inc.
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Related links:
http://www.biogen.com.
Company News On-Call:
http://www.prnewswire.com/comp/101550.html
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
CONTACT:
Amy McKnight, Associate Director, Public
Affairs, +1-617-679-2723, or Elizabeth Woo Director, Investor
Relations, +1-617-679-2812, both of Biogen, Inc.
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