Biogen, Inc. (NASDAQ: BGEN) today announced that the FDA’s Dermatologic & Ophthalmic Drug Advisory Committee voted to recommend approval of AMEVIVE ® (alefacept) for the treatment of moderate-to-severe chronic plaque psoriasis.
Burt A. Adelman, M.D., Biogen’s Executive Vice President of Research & Development, said, “This is an important step forward in the development of AMEVIVE. We are encouraged by the results of today’s meeting and we look forward to continuing to work with FDA to bring AMEVIVE to market as a new treatment for psoriasis.”
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.
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® (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.
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.
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. Final decision on approval of AMEVIVE will be made by FDA. There is no guaranty FDA will follow the Advisory Committee’s recommendation. 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 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.
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