Biogen, Inc. (NASDAQ: BGEN) today announced that the Food and Drug Administration (FDA) has committed to complete the review of its AMEVIVE® (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.
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 U.S. and European 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 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.
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.
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