Commenting on yesterday’s FDA decision, Biogen, Inc. (NASDAQ/BGEN) said it is well prepared for the arrival of Serono’s Rebif® to the U.S. market. Biogen is confident that AVONEX, based on its profile of long-term efficacy, safety, and convenience, will maintain its established position as the leading MS therapy in the United States.
James C. Mullen, Biogen’s President and CEO said, “We are confident AVONEX once-a-week therapy will remain the standard of care for people with MS and their physicians. AVONEX has clearly established that it is effective over years of treatment. Today’s decision advances Rebif’s US. entry by one year, but Biogen already competes successfully against Serono in other parts of the world, and we certainly are well prepared to compete in the United States. In Europe, where both MS products have been available for over four years, more patients are being treated with AVONEX than with Rebif.”
“People with MS don’t want just another interferon, especially one with an inferior safety profile requiring injections three times a week,” Mullen said. “What the MS community is looking for is the next generation of treatments. We believe AVONEX represents the treatment option of choice, and as the world leader in MS therapy and research, Biogen is committed to bringing innovative treatments in the future.”
NOTE: The Company will hold a conference call for analysts and media today, March 8, at 8:30 a.m. EST. It will also be broadcast via the Internet at 8:30 EST and will be accessible through the Biogen homepage, http://www.biogen.com.
The telephone numbers for the call are:
US/Canada Dial-In Number: (877) 650-1145
International/Local Dial-In Number: (706) 643-1326
AVONEX is for the treatment of relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. It is approved to reduce relapses and slow the progression of disability. It is believed that AVONEX works by slowing down the underlying disease process in relapsing forms of MS. AVONEX is taken just once a week because it is an intramuscular (IM) injection. Because AVONEX is injected directly into the muscle, it is released slowly into the bloodstream. IM injections allow effective amounts of AVONEX to stay in the body longer, thus not requiring frequent injections.
The most common side effects associated with AVONEX treatment are flu-like symptoms, muscle ache, fever and chills. AVONEX should be used with caution in people with depression and in people with seizure disorders. AVONEX should not be used by pregnant women. People with cardiac disease should be closely monitored. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX.
About Biogen, Inc.
Biogen, Inc., winner of the U.S. National Medal of Technology, is a biopharmaceutical 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 for treatment of relapsing forms of multiple sclerosis, and from the sales by licensees of a number of products. (Please see full prescribing information at http://www.avonex.com.) 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. AVONEX is a registered trademark of Biogen, Inc. Rebif is a trademark of Serono Laboratories.
In addition to historical information, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Reference is made in particular to forward-looking statements regarding Biogen’s current expectation that AVONEX will remain the preferred therapy among multiple sclerosis patients and their physicians. These statements are based on the Company’s current beliefs and expectations as to such future outcomes. Factors which could cause actual results to differ materially from the Company’s current expectations include, without limitation: unanticipated changes in the level of patient satisfaction with AVONEX; the nature of regulatory, pricing, and reimbursement decisions worldwide with respect to the Company’s product and competitors’ products; the impact of competition and of competitor’s activities on the market and on AVONEX’s position, and the other risks and uncertainties detailed from time to time in the Company’s periodic reports filed with the Securities and Exchange Commission.