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`Oral Compound BG-12 Achieves Primary Endpoint in Phase II Study of
`Relapsing-Remitting Multiple Sclerosis; Treatment with BG-12 Led to
`Statistically Significant Reductions in MRI measures
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`B|OW|RE2K
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`May 30, 2006 10:00 AM Eastern Daylight Time
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`LAUSANNE, Switzerland--(BUSINESS WIRE)--May 30, 2006--Biogen Idec (NASDAQ:
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`BIIB) and Fumapharm AG announced positive results from a Phase II study designed to
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`evaluate the efficacy and safety of BG-12, an oral fumarate, in patients with relapsing-
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`remitting multiple sclerosis (MS). The study achieved its primary endpoint, demonstrating
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`that treatment with BG-12 led to a statistically significant reduction in the total number of
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`gadolinium-enhancing brain lesions as measured by MRI with six months of treatment
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`versus placebo. These data were presented today at the annual meeting of the European
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`Neurological Society in Lausanne, Switzerland.
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`"We are encouraged that these Phase II data demonstrate that BG-12 may be a promising oral therapy to treat MS. As
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`part of our ongoing commitment to MS patients, we are working with regulatory authorities to determine the next steps in
`the development of this program," said Burt Adelman, MD, executive vice president, Development, Biogen Idec.
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`This Phase II multi-center, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10
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`countries in Europe. Patients were randomized to receive placebo or BG-12 at 120 mg, 360 mg, or 720 mg per day for
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`six months. The patient group treated with 720 mg of BG-12 per day had a 69% reduction in the mean number of
`gadolinium-enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720 mg dose
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`group also had a 48% reduction in newly enlarging T2-hyperintense lesions. BG-12 therapy was also associated with a
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`trend towards reduction in relapse rate. The patient group treated with 720 mg of BG-12 per day had a 32% reduction in
`relapse rate compared to placebo, however, the study was not designed to achieve statistical significance for this
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`endpoint.
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`The results of the 120 mg and 360 mg BG-12-treated groups were not statistically significant versus placebo. Patients
`were followed for an additional six months as part of a dose-blinded safety extension study.
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`The most common adverse events were flushing, gastrointestinal disorders, headache, and nasopharyngitis. The
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`incidence of liver enzyme elevation greater than or equal to three times the upper limit of normal at any time during the
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`placebo controlled phase of the study was between 2% and 8% in the three active treatment groups, compared with 5%
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`in the placebo group. Improvement in liver enzyme levels was seen after discontinuation of BG-12. Infection rates were
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`found to be balanced between the BG-12-and placebo-treated groups and no opportunistic infections occurred.
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`About Biogen Idec
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`Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global leader in the
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`development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries into
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`advances in human healthcare. For press releases and additional information about the company, please visit
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`http://www.biogenidec.com.
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`About Fumapharm AG
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`Fumapharm has licensed exclusive worldwide rights to develop and market BG-12 to Biogen Idec. Fumapharm is a
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`privately held pharmaceutical company headquartered in Lucerne, Switzerland. For more information, please visit
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`http://www.fumapharm.ch.
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`Safe Harbor/Fonrvard-Looking Statements
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`This press release contains fonlvard-looking statements regarding the development of BG-12 for multiple sclerosis. These
`statements are based on our current beliefs and expectations. They are subject to the risks inherent in drug
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`development, including the risks that the effects of the product in larger clinical trials may not be as expected or that there
`may be safety issues or other problems or delays that arise during clinical trials, unexpected technical or manufacturing
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`hurdles, or intellectual property disputes. There is no certainty that the risk/benefit profile of the product will be acceptable
`to the Company or to regulatory authorities for a particular indication. Drug development involves a high degree of risk.
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`Only a small number of research and development programs result in the commercialization of a product.
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`Success in early stage clinical trials does not ensure that later stage or larger scale clinical trials will be successful. For
`more detailed information on the risks and uncertainties associated with these fon/vard looking statements and Biogen
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`|dec's other activities see the periodic and other reports that Biogen Idec has filed with the SEC. Biogen Idec does not
`undertake any obligation to publicly update any forward-looking statements.
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`Contacts
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`Contacts
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`Media:
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`Biogen Idec
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`Amy Brockelman, 617-914-6524
`or
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`Investor:
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`Biogen Idec
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`Elizabeth Woo, 617-679-2812
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