Oral Compound BG-12 Achieves Primary Endpoint in Phase [| Study of
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`5/30/06 Bus. Wire 14:00:00
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`Business Wire
`Copyright © 2006 Business Wire
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`May30, 2006
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`Oval Compound BG-i2 Achieves Primary Endpoint in Phase II Study of Relapsing-Remitting
`Multiple Sclerosis; Treatment with BG-12 Led toStatistically Sienificant Reductions in MRI measures
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`BIOWIRE2K LAUSANNE,Switzerland--(BUSINESS WIRE)--May 30, 2006--Biogen Idec (NASDAQ: BIIB) and
`Fumapharm AG announcedpositive results from a Phase II study designed to evaluate the efficacy and safety of BG-12,
`an oral fumarate, in patients with relapsing-remitting multiple sclerosis (MS). The study achieved its primary endpoint,
`demonstrating that treatment with BG-12 led to a statistically significant reduction in the total number of gadolinium-
`enhancing brain lesions as measured by MRI with six months of treatment versus placebo. These data were presented
`todayat the annual meeting of the European Neurological Society in Lausanne, Switzerland.
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`"We are encouraged that these Phase IT data demonstrate that BG-12 may be a promising oral therapy to treat MS. As
`part of our ongoing commitment to MS patients, we are working with regulatory authorities to determinethe next steps
`in the development ofthis program," said Burt Adelman, MD,executive vice president, Development, Biogen Idec.
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`This Phase If multi-center, double-blind, placebo-controlled, dose-ranging study enrolled 257 patients at sites in 10
`countries in Europe. Patients were randomized to receive placebo or BG-12 at 120 mg, 360 mg, or 720 mgper dayforsix
`months, The patient group treated with 720 mg of BG-12 per day had a 69%reduction in the mean numberof gadolinium-
`enhancing lesions versus placebo as measured monthly from weeks 12 to 24 of the study. The 720 mg dose group also had
`a 48%reduction in newly enlarging T2-hyperintense lesions. BG-12 therapy was also associated with a trend towards
`reduction in relapse rate. The patient group treated with 720 mg of BG-12 per day had a 32%reductionin relapse rate
`compared to placebo, however, the study was not designed to achievestatistical significance for this 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
`incidence ofliver enzyme elevation greater than or equal to three times the upper limit of normal at any time during the
`placebo controlled phase ofthe study was between 2°and 8%in the three active treatment groups, compared with 5%
`in the placebo group. Improvement in liver enzyme levels was seen after discontinuation of BG-12. Infection rates were
`found to be balanced between the BG-12-and placebo-treated groups and no opportunistic infections occurred.
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`About Biogen Idec
`
`leader in the
`Biogen Idec creates new standards of care in oncology, neurology and immunology. As a global
`development, manufacturing, and commercialization of novel therapies, Biogen Idec transforms scientific discoveries
`into advances in human healthcare. For press releases and additional information about the company,please visit http://
`www. blogenidec.com.
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`Sawai (IPR2019-00789), Ex. 1016, p. 001
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`Gral Compound BG-12 Achieves Primary Endpoint in Phase ii Study of...
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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. Fumapharmis a
`privately held pharmaceutical company headquartered in Lucerne, Switzerland. For more information,pleasevisit http://
`www.fumapharm.ch.
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`Safe Harbor/Forward-Looking Statements
`
`This press release contains forward-looking statements regarding the development of BG-12 for multiple sclerosis. These
`statements are based on ourcurrent beliefs and expectations. They are subject to the risks inherent in drug development,
`includingthe risks that the effects of the productin largerclinical trials may not be as expected or that there may be
`safety issues or other problems ordelays that arise during clinicaltrials, unexpected technical or manufacturing hurdles,
`or intellectual property disputes. There is no certainty that the risk/benefit profile of the product will be acceptable to
`the Companyor to regulatory authorities for a particular indication. Drug development involves a high degree of risk.
`Only a small number of research and development programsresult 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 forward iooking statements and Biogen
`Idec's other activities see the periodic and other reports that Biogen Idec hasfiled with the SEC. Biogen Idec does not
`undertake anyobligation to publicly update any forward-looking statements.
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`CONTACT: Media: Biogen Idec Amy Brockelman, 617-914-6524 or Investor: Biogen Idec Elizabeth Woo, 617-679-2812
`KEYWORD: MASSACHUSETTSSWITZERLAND INTERNATIONAL CANADA LATINAMERICA EUROPE
`INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCTMARKETING
`AGREEMENTS
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`SOURCE: Biogen Idec
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`~-.— Index References ----
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`News Subject: (Major Corporations (1MA93)}
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`Industry: (Pharmaceuticals & Biotechnology (1PH13); Immunology (1IM66); Muscular & Neuromuscular Disease
`(1MU90); Immunology Drugs (11M32); Manufacturing (1MA74); Biopharmaceuticals (1BI13); Healthcare Regulatory
`(LHE04): Healthcare (1 HE06); Allergy & Immunology (1 AL96); Neurology (INE95); Drug Approval Process (IDR91);
`Multiple Sclerosis & Demyelination (1M U88): Internal Medicine (1IN54); Healthcare Practice Specialties (1HE49))
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`Region: (Americas (1AM92); North America (1NO39): Western Europe (LWE4)1); Europe (1EU83); USA (US73);
`Central Europe (1CE50); Switzerland (SW77))
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`Language: EN
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`(AG; EUROPEAN NEUROLOGICAL SOCIETY; FUMAPHARM; FUMAPHARMAG,
`Indexing:
`NASDAQ; BUB; ORAL COMPOUND; SEC) (Amy Brockelman; Biogen; Biogen Idec; Burt Adelman; Idec: Idec
`Elizabeth Woo; Improvement)
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`Keywords: MASSACHUSETTS SWITZERLAND INTERNATIONAL CANADA LATINAMERICA EUROPE({):
`(PHARMACEUTICALMEDICALBIOTECHNOLOGY PRODUCTMARKETING AGREEMENTS)
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`Sawai (IPR2019-00789), Ex. 1016, p. 002
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`Oral Compound BG-12 Achieves Primary Endpoint in Phase ll Study of...
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`Ticker Symbol: NASDAQ: BHUB
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`Sawai (IPR2019-00789), Ex. 1016, p. 003
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