Ora; Compennd $642 Achieves imagery Endpoint in 9haee ll Study of
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`flewsttoern
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`5/30/06 Bus. Wire 14:00:00
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`Business Wire
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`Copyright {’9 2006 Business Wire
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`May 30, 2006
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`Gral Compound BGusa Achieves Frimaiy Endpoint in Phase i1 Study of Relapsingl‘tenti{ting
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`Multiple Sclerosis; Treatment with 364$ Led to Statistician? Significant Reductions in MRE measures
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`BIOWIREZK LAUSANNE, Switzerland-{BUSINESS WIRE—‘May 30, 2006~Biogen Idec (NASDAQ: BUB) and
`Fumapharrn AG announced positive results from a Phase II study designed to evaluate the efficacy and safety of BG—IZ,
`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
`today at the annual meeting of the European 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
`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 Adelrnan, MD, executive vice president, Development, Biogen Idec.
`
`This Phase 11 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 mg per day for six
`months The patient group treated with 720 mg of BG- 1 2 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 group also had
`a 48% reduction in newly enlarging TZ-hyperintense lesions. 86- 2 therapy was also associated with a trend towards
`reduction in relapse rate. The patient group treated with 720 mg of BG-12 per da}i had a 32% reduction in relapse rate
`compared to placebo, however, the stud}i was not designed to achieve statistical significance for this endpoint.
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`The results of the 120 mg and 360 mg BG-lZ—treated groups were not statistically significant versus placebo. Patients
`were t’oiiowed for an additional six months as part of a doseblinded safety extension study.
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`The most common adverse esents were flashing gastrointestinal disorders. headache, and nasopharyngitis, The
`incidence of Eirer enzyme eles‘ation greater than or eqnai to three times the. ripper iimit of normai at any time during the
`placebo controiled phase of the stndy was between 235% and 8135.: ii: the three active treatment groopst compared with Sits?)
`in the placebo group. lrnprorement in liver enzyme ievels was seen after discontinnation of 33842. infection rates were
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`found to he haianced between the gamma piacehotreated groups and no opportunistic infections occurred
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`Ahont Biogen Idec
`
`tender in the
`Biogen idec creates new standards of care in oncology neewiogg and immunology, As a giohai
`derelopmenz manufaetnréng, and commerciaiiaaiion of noset therapies Biogen idea: transierrns scientific discos-Ferries
`into advances in human heatihcare. For press reieases and additionai information sheet the company please visit httpfis"
`maehiegeaide teem.
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`Sawai (IPR2019-00789), Ex. 1016, p. 001
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`§rat Compound BQ-iz Aeiileees Primary Endpoint in ‘Pitase it Study of.”
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`About Furnapharm AG
`
`Fumapharm has licensed exclusive worldwide rights to develop and market BG-lll to Biogen Idec. Furnapharm is a
`privately held pharmaceutical company headquartered in Lucerne. Switzerland, For more informationl please visit httpzf!
`wwwfurnapharinch.
`
`Safe HarborfForwardlooking Statements
`
`This press release contains forward-looking statements regarding the development of 80- l 2 for multiple sclerosis. These
`statements are based on our current beliefs and expectations. They are subject to the risks inherent in drug 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 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.
`Only a small number of research and development programs result in the commercialization of a product.
`
`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 looking statements and Biogen
`
`Idec’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.
`
`CONTACT: Media: Biogen Idec Amy Brockelman. 617—914-6524 or Investor: Biogen Idec Elizabeth Woo, 617—679-2812
`KEYWORD: MASSACHUSETTS SWITZERLAND INTERNATIONAL CANADA LATINAMERICA EUROPE
`INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCTMARKETING
`AGREEMENTS
`
`SOURCE: Biogen Idec
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`--- Index References «~-
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`News Subject: (Major Corporations ( l MA93))
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`Industry: (Pharmaceuticals & Biotechnology (IPHI3); Immunology (IIM66); Muscular & Neuromuscular Disease
`(IMU99); Immunology Drugs (lIM32); Manufacturing ( I MAM); Biopharmaceuticals ( l BI l 3}: Healthcare Regulatory
`{lHEOfil}; Healthcare ( lHEGé}; Allergy St Immunology (1AL96); Neurology (INE95); Drug Approval Process ( l DRQI};
`Multiple Sclerosis & Demyelination {lMUBS}; Internal Medicine (IINSEl); Healthcare Practice Specialties ( l HEdQH
`
`Region: {Americas {iAl’v’l92h North America {INOBQ}; Western Europe {IWEzll}; Europe (EELSSSE: BSA {IUS‘E3};
`Central Europe { 1C E58); Switzerland 5 E SW??}}
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`Language: EN
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`(AG; EUROFEaN NESROLOGICAL SOCIETY; FUMAPHARI‘VI; FUMAPHARM AG;
`Indexing:
`NASDAQ: BUB; ORAL COMPOUND: SEC} {Amy Brockelrnan; Biogen; Biogen ldec; Burt Adelrnan; ldec; Idec
`Elizaoeth Woo; improvement}
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`Keywords: MASSACHSSET’FS SWITZERLAND lNTERNATlONA L CANADA LATINAMERlCA EERORE if};
`{PHARMACELETICAL MEDICAL BIQTEEECHNGLGGY i’ROQSCTh/‘lfit R K ETING AGREEMENTS}
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`Sawai (IPR2019-00789), Ex. 1016, p. 002
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`Qra§ Samgfizsétd 8342 Asfiéeves :‘3’33’3’3333y Efiiéggéfii if? $5h353 i5 S‘Euc‘iy {3&3
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`Ticker Symboi: NASDAQzBHB
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`Word Count; 9175
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` 2:33;? 63;?) l'ééwzgéw‘gzé
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`HewsRmiz-‘g
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`Sawai (IPR2019-00789), Ex. 1016, p. 003
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