`8%?2 Psoriasis Sinai meets Primary End oini‘ {Mai Componnd Aiso Eeing.”
`
`Newsfteem
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`4j7/05 Bus. Wire 12:00:00
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`Business Wire
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`Copyright © 2005 Business V‘Vire
`
`April 7, 2005
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`3312 Psoriasis Study Meets Primary Endpoint; Orai Compound Rise Being Studied for MS in Phase li Trial
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`CAMBRIDGE Mass, SAN DIEGO & LUCERNE, Switzerland—4BUSINESSWIRE)~-April 7. 2005——Biogen Idec
`(NASDAQ: 131113) and Fumapharm AG today announced resuits from a Phase Ill study designed to evaluate the efficacy
`and safety of 136-12, an oral fumarate, in the treatment of moderate to severe psoriasis. The trial met the primary
`endpoint and patients receiving BG—12 demonstrated a statistically significant clinical improvement as measured by a
`lower median psoriasis severity score after 16 weeks of treatment than patients receiving placebo.
`
`"These data will be used to support a filing for market authorization in Germany this year," said Burt A. Adelman.
`M.D., Biogen Idec‘s Executive Vice President, Development. “We will work with our partner, Fumapharm, to determine
`the next steps for the 86—12 program. Additional Phase III studies would need to be conducted for applications in the
`US and the rest of Europe."
`
`The trial, conducted by Fumapharm. was a multicenter, double—blind, placebo—controlled Phase III study of 175 patients
`with moderate to severe psoriasis. Patients were randomized to receive placebo (11:70) or 720 mg of BG—l2 a day (n=105)
`
`for 16 weeks. Patients were evaluated using the psoriasis area and severity index (PASI), a common measure of overall
`psoriasis severity. The primary endpoint was the PASI score at 16 weeks.
`
`At 16 weeks, the median PASI was 5.8 for the BG-l 2 group and 14.2 for the placebo group. Median percentage reduction
`from baseline PAS! was 68% for patients receiving BG~12 and 10% for patients receiving placebo:
`
`In the study: the most commonly reported adverse events were flushing and diarrhea. In additiont one patient was
`hospitalized For pneumonia and one patient was hospitalized for kidney stones, The data from the study will be presented
`at an upcoming medical meeting,
`
`Biogen idec also announced that a Phase ii stud}! of BGJZ in patients with relapsing-remitting mnitipie scierosis
`{MS} was initiated in Norember 28%. The steely, being condacted in Earope, is a piaeebotcontreiledl dose—ranging
`stnd}; designed to assess the efficacy and safety profiie of 134342 The primary endpoint of the stud}! Wiil be an MR1
`measnrement of the amonnt of brain iesion activity at six months. Appi‘oxiniateiy Zéii patients are expected to be enroiieri
`in the study across 1i} conntries.
`
`About BG~12
`
`in October 253331 Biogen Idec iiccescd cacinsire woridwide righis to deveiop and market 8113-12 from anapharrn AS,
`a prieateig heid pharmaeentieai company beadeaartered in Laeerne, Switzeriand. 8642 is an orai {anaemia deréeatia’e
`
`with an imm‘anomodniatory mechanism of actions Biogen Ides is eeainaéing B§»i2 in a range of diseases.) ineieding
`psoriasis and in?)
`
`Sawai (IPR2019-0666), Ex. 1026, p. 001
`
`

`

`3&3 i’seeiaeés Siege fieeée Primeeg Eefieeieeg Gee§ Cemeeend figse Eeéng...
`
`Abeuz Biegen Idea:
`
`Biegen idee {NASDAQ 82133) eeeaies new standards ef eere in eneemgy and immunoiogy. As e giebei leader in ihe
`deveiopmentg manufacmring, and eemmereializatiea ef novei therapies? Biegen Idea transforms scientific éiseeveries
`into advances in Remain heaiiheare. For press reieases and additiona} infermation about the company please visii htipzif
`ewwbiegeniéeecem.
`
`Safe Berber
`
`This press reiease ecmtains forwardmieeking statements regardieg the deeeiepment of 86-3 2. These stammcms are based
`an em" current beiiefs and expeeiaiions, The); are subjeet {e the risks ieherem in {3mg deeeiepmem, ineiading {he risks {hat
`the effects efihe precinct in iarger climate} {dais may nei be as expected or the: there may be safety issues or other preblems
`er deiaye ihat arise during eiinieei trieie, unexpected teehnieai or manufacturing herdiee, or imelieetual property disputes.
`There ii; 119 certainiy that the riskibenefit profile ofihe drug wifi be aceepiabie 16 the Company or m reguiamry authorities
`
`for a pertieuiar indicatien. Drag deveiopmem inveiees a high degree of risk. 0:11}! 3 51132111 number of research and
`deveiepmem pregmms metal: in the cemmereializetien 01" a precinct. Success in animal models or eafiy stage clinical}
`teiais {lees not meme that later etage or iaxger scale clinical trims win be successmi, 9‘01“ more deiailed information an
`the risks anti uncertainties associated with these ferwerd looking staLements and Biegen idea’s other aetiviiies see the
`
`periedie and other reperis that Biogen Idea has flied with the SEC. Biogen Idec dees not undertake any ebiigation to
`publicly update anyforward»'1ooking statemenis,
`
`CONTACT: Media Cemeet: Biogen Idec Jese Juvesg 617-914—6524 Associate Skeeter, Public Affairs or investmen:
`Community Contact: Biogen Idee Oscar Veiastegui, {311679—2312 Senior Manager: investor Relations
`KEYWORD: MASSACHUSETTS INTERNATIONAL AFRICAIMIDDLE EAST LATINAMERKA ASiA
`PACIFIC EUROPE Biomedical
`
`INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCT
`
`SOURCE: Biegen Idee
`
`--- Index References -—-
`
`Cempany: SEC SOCIETE EUROEEENNE 13E COMMUNICATION
`
`News Subject {Majm Cemerefiens {1 MA93/3}
`
`Indesfiy: {Pharmaeemieais 8:. Bieieeheeiegy {iPHB}; Deemeieiegy {£35133}; Muscular 3: Neammusemar Disease
`{ 3&11399}; fleeufaeturing {IMAE}; Heaiiheare {31-11306}; Neureiegg {lNE‘BS}; Drug Approeei Process {EER’Qi};
`Exieiiieie Sciemeie $2 Demyeliaeeien {$931388}; intereai Medieine { ZINS4}; Heaiiheere Pmetiee Seeeiaiiies (1H84933
`
`Regime {Amei’ieee {'EAMEZ’E}; E‘fiefih Ameriee {ii‘éfififi}; Weeieen Eeeepe {iW'fiéé}; Eemee {@383}; Seeirei Eerepe
`{Eiflfifi}; {3333; {$13533}; Swéizefieeé { i SW??§; {Zeiifemie {3,CA§§}§
`
`Leegeege: EEK:
`
`(Biker iesflexéeg: {ASB’iE’lGEfiAL FEASE 331: AG; EEKO??? BiGfiéESiCALiE‘éBQSTRY; §£§MA9HA£M all}; fii;
`Mgifié QONTAC’Y; RASEEAQ: 8118; FAQ; efieee; F‘E’fiSE Ii}; SEC; STE’SiEB} {Aggteximeieiyg Biegee; ,Qiagee
`,iéee; 322:7? A“ éeeimee: Femagherre; wee; Ease Ewes; Qseer fif’eieeiegei; Safe Hezbee}
`
`Keeweefig: 3§A$S$CEQS§Y§S éfi’iifi-Rfig’fififiefis L éizgifififfifflfifflefi 3A5”? ifia’fifié ME}? 1C5}; eeie ¥’A{Ti§3§{:
`ESR§?E Biemeéieei-{f}; {E’BARfiéfiEiETKZ‘fiL MEBIfifiL Bifi?£€H%QL{}G¥ ?R{}i}fi{3?}
`
`Sawai (IPR2019-0666), Ex. 1026, p. 002
`
`

`

`$643 Pgariaais Sixé}! mag Pg‘émary Emigwifii; Gi‘ai Cmngmamé Aisg 845mg"
`
`Ticker Symbol: NASDAQzBIIB
`
`Word Count: 954
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`
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`HewsF-Emm
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`Sawai (IPR2019-0666), Ex. 1026, p. 003
`
`