`
`C ORPORATION. (“WEST") BUSINESS WIRE ARTICLES ON WESTLAWNEXT
`
`I swear that
`
`I.
`
`Is.)
`
`My name is Jennifer Rock and I have been employed by West Publishing Corporation in the
`area which acquires news articles for inclusion on Westlaw for 14 years.
`
`The following information is based on my knowledge of West’s customary and routine
`business practices during the time I have been employed.
`
`West obtains news articles under license from Business Wire for inclusion on Westlaw to
`
`permit authorized subscribers to access these articles.
`
`West includes the text of the news articles on Westlaw as they are received from Business
`Wire.
`
`The three articles attached to this affidavit are accurate copies of the articles as they appear
`on Westlaw as of today’s date.
`
`These three articles, to the best of my knowledge and belief, would have been available to
`authorized Westlaw subscribers as of the following times:
`
`a. Business Wire article titled “BG-l 2 Psoriasis Study Meets Primary Endpoint: Oral
`
`Compound Also Being Studied for MS in Phase II Trial" was available on April 7.
`2005 at 07:15:03 a.m. CT.
`
`b. Business Wire article titled “Phase [I Study of Oral Compound 80-1 2 Meets Primary
`
`Endpoint in Multiple Sclerosis" was available on January 9. 2006 at 07:49:24 a.m.
`CT.
`
`c. Business Wire article titled “Oral Compound BG-12 Achieves Primary Endpoint in
`
`Phase II Study of Relapsing—Remitting Multiple Sclerosis; Treatment with 80-12
`
`Led to Statistically Significant Reductions in MRI measures" was available on May
`30. 2006 at 09:13:05 a.m. CT.
`
`I affirm that the statements contained herein are known by me or believed by me to be true and
`correct.
`
` Jennifer PI!)
`
`
`
`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 1
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`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 2
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`
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`$3242 §$eriasis Starts; steers Primary Endpoint; Qrai Sompound Aise Eeing.”
`
`Neaestteom
`
`4/7/05 Bus. Wire 12:00:00
`
`Business Wire
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`Copyright © 2005 Business Wire
`
`April 7, 2005
`
`13312 Psoriasis Study Meets Primary Endpoint; Oral Compound Also Being Studied for MS in Phase II Trial
`
`CAMBRIDGE Mass, SAN DIEGO & LUCERNE, Switzerland—4BUSINESSWIRE)—-April 7. 2005——Biogen Idec
`(NASDAQ: BIIB) and Fumapharm AG today announced results from a Phase III study designed to evaluate the efficacy
`
`and safety of BG-l2, 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 multicenterg double—blind, placebo-controlled Phase III study of l75 patients
`
`with moderate to severe psoriasis. Patients were randomized to receive placebo (hr—'70) or 720 mg of BG— 1 2 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 l6 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 PASI 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 addition 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 ldee also announced that a Phase ll stud}! of 8842 in patients with relapsing-remitting multiple sclerosis
`{MS} was initiated in November 28%. The study, being eondaeted in Eerope. is a plaeeboteontroiledi dose—ranging
`study designed to assess the eifieaey and safety profile of” BGJZ The primary endpoint of the study will he an M31
`measurement of the amount of brain lesion activity at six months. Approximately 2&0 patients are expected to he enroiled
`in the study across It} eountries.
`
`About 8642
`
`In Getoeer 2833? Biegen ldee iieensed eseiusis’e worééwide rights to deveiop and market 36-12 from Fumapharrn 3333,
`a privately heist pharmaeeatieal company headeuartereé in Leeernei Switzeriand. 86-32 is an oral f'umarate derératise
`
`with an immunomortniatorg meehanisin of series Biogen Ides is erainating B§»t2 in a range of diseases imitating
`
`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 3
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`
`
`$342 t’eee’éasis State‘s: fieete 9rimerg Eefieeittt; {Beet Cemeeené geese fieéeg...
`
`Abeut Biegen Idea:
`
`Biegen ides (NASDAQ: BIIB} creates new standards ef eare in oneetegy and immunology. As a giebai leader in the
`deveiepment, manufacturing, and eemmet‘ciaiizatien :3? news} therapies, Biegen Ides transforms seientifie éisceveries
`into advances in heman healtheate. Fer press teieases anti adéitionai intbrmatiort about the eempanya please visit httpjf
`ewwbiegeniéeeeem.
`
`Safe Herbs:
`
`This press retease acetates forwardmieetting statements regarding the deveiepment 0fBG~12. These statements are based
`on our current beiiefs anti expectations, The); are subjeet tab the risks tattetent in timg development, including the risks that
`the effects efthe precinct in target clinicat tfiats may net be as expected or that there may be safety issues at other problems
`er detays that arise during ctinieei triats, unexpected technical or manufactutittg hurdies, or intelieetual progeny disputes.
`There is no certainty that the riskibettefit prefiie tithe drug wit} be aceeptabte to the Company or ti; regulatory authorities
`
`for a pertieuier indicatien. 9mg development inmives a high degree of risk. Only a small number of research and
`devetepment programs teseit in the cammereielizatian ef a product. Success in animal models or eafiy stage eiinieat
`triais {tees net erasure that later stage or target“ scale clinical triads Witt be successful, $01“ more detaiied information an
`the risks and uncertainties associated with these fetwerd leaking statements and Biegen Idec’s other activities see the
`
`periedie and other reports that Biegen Idea has filed with the SEC. Biogen Idea dees not undertake any ebiigation to
`publish; update any forwardJooking statements,
`
`CONTACT: Media Contact: Biogen Idea Jese Juvesg 6137-9181—6524 Associate Director, Pubiic Affairs or Investment
`Community Contact: Biogen Itiec Oscar Veiastegui, 611619—2312 Senior Manager, Investor Relations
`KEYWORD: MASSACHUSETTS INTERNATIONAL AFRICAIMIDDLE EAST LATINAMERICA ASIA
`PACIFIC EUROPE Biomedical
`
`INDUSTRY KEYWORD: PHARMACEUTICAL MEDICAL BIOTECHNOLOGY PRODUCE”
`
`SOURCE: Biegen Idec
`
`«- Imlex References --—
`
`Cempany: SEC SOCIETE EUR095ENNE 13E COMMUNICATION
`
`News Subject: {Majer Cemetetiens {1MA9333
`
`Indestry; {t’hamacetttieais 8t Bieteeheetegy {iPHB}; Betmeteiegy {1353?}; Muscular 3: Neuremuscuiat Disease
`t1MU§8§g Z’séettufaeturittg (IMA?4}; Heattheat’e {ti-112%); Neureiegg {iNEfii‘S}; Drug Approx-ta} Preeess {iIDR’Qi};
`fleittete Seietesis 3: Demyeténstiett { t M1383}; interest Medieine { 31%54}; Eeaitheere Praetiee Seeeiatties {tHEI-QE}
`
`Regime {fimetiees {'izfitstiiéZ}; fiefitt Amettee {ZE‘EQE§§; Westeszt Eetepe {fitt‘fiez}; E'itt’t)}§€ {38383}; fientrat Essepe
`{3:353}; {3333; {3138313}; Seétzetteed {tSW’E’E}; {Zetit‘emis { tCAfitg}:
`
`Leegttege: Etc"
`
`Other tefiextsg: {AQDtE’IGEfiAL E’EASE Bi: AG; i—EIEROFE B‘IQMESIfiALIE‘éQ’QSTRY; Ftfitt’iAI’HARtfi All}; iii;
`stems CONTACT; fiASQAQ: 81178; I’ASi; i’figtSE; fittest? It}; SEC; STUQiEB} {Aggresimetetyg Biegee; ,Qtegee
`
`iéee; 33st 5% geetmett: Fumegtterte; Ides; jese Ewes; Qseer Vetesteget; fiefe Hazbes}
`
`Keysesfis: elifififiéfififigfififi EQTEREATEGE‘EAL géFRifififfiéIIBBLE 8533'? Lg’ftt‘égifiéfifiififi Afiiz’k RASIFIQ
`
`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 4
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`
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`$643 ifigariaais Sag}; E‘g‘ifietfi Pgimary Efié§eif¥i§ {3313? Cgkmpfiamé éise Eéifigm
`
`Ticker Symbol: NASDAQzBIIB
`
`Word Count: 954
`
`
`
`
`
`fiewsfimm
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`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 5
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`
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`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 6
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`
`
`
`ehase it see of Sea; Com easel 39612 assets Primary Endgame: in footnote Seiesosis
`
`Bieaasfioom
`
`1/9/06 Bus. Wire 13:30:00
`
`Business Wire
`
`Copyright © 2006 Business Wire
`
`January 9, 2006
`
`Phase it Study of Oral Compound Bade Meets Primary Endpoint in Multiple Seierosis
`
`BIOWIREZK CAMBRIDGE. Mass. & LUCERNE, Switzerland-{BUSINESS WIRE—Jan. 9; 2006--Biogen Idee
`(NASDAQ: BIIB) and Fumapharm AG today announced that 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) met its primary endpoint.
`Treatment with BG-l2 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. This Phase II multi-eenter, double-blind,
`
`placebo-controlled study enrolled approximately 250 patients at sites in 10 countries in Europe.
`
`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 Idee transforms scientific discoveries
`
`into advances in human healthcare. For press releases and additional information about the company, please Visit http://
`wwwbiogenideecom.
`
`About Fumapharm AG
`
`Fumapharm has licensed exclusive worldwide rights to develop and market BG-12 to Biogen Ides; Fumapharm is a
`privately held pharmaceutical company headquartered in Lucerne, Switzerland. For more information. please Visit httpzf/
`wwwfumapharmeh,
`
`CONTACT: Biogen Idec MEDIA CONTACT: Amy Broekelman, 61?-9l4-6524 Senior Manager, Public Affairs or
`INVESTOR CONTACT: Oscar Velastegui, 61?-679—28l2 Senior Manager; Investor Relations
`KEYWORD: MASSACHUSETTS SWITZERLANE) INTERNATIONAL LATIN AMERICAEUROPE
`INQUSTRY KEYWORfi: PHARMACEGTTCAL MEDICAL BIOTECHNGLOGY PRODL‘CT
`
`SOLIRUZ: Biogen idea
`
`m. index Referenees .....
`
`Company: BTOGEN {SEC INC
`
`News Subject: {Major Corporations {EMA93‘33
`
`industry: {Pharmaceutieais & Bioteehnoiogjg {EPHEE}: lmmanotogy mates; aioseaiar 3: Neuromaseaiar Sisease
`
`if i MSQQ; aiaeafaetaringt i M95234}; Biopttarmaeeetieaia {i 8% l 3}; iieaitlieare if i 33%3; Aiiergg 5e immonoiogy { i awe};
`
`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 7
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`
`
`$32333 ii 3:35;? 2:}? Chat {3222;292:2353 B$212 aegis fifimafy gfiégfiifii 352 giafiégaig Saégmgés
`
`Neuroiogy {1NE9S}; Muliipla Seierosis 8: Demyeiinaiion {iMUSS}; 3131;321:211 Medicine {EINSSZ}; Healihcare Praciice
`Spaciaifies {1383?};
`
`Ragiim: {Americas { 1AM§2}; Noah America {135039}; Wegmm Europe {iWEdi}; Latin America {iLAifS}; Europe
`REESE}; {SA {38538}; {33mm} Eurspe {I CESG}; Switzafland { 15%??733
`
`Laaguage: EN
`
`0:116: Indexing: (AG; BiOGEN IDEC; FUMAPHARM; FUMA?HARM AG; NASEAQ: 33118} {Army Bmskelman;
`(332:3: 'Veiaszegai; I’hasg; Pahiic Affairs}
`
`Keywords: MASSACHUEETTS SWITZERLAND INTERNEH‘IQNAL LATIN AMERICAEUROPE {f};
`{PHARMACEUTICAL MEDICAL BIGTECHNQLOGY PRODUCT}
`
`Ticker Symbci: NASDAQzBIIB
`
`Ward (Emmi: 331
`
` E93223 a? §E2’,2;;
`E3}?
`
`Hawsfimm
`
`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 8
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`
`
`Greg Component $312 Rehiaves Primary Endpoint in Phase ll Study of,”
`
`HewsRoom
`
`5/30/06 Bus. Wire 14:00:00
`
`Business Wire
`
`Copyright (Q 2006 Business Wire
`
`May 30, 2006
`
`Oral Compound Bguia? Achieves Primary Endpoint in Phase {l Study of Relapsing~Remitting
`
`Multiple Sclerosis; Treatment with 81342: Led to Statisticaily Significant Reductions in MRE measures
`
`BIOWIREZK LAUSANNE. Switzerland-{BUSINESS WIRE)—‘May 30, 2006--Biogen ldec (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-lZ 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.
`
`“We are encouraged that these Phase II data demonstrate that BG-l2 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 Adelman, MD, executive vice president, Development, Biogen Idec.
`
`This Phase II 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~lZ at 120 mg, 360 mg. or 720 mg per day for six
`months. The patient group treated with 720 mg ofBG- 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 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 86-12 per da}i had a 32% reduction in relapse rate
`compared to placebo, however, the study was not designed to achieve statistical significance for this endpoint.
`
`The results of the 120 mg and 360 mg BGnIZ—treated groups were not statistically significant versus placebo. Patients
`were foliowed for an additional six months as part of a doseblinded safety extension study.
`
`The most common adverse events were flushing gastrointestinal disorders. headache. and nasophargngitis, The
`incidence of infer enzyme elevation greater than or eonai to three times the rapper innit of normai at any time during the
`piacebo controlled phase of the study was between 25%; and 8% in the three active treatment groopst compared with 5%
`in the placebo group. improvement in liver enzyme tevels was seen after discontinnation of B542. infection rates were
`
`found to be haianced between the 86-12am placebo-treated groups and no opportunistic infections occurred.
`
`About Biogen Idec
`
`ieader in the
`fits a giohai
`Biogen Idec creates new standards of care in oncoiogjai neurology and immunology,
`deizelopmentt manufacturing, and commerciaiizaiioa of noeet therapiest Singers idea: transforms scientific discoeeries
`into advances in human heaithcare. For press releases and additionai information sheet the company. piease visit httpfis"
`
`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 9
`
`
`
`
`Qrat Compound 33?? achieees Primary Endpoint in Reese it Study of
`
`About Fumapharm AG
`
`Fumapharm has licensed exclusive worldwide rights to develop and market BG-lZl to Biogen Idec. Fumapharm is a
`privately held pharmaceutical company headquartered in Lucerne. Switzerland. For more information, please Visit httpzf/
`wwwlumapharmch.
`
`Safe HarborfForward~Looking 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
`AGREEM ENTS
`
`SOURCE: Biogen Idec
`
`-—- Index References -—--
`
`News Subject: (Major Corporations (1MA93))
`
`Industry: (Pharmaceuticals & Biotechnology {IPHI3); Immunology (lIM66); Muscular & Neuromuscular Disease
`(1MU9G); Immunology Drugs ( l IM32); Manufacturing (IMAM); Biopharmaceuticals (113113}: Healthcare Regulatory
`{lHEG4}; Healthcare {IHEGé}; Allergy Sr Immunology (name); Neurology (INE95); Drug Approval Process (lDRQl);
`Multiple Scierosis & Demyelination (lMUSSl; Internal Medicine (llNfiil); Healthcare Practice Specialties ( “1549»
`
`Region: {Americas {lAM‘E’E}; North America thOBQ); Western Europe {IWEKtl}; Europe {'IELESS}; BSA US$723};
`Central Europe ii 1C E58); Switzerland t 1 SW??}}
`
`Language: EN
`
`(AG; EUROPEAN NEBROLOGICAL SOCIETY; FUMAPHARM; FUMAPNARM AG;
`Indexing:
`NASDAQ: BIZB; ORAL COMPOUND: SEC} {Amy Brockelrnan; Biogen; Biogen ldec; Burt Adelman; idec; Idec
`Elizabeth Woo; improvement}
`
`Keywords: MASSACHESET’FS SWITZERLAND INTERNATIONAL CANADA LATINAMERICA EUROI’E {f};
`{PHARMACESTICAL MEDiCAL BIOTECHNOLOGY §3ROD£E€TMARKETING AGREEMENTS}
`
`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 10
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`
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`{Erai 53232133233396! 3312 Aefiéeves §3§m33§3 Efiéggéfit if“? ffifiage :5 Séuéy {331.3
`
`Ticker Symboi: NASDAQzBHB
`
`Word Count: 9116
`
` 2:333? 3;?) [33333323333323
`
`Eewsfémm
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`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 11
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`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 12
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