throbber
DECLARATION REGARDING THOMSON REUTERS/WEST PUBLISHING
`
`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
`
`

`

`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 2
`
`

`

`$3242 §$eriasis Starts; steers Primary Endpoint; Qrai Sompound Aise Eeing.”
`
`Neaestteom
`
`4/7/05 Bus. Wire 12:00:00
`
`Business Wire
`
`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
`
`

`

`$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
`
`

`

`$643 ifigariaais Sag}; E‘g‘ifietfi Pgimary Efié§eif¥i§ {3313? Cgkmpfiamé éise Eéifigm
`
`Ticker Symbol: NASDAQzBIIB
`
`Word Count: 954
`
`
`
`
`
`fiewsfimm
`
`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 5
`
`

`

`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 6
`
`

`

`
`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
`
`

`

`$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
`
`

`

`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
`
`

`

`{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
`
`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 11
`
`

`

`MYLAN PHARMS. INC. EXHIBIT 1122 PAGE 12
`
`

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket