Pub shed on Biogen Media (http://med a.b ogen.com) on 4/11/11 7:00 am EDT
`
`Biogen Idec Announces Positive Top-Line Results from
`the First Phase 3 Trial Investigating Oral BG-12
`(DIMETHYL FUMARATE) in Multiple Sclerosis
`Release Date:
`Monday, Apr 11, 2011 7:00 am EDT
`Terms:
`Neuro ogy [1]
`Dateline City:
`WESTON, Mass.
`- DEFINE Study Achieves Primary and All Secondary Endpoints for Both
`Study Doses -
`- Full Data to Be Presented at a Future Medical Meeting -
`
`(BUSINESS WIRE [2]) B ogen Idec [3] (NASDAQ: BIIB) announced today pos t ve top ne resu ts from DEFINE,
`WESTON, Mass.
`the f rst of two p vota Phase 3 c n ca tr a s des gned to eva uate the nvest gat ona ora compound BG 12 (d methy
`fumarate) as a monotherapy n peop e w th re aps ng rem tt ng mu t p e sc eros s (RRMS). Resu ts showed that 240 mg of BG
`12, adm n stered e ther tw ce or three t mes a day, met the pr mary study endpo nt, demonstrat ng a h gh y stat st ca y
`s gn f cant reduct on (p<0.0001) n the proport on of pat ents w th RRMS who re apsed at two years compared w th p acebo.
`Both doses of BG 12 a so met a of the secondary study endpo nts, prov d ng a stat st ca y s gn f cant reduct on n
`annua zed re apse rate, n the number of new or new y en arg ng T2 hyper ntense es ons, n new gado n um enhanc ng (Gd+)
`es ons, and n the rate of d sab ty progress on as measured by the Expanded D sab ty Sever ty Sca e (EDSS) at two years.
`DEFINE was a g oba , random zed, doub e b nd, p acebo contro ed, dose compar son study to determ ne the eff cacy and
`safety of BG 12 n peop e w th RRMS. In add t on to meet ng the pr mary and a secondary endpo nts, n t a data from the tr a
`showed that BG 12 demonstrated a favorab e safety and to erab ty prof e. The overa nc dence of adverse events and
`ser ous adverse events was s m ar among the p acebo group and both BG 12 treatment groups. The safety prof e was
`cons stent w th what was seen n the pub shed Phase 2 study of BG 12. Further ana yses of the DEFINE study are ongo ng,
`and the company ant c pates present ng deta ed data at a future med ca meet ng.
`“The s gn f cant c n ca responses seen n the DEFINE study represent an mportant step forward n the deve opment of BG
`12 for mu t p e sc eros s (MS),” sa d Doug as W ams, Ph.D., B ogen Idec’s Execut ve V ce Pres dent of Research and
`Deve opment. “We are very p eased w th these data and be eve that BG 12 has the potent a to offer MS pat ents a h gh y
`effect ve ora treatment opt on w th a strong safety prof e.”
`Data from sc ent f c stud es nd cate that BG 12 has the potent a to be d st nct ve by reduc ng the entry nto and the act on
`of nf ammatory ce s on the Centra Nervous System (CNS), as we as potent a y protect ng CNS ce s from ox dat ve stress
`and death by act vat on of the Nrf 2 pathway.
`BG 12 rece ved Fast Track des gnat on from the U.S. Food and Drug Adm n strat on (FDA) n 2008. In add t on to DEFINE,
`another Phase 3 RRMS c n ca tr a , CONFIRM, s current y underway. Th s study s eva uat ng BG 12 and an act ve reference
`comparator, g at ramer acetate, aga nst p acebo on c n ca re apse, magnet c resonance mag ng (MRI) measures of MS,
`progress on of d sab ty, and safety. Resu ts from CONFIRM are expected n the second ha f of 2011.
`About the DEFINE Trial
`DEFINE (Determ nat on of the Eff cacy and safety of ora Fumarate IN rE aps ng rem tt ng MS) was a g oba , random zed,
`doub e b nd, p acebo contro ed, dose compar son study to determ ne the eff cacy and safety of BG 12 n more than 1,200
`peop e w th RRMS. The study eva uated two doses of BG 12: 240 mg tw ce a day and 240 mg three t mes a day. The pr mary
`object ve was to determ ne f BG 12 s effect ve n reduc ng the proport on of re aps ng pat ents at two years. Secondary
`endpo nts nc uded reduct on n the number of new or new y en arg ng T2 hyper ntense es ons and new Gd+ es ons as
`measured by MRI, reduct on n annua zed re apse rate, and reduct on of d sab ty progress on as measured by EDSS.
`Add t ona endpo nts nc uded the safety and to erab ty of BG 12.
`About Biogen Idec
`B ogen Idec uses cutt ng edge sc ence to d scover, deve op, manufacture, and market therapeut c products for the
`treatment of ser ous d seases w th a focus on neuro og ca d sorders. Founded n 1978, B ogen Idec s the wor d s o dest
`ndependent b otechno ogy company. Pat ents wor dw de benef t from ts ead ng mu t p e sc eros s therap es, and the
`company generates more than $4 b on n annua revenues. For product abe ng, press re eases and add t ona nformat on
`
`Page 1 of 2
`
`Biogen Exhibit 2031
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Biogen Idec Announces Positive Top-Line Results from
`the First Phase 3 Trial Investigating Oral BG-12
`(DIMETHYL FUMARATE) in Multiple Sclerosis
`Release Date:
`Monday, Apr 11, 2011 7:00 am EDT
`Terms:
`Neuro ogy [1]
`Dateline City:
`WESTON, Mass.
`- DEFINE Study Achieves Primary and All Secondary Endpoints for Both
`Study Doses -
`- Full Data to Be Presented at a Future Medical Meeting -
`
`(BUSINESS WIRE [2]) B ogen Idec [3] (NASDAQ: BIIB) announced today pos t ve top ne resu ts from DEFINE,
`WESTON, Mass.
`the f rst of two p vota Phase 3 c n ca tr a s des gned to eva uate the nvest gat ona ora compound BG 12 (d methy
`fumarate) as a monotherapy n peop e w th re aps ng rem tt ng mu t p e sc eros s (RRMS). Resu ts showed that 240 mg of BG
`12, adm n stered e ther tw ce or three t mes a day, met the pr mary study endpo nt, demonstrat ng a h gh y stat st ca y
`s gn f cant reduct on (p<0.0001) n the proport on of pat ents w th RRMS who re apsed at two years compared w th p acebo.
`Both doses of BG 12 a so met a of the secondary study endpo nts, prov d ng a stat st ca y s gn f cant reduct on n
`annua zed re apse rate, n the number of new or new y en arg ng T2 hyper ntense es ons, n new gado n um enhanc ng (Gd+)
`es ons, and n the rate of d sab ty progress on as measured by the Expanded D sab ty Sever ty Sca e (EDSS) at two years.
`DEFINE was a g oba , random zed, doub e b nd, p acebo contro ed, dose compar son study to determ ne the eff cacy and
`safety of BG 12 n peop e w th RRMS. In add t on to meet ng the pr mary and a secondary endpo nts, n t a data from the tr a
`showed that BG 12 demonstrated a favorab e safety and to erab ty prof e. The overa nc dence of adverse events and
`ser ous adverse events was s m ar among the p acebo group and both BG 12 treatment groups. The safety prof e was
`cons stent w th what was seen n the pub shed Phase 2 study of BG 12. Further ana yses of the DEFINE study are ongo ng,
`and the company ant c pates present ng deta ed data at a future med ca meet ng.
`“The s gn f cant c n ca responses seen n the DEFINE study represent an mportant step forward n the deve opment of BG
`12 for mu t p e sc eros s (MS),” sa d Doug as W ams, Ph.D., B ogen Idec’s Execut ve V ce Pres dent of Research and
`Deve opment. “We are very p eased w th these data and be eve that BG 12 has the potent a to offer MS pat ents a h gh y
`effect ve ora treatment opt on w th a strong safety prof e.”
`Data from sc ent f c stud es nd cate that BG 12 has the potent a to be d st nct ve by reduc ng the entry nto and the act on
`of nf ammatory ce s on the Centra Nervous System (CNS), as we as potent a y protect ng CNS ce s from ox dat ve stress
`and death by act vat on of the Nrf 2 pathway.
`BG 12 rece ved Fast Track des gnat on from the U.S. Food and Drug Adm n strat on (FDA) n 2008. In add t on to DEFINE,
`another Phase 3 RRMS c n ca tr a , CONFIRM, s current y underway. Th s study s eva uat ng BG 12 and an act ve reference
`comparator, g at ramer acetate, aga nst p acebo on c n ca re apse, magnet c resonance mag ng (MRI) measures of MS,
`progress on of d sab ty, and safety. Resu ts from CONFIRM are expected n the second ha f of 2011.
`About the DEFINE Trial
`DEFINE (Determ nat on of the Eff cacy and safety of ora Fumarate IN rE aps ng rem tt ng MS) was a g oba , random zed,
`doub e b nd, p acebo contro ed, dose compar son study to determ ne the eff cacy and safety of BG 12 n more than 1,200
`peop e w th RRMS. The study eva uated two doses of BG 12: 240 mg tw ce a day and 240 mg three t mes a day. The pr mary
`object ve was to determ ne f BG 12 s effect ve n reduc ng the proport on of re aps ng pat ents at two years. Secondary
`endpo nts nc uded reduct on n the number of new or new y en arg ng T2 hyper ntense es ons and new Gd+ es ons as
`measured by MRI, reduct on n annua zed re apse rate, and reduct on of d sab ty progress on as measured by EDSS.
`Add t ona endpo nts nc uded the safety and to erab ty of BG 12.
`About Biogen Idec
`B ogen Idec uses cutt ng edge sc ence to d scover, deve op, manufacture, and market therapeut c products for the
`treatment of ser ous d seases w th a focus on neuro og ca d sorders. Founded n 1978, B ogen Idec s the wor d s o dest
`ndependent b otechno ogy company. Pat ents wor dw de benef t from ts ead ng mu t p e sc eros s therap es, and the
`company generates more than $4 b on n annua revenues. For product abe ng, press re eases and add t ona nformat on
`
`Page 1 of 2
`
`Biogen Exhibit 2031
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`about the company, please visit www.biogenidec.com [4].
`Safe Harbor
`This press release includes forward-looking statements, including statements about the development and commercialization
`of BG-12 in MS. These forward-looking statements may be accompanied by such words as "anticipate," "believe,"
`"estimate," "expect," "forecast," "intend," "may," "plan," "will" and other words and terms of similar meaning. You should not
`place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results
`to differ materially from those reflected in such statements, including meeting endpoints in clinical trials, obtaining
`regulatory approval, the occurrence of adverse safety events, product competition, the availability of reimbursement for our
`products, adverse market and economic conditions, problems with our manufacturing processes and our reliance on third
`parties, failure to comply with government regulation and possible adverse impact of changes in such regulation, our ability
`to protect our intellectual property rights and the cost of doing so, and the other risks and uncertainties that are described
`in the Risk Factors section of our most recent annual or quarterly report and in other reports we have filed with the SEC.
`These statements are based on our current beliefs and expectations and speak only as of the date of this press release.
`We do not undertake any obligation to publicly update any forward-looking statements.
`Language:
`English
`Contact:
`Biogen Idec
`Media:
`Kate Weiss, 781-464-3260
`or
`Investor:
`Wendy Gabel, 781-464-2442
`Ticker Slug:
`Ticker:BIIB
`Exchange:NASDAQ
`ISIN:
`US09062X1037
`
`Source URL: http://med a.b ogen.com/press re ease/mu t p e sc eros s ms/b ogen dec announces pos t ve top ne resu ts f rst
`phase 3 tr
`Links:
`[1] http://med a.b ogen.com/category/press re ease category/%5Bcatpath raw%5D 1
`[2] http://www.bus nessw re.com
`[3] http://cts.bus nessw re.com/ct/CT?
`d=smart nk&ur =http%3A%2F%2FWWW.BIOGENIDEC.COM&esheet=6678376& an=en
`US&anchor=B ogen+Idec& ndex=1&md5=fd0c6c4bbdee6fa3052a14c4b92f1abe
`[4] http://cts.bus nessw re.com/ct/CT?
`d=smart nk&ur =http%3A%2F%2Fwww.b ogen dec.com%2F&esheet=6678376& an=en
`US&anchor=www.b ogen dec.com& ndex=2&md5=1f8b90823de6c404285ee5f9e5f7fe53
`
`Page 2 of 2
`
`
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