Biogen Idec Announces Positive Top-Line Results from the First
`Phase 3 Trial Investigating Oral BG-12 (DIMETHYL FUMARATE) in
`Multiple Sclerosis
`media.biogen.com/news-re eases/news-re ease-deta s/b ogen- dec-announces-pos t ve-top- ne-resu ts-f rst-phase-3
`
`April 11, 2011 at 7:00 AM EDT
`
`- DEFINE Study Achieves Primary and All Secondary Endpoints for Both Study Doses -
`
`- Full Data to Be Presented at a Future Medical Meeting -
`
`WESTON, Mass.--(BUSINESS WIRE)--Biogen Idec (NASDAQ: BIIB) announced today positive top-
`line results from DEFINE, the first of two pivotal Phase 3 clinical trials designed to evaluate the
`investigational oral compound BG-12 (dimethyl fumarate) as a monotherapy in people with
`relapsing-remitting multiple sclerosis (RRMS). Results showed that 240 mg of BG-12,
`administered either twice or three times a day, met the primary study endpoint, demonstrating
`a highly statistically significant reduction (p<0.0001) in the proportion of patients with RRMS who
`relapsed at two years compared with placebo. Both doses of BG-12 also met all of the
`secondary study endpoints, providing a statistically significant reduction in annualized relapse
`rate, in the number of new or newly enlarging T2 hyperintense lesions, in new gadolinium-
`enhancing (Gd+) lesions, and in the rate of disability progression as measured by the Expanded
`Disability Severity Scale (EDSS) at two years.
`
`DEFINE was a global, randomized, double-blind, placebo-controlled, dose-comparison study to
`determine the efficacy and safety of BG-12 in people with RRMS. In addition to meeting the
`primary and all secondary endpoints, initial data from the trial showed that BG-12
`demonstrated a favorable safety and tolerability profile. The overall incidence of adverse events
`and serious adverse events was similar among the placebo group and both BG-12 treatment
`groups. The safety profile was consistent with what was seen in the published Phase 2 study of
`BG-12. Further analyses of the DEFINE study are ongoing, and the company anticipates
`presenting detailed data at a future medical meeting.
`
`“The significant clinical responses seen in the DEFINE study represent an important step forward
`in the development of BG-12 for multiple sclerosis (MS),” said Douglas Williams, Ph.D., Biogen
`Idec’s Executive Vice President of Research and Development. “We are very pleased with these
`data and believe that BG-12 has the potential to offer MS patients a highly effective oral
`treatment option with a strong safety profile.”
`
`Data from scientific studies indicate that BG-12 has the potential to be distinctive by reducing
`the entry into and the action of inflammatory cells on the Central Nervous System (CNS), as well
`as potentially protecting CNS cells from oxidative stress and death by activation of the Nrf-2
`pathway.
`
`1/3
`
`Biogen Exhibit 2131
`Mylan v. Biogen
`IPR2018-01403
`
`Page 1 of 3
`
`

`

`BG-12 received Fast Track designation from the U.S. Food and Drug Administration (FDA) in
`2008. In addition to DEFINE, another Phase 3 RRMS clinical trial, CONFIRM, is currently
`underway. This study is evaluating BG-12 and an active reference comparator, glatiramer
`acetate, against placebo on clinical relapse, magnetic resonance imaging (MRI) measures of MS,
`progression of disability, and safety. Results from CONFIRM are expected in the second half of
`2011.
`
`About the DEFINE Trial
`
`DEFINE (Determination of the Efficacy and safety of oral Fumarate IN rElapsing-remitting MS)
`was a global, randomized, double-blind, placebo-controlled, dose-comparison study to
`determine the efficacy and safety of BG-12 in more than 1,200 people with RRMS. The study
`evaluated two doses of BG-12: 240 mg twice a day and 240 mg three times a day. The primary
`objective was to determine if BG-12 is effective in reducing the proportion of relapsing patients
`at two years. Secondary endpoints included reduction in the number of new or newly enlarging
`T2 hyperintense lesions and new Gd+ lesions as measured by MRI, reduction in annualized
`relapse rate, and reduction of disability progression as measured by EDSS. Additional endpoints
`included the safety and tolerability of BG-12.
`
`About Biogen Idec
`
`Biogen Idec uses cutting-edge science to discover, develop, manufacture, and market
`therapeutic products for the treatment of serious diseases with a focus on neurological
`disorders. Founded in 1978, Biogen Idec is the world's oldest independent biotechnology
`company. Patients worldwide benefit from its leading multiple sclerosis therapies, and the
`company generates more than $4 billion in annual revenues. For product labeling, press
`releases and additional information about the company, please visit www.biogenidec.com.
`
`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
`
`2/3
`
`Page 2 of 3
`
`

`

`this press release. We do not undertake any obligation to publicly update any forward-looking
`statements.
`
`3/3
`
`Page 3 of 3
`
`