®
`TECFIDERA (Dimethyl Fumarate) Approved in the European Union as a
`First-Line Oral Treatment for Multiple Sclerosis
`
`- Biogen Idec to Begin Launching TECFIDERA in Initial EU Countries in the
`
`Coming Weeks -
`
`Biogen Exhibit 2034
`Biogen MA, Inc. v. Forward Pharma A/S
`Interference No. 106,023
`
`Biogen Exhibit 2005
`Mylan v. Biogen
`IPR2018-01403
`
`Page 1 of 5
`
`

`

`February 03, 2014 08:53 AM Eastern Standard Time
`
`®
`CAMBRIDGE, Mass.--(BUSINESS WIRE)--TECFIDERA (dimethyl fumarate) has been approved by the
`
`European Commission (EC) as a first-line oral treatment for people with relapsing-remitting multiple sclerosis
`
`(RRMS), the most common form of multiple sclerosis (MS). Biogen Idec (NASDAQ: BIIB) will begin to introduce
`
`TECFIDERA in initial European Union (EU) countries in the coming weeks.
`
`TECFIDERA was first approved in the United States in March 2013 and became the country’s number one
`
`1
`prescribed oral therapy for relapsing forms of MS after six months. TECFIDERA was also approved in Canada
`
`and in Australia in 2013.
`
`“TECFIDERA exemplifies our commitment to deliver innovative therapies that help people living with serious
`
`diseases,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “We already have seen
`
`TECFIDERA’s significant impact on transforming the standard of care for MS where it is available and are
`
`excited to quickly bring its benefits to patients in the EU as well.”
`
`The EC approval is based on a robust clinical development program that included two global Phase 3 clinical
`
`trials, DEFINE and CONFIRM, as well as an ongoing extension study, ENDORSE, in which some patients have
`
`been followed for up to six and a half years. TECFIDERA has been clinically shown to significantly reduce
`
`important measures of disease activity, including relapses and the development of brain lesions, as well as to
`
`slow disability progression, while demonstrating a favorable safety and tolerability profile.
`
`“As a physician, I am all too familiar with the challenges my patients experience while managing their MS.
`
`TECFIDERA may lower this burden for many because it is an oral therapy that has been proven to lessen
`
`disease activity effectively while maintaining a favorable safety profile,” said Ralf Gold, M.D., professor and
`
`chair of the Department of Neurology, St. Josef-Hospital/Ruhr-University Bochum and lead investigator of
`
`DEFINE. “Moreover, the positive experience we have had with TECFIDERA throughout its extensive clinical
`
`program gives me confidence about the benefits this oral therapy may offer my patients in the EU.”
`
`TECFIDERA is the fourth therapy Biogen Idec offers to people living with MS.
`
`About the TECFIDERA Phase 3 Clinical Program
`
`The efficacy and safety of TECFIDERA were evaluated in two large, global Phase 3 clinical studies, DEFINE
`
`and CONFIRM.
`
`In DEFINE, TECFIDERA administered twice daily significantly reduced the proportion of patients who relapsed
`
`by 49 percent (p<0.0001), the annualized relapse rate (ARR) by 53 percent (p<0.0001), and the risk of 12-week
`
`confirmed disability progression, as measured by the Expanded Disability Status Scale (EDSS), by 38 percent
`
`(p=0.0050) compared to placebo at two years. In CONFIRM, which also included an active reference
`
`comparator of glatiramer acetate (GA) compared to placebo, twice-daily TECFIDERA significantly reduced
`
`Page 2 of 5
`
`

`

`ARR by 44 percent (p<0.0001) and the proportion of patients who relapsed by 34 percent (p=0.0020) compared
`
`to placebo at two years. While not statistically significant, TECFIDERA showed a 21 percent reduction in the
`
`risk of 12-week confirmed disability progression in CONFIRM compared to placebo at two years.
`
`In both DEFINE and CONFIRM,TECFIDERA also significantly reduced lesions in the brain compared to
`
`placebo, as measured by magnetic resonance imaging (MRI). Glatiramer acetate data in CONFIRM, compared
`
`to placebo, was consistent with EU product labeling.
`
`The most common adverse events (AEs) associated with TECFIDERA were flushing and gastrointestinal (GI)
`
`events (i.e., diarrhea, nausea, abdominal pain, upper abdominal pain). Overall, clinical trial discontinuations
`
`due to flushing (3%) and GI events (4%) were low.
`
`Mean lymphocyte counts decreased during the first year of treatment and then remained stable. There were no
`
`opportunistic infections in TECFIDERA-treated patients and no overall increased risk of serious infections.
`
`®
`About TECFIDERA
`
`TECFIDERA (dimethyl fumarate) gastro-resistant hard capsules are indicated for the treatment of adult patients
`
`with relapsing-remitting multiple sclerosis (RRMS). TECFIDERA has been shown to reduce multiple sclerosis
`
`(MS) relapses and MS brain lesions, as well as to slow the progression of disability, while demonstrating a
`
`favorable safety and tolerability profile. The efficacy and safety of TECFIDERA has been studied in a large,
`
`global clinical program, which includes an ongoing long-term extension study. As of September 2013,
`
`approximately 35,000 patients were being treated with TECFIDERA globally.
`
`2
`
`It is believed that TECFIDERA provides a new approach to treating MS by activating the Nrf2 pathway,
`
`although its exact mechanism of action is not fully understood. This pathway provides a way for cells in the
`
`body to defend themselves against inflammation and oxidative stress caused by conditions like MS.
`
`According to the EU Summary of Product Characteristics (SmPC), the starting dose of TECFIDERA is 120 mg
`
`twice a day orally. After seven days, the recommended dose should be increased to 240 mg twice a day.
`
`The most common adverse reactions for TECFIDERA are flushing and gastrointestinal (GI) events (i.e.,
`
`diarrhea, nausea, abdominal pain, upper abdominal pain), which were mostly mild or moderate in patients
`
`experiencing these reactions in clinical trials. For patients who experience these side effects, they tend to begin
`
`primarily during the first month of treatment and may continue to occur intermittently throughout treatment with
`
`TECFIDERA.
`
`TECFIDERA may decrease lymphocyte counts. TECFIDERA has not been studied in patients with pre-existing
`
`low lymphocyte counts. A complete blood count (CBC) is recommended prior to initiating treatment. A follow up
`
`CBC is also recommended after six months of treatment, every six to 12 months thereafter and at the discretion
`
`of the physician.
`
`Changes in renal and hepatic laboratory tests have been seen in clinical trials in patients treated with
`
`TECFIDERA. The clinical implications of these changes are unknown. Liver and kidney function tests are
`
`recommended prior to starting treatment, after three and six months of treatment, every six to 12 months
`
`thereafter and at the discretion of the physician.
`
`TECFIDERA is not recommended during pregnancy or in women of child bearing potential not using
`
`appropriate contraception.
`
`Additional resources on TECFIDERA are available to the media upon request.
`
`About Biogen Idec
`
`Page 3 of 5
`
`

`

`Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients
`
`worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune
`
`disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company. Patients
`
`worldwide benefit from its leading multiple sclerosis therapies. For product labeling, press releases and
`
`additional information about the Company, please visit www.biogenidec.com.
`
`Safe Harbor
`
`This press release contains forward-looking statements, including statements about the potential benefits and
`
`therapeutic impact of TECFIDERA. These forward-looking statements may be accompanied by such words as
`
`“anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,”
`
`“target,” “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 uncertainty of success in commercialization of TECFIDERA,
`
`unexpected hurdles or difficulties in launching TECFIDERA in EU countries, difficulties obtaining or changes in
`
`the availability of reimbursement for TECFIDERA, problems with our manufacturing processes and our reliance
`
`on third parties to manufacture and supply TECFIDERA, the occurrence of adverse safety events, failure to
`
`comply with government regulation, our ability to protect our intellectual property and other proprietary rights,
`
`product liability claims 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 U.S. Securities and Exchange
`
`Commission (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.
`
`1
`
`Based on number of prescriptions from IMS NPA™ Weekly Data (27 September 2013) and Biogen Idec data
`
`on file.
`
`2
`
`Biogen Idec data on file.
`
`Contacts
`US MEDIA CONTACT:
`
`Biogen Idec
`
`Kate Niazi-Sai, +1 781-464-3260
`
`public.affairs@biogenidec.com
`
`or
`
`EX-US MEDIA CONTACT:
`
`Biogen Idec International
`
`Shannon Altimari, +41 41 392 1702
`
`publicaffairs.EU@biogenidec.com
`
`or
`
`INVESTOR CONTACTS:
`
`Biogen Idec
`
`Claudine Prowse, Ph.D., +1 781-464-2442
`
`IR@biogenidec.com
`
`or
`
`Carlo Tanzi, Ph.D., +1 781-464-2442
`
`IR@biogenidec.com
`
`Page 4 of 5
`
`

`

`Page 5 0f 5
`
`Page 5 of 5
`
`