Biogen Idec to Present New Clinical Data from Its Robust Neurology Portfolio at AAN Annual Meeting

  Biogen Idec to Present New Clinical Data from Its Robust Neurology Portfolio
  at AAN Annual Meeting

       - Two-Year Data from Pivotal Phase 3 ADVANCE Study for PLEGRIDY™
                  (Peginterferon Beta-1a) to Be Presented -

  - New TECFIDERA^® (dimethyl fumarate) Data Underscore Efficacy, Consistent
   with Growing Global Experience with Greater than 65,000 Patients Treated
                                Worldwide^1 -

- Presentations Demonstrate Breadth of Company’s Innovative Neurology Pipeline

Business Wire

CAMBRIDGE, Mass. -- April 14, 2014

Biogen Idec (NASDAQ: BIIB) will present more than 60 company-sponsored
platform and poster presentations on data supporting its marketed and
investigational therapies for neurological diseases at the 66^th American
Academy of Neurology (AAN) Annual Meeting in Philadelphia, April 26 – May 3,
2014. The scope and rigor of the data reflects Biogen Idec’s leadership in
advancing neurological research and enhancing patient outcomes in multiple
sclerosis (MS) and other diseases.

“For more than 20 years, Biogen Idec has been dedicated to improving the lives
of people with MS,” said Alfred Sandrock, M.D., Ph.D., group senior vice
president, and chief medical officer at Biogen Idec. “We have a broad
portfolio and pipeline of innovative MS medicines, we perform important
research that continues to advance our understanding of this disease, and we
provide meaningful support services for people living with MS. The breadth of
data we are presenting at AAN reinforces our enduring commitment to reducing
the impact of MS and other serious neurodegenerative diseases.”

As part of its ongoing commitment to further understand the underlying causes
of neurological disease, Biogen Idec is presenting new data to help patients
and their healthcare providers make optimal treatment decisions and improve
patient outcomes. In addition, data at AAN will include results from studies
of its currently marketed products, TECFIDERA^® (dimethyl fumarate), TYSABRI^®
(natalizumab), AVONEX^® (interferon beta-1a) and FAMPYRA^® (prolonged-release
fampridine tablets), as well as findings from the clinical programs of its MS
pipeline candidates PLEGRIDY™ (peginterferon beta-1a), daclizumab high-yield
process (DAC HYP) and Anti-LINGO-1 (BIIB033).

In addition to data presented at the meeting, Biogen Idec will support the
American Brain Foundation’s 2014 Brain Health Fair. On Saturday, April 26
Biogen Idec will help sponsor a free, day-long family event that aims to
connect thousands of patients, families and caregivers affected by
neurological disease. The Brain Health Fair will offer scientific
presentations and discussions, educational activities, and a film festival
competition that aims to increase public awareness and understanding of
neurological disease. Registration is free at

Notable data from Biogen Idec at AAN 2014 in MS and Alzheimer’s disease:


  *Do MRI Lesions Predict MS Relapses? –  Poster P3.190 – Tuesday, April 29,
    – 3:00 PM
  *Multiple Sclerosis Decision Model (MSDM): A Multifactorial Model To
    Monitor Treatment Response And Disease Course In Relapsing Remitting
    Multiple Sclerosis –  Poster P3.133 - Tuesday, April 29 – 3:00 PM
  *Epidemiological Study To Identify Factors That Influence Clinical Decision
    Making In Patients With Relapsing Remitting Multiple Sclerosis (RRMS)
    After At Least 2 Years Of Treatment With Immunomodulators In Germany
    (EPIDEM) – Poster P7.243 – Thursday, May 1 – 3:00 PM


  *Gastrointestinal Tolerability of Delayed-Release Dimethyl Fumarate in a
    Multicenter, Open-Label Study of Patients With Relapsing Forms of Multiple
    Sclerosis – Poster P2.227 – Tuesday, April 29 – 7:30 AM
  *Clinical Efficacy of Delayed-Release Dimethyl Fumarate in
    Relapsing-Remitting Multiple Sclerosis (RRMS) Patients with Highly Active
    Disease: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies
    – Poster P3.189 – Tuesday, April 29 – 3:00 PM
  *Clinical Efficacy of Delayed-Release Dimethyl Fumarate in Minority
    Patients with Relapsing-Remitting Multiple Sclerosis (RRMS): An Integrated
    Analysis of the Phase 3 DEFINE and CONFIRM Studies – Poster P3.171 –
    Tuesday, April 29 – 3:00 PM
  *Dimethyl Fumarate Utilizes Nrf2-independent and Nrf2-dependent Pathways
    for Immune Modulation – Platform S53.006 – Thursday, May 1 – 2:15 PM


  *Natalizumab Treatment Improves Walking Speed in MS Patients: A Post Hoc
    Analysis of AFFIRM – Platform S4.006 – Tuesday, April 29 – 2:15 PM
  *Comparative Efficacy of Switching to Natalizumab Versus Switching to
    Interferon-Beta or Glatiramer Acetate after On-Treatment MS Relapse Using
    Propensity-Matched Registry Data – Poster P3.175 – Tuesday, April 29 –
    3:00 PM
  *Comparison of Switching to Natalizumab Versus Remaining on Interferon-Beta
    or Glatiramer Acetate after On-Treatment MS Relapse Using
    Propensity-Matched Registry Data – Poster P7.208 – Thursday, May 1 – 3:00


  *Prospective Evaluation of Persistence, Treatment Adherence, Quality of
    Life, and Treatment Satisfaction in Patients Treated with an Intramuscular
    Interferon Beta-1a Autoinjector in a Real-World Clinical Setting – Poster
    P7.231 – Thursday, May 1 – 3:00 PM


  *Prolonged-Release Fampridine Treatment and Walking Ability and Balance in
    Patients with Multiple Sclerosis: Results of the Randomized, Double-Blind
    MOBILE Study- Data Blitz Presentation 010 – Wednesday, April 30 – 6:42 PM;
    Poster 010 – Wednesday, April 30 – 6:15 PM


  *Analysis of 2-year Clinical Efficacy and Safety of Peginterferon Beta-1a
    in Patients with Relapsing-Remitting Multiple Sclerosis: Data from the
    Pivotal Phase 3 ADVANCE Study – Platform S4.005 – Tuesday, April 29 – 2:00
  *Peginterferon Beta-1a Significantly Increases the Proportion of Patients
    with Freedom from Measured Disease Activity in Relapsing-Remitting
    Multiple Sclerosis: Findings from the ADVANCE Study – Platform S4.007 –
    Tuesday, April 29 – 2:30 PM
  *Peginterferon Beta-1a May Improve Recovery Following Relapses: Data from
    the Pivotal Phase 3 ADVANCE Study in Patients with Relapsing-Remitting
    Multiple Sclerosis – Platform S4.003 – Tuesday, April 29 – 1:30 PM; Poster
    I7-1.002 – Wednesday, April 30 – 4:30 PM


  *Decrease in T1 black hole volume over 2 years of daclizumab high-yield
    process treatment – Poster P3.188 – Tuesday, April 29 – 3:00 PM
  *Reduction in brain atrophy with extended daclizumab HYP treatment: Results
    of SELECT and the SELECT extension study – Poster P3.187 – Tuesday, April
    29 – 3:00 PM

Anti-LINGO -1

  *Efficacy and Safety of Anti LINGO-1 for the Treatment of Relapsing Forms
    of Multiple Sclerosis: Design of the Phase 2 SYNERGY Trial – Poster
    P3.154, – Tuesday, April 29 – 3:00 PM


  *Experience in a Phase 1b Clinical Trial – Poster P3.207 – Tuesday, April
    29, 2014 – 3:00 PM

Full session details and data presentation listings for the 2014 Annual
Meeting can be found through the AAN website

About Biogen Idec

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 labelling, press releases and additional information about the
Company, please visit


TECFIDERA is an oral therapy for relapsing forms of MS, including
relapsing-remitting MS, the most common form of MS. TECFIDERA is currently
approved in the United States, the European Union, Canada and Australia.
Through a robust clinical trial program and commercial launches starting with
the United States in March 2013, greater than 65,000 patients have been
treated with TECFIDERA worldwide ^ 2.

TECFIDERA has been proven to reduce MS relapses, progression of disability and
MS brain lesions, while demonstrating a favourable safety and tolerability
profile. In clinical trials, the most common adverse events associated with
TECFIDERA were flushing and gastrointestinal (GI) events. Other side effects
included a decrease in mean lymphocyte counts during the first year of
treatment, which then plateaued. The efficacy and safety of TECFIDERA has been
studied in a large, global clinical program, which includes an ongoing
long-term extension study. It is believed that TECFIDERA provides a new
approach to treating MS by activating the Nrf2 pathway, although its exact
mechanism of action is unknown. This pathway provides a way for cells in the
body to defend themselves against inflammation and oxidative stress caused by
conditions like MS.

For additional important safety information, and the United States full
prescribing information, please


TYSABRI is approved in more than 65 countries. In the United States, TYSABRI
is indicated as monotherapy for the treatment of patients with relapsing forms
of MS. TYSABRI increases the risk of PML. When initiating and continuing
treatment with TYSABRI, physicians should consider whether the expected
benefit of TYSABRI is sufficient to offset this risk. In theEuropean Union,
it is indicated as a single disease modifying therapy in highly active
relapsing-remitting MS (RRMS) for adult patients who have high disease
activity despite treatment with a beta interferon or glatiramer acetate or
patients with rapidly evolving severe RRMS.

TYSABRI has advanced the treatment of MS patients with its established
efficacy. Data from the Phase 3 AFFIRM trial, which was published in theNew
England Journal of Medicine, showed that after two years, TYSABRI treatment
led to a 68 percent relative reduction (p<0.001) in the annualized relapse
rate when compared with placebo and reduced the relative risk of disability
progression by 42-54 percent (p<0.001).

TYSABRI increases the risk of PML, an opportunistic viral infection of the
brain which usually leads to death or severe disability. Infection by the JC
virus (JCV) is required for the development of PML and patients who are
anti-JCV antibody positive have a higher risk of developing PML. Factors that
increase the risk of PML are presence of anti-JCV antibodies, prior
immunosuppressant use, and longer TYSABRI treatment duration. Patients who
have all three risk factors have the highest risk of developing PML. TYSABRI
increases the risk of developing encephalitis and meningitis caused by herpes
simplex and varicella zoster viruses. Serious, life-threatening, and sometimes
fatal cases have been reported in the postmarketing setting in multiple
sclerosis patients receiving TYSABRI. Other serious adverse events that have
occurred in TYSABRI-treated patients include hypersensitivity reactions (e.g.,
anaphylaxis) and infections, including opportunistic and other atypical
infections. Clinically significant liver injury has also been reported in the
post-marketing setting. A list of adverse events can be found in the full
TYSABRI product labeling for each country where it is approved.

For additional important safety information, and the United States full
prescribing information, please


AVONEX is one of the most prescribed treatments for relapsing forms of MS
worldwide. AVONEX is indicated for the treatment of patients with relapsing
forms of MS to slow the accumulation of physical disability and decrease the
frequency of clinical exacerbations. Patients with MS in whom efficacy has
been demonstrated include patients who have experienced a first clinical
episode and have MRI features consistent with MS.

Symptoms of depression, suicidal ideation, or psychosis, and cases of suicide,
have been reported with increased frequency with patients receiving AVONEX.
Severe hepatic injury, including cases of hepatic failure has been reported
rarely in patients. Rare cases of anaphylaxis have been reported. While beta
interferons do not have any known direct cardiac toxicity, cases of congestive
heart failure, cardiomyopathy, and cardiomyopathy with congestive heart
failure have been reported in patients without known predisposition. Decreased
peripheral blood counts have been reported from postmarketing experience.
Seizures have been reported in patients using AVONEX, including patients with
no prior history of seizure. Autoimmune disorders of multiple target organs
have been reported. Routine periodic blood chemistry, hematology, liver
function, and thyroid function tests are recommended. AVONEX should be used
during pregnancy only if the potential benefit justifies the potential risk to
the fetus. The most common side effects associated with AVONEX treatment are
flu-like symptoms, including chills, fever, myalgia, and asthenia.

For additional important safety information, and the United States full
prescribing information, please


FAMPYRA is a prolonged-release (sustained release) tablet formulation of the
drug fampridine (4-aminopyridine, 4-AP or dalfampridine). FAMPYRA has been
developed to improve walking in adult patients with MS. In MS, damaged myelin
exposes channels in the membrane of axons allowing potassium ions to leak,
weakening the electrical current sent through nerves. Studies have shown that
fampridine can increase conduction along damaged nerves, which may result in
improved walking ability.

In clinical trials, the highest incidence of adverse reactions identified with
FAMPYRA given at the recommended dose was urinary tract infection, although
infection was often not proven by culture. Other adverse drug reactions
identified were mainly divided between neurological disorders, such as
insomnia, balance disorder, dizziness, paraesthesia, headache and
gastrointestinal disorders including nausea, dyspepsia and constipation. In
post-marketing experience, there have been reports of seizure. Confounding
factors may have contributed to the occurrence of seizure in some patients.

This prolonged-release formulation was developed and is being commercialized
inthe United StatesbyAcorda Therapeutics, Inc.(NASDAQ: ACOR) under the
trade name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg.Biogen
Ideclicensed rights from Acorda to develop and commercialize fampridine in
all markets outsidethe United States.Biogen Idec commercializes fampridine
in these markets under the trade name Fampyra®.


PLEGRIDY is a new molecular entity in which interferon beta-1a is pegylated to
extend its half-life and prolong its exposure in the body. PLEGRIDY, an
investigational candidate, is a member of the interferon class of treatments,
which is often used as a first-line treatment for MS.

Regulatory authorities in the United States and the European Union accepted
the marketing applications for the review of PLEGRIDY in relapsing forms of MS
in 2013.

About Daclizumab High-Yield Process

Daclizumab high-yield process (DAC HYP) is in late-stage clinical development
for the treatment of RRMS, the most common form of MS. DAC HYP is a humanized
monoclonal antibody that binds to CD25, a receptor subunit that is expressed
at high levels on T cells that are thought to become abnormally activated in
autoimmune conditions, such as MS. Data from previous clinical trials showed
that DAC HYP increases CD56bright Natural Killer (NK) cells, which target the
activated immune cells that can play a key role in MS without causing general
immune cell depletion.

DAC HYP is currently being studied in the DECIDE Phase 3 clinical trial, which
is evaluating the efficacy and safety of once-monthly subcutaneous DAC HYP as
a monotherapy compared to interferon beta-1a therapy.

Biogen Idec is developing DAC HYP in collaboration with AbbVie, Inc.

^1 Biogen Idec data on file
^2 Biogen Idec data on file


Biogen Idec
Hayley Soffer, +1 781-464-3260
Lindsey Smith, +1 781-464-3260
Biogen Idec
Carlo Tanzi, Ph.D., +1 781-464-2442
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