Biogen Idec to Present Extensive New Data from Its Robust Multiple Sclerosis Portfolio at ECTRIMS

  Biogen Idec to Present Extensive New Data from Its Robust Multiple Sclerosis
  Portfolio at ECTRIMS

   – More than 55 company-sponsored presentations underscore Biogen Idec’s
            commitment to treatment advances for people with MS –

     - Company will also launch Registry Research Fellowship Programme -


Business Wire

WESTON, Mass. -- September 23, 2013

Biogen Idec (NASDAQ: BIIB) will present 58 data sets from the company’s
multiple sclerosis (MS) clinical portfolio of approved and investigational
products at the 29^th Congress of the European Committee for Treatment and
Research in Multiple Sclerosis (ECTRIMS) in Copenhagen, Denmark, October 2-5.

The collection of data being presented at ECTRIMS represents Biogen Idec’s
industry-leading expertise in MS research and showcases the company’s deep
understanding of differing patient needs. Through decades of cutting-edge
science, Biogen Idec has more experience than any other company in advancing
the treatment of this disease, recognising that physicians need therapeutic
choices to meet treatment goals.

“Biogen Idec is proud to be at the forefront of innovation in MS, which has
been made possible through our research and development efforts over the past
30 years,” said Douglas E. Williams, Ph.D., executive vice president, Research
and Development at Biogen Idec. “Our commitment has enabled us to bring a
number of therapy options to patients, and we are excited to be presenting
data on some promising candidates which have the potential to broaden the
treatment spectrum for people living with this chronic, debilitating disease.”

Data at ECTRIMS will be presented from across Biogen Idec’s portfolio,

Approved medicines:

TYSABRI^® (natalizumab): offers established efficacy that has been proven to
reduce relapses and slow disability progression.

TECFIDERA^® (dimethyl fumarate): an oral treatment for relapsing forms of MS,
including relapsing-remitting MS (RRMS), which has been clinically proven to
significantly reduce important measures of disease activity with a favorable
safety/tolerability profile. TECFIDERA is currently approved in the United
States, Canada and Australia.

FAMPYRA^® (prolonged-release fampridine tablets): the first approved treatment
to address the unmet medical need of walking improvement in MS patients,
demonstrating efficacy in patients with all MS types. Approved in the European

Investigational medicines:

PLEGRIDY^TM  (pegylated interferon beta-1a): a potential new molecular entity
for relapsing forms of MS in which interferon beta-1a is pegylated to extend
its half-life and prolong its exposure in the body. Pegylation offers a
less-frequent dosing schedule.

DACLIZUMAB HIGH-YIELD PROCESS (DAC HYP): is being developed as a once-monthly
subcutaneous injection. DAC HYP is believed to target the activated immune
cells that can play a key role in MS without causing general immune cell
depletion. DAC HYP is being developed under a collaboration agreement
withAbbVie, Inc.

Anti-LINGO-1 (BIIB033): is the first candidate being investigated for its
potential to repair neurons damaged by MS.

Registry Research Fellowship Program opening for applications

At ECTRIMS, Biogen Idec will also launch The Multiple Sclerosis Registry
Research Fellowship Program, an initiative which solidifies our ongoing
commitment to clinical research in order to improve the lives of people living
with MS. Grants awarded through the program will provide an annual stipend of
up to €75,000 per fellow, for training in research with large real-world
evidence datasets in MS.

Full session details of the 2013 Annual Meeting can be found on the ECTRIMS

The titles of key Biogen Idec abstracts are as follows:


October 3

  *Poster #519: Effects of natalizumab treatment on freedom from disease
    activity by baseline characteristics in AFFIRM
  *Poster #524: Natalizumab reduces the disabling amplitude of multiple
    sclerosis relapses and improves post-relapse residual disability

October 4

  *Poster #1050: Disease activity and disability progression decrease beyond
    two years on natalizumab in relapsing multiple sclerosis patients in the
    TYSABRI® (natalizumab) Observational Programme


October 3

  *Poster #538: 4-year follow-up of oral BG-12 (dimethyl fumarate) treatment
    in relapsing remitting multiple sclerosis (RRMS): integrated clinical
    efficacy data from the DEFINE, CONFIRM, and ENDORSE studies

October 4

  *Poster #1004: 4-year follow-up of oral BG-12 (dimethyl fumarate) treatment
    in relapsing remitting multiple sclerosis (RRMS): integrated magnetic
    resonance imaging (MRI) outcomes from DEFINE, CONFIRM, and ENDORSE
  *Poster #1127: Interim analysis of quality of life in patients with
    relapsing remitting multiple sclerosis treated with BG-12 (dimethyl
    fumarate) in the ENDORSE study
  *Poster #996: Safety profile of BG-12 (dimethyl fumarate) in relapsing
    remitting multiple sclerosis: long-term interim results from the ENDORSE
    extension study
  *Poster #990: Effect of BG-12 (dimethyl fumarate) in newly diagnosed
    relapsing remitting multiple sclerosis (RRMS) patients from the DEFINE and
    CONFIRM studies
  *Poster #1100: Dimethyl fumarate and monomethyl fumarate are distinguished
    by non-overlapping pharmacodynamic effects in vivo


October 3

  *Poster #665: Long-term prolonged-release fampridine treatment and
    health-related quality of life outcomes: nine-month interim analysis of
    the ENABLE study
  *Poster #658: Health-related quality of life outcomes following long-term
    treatment with prolonged-release fampridine: impact on psychological
    outcomes in the ENABLE study

October 4

  *Poster #1128: Changes in physical functioning and activity following
    long-term treatment with prolonged-release fampridine in the ENABLE study


October 3

  *Poster #514: Peginterferon beta-1a provides improvements in clinical and
    radiological disease activity in relapsing-remitting multiple sclerosis:
    year 1 findings from the phase 3 ADVANCE study

October 4

  *Poster #989: Magnetic resonance imaging results from the first year of the
    ADVANCE study, a pivotal phase 3 trial of peginterferon beta-1a in
    patients with relapsing-remitting multiple sclerosis


October 3

  *Poster #545: The use of magnetic resonance imaging to monitor the safety
    of anti-LINGO-1: findings from phase I studies in healthy volunteers and
    subjects with multiple sclerosis
  *Poster #378: Blocking LINGO1 promotes axonal regeneration in the rat optic
    nerve crush model


October 4

  *Poster #977: Reduction in brain atrophy with extended daclizumab HYP
    treatment: results of SELECT and the SELECT extension study
  *Poster #864: Evaluation of immunogenicity in multiple sclerosis patients
    continuously treated with daclizumab-HYP during the SELECT and SELECTION
    clinical trials.

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, and the company generated more
than $5 billion in annual revenues in 2012. For product labeling, press
releases and additional information about the company, please visit:


TYSABRI is approved in more than 65 countries. TYSABRI is approved inthe
United States as a monotherapy for relapsing forms of MS, generally for
patients who have had an inadequate response to, or are unable to tolerate, an
alternative MS therapy due to the risk of progressive multifocal
leukoencephalopathy (PML). In theEuropean Union, it is approved for highly
active relapsing-remitting MS (RRMS) in adult patients who have failed to
respond to beta interferon or glatiramer acetate or have 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. 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.

As a result of the acquisition from Elan, TYSABRI will be marketed and
distributed solely by Biogen Idec. For full prescribing information and more
information about TYSABRI, 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 trial, 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.

For more information about FAMPYRA, 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, Canada and Australia, and is under review by
regulatory authorities in the European Union.

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 with more than 3,600 MS patients,
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 more information about TECFIDERA, please visit


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 is a
member of the interferon class of treatments, which is often used as a
first-line treatment for MS.

Regulatory authorities in the US and the EU accepted the marketing
applications for the review of PLEGRIDY in relapsing forms of MS in July 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.

About the Registry Research Fellowship Program

Information about the Biogen Idec Multiple Sclerosis Registries Research
Fellowship Program is available online at or
by contacting the company Grants Office by phone at 617-914-1299 or by email


Annabel Cowper, +41 79 737 66 04
Carlo Tanzi, Ph.D., +1 781-464-2442
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