Biogen
Idec (NASDAQ: BIIB) will highlight its commitment to using novel
science to address unmet medical needs in neurology at the upcoming 64th
American Academy of Neurology (AAN) Annual Meeting. The meeting, held in
New Orleans April 21-28, 2012, features 49 company-sponsored platform
and poster presentations that demonstrate how, through focused research
and development programs, Biogen Idec is pursuing treatments for
neurological diseases with high unmet need.
In addition to presenting data from three marketed products in multiple
sclerosis (MS) - TYSABRI® (natalizumab), AVONEX®
(interferon beta-1a), and FAMPYRA® (prolonged-release
fampridine tablets) - the company will present results from
investigational trials of its late-stage pipeline, including: BG-12,
PEGylated interferon beta-1a, and daclizumab high-yield process (DAC
HYP) for MS; and dexpramipexole, a potential treatment for amyotrophic
lateral sclerosis (ALS).
"We are committed to using novel science to tackle the unmet medical
needs of those living with chronic and debilitating neurologic
conditions," said Douglas E. Williams, Ph.D., executive vice president,
Research and Development at Biogen Idec. "Our focus on research and
development of MS therapies has resulted in numerous product offerings
and an extensive pipeline addressing the individual needs of many MS
patients, both now and in the future. As we expand this expertise into
other diseases areas such as ALS, we will continue to make progress
toward addressing significant unmet medical needs in neurology."
Key study results to be presented include:
-
BG-12: Detailed results from CONFIRM (Comparator
and an Oral Fumarate in RRMS), the
second pivotal Phase 3 study evaluating the investigational oral
compound in people with relapsing-remitting MS (RRMS), will be
presented for the first time.
-
TYSABRI: Important new data from two studies:
-
The ongoing TYSABRI Observational Program (TOP) assessing
long-term outcomes in RRMS patients in the postmarketing setting
-
TYNERGY, a multicenter one-year clinical follow-up study conducted
to evaluate the effect of TYSABRI on MS-related fatigue
-
DEXPRAMIPEXOLE: Design, methodology and baseline
features of EMPOWER, the largest randomized, placebo-controlled, Phase
3 clinical trial conducted in patients with ALS to date
Additional presentations include long-term data for AVONEX; data
highlighting FAMPYRA, the first oral formulation indicated for the
improvement of walking in adult MS patients with walking disability; and
full data from the DAC HYP Phase 2b SELECT trial.
Notable data from Biogen Idec at AAN 2012:
BG-12
-
Clinical Efficacy of BG-12 in Relapsing-Remitting Multiple Sclerosis
(RRMS): Data From the Phase 3 CONFIRM Study - Platform S01.003
-
Safety and Tolerability of BG-12 in Patients With Relapsing-Remitting
Multiple Sclerosis (RRMS): Analyses From the CONFIRM Study - Platform
S41.005
TYSABRI
-
Updated Incidence of Progressive Multifocal Leukoencephalopathy in
Natalizumab-Treated Multiple Sclerosis Patients Stratified by
Established Risk Factors - Platform S41.001
-
Anti-JCV Antibody Prevalence in Patients with Relapsing Multiple
Sclerosis Receiving or Considering Treatment with Natalizumab:
Baseline Results of STRATIFY-2 - Platform S41.002
-
Long-Term Safety and Efficacy and Association Between Baseline
Treatment History and Postbaseline Relapses in Multiple Sclerosis
Patients Treated with Natalizumab in the TYSABRI Observational Program
(TOP) - Poster P04.134
-
Natalizumab Reduces Fatigue as Measured by the Fatigue Scale for Motor
and Cognitive Functions (FSMC) - First Results from the TYNERGY Trial
- Poster P07.081
AVONEX
-
An Early Disease Activity Composite Can Predict Long-Term Disease
Outcome in CHAMPIONS - Discussed Poster PD5.010
-
Does Change in Patient-Reported QOL Correlate with Change in Other
Clinical and MRI Measures in Early MS? Analysis of the 10-Year
CHAMPIONS Cohort - Poster P07.100
FAMPYRA
-
Relationship between Heat Intolerance and Response to
Prolonged-Release Fampridine in Patients with Multiple Sclerosis - Poster
P07.078
-
Response to Prolonged-Release Fampridine in Multiple Sclerosis
Patients with Various Walking-Related MS Symptoms - Poster P07.079
DAC HYP
-
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the
Safety and Efficacy of Daclizumab HYP Monotherapy in
Relapsing-Remitting Multiple Sclerosis: Primary Results of the SELECT
Trial - Platform S01.005
-
CD56bright Natural Killer Cell Expansion Predicts Response
to Daclizumab HYP Treatment in RRMS: Results of the SELECT Trial - Platform
S31.004
PEGYLATED INTERFERON BETA-1A
-
ADVANCE Phase 3 Study of PEGylated Interferon Beta-1a for Relapsing
Multiple Sclerosis: Patient Baseline Characteristics - Poster
P01.133
-
PEGylated Interferon Beta-1a Pharmacokinetics, Pharmacodynamics and
Safety in Subjects with Normal or Impaired Renal Function - Poster
P06.165
DEXPRAMIPEXOLE
-
The EMPOWER Study: Design, Methodology and Baseline Features of the
First Phase 3 Clinical Trial of Dexpramipexole for Patients with ALS - Platform
S25.004
Full session details and data presentation listings for the 2012 Annual
Meeting can be found through the AAN website (www.aan.com/go/am12).
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 generates more
than $5 billion in annual revenues. For product labeling, press releases
and additional information about the company, please visit www.biogenidec.com.
About TYSABRI
TYSABRI is approved in more than 65 countries. TYSABRI is approved in
the 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. In the European Union, it is
approved for highly active RRMS in adult patients who have failed to
respond to beta interferon 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 the New
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 progressive multifocal leukoencephalopathy
(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.
TYSABRI is marketed and distributed by Biogen Idec Inc. and Elan
Corporation, plc. For full prescribing information and more information
about TYSABRI, please visit www.biogenidec.com
or www.elan.com.
About AVONEX
AVONEX is one of the most prescribed treatments for relapsing forms of
MS worldwide. It has been approved for use in the United States and
European Union for more than 15 years. 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.
AVONEX should be used with caution in patients with depression or other
mood disorders and in patients with seizure disorders. AVONEX should not
be used by pregnant women. Patients should also be monitored for signs
of hepatic injury. Rare cases of anaphylaxis have been reported.
Patients with cardiac disease should be closely monitored. Routine
periodic blood chemistry and hematology tests are recommended during
treatment with AVONEX.
The most common side effects associated with AVONEX treatment are
flu-like symptoms, including chills, fever, myalgia, and asthenia.
About FAMPYRA
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. This
prolonged-release formulation was developed and is being commercialized
in the United States by Acorda Therapeutics, Inc. (NASDAQ: ACOR) under
the trade name AMPYRA® (dalfampridine) Extended Release
Tablets, 10 mg. Biogen Idec licensed rights from Acorda to develop and
commercialize fampridine in all markets outside the United States.
About BG-12
BG-12 (dimethyl fumarate) is an investigational oral therapy for which
two large pivotal Phase 3 clinical studies for the treatment of RRMS,
the most common form of MS, have been completed. Biogen Idec has
recently filed regulatory submissions for BG-12 in the United States and
European Union. BG-12 is the only currently known investigational
compound for the treatment of RRMS that has experimentally demonstrated
activation of the Nrf-2 pathway. In 2011, Biogen Idec announced positive
data from DEFINE and CONFIRM, two global, placebo-controlled Phase 3
clinical trials that evaluated 240 mg of BG-12, administered either
twice a day or three times a day, for two years.
About Daclizumab High-Yield Process
Daclizumab high-yield process (DAC HYP) is a subcutaneous formulation of
daclizumab 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 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 1-a therapy.
About PEGylated Interferon Beta-1a
PEGylated interferon beta-1a is currently under investigation in a Phase
3 clinical trial for the treatment of relapsing MS. PEGylated interferon
beta-1a, administered via subcutaneous injection, is being evaluated for
its ability to last longer in a patient's system, potentially leading to
an MS treatment that would require fewer injections.
About Dexpramipexole
Dexpramipexole is a novel, orally administered compound under
development for the treatment of ALS. It has shown neuroprotective
properties in both in vitro assays and in vivo ALS models. In a Phase 2
study, dexpramipexole achieved its primary objective evaluating safety
and tolerability and also showed a trend toward dose-related slowing of
functional decline and a trend toward extending survival at the highest
dose (150 mg twice daily). Dexpramipexole has been granted Fast Track
status by the U.S. Food and Drug Administration (FDA), which may result
in an expedited review, and has received orphan drug designation for the
treatment of ALS from both the FDA and the European Medicines Agency.
Biogen Idec and Knopp Neurosciences have an exclusive, worldwide license
agreement for dexpramipexole.
Safe Harbor
This press release contains forward-looking statements, including
statements about the anticipated development, timing and therapeutic
scope of programs in our clinical pipeline. These forward-looking
statements may be accompanied by such words as "anticipate," "believe,"
"estimate," "expect," "forecast," "intend," "may," "plan," "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 the risk that unexpected concerns and adverse safety events
may arise during clinical trials, regulatory authorities may require
additional information or may fail to approve any potential new therapy,
competition, the ability to protect intellectual property rights and the
cost of doing so, uncertainty of success in commercializing products,
changes in the availability of product reimbursement, failure to comply
with government regulation and possible adverse impact of changes in
such regulation, product liability claims, and the other risks and
uncertainties that are described in the Risk Factors section of Biogen
Idec Inc.'s most recent annual or quarterly report and in other reports
Biogen Idec Inc. has filed with the U.S. Securities and Exchange
Commission. These statements are based on current beliefs and
expectations and speak only as of the date of this press release. No
obligation to publicly update any forward-looking statements is
undertaken.

MEDIA CONTACT:
Biogen Idec Public Affairs
Jeff Boyle,
+1 781-464-3260
or
INVESTOR CONTACT:
Biogen Idec
Investor Relations
Wendy Gabel, +1 781-464-2442