Biogen Idec's Commitment to MS Demonstrated Through Significant Scientific Data Being Presented at the 28th ECTRIMS
– More than 50 Company- and Partner-Sponsored Presentations from the Biogen Idec MS Franchise and Pipeline to be Presented at the MS Community's Largest Medical Meeting –
WESTON, Mass.--(BUSINESS WIRE)--Oct 10, 2012 - Biogen Idec (NASDAQ: BIIB) will have extensive data from the company's leading multiple sclerosis (MS) franchise presented during the 28th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Lyon, France, October 10 – 13. Fifty-three poster and platform presentations will further showcase Biogen Idec's commitment to advancing the treatment of MS and improving the lives of people living with the disease around the world.
“For nearly 20 years, Biogen Idec has had a steadfast commitment to the MS community. This began with the approval of AVONEX and then TYSABRI, and continues today with the global regulatory submissions for oral dimethyl fumarate,” said Alfred Sandrock, M.D., Ph.D., senior vice president, development sciences and chief medical officer, Biogen Idec. “Our continued dedication to the advancement of MS treatment is evident in our pipeline, which is the deepest in the industry. Though significant advances have been made, we will not rest while there is so much more we can do to improve the lives of those living with MS.”
Data from the Biogen Idec MS
Pipeline
Key scientific highlights being presented during ECTRIMS from the
company's pipeline will include analyses of pooled data from the
Phase 3 DEFINE and CONFIRM clinical trials of oral dimethyl
fumarate (BG-12), primary results from the daclizumab high-yield
process (DAC HYP) SELECTION study, and early-stage research showing
the results of a study of anti-LINGO 1 (BIIB033) in optic nerve
damage in animal models.
Dimethyl Fumarate
Dimethyl fumarate has been studied as an oral agent for MS and is
currently under regulatory review in the United States, European
Union, Switzerland, Australia and Canada for the treatment of MS.
Detailed data from the program's two Phase 3 clinical trials,
DEFINE and CONFIRM, were recently published in The New England
Journal of Medicine. There will be 14 posters, one platform
presentation and one late breaking news poster presented.
Highlights include:
- Clinical efficacy of BG-12 in relapsing-remitting multiple sclerosis: an integrated analysis of the Phase 3 DEFINE and CONFIRM studies – Platform 151
- Safety and tolerability of BG-12 in patients with relapsing-remitting multiple sclerosis: an integrated analysis of the placebo-controlled studies – Poster 484
- Effects of BG-12 on magnetic resonance imaging outcomes in relapsing-remitting multiple sclerosis: an integrated analysis of the Phase 3 DEFINE and CONFIRM studies – Poster 920
- Long-term safety and tolerability of oral BG-12 (dimethyl fumarate) in relapsing-remitting multiple sclerosis: interim results from ENDORSE – Late Breaker Poster 1103
DAC HYP
DAC HYP is an investigational, once-monthly subcutaneous therapy
that is in Phase 3 clinical development for the treatment of RRMS.
Five DAC HYP posters will be presented, along with one late
breaking news platform presentation of the primary results from the
SELECTION study, a randomized, double-blind extension study
designed to assess sustained efficacy and safety of DAC HYP in the
second year of treatment. Highlights include:
- The effect of daclizumab HYP on sustained disability progression in the SELECT trial – Poster 949
- Effect of daclizumab HYP treatment in highly active relapsing-remitting multiple sclerosis: results from the SELECT study – Poster 463
- Primary results of the SELECTION trial of daclizumab HYP in relapsing multiple sclerosis – Late Breaker Presentation 169
Anti-LINGO 1
Anti-LINGO 1 is a monoclonal antibody in early stage clinical
trials. Previous data from animal models have shown that it
promotes remyelination and axon survival. Proof of concept studies
in optic neuritis are expected to start in the fourth quarter of
this year, and during the second half of 2013 for MS. Two
company-sponsored anti-LINGO 1 posters will be presented at the
Congress:
- BIIB033 Anti-LINGO-1 antibody reduces optic nerve axonal degeneration in MOG- EAE rodent models – Poster 785
- Technical feasibility of implementing multifocal VEP for multicentre clinical trials – Poster 281
Data from the Biogen Idec MS Franchise
TYSABRI
TYSABRI is approved in the United States for relapsing forms of MS
and in the European Union for RRMS. There will be 10 company- and
partner-sponsored TYSABRI posters and one platform presentation.
Highlights include:
- Long-term safety and efficacy of natalizumab and assessment of 2-year freedom from clinical disease activity in patients with multiple sclerosis in the TYSABRI Observational Program (TOP) – Poster 519
- Improvement of MS-related fatigue also significantly improves quality of life in patients treated with natalizumab: results from the TYNERGY trial – Poster 445
- Relation of disease activity-free status to visual function in the AFFIRM trial – Poster 557
- Utilization of JC-virus antibody testing in clinical practice – Poster 546
AVONEX
AVONEX is one of the most prescribed treatments for relapsing forms
of MS worldwide. AVONEX PEN, the first intramuscular autoinjector
approved for MS, is available in the United States and European
Union for those choosing AVONEX to treat their MS. Ten AVONEX
posters will be presented. Highlights include:
- Interim analysis of AMETYST: a Phase 4 observational study of the impact of intramuscular interferon beta-1a on quality of life, disability, and cognition in patients with clinically isolated syndrome/clinically definite multiple sclerosis – Poster 1047
- Interferon beta?1a (AVONEX) as treatment option for untreated MS patients (AXIOM) – Poster 1007
FAMPYRA
FAMPYRA is a novel MS treatment approved in the European Union to
improve walking in adult patients with MS who have walking
disability (EDSS between 4.0 and 7.0). There will be seven company-
and partner-sponsored posters focusing on FAMPYRA. Highlights
include:
- Dalfampridine extended release tablets: safety profile after 2 years of post-marketing experience in the United States – Poster 1026, sponsored by Acorda Therapeutics
- An alternative approach to estimate the health economic value of a non-disease modifying therapy for patients with multiple sclerosis: a Swedish application – Poster 1032
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 Dimethyl Fumarate
Dimethyl fumarate, also known as BG-12, is an investigational oral
therapy in late-stage clinical development for the treatment of
relapsing-remitting multiple sclerosis (RRMS), the most common form
of MS. Dimethyl fumarate is the only currently known
investigational compound for the treatment of RRMS that has
experimentally demonstrated activation of the Nrf-2 pathway.
Dimethyl fumarate is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.
About DAC HYP
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 (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 1-a therapy.
Biogen Idec is developing DAC HYP in collaboration with Abbott.
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 relapsing-remitting MS
(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 (NYSE: ELN). For full prescribing information, including boxed warning and important safety 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. 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.
Two AVONEX dosing innovations were recently approved by regulators in the United States and European Union. The first is a clinically-supported schedule for gradually escalating the dose of AVONEX at the start of therapy, which has been shown to reduce the incidence and severity of flu-like symptoms that can occur with AVONEX treatment. The second, AVONEX PEN, is the first single-use, once-a-week, fully integrated intramuscular autoinjector for MS. It is designed for use with AVONEX treatment in patients with relapsing forms of MS. AVONEX PEN integrates the currently approved AVONEX Prefilled Syringe and incorporates a smaller needle (25 gauge, 5/8 inch), which is thinner and 50 percent shorter than the standard AVONEX Prefilled Syringe needle.
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. There are no adequate and well-controlled studies in pregnant women. 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 complete United States full prescribing information, please visit www.AVONEX.com.
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.
Biogen Idec Safe Harbor Statement
This press release contains forward-looking statements, including
statements about product development and commercialization. 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. Drug development and commercialization involve a high
degree of risk. Factors which could cause actual results to differ
materially from current expectations include the risk that we may
not fully enroll our planned clinical trials, adverse safety events
may occur, regulatory authorities may require additional
information or may fail to approve any potential new therapy,
product reimbursement may be limited or unavailable, there may be
problems with manufacturing processes, intellectual property rights
may not be adequately protected, 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 SEC. These
statements are based on current beliefs and expectations and speak
only as of the date of this press release. Biogen Idec Inc. does
not undertake any obligation to publicly update any forward-looking
statements.
Contact: Biogen Idec
Media Contact:
Shannon Altimari, +41 79 732 14 11
or
Investor Contact:
Kia Khaleghpour, +1 781 464 2442
Posted: October 2012

