– More than 53 Company-Sponsored Posters and Platform Presentations Accepted from the Industry’s Leading and Most Innovative MS Franchise –
WESTON, Mass.--(BUSINESS WIRE)--Today Biogen Idec (NASDAQ: BIIB) announced a robust selection of data from the company’s multiple sclerosis (MS) franchise will be presented in 48 posters and five platform presentations during the 5TH Joint Triennial Congress of the European and Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS and ACTRIMS) in Amsterdam, Netherlands, October 19 – 22. These data highlight the company’s portfolio of marketed products, TYSABRI® (natalizumab), AVONEX® (interferon beta-1a) and FAMPYRA® (prolonged-release fampridine), as well as two late-stage investigational compounds, oral BG-12 (dimethyl fumarate) and daclizumab high-yield process (DAC HYP). Detailed data from DEFINE, the first of two pivotal Phase 3 clinical trials designed to evaluate BG-12 as an oral, monotherapy in people with relapsing-remitting multiple sclerosis (RRMS), and SELECT, a global, registrational Phase 2b clinical trial designed to evaluate DAC HYP in people with RRMS, will be presented at the Congress.
“The substantial amount of data presented at this year’s ECTRIMS and ACTRIMS demonstrates our unwavering commitment to those living with MS and novel scientific approaches to understanding and treating the disease,” said Douglas E. Williams, Ph.D., Executive Vice President, Research and Development at Biogen Idec.
In addition to the extensive data being presented at the Congress, Biogen Idec and Elan Corporation, plc, (NYSE: ELN) will host a satellite symposium, “Addressing MS Patient Needs Today and Tomorrow” on October 20 at 12:45 – 13:45 CEST. The agenda for the symposium will focus on addressing the individual treatment needs of each MS patient and includes presentations from MS experts from the U.S. and Europe.
“Over the past year, we have seen significant advances in our MS franchise with the approval of risk stratification language in the EU product label for TYSABRI; the approvals of FAMPYRA and the AVONEX PEN by the European Commission; and positive top-line registrational data for both oral BG-12 and DAC HYP,” continued Dr. Williams. “We are proud of these accomplishments as well as our robust research and development plans for our existing products and investigational MS treatments, positioning the company for substantial growth and industry leadership.”
Highlights of Biogen Idec’s ECTRIMS and ACTRIMS Data
TYSABRI is approved in the U.S. for relapsing forms of MS and in the EU for RRMS. It has been used by thousands of patients worldwide. The European Commission (EC) recently updated the TYSABRI label to include three factors to help stratify the risk of progressive multifocal leukoencephalopathy (PML), helping physicians and patients make more informed treatment decisions. There will be 25 company-sponsored TYSABRI posters and three platform presentations. Highlights of the presented posters focus on the benefit of TYSABRI to MS patients, as well as further data supporting risk stratification efforts:
- Long-term outcomes in natalizumab-treated patients who were free of disease activity over the 2-year AFFIRM study – Poster 513
- Assessment of annualized relapse rate and Expanded Disability Status Scale score changes over time in the TYSABRI (natalizumab) Observational Program – Poster 509
- TRUST study results: effects of natalizumab on bladder function – Poster 1040
- JCV Epidemiology in MS: Epidemiology of Anti-JC Virus Antibody Prevalence in Multiple Sclerosis Patients – Poster 801
- Contribution of Natalizumab treatment duration, prior immunosuppressant use, and anti-JC Virus antibody status to the risk of progressive multifocal leukoencephalopathy in natalizumab-treated Multiple Sclerosis patients – Poster 995
- Updated safety and efficacy of natalizumab in the ongoing STRATA study – Poster 981
BG-12 is an investigational oral therapy in late-stage clinical development for the treatment of relapsing forms of MS. In April, Biogen Idec announced positive top-line results from DEFINE, the first of two Phase 3 clinical trials for BG-12. There will be six posters at ECTRIMS, as well as a platform presentation on the detailed efficacy results of the DEFINE trial. Highlights include:
- Clinical efficacy of BG-12, an oral therapy, in relapsing-remitting MS: data from the Phase 3 DEFINE trial – Platform 95
- Efficacy on MRI endpoints of BG-12, an oral therapy, in relapsing-remitting MS: data from the Phase 3 DEFINE trial – Poster 831
- Safety and tolerability of BG-12 in the Phase 3 DEFINE trial in patients with relapsing-remitting MS – Poster 994
FAMPYRA is a novel MS treatment which was approved by the EC in July to improve walking in adult patients with MS who have walking disability (EDSS between 4.0 and 7.0). There will be seven posters focusing on data for FAMPYRA and two posters focusing on walking ability. Highlights include:
- Multiple Sclerosis Walking Scale (MSWS-12): Exactly what clinical benefit do prolonged-release fampridine responders actually get? – Poster 721
- Assessing changes in walking ability in Multiple Sclerosis – Poster 247
- Responses to items of the MSWS-12 differ depending on EDSS and the impact of prolonged-release fampridine on walking speed – Poster 1037
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. In June, AVONEX PEN was approved as the first single-use, once-a-week, fully integrated intramuscular autoinjector available for patients with relapsing MS. Six AVONEX and AVONEX PEN posters will be presented. Highlights include:
- Safe and effective use of the single-use Autoinjector for intramuscular interferon beta-1a in Multiple Sclerosis – Poster 583
- Dose titration of intramuscular interferon beta-1a reduces the severity and incidence of flu-like symptoms – Poster 1057
- Evaluating the predictive value of early indicators of long-term disability in ASSURANCE – Poster 1011
DAC HYP is an investigational once-monthly subcutaneous formulation of daclizumab that is in late-stage clinical development for the treatment of RRMS. Biogen Idec is developing DAC HYP in collaboration with Abbott. In August, Biogen Idec and Abbott announced positive top-line results from the Phase 2b SELECT trial, the first of two registrational trials for DAC HYP. Additional data from SELECT will be presented as a late-breaking platform presentation at ECTRIMS:
- 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 149
About Biogen Idec
Biogen Idec uses cutting-edge science to discover, develop, manufacture and market therapies for serious diseases with a focus on neurology, immunology and hemophilia. 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 $4 billion in annual revenues. For product labeling, press releases and additional information about the company, please visit www.biogenidec.com.
TYSABRI is approved in more than 60 countries. In the U.S., it is approved for relapsing forms of multiple sclerosis (MS) and in the European Union for relapsing-remitting MS.
TYSABRI has advanced the treatment of MS patients with its established efficacy. It has been proven to reduce flare-ups and slow physical disability progression. Data from the Phase III 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 that usually leads to death or severe disability. 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 patients treated with TYSABRI in the post-marketing setting. Common adverse events reported in TYSABRI-treated MS patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, and rash.
BG-12 is an investigational oral therapy in late-stage clinical development for the treatment of relapsing forms of MS. BG-12 is the only compound in clinical trials for the treatment of MS known to activate the Nrf-2 pathway. Research suggests that BG-12 has the potential to reduce the activity and impact of inflammatory cells on the Central Nervous System (CNS) and induce direct cytoprotective responses in CNS cells. These effects may enhance the CNS cells’ ability to mitigate the toxic inflammatory and oxidative stress that plays a role in MS pathophysiology.
In April 2011, Biogen Idec announced positive top-line data from DEFINE, the first of its two Phase 3 clinical trials. Top-line data from the second Phase 3 trial of BG-12, CONFIRM, is anticipated in the second half of 2011.
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 multiple sclerosis (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 commercialised in the U.S. 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 U.S.
AVONEX is used worldwide as a treatment for relapsing forms of MS to slow the progression of physical disability and reduce relapses. AVONEX is also approved for patients who have their first clinical episode and have a brain MRI scan consistent with MS.
The most common side effects associated with AVONEX MS treatment are flu-like symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting, pain and asthenia.
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 with cardiac disease should be closely monitored. Patients should also be monitored for signs of hepatic injury. Routine periodic blood chemistry and hematology tests are recommended during treatment with AVONEX. Rare cases of anaphylaxis have been reported.
For information regarding the European Summary of Product Characteristics visit http://www.ema.europa.eu/ema. For the complete United States prescribing information, please visit http://www.AVONEX.com.
Daclizumab high-yield process (DAC HYP) is a subcutaneous formulation of daclizumab in late-stage clinical development 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 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 being 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.
This press release contains forward-looking statements, including statements about the company’s outlook. 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 our dependence on our three principal products, AVONEX, RITUXAN and TYSABRI, the importance of TYSABRI's sales growth, product competition, uncertainty of success in commercializing other products, the occurrence of adverse safety events with our products, changes in the availability of reimbursement for our products, adverse market and economic conditions, our dependence on collaborations and other third parties over which we may not always have full control, failure to execute our growth initiatives, failure to comply with government regulation and possible adverse impact of changes in such regulation, charges and other costs relating to our properties, problems with our manufacturing processes and our reliance on third parties, fluctuations in our effective tax rate, our ability to attract and retain qualified personnel, the risks of doing business internationally, our ability to protect our intellectual property rights and the cost of doing so, product liability claims, fluctuations in our operating results, the market, interest and credit risks associated with our portfolio of marketable securities, our level of indebtedness, environmental risks, aspects of our corporate governance and collaborations, representation of activist shareholders on our board of directors, 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 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.