TECFIDERA® (dimethyl fumarate) Data Demonstrate Strong and Sustained Efficacy Across Broad Range of MS Patients
Neurology Pipeline Highlights Potential Innovations in Remyelination with Anti-LINGO-1 and Alzheimer’s Disease with Aducanumab (BIIB037)
Ongoing “State of MS” Initiative Provides Additional Insights for Improving MS Care
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Biogen (NASDAQ: BIIB) will present new clinical data supporting the company’s marketed and investigational therapies for neurological diseases at the 67th American Academy of Neurology (AAN) Annual Meeting in Washington D.C., April 18 – 25, 2015. The 73 company-sponsored platform and poster presentations represent Biogen’s enduring commitment to develop innovative medicines that have the potential to transform patient lives and create solutions that enhance understanding of neurodegenerative diseases and management.
“Biogen is committed to exploring ways to transform the care of patients living with MS and other neurodegenerative diseases both through its broad portfolio of MS therapies and extensive pipeline, as well as innovative company initiatives,” said Kate Dawson, vice president, US Medical Affairs. “At AAN, we will feature new scientific data, including research highlighting the efficacy and favorable safety profile of TECFIDERA, the most prescribed oral medicine for relapsing MS in the US.”
Biogen will present data from its currently approved product portfolio: TECFIDERA (dimethyl fumarate), TYSABRI® (natalizumab) and PLEGRIDY® (peginterferon beta-1a), as well as findings from the clinical programs of its neurology pipeline candidates, ZINBRYTA™ (daclizumab high-yield process), which is being developed jointly with AbbVie, anti-LINGO-1 (BIIB033) and aducanumab (BIIB037).
Biogen will also present data from company initiatives aimed at improving patient care beyond therapy, including highlights from an international survey of patients and neurologists about the current “State of MS” and importance of physician/patient collaboration.
Highlights of Biogen’s AAN Data for Presentation:
EMERGING APPROACHES TO MS MANAGEMENT
- The State of Multiple Sclerosis Survey: Relationship of Expectations, Decision-Making, Communication, and Satisfaction with Treatment (poster P3.235) will be available during poster session III on Tuesday, April 21, 2015 at 2:00 p.m. ET
- Remote Tracking of Walking Activity in MS patients in a Real World Setting (poster P3.209) will be available during poster session III on Tuesday, April 21, 2015 at 5:00 p.m. ET
- Consensus Opinion of US Neurologists on Practice Patterns in Radiologically or Clinically Isolated Syndromes and Relapsing-Remitting Multiple Sclerosis (poster P3.234) will be available during poster session III on Tuesday, April 21, 2015 at 5:00 p.m. ET
- Clinical Efficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Relapsing-Remitting Multiple Sclerosis Patients with Highly Active Disease: An Integrated Analysis of the Phase 3 DEFINE and CONFIRM Studies (poster P7.228) will be available during poster session VII on Thursday, April 23, 2015 at 2:00 p.m. ET
- Long-Term Efficacy of Delayed-Release Dimethyl Fumarate for Relapsing-Remitting Multiple Sclerosis According to Prior Therapy: Integrated Analysis of the DEFINE, CONFIRM, and ENDORSE Studies (poster P7.229) will be available during poster session VII on Thursday, April 23, 2015 at 2:00 p.m. ET
- Disease Course in Multiple Sclerosis (MS) Patients Switching from Fingolimod to Natalizumab (poster P3.284) will be available during poster session III on Tuesday, April 21, 2015 at 2:00 p.m. ET
- Natalizumab-Treated Patients with Multiple Sclerosis Have Low Rates of Brain Volume Decrease and Low MRI Disease Activity in the Long-Term STRATA Study (poster P7.260) will be available during poster session VII on Thursday, April 23, 2015 at 2:00 p.m. ET
- Rationale for EDSS-Plus, the Primary Composite Endpoint of Disability Progression in the ASCEND Phase 3 Study of Natalizumab for Secondary Progressive Multiple Sclerosis: A Post Hoc Analysis of IMPACT Study Data (poster P7.240) will be available during poster session VII on Thursday, April 23, 2015 at 2:00 p.m. ET
- Long-Term Safety and Tolerability of Peginterferon Beta-1a: Interim Analysis from ATTAIN, a Phase 3 Extension Study (platform S4.002) will be presented on Tuesday, April 21, 2015 at 1:15 p.m. ET
- Long-Term Efficacy in MRI and No Evidence of Disease Activity Outcomes in Patients with Relapsing-Remitting Multiple Sclerosis Treated with Peginterferon Beta-1a (poster P7.266) will be available during poster session VII on Thursday, April 23, 2015 at 2:00 p.m. ET
- Daclizumab HYP Versus Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis: Primary Results of the DECIDE Study (platform S4.003) will be presented on Tuesday, April 21, 2015 at 1:30 p.m. ET
- Safety and Tolerability Results From the DECIDE Study: A Phase 3 Active-Comparator Study of Daclizumab HYP in Relapsing-Remitting Multiple Sclerosis (poster P7.230) will be available during poster session VII on April 23, 2015 at 2:00 p.m. ET
- Evidence of Remyelination with the Anti-LINGO-1 Monoclonal Antibody BIIB033 after Acute Optic Neuritis (data blitz and poster 008) will be presented at the Emerging Science Session on Wednesday, April 22, 2015 at 6:36 p.m. ET. The poster will be available immediately following the data blitz presentation from 6:15 p.m. to 7:45 p.m. ET
- Efficacy Analysis of the Anti-LINGO-1 Monoclonal Antibody BIIB033 in Acute Optic Neuritis: The RENEW Trial (poster P7.202) will be available during poster session VII on Thursday, April 23, 2015 5:00 p.m. to 6:30 p.m. ET
- Randomized Double-Blind, Placebo-Controlled, Multiple-Dose Phase 1hb Study of BIIB037, an Anti-Aβ Monoclonal Antibody, in Patients with Prodromal or Mild Alzheimer's Disease: Interim Results by Disease Stage and ApoE4 Status (data blitz and poster 001) will be presented at the Emerging Science Session on Wednesday, April 22, 2015 at 6:15 p.m. ET. The poster will be available immediately following the data blitz presentation from 6:15 p.m. to 7:45 p.m.
Full session details and data presentation listings for the 2015 AAN Annual Meeting can be found at the meeting website: https://www.aan.com/conferences/2015-annual-meeting/.
Through cutting-edge science and medicine, Biogen discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders. Founded in 1978, Biogen is the world’s oldest independent biotechnology company and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For product labeling, press releases and additional information about the company, please visit http://www.biogen.com.
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, Australia and Switzerland. Through a robust clinical trial program and commercial launches starting with the United States in March 2013, more than 135,000 patients have been treated with TECFIDERA worldwide.[i]
TECFIDERA has been proven to reduce rate of MS relapses, slow the progression of disability, and the number of MS brain lesions, while demonstrating a favorable safety and tolerability profile in a broad range of patients with relapsing forms of MS.[ii] 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. TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. A list of adverse events can be found in the full TECFIDERA product labeling for each country where it is approved.
The efficacy and safety of TECFIDERA have 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 visit www.TECFIDERA.com.
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 the European 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.
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 post marketing 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 visit www.TYSABRI.com.
PLEGRIDY is a subcutaneous injectable interferon therapy indicated for relapsing forms of multiple sclerosis, in which interferon beta-1a is pegylated to extend its half-life to permit a less frequent dosing schedule. PLEGRIDY is approved in the U.S. and Australia for the treatment of relapsing forms of MS, and authorized by the European Commission for use in relapsing-remitting MS.
Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure have been reported with interferon beta. Elevations in hepatic enzymes and hepatic injury have been observed with the use of PLEGRIDY in clinical studies. Depression, suicidal ideation and suicide have been reported in patients receiving interferon beta. Seizures are also associated with the use of interferon beta. Anaphylaxis and other serious allergic reactions are rare complications of treatment with interferon beta. Injection site reactions, including injection site necrosis, can occur with the use of subcutaneous interferon beta.
Congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure occur in patients receiving interferon beta. Interferon beta can cause decreased peripheral blood counts in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia. Autoimmune disorders of multiple target organs including idiopathic thrombocytopenia, hyper and hypothyroidism, and autoimmune hepatitis have been reported with interferon beta. A list of adverse events can be found in the full PLEGRIDY product labeling for each country where it is approved.
For additional important safety information, and the United States full prescribing information, please visit www.PLEGRIDY.com.
About ZINBRYTA™ (daclizumab high-yield process)
ZINBRYTA (daclizumab high-yield process) is an investigational drug and a new form of a humanized monoclonal antibody that selectively binds to the high-affinity interleukin-2 (IL-2) receptor subunit (CD25) that is expressed at high levels on T-cells that become abnormally activated in multiple sclerosis (MS). ZINBRYTA modulates IL-2 signaling without causing general immune cell depletion. ZINBRYTA is believed to work by decreasing abnormally-activated T-cells and pro-inflammatory lymphoid tissue inducer cells, and increasing CD56bright natural killer (NK) cells, which are important cells that help regulate the immune system.
Biogen and AbbVie are jointly developing ZINBRYTA.
About the Anti-LINGO-1 Phase 2 Development Program
Two Phase 2 trials (RENEW and SYNERGY) were designed to assess the biological activity and clinical potential of anti-LINGO-1 in demyelinating diseases.
RENEW was a randomized, double-blind, placebo controlled, Phase 2 study designed to evaluate the effect of anti-LINGO-1 in patients treated following a first episode of acute optic neuritis (AON). The study was the first to combine functional, structural and clinical efficacy endpoints in AON.
A separate Phase 2 dose-range finding, double-blind, placebo-controlled randomized 22 month study (SYNERGY) investigating anti-LINGO-1 in people with relapsing forms of MS (both RRMS and SPMS) is ongoing. SYNERGY is fully enrolled, and results are anticipated in 2016.
About Aducanumab (BIIB037)
Aducanumab (BIIB037) is an investigational compound being developed for the treatment of Alzheimer’s disease (AD). Aducanumab is a human recombinant monoclonal antibody (mAb) selected from a population of elderly, healthy donors and cognitively stable patients using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen Idec licensed aducanumab from Neurimmune under a collaborative development and license agreement.
Aducanumab targets aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients. Based on pre-clinical and interim Phase 1b data, treatment with aducanumab has been shown to reduce amyloid plaque levels.
This press release includes forward-looking statements, including statements about the potential impact of our programs and expected timing of results from clinical trials. 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 our current expectations include the risk that unexpected concerns may arise from additional data or analysis, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates, or we may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. 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.
[i] Biogen data on file
[ii] TECFIDERA is approved in the European Union for relapsing-remitting multiple sclerosis.