13:28 uur 24-04-2017

TECFIDERA® and TYSABRI® Data Demonstrate Improved Outcomes with Early MS Treatment

CAMBRIDGE, Mass.–(BUSINESS WIRE)– Biogen (NASDAQ: BIIB) announced new real-world data that show treatment with its leading multiple sclerosis (MS) therapies, TECFIDERA ®(dimethyl fumarate) and TYSABRI ® (natalizumab), early in the course of the disease may improve outcomes for people living with relapsing MS. These data were presented at the 69th annual meeting of the American Academy of Neurology (AAN) in Boston.

MS is a chronic, often disabling disease that attacks and causes inflammation within the central nervous system. Initiating an appropriate disease modifying therapy soon after diagnosis has been shown to slow the physical and cognitive decline associated with MS and may prevent the accumulation of future disability, allowing people living with MS to stay active longer.1,2

“The new real-world TECFIDERA and TYSABRI data presented at AAN emphasize the importance of effective treatment early in the course of one’s disease,” said Kate Dawson, M.D., vice president, U.S. Medical at Biogen. “Timely treatment with appropriate therapies can help mitigate damage caused by MS and delay long-term disability for people with the disease.”

Comparative Effectiveness Data Further Support Use of TECFIDERA in Early MS
TECFIDERA is the world’s most prescribed oral therapy for MS. A comparison of real-world data provides further evidence of its strong efficacy relative to other oral MS therapies, both in newly-treated MS patients and those previously treated with a prior disease modifying therapy (DMT). Researchers used U.S. insurance claims data to compare the time to first relapse among patients initiating TECFIDERA versus fingolimod or teriflunomide. These results show that TECFIDERA significantly reduced the risk of relapse by 30 percent compared to teriflunomide (hazard ratio [HR]: 1.302; p<0.01) in newly diagnosed patients and those previously treated with a prior DMT, and had comparable efficacy to fingolimod (HR: 0.995; p=0.94). These data are consistent with other comparative effectiveness data showing similar results to oral therapies and greater efficacy to interferon beta and glatiramer acetate.

Subgroup analyses of the open-label studies PROTEC and RESPOND assessed TECFIDERA in early MS and early switch patients, respectively. Results show that TECFIDERA significantly reduced the annualized relapse rate (ARR) over one year in the early MS subgroups, including those who switched to TECFIDERA from a prior DMT. Additional data presented at the meeting affirm the well-characterized, long-term safety profile of TECFIDERA in patients treated for up to nine years.

Early and Continued TYSABRI Treatment Leads to Better Outcomes in MS Patients with High Disease Activity
TYSABRI is the only targeted high-efficacy MS treatment with more than 10 years of clinical experience. New data from the TYSABRI Observational Program (TOP) reinforce the proven efficacy of TYSABRI and demonstrate that early and continued treatment leads to better clinical outcomes.

A subgroup analysis from TOP compared outcomes for treatment-naive patients who began taking TYSABRI shortly after MS symptom onset (≤1 year) with those who initiated TYSABRI after experiencing MS symptoms for some time (>1 and ≤5 years, or >5 years). Annualized relapse rate and disability worsening or improvement, as measured by the Expanded Disability Status Scale (EDSS), were assessed. Results show that, over three years, the likelihood of disability improvement was significantly greater for patients treated with TYSABRI within one year of MS symptom onset (49.3%), than for those treated between one to five years (38.1%) or more than five years (26.3%) following symptom onset. TYSABRI treatment also significantly reduced ARR compared with baseline in all three cohorts. Additional TOP data presented at the meeting show patients who continued TYSABRI treatment experienced better clinical outcomes than those who switched to another therapy.

Select TECFIDERA Data Presentation Details:

  • Comparative Effectiveness of Delayed-release Dimethyl Fumarate Versus Fingolimod and Teriflunomide on Risk of Relapse – Poster P6.375 – Friday, April 28, 8:30 a.m. – 5:30 p.m. ET
  • Comparative Analysis of MS Outcomes in Dimethyl Fumarate-treated Patients Relative to Propensity Matched Fingolimod, Interferon, Glatiramer Acetate, or Teriflunomide – Poster P6.372 – Friday, April 28, 8:30 a.m. – 5:30 p.m. ET
  • Effectiveness of Delayed-release Dimethyl Fumarate on Clinical Measures and Patient-reported Outcomes in Newly Diagnosed and Other Early Relapsing-remitting Multiple Sclerosis Patients: Subgroup Analysis of PROTEC – Poster P6.363 – Friday, April 28, 8:30 a.m. – 5:30 p.m. ET
  • Effectiveness of Delayed-release Dimethyl Fumarate on Clinical Measures and Patient-reported Outcomes in Relapsing Multiple Sclerosis (RMS) Patients Switching After Suboptimal Response to Glatiramer Acetate, Including Patients with Early MS: Subgroup Analysis of RESPOND – Poster P2.406 – Monday, April 24, 8:30 a.m. – 7:00 p.m. ET
  • Safety of Delayed-release Dimethyl Fumarate in Relapsing-remitting Multiple Sclerosis Patients from ENDORSE: Seven-year Interim Results – Poster P5.383 – Thursday, April 27, 8:30 a.m. – 7:00 p.m. ET

Select TYSABRI Data Presentation Details:

  • In Treatment-naive Patients with Relapsing-remitting Multiple Sclerosis (RRMS), Initiating Natalizumab Earlier is Associated with Greater Disability Improvement than Delaying Treatment: Real-world Results from the TYSABRI ® Observational Program (TOP) – Poster P6.350 – Friday, April 28, 8:30 a.m. – 5:30 p.m. ET
  • Real-world Relapsing-remitting Multiple Sclerosis (RRMS) Patients in the TYSABRI ® Observational Program (TOP) Who Discontinued Natalizumab: Why They Stopped, Which Therapies They Switched to, and How Their Disease Activity Changed – Poster P2.399 – Monday, April 24, 8:30 a.m. – 7:00 p.m. ET

About TECFIDERA ®
TECFIDERA is an oral therapy for relapsing forms of MS, including relapsing-remitting MS, the most common form of MS. More than 240,000 patients have been treated with TECFIDERA worldwide. 3

TECFIDERA has been proven to reduce the rate of MS relapses, slow the progression of disability, and impact the number of MS brain lesions, while demonstrating a favorable benefit-risk profile in people with relapsing forms of MS, notably newly diagnosed and early switch populations.  4 In clinical trials, the most common adverse events associated with TECFIDERA were flushing and gastrointestinal (GI) events. Other side effects include a decrease in mean lymphocyte counts during the first year of treatment, which then plateaued, and liver function abnormalities, which resolved upon treatment discontinuation. TECFIDERA is contraindicated in patients with a known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. Rare cases of progressive multifocal leukoencephalopathy (PML), a rare opportunistic viral infection of the brain which has been associated with death or severe disability, have been seen with TECFIDERA patients in the setting of prolonged moderate to severe lymphopenia.

The efficacy and safety of TECFIDERA have been studied in a large, global clinical program, which includes an ongoing long-term extension study.

For additional important safety information, and the United States full prescribing information, please visit  www.tecfidera.com or your respective country’s website.

About TYSABRI ®
TYSABRI is a disease modifying therapy (DMT) approved in more than 80 countries including the United States, the European Union, Canada, Australia and Switzerland. In the United States, TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of MS. In the European Union, it is indicated as single disease modifying therapy in adults with highly active relapsing-remitting multiple sclerosis (RRMS) for patients with highly active disease activity despite a full and adequate course of treatment with at least one DMT or patients with rapidly evolving severe RRMS. TYSABRI is proven effective, with 10 years of experience in treating RRMS, and more than 167,000 people treated worldwide and 559,000 patient-years of experience. 5

TYSABRI is a monoclonal antibody that selectively binds to α4-integrin and is thought to interrupt the activity of inflammatory cells in MS patients by blocking the interaction between α4β1-integrin and vascular cell adhesion molecule-1. Disruption of these molecular interactions prevents transmigration of leukocytes across the endothelium into inflamed parenchymal tissue. The specific mechanism(s) by which TYSABRI exerts its effects in MS have not been fully defined.

TYSABRI has advanced the treatment of MS patients with its proven ability to slow the progression of disability, reduce relapse rates, and impact the number of MRI brain lesions with a well-characterized safety profile. Data from the Phase 3 AFFIRM trial, which was published in the  New England Journal of Medicine, showed that at 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 to 54 percent (12-24-week sustained respectively, both p<0.001).

TYSABRI increases the risk of PML, a rare opportunistic viral infection of the brain which has been associated with death or severe disability. Risk factors that increase the risk of PML are the 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 and clinically significant liver injury has also been reported in the post-marketing setting. Serious, life-threatening, and sometimes fatal cases have been reported in the postmarketing setting in MS 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.

The overall benefit-risk profile of TYSABRI remains positive. For additional important safety information and the full United States prescribing information which includes a full list of adverse events, please visit  www.tysabri.com or your respective country’s website.

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases. Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics. For more information, please visit  www.biogen.com. Follow us on social media –  Twitter, LinkedIn,  Facebook,  YouTube.

Safe Harbor
This press release contains forward-looking statements, made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits, safety and efficacy of TECFIDERA and TYSABRI and the results of certain real-world data. These forward-looking statements may be accompanied by words such as “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will” and other words and terms of similar meaning. You should not place undue reliance on these statements or the scientific data presented. Drug development and commercialization involve a high degree of risk. Factors which could cause actual results to differ materially from Biogen’s current expectations include unexpected concerns that 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 Biogen’s drug candidates or expansion of product labeling; or Biogen may encounter other unexpected hurdles which may be impacted by, among other things, the occurrence of adverse safety events, failure to obtain regulatory approvals in certain jurisdictions, failure to protect intellectual property and other proprietary rights, product liability claims or third party collaboration risks, and the other risks and uncertainties that are described in the Risk Factors section of Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. 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, whether as a result of new information, future developments or otherwise.

1 Kappos, L., Freedman, M., Polman, C., et, al. (2007). Effect of early versus delayed interferon beta-1b treatment on disability after a first clinical event suggestive of multiple sclerosis: A 3-year follow-up analysis of the BENEFIT study. The Lancet, 389-397.
2 Goodin, D., & Bates, D. (2009). Review: Treatment of early multiple sclerosis: The value of treatment initiation after a first clinical episode. Multiple Sclerosis, 1175-1182.
3 Combined post-marketing and clinical trials exposure to TECFIDERA as of 31 January 2017.
4 TECFIDERA is approved in the European Union for relapsing-remitting multiple sclerosis.
5 As of 28 February 2017.

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