[October 18, 2017] |
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Biogen Confirms Commitment to Tackle Multiple Sclerosis Through Comprehensive Approach
Biogen
(NASDAQ: BIIB) confirms its comprehensive approach to tackle multiple
sclerosis (MS) at the seventh Joint Meeting of the European Committee
for Treatment and Research in MS and Americas Committee for Treatment
and Research in MS (ECTRIMS-ACTRIMS; 25 - 28 October).
"With more than 25 years of scientific leadership in MS, Biogen's
commitment is unwavering," said Michael Ehlers, executive vice
president, Research & Development at Biogen. "Our expertise puts Biogen
in a unique position with a comprehensive approach including active
research and clinical development on how to repair the damage to the
central nervous system from relapsing forms of MS, a portfolio of new
drug candidates that we are advancing to the clinic, our collaboration
to identify a digital biomarker, our focus to advance understanding of
the disease through global data collection with MS PATHS, active pursuit
of the genetic origins of progressive forms of MS, and our innovation in
value-based contract pilots in the U.S."
Key updates at ECTRIMS-ACTRIMS from Biogen include:
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The latest from the collaboration with Verily and Brigham and Women's
Hospital whose goal is to explore the use of digital biosensors to
assess patients outside of the clinic. Additional data on the possible
utility of predictive biomarkers to inform MS diagnosis and ongoing
disease monitoring, with the goal of assisting clinicians with their
decisions on how to treat based on the heterogeneic differences of
those living with MS, will also be presented.
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Interim reports from MS PATHS (Partners Advancing Technology and
Health Solutions), a collaboration with 10 leading MS centers in
Europe and the U.S. to leverage technology deployed in routine care to
generate standardized, high-quality data from a diverse, real-world
patient population. MS PATHS collects clinical, MRI and biologic data
from all patients in real-time, at the point of care, to better
understand the disease and ultimately improve the lives of those
living with MS.
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An assessment of the Big Multiple Sclerosis Data (BMSD) Network,
comprised of five MS registries and facilitated by Biogen. The network
will merge data from large MS registries that have collected
longitudinal data on nearly 140,000 people with MS. The scale of this
pooled MS data may enable greater understanding of MS and its impact.
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A comprehensive review of the Phase 2 SYNERGY trial that identified a
specific patient population for the investigational molecule
opicinumab (anti-LINGO-1) as a potential therapy to repair damage to
the central nervous system caused by MS.
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An innovative economic model using real-world data from the MSBase
Registry with a goal to demonstrate cost-effectiveness of treatment in
highly-active MS patients. The analysis supports value-based
reimbursement initiatives linked to patient outcomes. In July, Biogen
announced four pilots for value-based contracts with health plans
across the U.S. The contracts utilize real-world data to align price
with patient outcomes.
"With 10 centers now active and strong patient enrollment, our MS PATHS
collaboration provides a glimpse into the future of MS care and
research," said Alfred Sandrock, M.D., Ph.D., executive vice president
and chief medical officer at Biogen. "By leveraging technology we are
able to collect a robust set of real-world data that is unprecedented in
scale and will contribute to a more precise approach to managing
patients by supporting providers in real-time to meet the diverse needs
of people living with MS."
Highlights of Biogen's more than 80 platform and poster
presentations:
Opicinumab
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Predictors of an Opicinumab Treatment Effect and Identification of an
Efficacy Subpopulation: A Post Hoc Analysis of the SYNERGY Study -
Poster P718 - Thursday, 26 October, 15:30-17:00 CET
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Overall Response Score: A Novel Disability Endpoint That Allows for
the Integrated Assessment f Improvement and Worsening Over Time in
Patients with MS - Poster P777 - Thursday, 26 October, 15:30-17:00
CET
MS Franchise
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Temporal Variability Profile of Serum Neurofilament Light Levels in
Multiple Sclerosis Patients - Platform 102 - Thursday, 26 October,
11:37-11:49 CET
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Biosensor Measures in Clinic and Free-living Settings Correlate (News - Alert) with
Multiple Sclerosis Disease Severity - Platform 191 - Friday, 27
October, 09:15-09:27 CET
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Big Multiple Sclerosis Data Network: Data Sharing Among Five Large MS
Registries - Poster P738 - Thursday, 26 October, 15:30-17:00 CET
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The Multiple Sclerosis Partners Advancing Technology and Health
Solutions (MS PATHS) Patient Cohort - Poster P336 - Thursday, 26
October, 15:30-17:00 CET
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Comparison of Case-mix in Multiple Sclerosis Patients Participating in
Randomized Control Trials, Prospective Observational Studies, and
Multiple Sclerosis Partners Advancing Technology and Health Solutions
(MS PATHS) - Poster P351 - Thursday, 26 October, 15:30-17:00
CET
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A Cost-effectiveness Analysis Using Real-world Data from the MSBase
Registry: Comparing Natalizumab to Fingolimod in Patients with
Inadequate Response to Disease Modifying Therapies in
Relapsing-remitting Multiple Sclerosis in Scotland - Poster P700
- Thursday, 26 October, 15:30-17:00 CET
About Biogen At Biogen, our mission is clear: we are
pioneers in neuroscience. Biogen discovers, develops and delivers
worldwide innovative therapies for people living with serious
neurological and neurodegenerative diseases. Founded in 1978 as one of
the world's first global biotechnology companies by Charles Weissman and
Nobel (News - Alert) Prize winners Walter Gilbert and Phillip Sharp, today
Biogen has the leading portfolio of medicines to treat multiple
sclerosis; has introduced the first and only approved treatment for
spinal muscular atrophy; and is focused on advancing neuroscience
research programs in Alzheimer's disease and dementia, neuroimmunology,
movement disorders, neuromuscular disorders, pain, ophthalmology,
neuropsychiatry, and acute neurology. Biogen also manufactures and
commercializes biosimilars of advanced biologics. We routinely post
information that may be important to investors on our website at www.biogen.com. To
learn more, please visit www.biogen.com
and follow us on social media - Twitter,
LinkedIn,
Facebook,
YouTube.
Biogen Safe Harbor This press release contains
forward-looking statements, including statements relating to the
potential impact of our programs, development and potential benefits,
safety and efficacy of investigational drugs, including opicinumab,
results of certain clinical studies and real-world data. These
statements may be identified by words such as "aim," "believe,"
"except," "may," "plan," "potential," "will" and similar expressions,
and are based on our current beliefs and expectations. You should not
place undue reliance on these statements or the scientific data
presented. Drug development and commercialization involve a high degree
of risk, and only a small number of research and development programs
result in commercialization of a product. Results in early stage
clinical trials may not be indicative of full results or results from
later stage or larger scale clinical trials and do not ensure regulatory
approval. Factors which could cause actual results to differ materially
from our current expectations include the risk that we may not fully
enroll our clinical trials or enrollment will take longer than expected,
unexpected concerns may arise from additional data or analysis,
including data, analysis or results obtained during our clinical trials,
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 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, third party collaboration risks. The foregoing
sets forth many, but not all, of the factors that could cause actual
results to differ from our expectations in any forward-looking
statement. Investors should consider this cautionary statement, as well
as the risk factors identified in 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.
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