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:
- 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.
- 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.
- 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.
- 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.
- 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:
- 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
- Overall Response Score: A Novel Disability Endpoint That Allows for the Integrated Assessment of Improvement and Worsening Over Time in Patients with MS – Poster P777 – Thursday, 26 October, 15:30-17:00 CET
- Temporal Variability Profile of Serum Neurofilament Light Levels in Multiple Sclerosis Patients – Platform 102 – Thursday, 26 October, 11:37–11:49 CET
- Biosensor Measures in Clinic and Free-living Settings Correlate with Multiple Sclerosis Disease Severity – Platform 191 – Friday, 27 October, 09:15-09:27 CET
- Big Multiple Sclerosis Data Network: Data Sharing Among Five Large MS Registries – Poster P738 – Thursday, 26 October, 15:30-17:00 CET
- The Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) Patient Cohort – Poster P336 – Thursday, 26 October, 15:30-17:00 CET
- 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
- 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
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 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.
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Tilaa tiedotteet sähköpostiisi
Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Phase 3 Data on Filgotinib in Biologic-Experienced Rheumatoid Arthritis to Be Presented at 2018 ACR/ARHP Annual Meeting21.10.2018 01:30 | Tiedote
Gilead Sciences, Inc. (Nasdaq: GILD) and Galapagos NV (Euronext & NASDAQ: GLPG) today announced detailed results from the Phase 3 FINCH 2 clinical trial of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response or intolerance to biologic agents. The data, which are being presented as a late-breaking poster at the 2018 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in Chicago, suggest filgotinib has a potential role in addressing important unmet needs in the treatment of rheumatoid arthritis. Positive efficacy data from FINCH 2 were previously announced in September 2018. The data show statistically significant improvements in the proportion of patients achieving a range of clinical efficacy endpoints, including the proportion of patients achieving American College of Rheumatology 20 percent (ACR20, primary endpoint), 50 percent
Manchester United and True Religion Launch Denim Range19.10.2018 20:37 | Tiedote
Manchester United (NYSE:MANU) and luxury denim brand True Religion have collaborated to launch a range of premium club branded denim wear. A first for the club, the new global partnership with the iconic American denim brand will see a range of men’s & women’s co-branded styles go on sale beginning 26th October in the club’s Megastore as well as online via United Direct and truereligion.com & eu.truereligion.com. The exclusive collection features jeans, shirts and jackets, including a highly desirable limited edition denim jacket embroidered with the club’s crest. Fans will have the opportunity to win a selection of clothing from the new range by visiting www.manutd.com/truereligion. Manchester United’s Group Managing Director, Richard Arnold, comments: “True Religion is a well-known, established name in fashion, creating unique designs without compromising on quality. The range we have collaborated on includes the same attention to detail and craftsmanship that has made True Religion
Arch Insurance Announces Strategic Leadership Changes19.10.2018 16:10 | Tiedote
Arch Insurance today announced that Matt Shulman will assume the newly created role of CEO, Arch Insurance North America, effective January 1, 2019. In this role, he will lead Arch Insurance’s operations in the United States and Canada. He will report to Nicolas Papadopoulo, Chairman and CEO of Arch Worldwide Insurance Group. Mr. Shulman, who has more than 20 years of experience in the insurance industry, has been with Arch Insurance since 2009 and has served as the President and CEO of Arch Insurance Europe since 2016. “Matt brings significant U.S. and international experience to this role. Under his leadership, together with our senior team, Arch Insurance will continue to enhance our value proposition to our customers through a robust, diversified product portfolio, creative solutions and excellent service,” Mr. Papadopoulo said. Arch Insurance has also created a new organizational structure with three Chief Underwriting Officers (CUO) dedicated to specific lines of business. These
Takeda to Present Results from Phase 3 ALTA-1L Trial Highlighting Intracranial Efficacy of ALUNBRIG® (brigatinib) Versus Crizotinib in First-Line Advanced ALK+ Non-Small Cell Lung Cancer19.10.2018 15:00 | Tiedote
Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that intracranial efficacy data from the Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1 st Line) trial showed improved intracranial progression-free survival (PFS) and intracranial objective response rate (ORR) with ALUNBRIG (brigatinib) compared to crizotinib among anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) patients. Data for these secondary endpoints will be presented in a poster discussion at the European Society for Medical Oncology (ESMO) 2018 Congress on Friday, October 19 at 2:00 p.m. CET in Munich, Germany. These results further support ALUNBRIG as a potential treatment for adults with ALK+ locally advanced or metastatic NSCLC who had not received a prior ALK inhibitor. ALUNBRIG is currently not approved as first-line therapy for advanced ALK+ NSCLC. “ALK+ NSCLC often spreads to the brain, so having options that can clearly demonstrate efficacy both in the brain an
Vertex Receives European CHMP Positive Opinion for KALYDECO® (ivacaftor) to Treat Patients With Cystic Fibrosis Aged 12 to <24 months With Certain Mutations in the CFTR Gene19.10.2018 14:54 | Tiedote
Vertex Pharmaceuticals (Europe) Limited today announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for KALYDECO® (ivacaftor) to include the treatment of people with cystic fibrosis (CF) aged 12 to <24 months who have at least one of the following nine mutations in their cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R. If the European Commission issues a favorable adoption of the EMA CHMP opinion for the extension of indication, ivacaftor will be the first and only medicine approved in Europe to treat the underlying cause of CF in patients aged 12 to <24 months, who have specific mutations in the CFTR gene. “Cystic fibrosis is a chronic, progressive disease that is present at birth, with symptoms often occurring in infancy, so early treatment is crucial to deliver the best possible outcomes for patients,” said Reshma Kewalr
Tradeshift Announces Q3 2018 Results19.10.2018 14:00 | Tiedote
Tradeshift, the leader in supply chain payments and marketplaces, today announced results from the third quarter of 2018, marking the tenth quarter in a row of successive growth and beating targets. Tradeshift’s third quarter growth stats announced today include: YoY revenue grew 400 percent (trailing 12 months) YoY new bookings grew 284 percent YoY gross merchandise volume (GMV) grew 262 percent New total contract value grew by $47M in Q3 Tradeshift’s customer roster continued strong growth this quarter adding 27 new customers, including Hertz, Shiseido, ECU, and Fortune 500 leaders in retail apparel, agriculture, engineering and construction, hospitality, travel and food delivery. Tradeshift also expanded its app ecosystem by adding a key partnership with Coface, a global credit insurer. Coface has announced a new app solution on the Tradeshift platform offering risk and business information services to help businesses make decisions by ensuring greater financial transparency between
Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.Tutustu uutishuoneeseemme