Biogen to Highlight Broad Research Commitment to MS Care at ECTRIMS Congress, Including New TECFIDERA® Data Demonstrating Importance of Early Treatment
Biogen (NASDAQ: BIIB) will present new clinical data for its multiple sclerosis (MS) portfolio of therapies, including the most-prescribed oral treatment, TECFIDERA® (dimethyl fumarate), at the 31st meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Barcelona, Spain, 7-10 October 2015.1 TECFIDERA data will demonstrate its strong and sustained efficacy in relapsing-remitting multiple sclerosis (RRMS) among patients who were early in the course of their disease or newly diagnosed.
Previous studies have suggested that delaying MS treatment may put some patients at a higher risk of disease progression than those treated with an effective disease modifying therapy (DMT) early in their disease course. With a chronic condition like MS, initiating treatment early may help slow disease activity.2,3
“TECFIDERA’s compelling combination of benefits has made it the most-prescribed oral MS medication globally.1 At ECTRIMS, Biogen will present data that underscore the benefits of early treatment of RRMS with TECFIDERA and reaffirm its favorable benefit-risk profile in a broad range of patients,” said Gilmore O’Neill, M.D., vice president of Multiple Sclerosis Research and Development at Biogen.
Biogen will also present additional findings from studies of its marketed and investigational MS therapies that aim to improve patient outcomes. Highlights include results from new analyses of the Phase 3 study of ZINBRYTATM (daclizumab high-yield process) and additional Phase 2 results for anti-LINGO-1 (BIIB033) in acute optic neuritis. Further clinical data presentations from company initiatives and collaborative research will focus on exploring innovations and technologies to enhance individualized treatment outcomes.
Highlights of Biogen’s ECTRIMS Data for Presentation:
- Efficacy of Delayed-Release Dimethyl Fumarate in Early Multiple Sclerosis: Post-Hoc Analysis of the Phase 3 DEFINE and CONFIRM Studies According to Baseline Disability – Poster P565 – Thursday, 8 October – 15:45-17:00 CEST
- Longer-Term Follow-Up of the Efficacy of Delayed-Release Dimethyl Fumarate in Newly Diagnosed Patients with RRMS: An Integrated Analysis of DEFINE, CONFIRM, and ENDORSE – Poster P564 – Thursday, 8 October – 15:45-17:00 CEST
- Long-Term Follow-Up of the Safety of Delayed-Release Dimethyl Fumarate in RRMS: Interim Results From the ENDORSE Extension Study – Poster P544 – Thursday, 8 October – 15:45-17:00 CEST
- Efficacy of Delayed-Release Dimethyl Fumarate Versus Glatiramer Acetate on a Novel Composite Outcome Measure of Inflammatory Disease Activity: Post-Hoc Analysis of the CONFIRM Study – Poster P1063 – Friday, 9 October – 15:30-17:00 CEST
- Comparative Efficacy of First-Line Natalizumab Versus IFNb or Glatiramer Acetate in Relapsing Multiple Sclerosis – Poster P559 – Thursday, 8 October – 15:45-17:00 CEST
- No Evidence of an Increased Risk for Malignancy Associated with Natalizumab Therapy in Nine Years of Postmarketing Surveillance – Poster P1094 – Friday, 9 October – 15:30-17:00 CEST
- Progression to Disability Milestones in Multiple Sclerosis with Long-Term Natalizumab Treatment – Poster P1092 – Friday, 9 October – 15:30-17:00 CEST
- COMPARE: A Phase 1 Pharmacokinetic Study of Subcutaneous Peginterferon Beta-1a Versus Subcutaneous Interferon Beta-1a Over Two Weeks in Healthy Subjects – Poster P1147 – Friday, 9 October – 15:30-17:00 CEST
- Peginterferon Beta-1a Dosed Every Two Weeks Maintained Efficacy Over Three Years in Patients with Relapsing-Remitting Multiple Sclerosis – Poster P1098 – Friday, 9 October – 15:30-17:00 CEST
- Effect of Daclizumab HYP Versus Intramuscular Interferon Beta-1a on No Evidence of Disease Activity in Patients with Relapsing-Remitting Multiple Sclerosis: Analysis of the DECIDE Study – Parallel Session 2:89 – Thursday, 8 October – 12:00 CEST
- Daclizumab HYP Provided Clinically Meaningful Benefits on Cognitive Outcomes Versus Intramuscular Interferon Beta-1a Over Two Years: Results from the DECIDE Study – Poster P535 – Thursday, 8 October – 15:45-17:00 CEST
- Efficacy of Daclizumab HYP Versus Intramuscular Interferon Beta-1a on Disability Progression Across Patient Demographic and Disease Activity Subgroups in DECIDE – Poster P561 – Thursday, 8 October – 15:45-17:00 CEST
- Correlation of Brain Volume and Physical Measures with Cognitive Function Using Baseline Data from the Anti-LINGO-1 SYNERGY Trial in Multiple Sclerosis – Poster P629 – Thursday, 8 October – 15:45-17:00 CEST
- Anti-LINGO-1 Monoclonal Antibody BIIB033 Improves Optic Nerve Latency in Acute Optic Neuritis: Primary Efficacy Analysis of the RENEW Study – Free Communications 3: Platform 165 – Friday, 9 October – 10:03-10:15 CEST
- Evidence that the Anti-LINGO-1 Monoclonal Antibody BIIB033 Protects Against Multifocal Visual Evoked Potential Amplitude Loss in the Fellow Eye of Subjects with Unilateral Acute Optic Neuritis – Parallel Session 13:231– Saturday, 10 October – 9:25-9:36 CEST
EMERGING APPROACHES TO MS MANAGEMENT
- The Self-Administered, iPad®-Based Processing Speed Test: Impact of Technician Presence on Task Performance – Poster P517 – Thursday, 8 October – 15:45-17:00 CEST
- Harnessing Real-Time Patient Data to Improve Clinical Outcomes and Research: The Multiple Sclerosis Partners Advancing Technology and Healthcare Solutions (MS PATHS) Initiative – Poster P821 – Friday, 9 October – 15:30-17:00 CEST
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 one of the world’s oldest independent biotechnology companies 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.
ABOUT TECFIDERA ®
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 165,000 patients have been treated with TECFIDERA worldwide.4
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 benefit-risk profile in a broad range of patients with relapsing forms of MS. 5 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. Rare cases of PML have been seen with TECFIDERA patients in the setting of severe and prolonged lymphopenia.
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 treats 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.
ABOUT TYSABRI ®
TYSABRI is a DMT 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. In the European Union, it is indicated as a single disease modifying therapy in highly active relapsing-remitting MS 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 increases the risk of progressive multifocal leukoencephalopathy (PML). When initiating and continuing treatment with TYSABRI, physicians should consider whether the expected benefit of TYSABRI is sufficient to offset this risk.
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 67 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 percent (p<0.001).
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 multiple sclerosis have not been fully defined.
TYSABRI increases the risk of PML, an opportunistic viral infection of the brain which usually leads to death or severe disability. Risk 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 postmarketing 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 or your respective country’s website.
ABOUT PLEGRIDY ®
PLEGRIDY is a subcutaneous pegylated interferon dosed once every two weeks for relapsing forms of MS,6 including relapsing-remitting MS, the most common form of MS. PLEGRIDY is currently approved in the United States, the European Union, Canada, Australia, and Switzerland. Biogen continues to work toward making PLEGRIDY available in additional countries across the globe.
The efficacy and safety of PLEGRIDY is supported by one of the largest pivotal studies with interferons conducted in people living with RRMS. In clinical studies, PLEGRIDY has been proven to significantly reduce the rate of MS relapses, slow the progression of disability, and reduce the number of MS brain lesions while demonstrating a favorable safety profile for patients with relapsing forms of MS. In clinical trials, the most common adverse events associated with PLEGRIDY were injection site reactions and flu-like symptoms. Other side effects reported include liver problems, including liver failure and increases in liver enzymes; depression or suicidal thoughts; serious allergic reactions; cardiac problems, including congestive heart failure; autoimmune disorders; decreases in white blood cell or platelet counts; and seizures. A list of adverse events can be found in the full PLEGRIDY product labeling for each country where it is approved.
It is believed that PLEGRIDY modulates immune responses that are thought to play a role in MS although its exact mechanism of action is unknown.
For additional important safety information and United States full prescribing information, please visit www.plegridy.com, or your respective country’s website.
About ZINBRYTA™ (daclizumab high-yield process)
ZINBRYTA (daclizumab high-yield process) is an investigational compound being developed for the treatment of relapsing forms of MS. ZINBRYTA is 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 MS. ZINBRYTA modulates IL-2 signaling without causing general immune cell depletion. Biogen and AbbVie are jointly developing ZINBRYTA.
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, important cells that help regulate the immune system.
ZINBRYTA is currently under regulatory review in the United States and the European Union.
ABOUT ANTI-LINGO-1 (BIIB033)
Anti-LINGO-1 (BIIB033) is an investigational compound being developed for the treatment of multiple sclerosis. Anti-LINGO-1 is a fully human monoclonal antibody that targets LINGO-1, a protein expressed selectively in the central nervous system (CNS) that is known to play a central role in regulating axonal myelination and regeneration.
Two global Phase 2 trials, RENEW and SYNERGY, were designed to assess the biological activity and clinical potential of anti-LINGO-1 in acute optic neuritis (AON) and relapsing forms of MS. In RENEW, anti-LINGO-1 was evaluated in patients following a first episode of AON. Anti-LINGO-1 demonstrated an improvement in recovery of optic nerve latency (time for a signal to travel from the retina to the visual cortex) relative to placebo. RENEW was the first clinical study to provide evidence of biological repair in the CNS by facilitating remyelination following an acute inflammatory injury.
SYNERGY is a separate Phase 2 study which aims to measure the impact of anti-LINGO-1 in combination with an anti-inflammatory therapy on improving and slowing disease progression among participants with relapsing forms of MS (both relapsing-remitting MS and secondary-progressive MS). The study is ongoing with results expected in 2016.
This press release includes forward-looking statements, including statements about the potential benefits of our products and 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 and only a small number of research and development programs result in commercialization of a product. There is a risk that positive results in a clinical trial may not be replicated in subsequent or confirmatory trials or success in early stage clinical trials may not be predictive of results in later stage or large scale clinical trials or trials in other potential indications. Other 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.
1 Combined post-marketing and clinical trials exposure to TECFIDERA as of July 31, 2015
2 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.
3 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.
4 Pozzilli C, Phillips JT, Fox RJ, et. al. (2015, October). Long-Term Follow-up of the Safety of Delayed-Release Dimethyl Fumarate in RRMS: Interim Results From the ENDORSE Extension Study. Poster session presented at the 31st meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), Barcelona, Spain.
5 TECFIDERA is approved in the European Union for relapsing-remitting multiple sclerosis.
6 PLEGRIDY is approved in the European Union and Canada for relapsing-remitting multiple sclerosis.
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Summer Business with Yourtyres.co.uk: New Shop Feature and High-Performance Tyre Models16.3.2018 14:11 | Pressemelding
Each year, summer trade means great challenges for car garages and tyre dealers. As a result and at just the right time, Yourtyres.co.uk, the online trade customer shop by Europe’s leading online tyre dealer Delticom, is introducing a new feature intended to make the daily work of the shop’s customers easier: An advice mode is available from now on at Yourtyres.co.uk. When changing from the purchasing to the sales view, the individual end customer prices are displayed instead of the actual purchase prices. In order to use this feature, users of Yourtyres.co.uk simply have to insert their individual markups for the different item groups. From the markup and the purchase price, the online shop automatically calculates the personal end customer price. The usual purchasing view is also still available. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005448/en/ An advice mode immediately helps trade customers use the full pot
Available Now: The Smartphone Made for the Way We Communicate Today, the Galaxy S9 and S9+16.3.2018 12:00 | Pressemelding
Samsung Electronics America, Inc. announced that the new, award-winning Galaxy S9 and Galaxy S9+, which have been recognized by smartphone reviewers worldwide for their best-in-class display, design and camera, are now available for purchase at U.S. wireless network providers and retail stores. The phones come in three colors: Midnight Black, Coral Blue, and the new Lilac Purple. The Galaxy S9 has a suggested retail price of $719.99, while the Galaxy S9+ is available for $839.99. Both unlocked and carrier versions of the Galaxy S9 and Galaxy S9+ are also available for purchase on Samsung.com. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005175/en/ Designed for the way we communicate today, Samsung's new Galaxy S9 and Galaxy S9+ are available in the U.S. at wireless network providers, retailers and on Samsung.com. (Photo: Business Wire) “The Galaxy S9 and S9+ are designed for the visual and social generation—the consum
CONQUEST Group Announced the Expansion of its Asset Management Business with the Appointment of Philippe Taillardat to the Role of Director16.3.2018 09:00 | Pressemelding
Philippe Taillardat brings to CONQUEST over 25 years of Asset Management and Investment Banking experience, primarily in principal investing, financial advisory, equity and debt financing across global infrastructure and sustainable energy sectors. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005030/en/ Philippe Taillardat (Photo: CONQUEST Group) Philippe was most recently Co-Head of Infrastructure Investments Europe at First State Investments, which he helped transform into one of the leading billion+ European infrastructure fund manager in core / core+ strategies. Earlier in his career, Philippe held various senior banker and investment roles at Amundi, Credit Agricole CIB, Credit Suisse, AXA and BNP Paribas. Frédéric Palanque, Managing Director of CONQUEST Group, said, "We are delighted to welcome such a recognized professional. CONQUEST is trusted for providing value-added advice in complex and highly confidential
AccelStor All-Flash Solutions Unlock Data Possibilities for AI and Cloud16.3.2018 09:00 | Pressemelding
AccelStor, an innovative all-flash array (AFA) provider for the big data era, is excited to announce its participation in the upcoming Cloud Expo Europe, taking place from March 21 to 22 at Booth C1850 in the ExCel London exhibition centre. Besides presenting latest all-flash storage solutions breaking through performance and availability barriers for artificial intelligence (AI), virtualization and private cloud, AccelStor will present a live demonstration of its new generation NeoSapphire high availability models, one of the highlights not to be missed this year. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005010/en/ AccelStor's new generation NeoSapphire High Availability all-flash array AccelStor NeoSapphire all-flash arrays are highly integrated with virtualization and private cloud platforms, supporting VMware vSphere and OpenStack Cinder. NeoSapphire’s “high availability” series features symmetric active-activ
Westinghouse Completes First Major Decommissioning Work at a Nordic Commercial Nuclear Reactor16.3.2018 08:45 | Pressemelding
Westinghouse Electric Company announced today that it has completed a major decommissioning project at the former Barsebäck nuclear power plant in Skåne, Sweden. Barsebäck Unit 2 ceased operation in 2005 and decommissioning work began in August 2016. Westinghouse’s scope of work included the underwater segmentation and packaging of the reactor vessel internals, as well as the upfront engineering studies and equipment manufacturing and qualification. “Westinghouse is proud to deliver this major decommissioning project on time and on budget,” said Yves Brachet, Westinghouse senior vice president, Global Decommissioning, Decontamination, Remediation and Waste Management. “Our global expertise in this area will help our customers in the Nordic region to safely manage a variety of end-of-life opportunities for commercial nuclear power plants.” Leadership at Barsebäck Kraft AB (BKAB) is equally satisfied with this successful initial step of the first dismantling of a commercial nuclear power
Lighting Manufacturer LTS Licht & Leuchten, Part of the Fargerhult Group, to Offer Selected Spot- & Downlights with Seoul Semiconductor’s SunLike Series Natural Spectrum LEDs16.3.2018 08:02 | Pressemelding
Seoul Semiconductor, a global innovator of LED products and technology, announced that its SunLike Series natural spectrum LEDs, which implement light closest to the spectrum of natural sunlight, has been adopted for selected luminaires of LTS Licht & Leuchten GmbH, a German manufacturer of high-quality luminaires for hospitality, retail, and office applications. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180316005206/en/ LTS Jett 100 spotlights equipped with SunLike LED technology (Photo: Business Wire) LTS has adopted SunLike natural spectrum LEDs for selected products, including the Jett 100 and CSA 60 spotlights. A series of spotlights with a discreet and individual appearance, and clear, straightforward design lines, Jett spotlights harmoniously blend in with any type of retail application. The high color rendering and superior luminous intensity of these spotlights enable lighting designers to achieve accentuated ar