Business Wire

Biogen Announces AFFINITY Phase 2 Trial Initiation for Opicinumab (Anti-LINGO-1) in Multiple Sclerosis

Del

Biogen (NASDAQ: BIIB) announced today the recent initiation of the Phase 2 clinical trial AFFINITY, designed to evaluate opicinumab as an investigational add-on therapy in people with relapsing multiple sclerosis (MS). The trial follows the comprehensive review of SYNERGY, a Phase 2 trial, which identified a specific population that may be more likely to respond to treatment.

These data are being presented at MSParis2017, 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).

The post-hoc analysis of SYNERGY data indicated an increased clinical effect of opicinumab versus placebo (when used at the same time as interferon beta-1a intramuscular injection) in patients who had the disease for shorter periods of time and in whom MRI showed certain brain features that suggest repair of MS lesions may be possible through remyelination.1

“As part of our long-standing commitment to the MS community, Biogen remains dedicated to advancing the treatment of MS and continues to pursue next-generation research to understand the therapeutic potential of repairing damage caused by the disease,” said Michael Ehlers, executive vice president, Research & Development at Biogen. “The SYNERGY data provide intriguing evidence that opicinumab, which has demonstrated remyelination properties in a previous Phase 2 study, may have a treatment effect in certain patients.”

The recently-initiated AFFINITY study is a multicenter, randomized, double-blind, placebo-controlled, Phase 2 study that aims to enroll 240 people with relapsing MS. It will evaluate opicinumab as an add-on therapy in patients who are adequately controlled on their anti-inflammatory disease-modifying therapy (DMT), versus the DMT alone. The primary endpoint of the study, Overall Response Score (ORS), is an integrated measure of both the improvement and worsening of disability over time.

“When analyzing the SYNERGY results, we discovered which patients with relapsing MS may be more responsive to opicinumab, and this became a significant component of the trial design for AFFINITY,” said Professor Gavin Giovannoni, chair of Neurology, Blizard Institute, Barts and The London School of Medicine and Dentistry. “We now have an exciting opportunity to apply a more precise biological approach when evaluating the potential of opicinumab as a therapy that may improve patients’ disability and lead to a better overall outcome.”

Data on opicinumab will be presented as follows:

  • 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

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 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 development of and potential benefits, safety and efficacy of the investigational drug, 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: uncertainty of success in the development of opicinumab, which may be impacted by, among other things, the occurrence of adverse safety events, the risk that we may not fully enroll our clinical trials or enrollment will take longer than expected, unexpected concerns that 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 such as, among other things, 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.

1 As measured by magnetization transfer ratio (MTR) and diffusion tensor imaging-radial diffusivity (DTI-RD).

Contact information

Biogen
MEDIA CONTACT:
Lindsey Smith, +1-781-464-3260
public.affairs@biogen.com
or
INVESTOR CONTACT:
Ben Strain, +1-781-464-2442
IR@biogen.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(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

Philip Morris International Launches Next Generation of IQOS, the World’s Leading Heated Tobacco Product23.10.2018 02:30Pressemelding

In its passion and drive to provide better choices to people who smoke, Philip Morris International Inc. (“PMI”) (NYSE: PM), the global leader in smoke-free innovation and science, has launched the next generation of IQOS. The new IQOS 3 and IQOS 3 MULTI integrate extensive consumer insights and feedback to improve design and user experience while maintaining signature taste, sensory attributes and ritual—all underpinned by strong scientific substantiation. The new versions aim to further encourage a growing number of smokers to switch, to the benefit of their health, public health and, ultimately, society. The new iterations were launched today in Tokyo, Japan—the country considered the birthplace of IQOS. The iconic brand offers the best in taste and satisfaction in the category, and almost 6 million adult smokers have already quit cigarettes—with more than half of those in Japan. “Our dream was to create a better alternative for smokers, and IQOS has made this dream a reality; it’s

Logitech Delivers Record Q2 Sales and Double-Digit Profit Growth23.10.2018 01:00Pressemelding

Logitech International (SIX: LOGN) (Nasdaq: LOGI) today announced financial results for the second quarter of Fiscal Year 2019. Q2 sales were $691 million, up 9 percent in US dollars and 10 percent in constant currency, compared to Q2 of the prior year. Q2 GAAP operating income reached $65 million, compared to $59 million in the same quarter a year ago. Q2 GAAP earnings per share (EPS) grew 15 percent to $0.38, compared to $0.33 in the same quarter a year ago. Q2 non-GAAP operating income grew 18 percent to $85 million, compared to $71 million in the same quarter a year ago. Q2 non-GAAP EPS grew 26 percent to $0.49, compared to $0.39 in the same quarter a year ago. Q2 cash flow from operations was $85 million, up 24 percent compared to Q2 of the prior year. Cash flow from operations for the fiscal year to date was $97 million, compared to $67 million for the same period a year ago. “Q2 showcased the power and diversity of our portfolio,” said Bracken Darrell, Logitech president and chi

SmartStream Steps Ahead with New Industry Digital Payments Solution22.10.2018 23:01Pressemelding

SmartStream Technologies, the financial Transaction Lifecycle Management (TLM®) solutions provider, today announced the launch of TLM Aurora, the next generation of Corona, the industry’s leading reconciliation platform – the first new module is designed to support the new industry standards in the digital payments world, by providing connectors to SWIFT GPI, RTGS, as well as Blockchain based networks, allowing for real-time operational control, proactive exception management and low TCO. TLM Aurora provides the new generation of integrated operational control for the digital marketplace. As transactions increase in variability, velocity and volume, the need for scalable, real-time, integrated reconciliations is greater than ever. TLM Aurora supports organisations in performing operations such as SWIFT and SEPA transfers, mobile, cash and card payments, digital currencies, settlements and reconciliations. The solution is agile enough to support the smallest of organisations and can be

CoreLogic to Acquire Symbility Solutions Inc.22.10.2018 22:12Pressemelding

CoreLogic (NYSE: CLGX), a leading global provider of property information, insight, analytics and data-enabled solutions, today announced the Company has entered into a definitive agreement to acquire the outstanding shares of Symbililty Solutions Inc. (“Symbility”) (TSX.V: SY) not already owned by CoreLogic. CoreLogic currently holds approximately a 28% ownership interest in Symbility. Symbility, founded in 2004, is a leading provider of subscription and cloud-based property insurance claims workflow solutions for the Property & Casualty insurance industry. Symbility also provides an extensive array of innovative enterprise mobile and application software solutions. The company is headquartered in Toronto, Canada and operates in the U.S., Canada, the United Kingdom, Germany, Netherlands, Australia and New Zealand. “Symbility expands our footprint in property and casualty insurance domestically and in key markets around the globe. Further scaling our insurance and international footpri

Pacific Drilling Awarded Contract for the Pacific Bora22.10.2018 21:00Pressemelding

Pacific Drilling S.A. (OTC: PACDQ) (“Pacific Drilling” or the “Company”) announced today that its deepwater drillship the Pacific Bora has been awarded a contract by Nigerian Agip Exploration Limited (a subsidiary of Eni SpA) for drilling operations in Nigeria. The term of the contract is for one firm well plus two additional option wells. The contract is expected to commence in mid to late November 2018 and firm contract backlog is estimated at $9 million. Pacific Drilling Chief Executive Officer Paul Reese commented: “On the heels of our previous announcement of new work for Pacific Santa Ana in Mauritania, we are pleased to have secured this contract for the Bora which reflects our substantial experience in Nigeria and our uninterrupted commitment to providing exceptional drilling services to our clients.” Currently offshore Abidjan, Côte d'Ivoire, the Pacific Bora is a sixth generation deepwater, dynamically-positioned drillship capable of operating in water depths up to 10,000 fee

ResMed Wins German Patent Infringement Case Against Fisher & Paykel22.10.2018 20:30Pressemelding

ResMed (NYSE: RMD) (ASX: RMD), the world’s leading tech-driven medical company and innovator in sleep apnea and respiratory care, today announced the results of a court and patent office ruling in Germany in ResMed’s favor. A trial court ruling from the Munich District Court states that the headgear used on two Fisher & Paykel CPAP masks – the Simplus full face and Eson 2 nasal mask – infringes ResMed patent EP 2 373 368 B1 in Germany. In a separate decision, the Opposition Division of the European Patent Office had already decided that the patent asserted against Fisher & Paykel is valid. Each decision may be appealed by Fisher & Paykel. “We applaud the Munich District Court for reaching this just finding, and are exploring all options in light of the fact that Fisher & Paykel is selling CPAP masks with headgear that infringes a valid ResMed patent in Germany,” said ResMed Chief Administrative Officer and Global General Counsel David Pendarvis. “We will continue to defend our intellec