Business Wire

Real World Data Being Presented at EULAR 2017 Demonstrate Acceptance and Confirm Sustainability of Effectiveness, Safety and Adherence among Patients Switching To BENEPALI® (Etanercept Biosimilar of Biogen) from Reference Etanercept

Del

Real world evidence from investigator-initiated studies supported by Biogen (NASDAQ: BIIB), demonstrating sustained efficacy and safety, and high acceptance and adherence in patients initiating treatment with BENEPALI® (etanercept), are being presented at the Annual European Congress of Rheumatology (EULAR) 2017, held 14–17 June in Madrid, Spain.1,2,3 Within the EU, approximately 50,000 patients are currently being treated with anti-TNF biosimilars from Biogen across 16 countries.4

Two real world studies evaluate the safety and efficacy of BENEPALI® in patients following a switch from reference etanercept. In 1,548 patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or axial spondyloarthritis (SpA) from the DANBIO registry, disease activity was shown to be largely unaffected at 3 months post-switch and comparable to that observed in the 3 months prior to switch.1 Furthermore, in a separate cohort of 92 patients with RA, PsA or ankylosing spondylitis (AS) in the UK, a low rate of treatment discontinuations due to inefficacy or adverse events was demonstrated at 6 months post-switch.2

Further real world data highlight the acceptance of BENEPALI® and adherence to treatment among patients who were switched from reference etanercept, according to a defined transition protocol. In one UK study of 96 adult patients treated for RA, PsA or AS, 99% agreed to switch.2 91% of the group remained on BENEPALI® at 6 months.2 In another study of 643 patients with rheumatic disease in the Netherlands, 99% (636 patients) agreed to switch to BENEPALI® from reference etanercept. At 3 months, 36 of the 636 patients had discontinued treatment.3 Both studies reflect that treatment with BENEPALI® provides persistency within the expectations of the reference product.2,3

“Biogen continues to make a difference in the lives of patients through our portfolio of anti-TNF biosimilar products, which play an important role in ensuring more people have access to the treatments they need,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “Our ongoing efforts to forge partnerships with healthcare organizations and systems have opened doors for biosimilar adoption in a number of European countries, although more can be done to set the right policy environment so that all countries can unlock the full value of these therapies.”

The abstracts being presented at EULAR 2017, showcasing data from Biogen-supported studies, include:

  • Thakur K, et al. Etanercept Biosimilar Usage and Associated Cost Savings in Germany [THU0656] – Thursday, June 15, 2017, 1:10pm CEST, Poster Area
  • Glintborg B, et al. Clinical Outcomes from a Nationwide Non-Medical Switch from Originator to Biosimilar Etanercept in Patients with Inflammatory Arthritis after 5 Months Follow-Up. Results from the DANBIO Registry [FRI0190] – Friday, June 16, 2017, 1:40pm CEST, Poster Area
  • Tweehuysen L, et al. Higher Acceptance and Persistence Rates after Biosimilar Transitioning in Patients with a Rheumatic Disease after Employing an Enhanced Communication Strategy [FRI0200] – Friday, June 16, 2017, 11:45am CEST, Poster Area
  • Sigurdardottir V, et al. Switching from Reference Product Etanercept to the Biosimilar SB4 in a Real-Life Setting: Follow-Up of 147 Patients [SAT0173] – Saturday, June 17, 2017, 10:15am CEST, Poster Area
  • Holroyd C, et al. Switching from Bio-Original Etanercept to Biosimilar Etanercept SB4: Patient Acceptability and Outcomes in the Real World [AB0377] – Publication Only

About BENEPALI ®
BENEPALI is an etanercept biosimilar to the reference product Enbrel®.5 BENEPALI is approved in Europe for the treatment of adults with moderate to severe RA, psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. BENEPALI is currently available in 16 European countries.4

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.

Biogen Safe Harbor
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 is a lengthy and complex process, which involves a high degree of risk. Factors that could cause actual results to differ materially from our current expectations include: the risk that unexpected concerns may arise from additional data or analysis, or regulatory authorities may require additional data or information or further studies, or may fail to approve, or refuse to approve, or may delay approval of our biosimilar drug candidates risks related to our dependence on third parties for the development and commercialization of biosimilars; risks of legal actions, regulatory scrutiny or other challenges to biosimilars; and the risks of 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.

This medicinal product is subject to additional monitoring.

References

1 Glintborg B, et al. Clinical outcomes from a nationwide non-medical switch from originator to biosimilar etanercept in patients with inflammatory arthritis after 5 months follow-up. Results from the DANBIO registry. Abstract presented at EULAR 14–17 June 2017, Madrid, Spain. Abstract #FRI0190.
2 Holroyd C, et al. Switching from bio-original etanercept to biosimilar etanercept SB4: patient acceptability and outcomes in the real world. Abstract presented at EULAR 14–17 June 2017, Madrid, Spain. Abstract #AB0377.
3 Tweehuysen L, et al. Higher Acceptance and Persistence Rates after Biosimilar Transitioning in Patients with a Rheumatic Disease after Employing an Enhanced Communication Strategy. Abstract presented at EULAR 14–17 June 2017, Madrid, Spain. Abstract #FRI0200.
4 Biogen data on file. June 2017.
5 Enbrel® is a registered trademark of Wyeth LLC.

Contact information

BIOGEN EU MEDIA CONTACT:
Benjamin Russell, +41 41 392 19 22
publicaffairs.EU@biogen.com
or
BIOGEN INVESTOR CONTACT:
Mike Hencke, +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

Emmaus Life Sciences Announces the New England Journal of Medicine has Published the Phase 3 Trial Results of Endari™ (L-Glutamine Oral Powder) in Sickle Cell Disease18.7.2018 21:45Pressemelding

VIEW E-MEDIA KIT – Emmaus Life Sciences, Inc. (Emmaus) announced today that the New England Journal of Medicine (NEJM) has published the results of its 48-week phase 3 clinical trial of Endari™ (L-glutamine oral powder) which supported the FDA approval in July 2017 to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. The article reports results that showed significantly fewer sickle cell crises in those receiving Endari compared to placebo by 25 percent; p=0.005 (median 3 vs. median 4) and significantly fewer hospitalizations by 33 percent; p=0.005 (median 2 vs. median 3). Additional findings showed lower cumulative days in hospital of 41 percent; p=0.02 (median 6.5 days vs. median 11 days) and a lower incidence of acute chest syndrome (ACS) by more than 60 percent; p=0.003 (13 of 152 patients [8.6%] had at least 1 ACS compared with 18 of 78 in the placebo group [23.1%]). The most common adverse reactions, occurring in great

Tigo Releases State-of-the-art Wireless Technology – Mesh – as the New Solar Communication Architecture for the TS4 Platform18.7.2018 19:41Pressemelding

Tigo®, pioneer of the smart modular Flex MLPE platform, today announced the release of its new Mesh communication architecture. This state-of-the-art wireless technology directly translates to customer benefits – including simplifying the solar design process and accelerating the commissioning steps. The complete Tigo solution uses a simple yet powerful data collection technology that covers the widest ranges of residential & commercial installations at the lowest cost. With Mesh and the recently announced Tigo Access Point (TAP), customers eliminate the need to address any roof obstruction or orientation constraint. To learn more about Mesh and TAP, register for Tigo’s free, online webinar “The Future of Solar is Wireless” on Wednesday July 25th, 2018 at 10am PDT. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180718005827/en/ Mesh is Tigo's proprietary software that allows each TS4 unit to act as a repeater, extending the

ViiV Healthcare Shares Data from Landmark 2-Drug Regimen Trials At AIDS 201818.7.2018 17:21Pressemelding

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, will be presenting over 20 abstracts, including data from the landmark GEMINI 1 & 2 clinical trials, at the 22nd International AIDS Conference (AIDS 2018), 23-27 July 2018, in Amsterdam, The Netherlands. The data being presented this year has a strong focus on novel exploratory therapeutic options and innovative treatment strategies, as well as improving awareness and understanding of key issues that continue to affect the HIV community. John C Pottage, Jr, MD, Chief Scientific and Medical Officer, ViiV Healthcare, commented, “As we see advancements in the treatment options available to people living with HIV, our research efforts over the past few years have been focused on moving beyond viral load and addressing some of the unresolved issues that people living with HIV face, such as the potential long-term risks and toxicities that can be associated with li

Xilam: H1 2018 Revenue: +50%18.7.2018 16:00Pressemelding

Regulatory News: The Xilam Group (Paris:XIL) posted consolidated H1 2018 revenue of EUR 13,866 thousand, an increase of 50%. This increase represents an excellent performance, as it follows on the heels of growth of 54% in H1 2017. Revenue for the first part of this financial year breaks down as follows. In thousands of euros 30.06.2018 (1) 30.06.2017 Change New productions 8,465 4,571 +85% Catalogue 5,385 4,652 +16% Other 16 16 +0% Revenue and subsidies 13,866 9,239 +50% (1) Unaudited data. Remarkable success for new releases +85% Excellent H1 growth was driven by the two main businesses, New Productions and Catalogue. In New Productions, H1 deliveries generated record revenue of EUR 8,465 thousand, an 85% increase compared with H1 2017, and confirmed Xilam’s position as a major European animation company. Catalogue revenue was up 16% compared with H1 2017, thanks again to traditional TV channels and digital platforms, in both France and abroad. A fast-paced delivery schedule Thanks t

Department for International Trade: Life Sciences at the Heart of UK Economy18.7.2018 12:38Pressemelding

The Government will today (Wednesday 18 July) host the second in a series of roundtables with stakeholders from key life science businesses, demonstrating the importance of the sector to the UK economy. The Chancellor, International Trade Secretary, Business Secretary and Health and Social Care Secretary will be amongst those that meet with senior representatives from leading UK and international life sciences companies as the UK positions itself as the global home of health innovation, welcoming overseas investment and seeking to boost exports in the process. Discussions at the roundtable will focus on how the future of the Life Sciences sector will be supported by the delivery of our modern Industrial Strategy, ensuring that the UK is ‘open for business’ with a positive business environment, our ambitions for a comprehensive agreement with the EU on our future relationship and the development and implementation of our independent trade policy. To date, the government has engaged sign

Universal Laser Systems Expands Its Materials Database with 3M, Victrex and Dexmet Materials18.7.2018 12:05Pressemelding

Universal Laser Systems (ULS) announces the addition of 3M™, Victrex® and Dexmet materials to its materials database, the most extensive repository of laser material processing parameters for materials in the range of 10 watts to 500 watts. The 3M, Victrex and Dexmet materials new to the ULS materials database were specifically added for laser processing with the ULTRA and XLS platforms, suited for high accuracy and precision laser cutting, laser ablation and laser surface modification. The materials include: 3M™ Extreme Sealing Tape 4412N 3M™ Thermally Conductive Silicone Interface Pad 5516 Victrex® APTIV® PEEK Film Dexmet PolyGrid® 8PTFE10-125ST Expanded PTFE Dexmet MicroGrid® AL 25 Expanded Aluminum Laser processing notes, describing the results of the laser-material interaction for these materials, are also available in the Materials Library on the ULS website to help potential customers explore the advantages of deploying laser technology within their manufacturing, research and d