Business Wire

Biogen and Samsung Bioepis Announce European Launch of IMRALDI™(adalimumab), Solidifying Leadership in European Anti-TNF Market

Jaa

Biogen (Nasdaq:BIIB) and Samsung Bioepis Co., Ltd. today announced the European launch of IMRALDI™ (adalimumab), a biosimilar referencing HUMIRA®. Starting today, IMRALDI™ will begin launching in major markets across Europe.

The launch of IMRALDI™ marks a significant milestone for Biogen and Samsung Bioepis, as the adalimumab product is the third anti-TNF biosimilar developed by Samsung Bioepis to be commercialized by Biogen across Europe. BENEPALI™ (etanercept) and FLIXABI™ (infliximab) were approved in 2016, and have approximately 100,000 patients currently under treatment with more than 6 million doses administered across 25 and 14 countries, respectively.ii

“We look forward to increasing patient access to this important medicine by leveraging our industry-leading position in the European anti-TNF market,” said Ian Henshaw, Head of Biogen’s Biosimilars Unit.

“The launch of IMRALDI marks what we believe to be a landmark moment for Biogen and Samsung Bioepis and for European healthcare systems. We hope IMRALDI will play an important role widening choice and increasing competition in one of the most high-value areas of the biopharmaceuticals market,” said Sang-Jin Pak, Chief Operating Officer, Samsung Bioepis. “In just six years, Samsung Bioepis has successfully developed the industry’s leading portfolio of anti-TNF biosimilars with a strong pipeline of further biosimilar candidates currently under development.”

“We are proud of our collaboration with Biogen, which brings together the development expertise of Samsung Bioepis with the commercial excellence of Biogen for the benefit of patients across Europe.”

The European Commission (EC) approved IMRALDI™ in August 2017 for the treatment of rheumatoid arthritis (RA), juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, adult and adolescent hidradenitis suppurativa, Crohn’s disease, paediatric Crohn’s disease, ulcerative colitis and uveitis.iii

The EC approval was based on data derived from a randomized, double-blind 52-week Phase 3 study, in which 544 patients with moderate to severe rheumatoid arthritis despite methotrexate (MTX) therapy were randomized to receive either SB5 or the adalimumab reference product (ADL). At Week 24, the ACR20 response rate was 72.4% in the SB5 group versus 72.2% in the ADL group. The safety profile of SB5 was comparable to ADL up to Week 24. At Week 24, 254 patients receiving ADL were re-randomized in a 1:1 ratio to continue on ADL or transitioned to SB5, and 254 patients receiving SB5 continued to receive SB5. Up to Week 52, the efficacy, safety and immunogenicity profiles remained comparable between all three treatment groups. There were no treatment emergent issues or clinically relevant immunogenicity precipitated by alternating subjects between treatments.iv v


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. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today 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, multiple sclerosis and 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 – TwitterLinkedInFacebookYouTube.

About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology and ophthalmology. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.

Biogen Safe Harbor
This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential benefits, safety and efficacy of IMRALDI; the results of certain Phase 3 studies of IMRALDI; the potential of Biogen’s commercial business, including IMRALDI, BENEPALI and FLIXABI; risks and uncertainties associated with drug development and commercialization, including the commercialization of IMRALDI; and market acceptance of biosimilars and related healthcare system matters. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will” and other words and terms of similar meaning. 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. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including uncertainty of success in commercialization of IMRALDI, which may be impacted by, among other things, the level of preparedness of healthcare providers to treat patients, difficulties in obtaining or changes in the availability of reimbursement for IMRALDI, the effectiveness of sales and marketing efforts and problems with the manufacturing process for IMRALDI; 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, including IMRALDI; the occurrence of adverse safety events; failure to obtain regulatory approvals in other jurisdictions; failure to protect intellectual property and other proprietary rights; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s 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 Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this press release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments, or otherwise.

# # #

i Humira® is a registered trademark of AbbVie Biotechnology Ltd.
ii Biogen data on file – ex-factory sales
iii https://www.ema.europa.eu/medicines/human/EPAR/imraldi
iv Weinblatt M, et al. FRI0161 Sustained Efficacy and Comparable Safety and Immunogenicity after Transition To SB5 (An Adalimumab Biosimilar) vs Continuation of The Adalimumab Reference Product in Patients with Rheumatoid Arthritis: Result of Phase III Study. Annals of the Rheumatic Diseases 2016;75:487.
v Weinblatt M, et al. A Phase III, Randomized, Double-Blind Clinical Study, Comparing SB5, An Adalimumab Biosimilar, with Adalimumab Reference Product (Humira®) in Patients with Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (24-week results) [abstract]. Arthritis Rheumatol 2015;67 (suppl 10).

Contact information

BIOGEN MEDIA CONTACT:
David Caouette
+1 617 679 4945
david.caouette@biogen.com
or
SAMSUNG BIOEPIS MEDIA CONTACT:
Mingi Hyun
+82-31-8061-1594
mingi.hyun@samsung.com

Tietoja julkaisijasta

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

HCL and Xerox Expand Strategic Partnership to Accelerate Operational Transformation19.3.2019 19:51:00 EETTiedote

HCL Technologies (HCL), a leading global technology company, announced that it signed a managed services agreement with Xerox (NYSE: XRX). Under the terms of the agreement, HCL will manage portions of Xerox’s shared services, including global administrative and support functions, including, among others, selected information technology and finance functions (excluding accounting). Leveraging HCL’s global scale and capabilities, Xerox will strategically evolve its shared services into process-first, technology-led digital operations. This seven-year agreement for an incremental $1.3 billion continues to build on the success of the Xerox-HCL relationship, which began in 2009 with product engineering and support services. Under that agreement, HCL currently manages aspects of Xerox’s mechanical, electrical and software engineering activities for printer and imaging product lines. Together, HCL and Xerox have delivered 215 U.S. patents and have created world-class R&D labs that are tightly

Abzena and Lipum AB Sign Integrated CMC Agreement to Produce a Novel Biologic for Autoimmune Inflammatory Diseases19.3.2019 18:18:00 EETTiedote

Abzena, the global biologics gene to GMP partner research organization, announced it has signed an agreement to support an integrated CMC program with Lipum, a company developing treatments for chronic inflammatory diseases. Abzena will support Lipum’s anti-BSSL antibody IND program to help develop a novel therapeutic option for autoimmune inflammatory diseases, including juvenile idiopathic arthritis. The 18-month program includes: development of a research cell bank using Abzena’s proprietary cell line and ambr® 15 automated high throughput bioreactors, generation of master cell banks, scale up using an ambr® 250 during process development, followed by cGMP manufacturing in Sartorius 500 L single use stirred tank bioreactors for clinical material. The work will take place at Abzena’s sites in Cambridge, UK and San Diego, USA. Jonathan Goldman, CEO of Abzena, said: “Autoimmune inflammatory diseases such as juvenile idiopathic arthritis represent significant unmet medical need. We are

Guardsquare now Protects JavaScript Hybrid Mobile Apps19.3.2019 18:00:00 EETTiedote

Guardsquare, the global reference in mobile protection, announces that DexGuard now protects JavaScript hybrid mobile applications for Android. The latest version of their state-of-the-art mobile security software, DexGuard 8.4, extends the existing code hardening capabilities with JavaScript obfuscation to provide superior protection to Android apps built with frameworks such as Cordova, Ionic and ReactNative. DexGuard currently provides its cutting-edge security solutions to the full-range of coding languages used for the Android platform, including JavaScript, Kotlin, Java and Native code (C/C++). Guardsquare’s technology answers to a growing global problem for enterprises rapidly undergoing digital transformation. As they quickly innovate and deploy more and more complex applications on increasingly powerful mobile devices, they often struggle with making these applications —running outside their corporate firewalls— secure. Still, for many companies and their mobile-centric custom

Saudi Arabia Takes Another Step Forward in Its Transformation Drive19.3.2019 17:00:00 EETTiedote

King Salman bin Abdulaziz of Saudi Arabia today launched four wellbeing projects for the kingdom’s capital Riyadh, which will significantly improve the lives of its citizens, transform the city into an attractive destination and make it one of the world’s most livable cities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190319005574/en/ The four wellbeing projects - King Salman Park, Sports Boulevard, Green Riyadh and Riyadh Art – complement the Saudi Vision 2030’s “Quality of Life” Program and are aligned with the U.N. Sustainable Development Goals, to create sustainable cities and communities, while driving urgent action against climate change. Developed with a government investment of US$23 billion, the four projects will offer opportunities worth US$15 billion for the private sector to invest in the residential, commercial, recreational and wellness areas. In addition to providing tens of thousands of new jobs, they wi

Andersen Global Adds Collaborating Firm in Romania19.3.2019 16:30:00 EETTiedote

Andersen Global today announced a collaboration agreement with Țuca Zbârcea & Asociații, a law firm with offices in Bucharest and Cluj-Napoca and its tax arm, Țuca Zbârcea & Asociații Tax. This is the first collaboration agreement in Romania, and continues Andersen Global’s expansion in Eastern Europe. Țuca Zbârcea & Asociații is a full-service independent law firm with more than 110 lawyers, including 28 partners in its Bucharest office. It also operates a secondary office in Cluj-Napoca, and has national coverage based on correspondent law offices in major cities. The firm employs a multidisciplinary approach to the legal practice including dedicated specialized divisions – tax, insolvency, and IP. In addition, Ţuca Zbârcea & Asociaţii set up Foreign Desks – China Desk, Israel Desk, Moldovan Desk – to address the growing needs of foreign investors looking to enter the Romanian market. The firm’s areas of practice include: corporate & commercial; mergers & acquisitions; dispute resolu

Online Gaming Reaches All-Time High with Gamers Avoiding Work, Friends and Love According to New Limelight Networks Research19.3.2019 16:10:00 EETTiedote

The popularity of online gaming continues to grow, with gamers playing more than seven hours each week, an increase of nearly 20 percent in the last year. Young adults are leading the online gaming charge, with gamers age 26 to 35 playing for eight hours, 13 minutes each week, a 25 percent increase from last year. That’s according to the latest “State of Online Gaming” research report on worldwide consumers’ gaming behaviors and expectations from Limelight Networks (Nasdaq: LLNW), a leading provider of edge cloud services. When gamers aren’t playing themselves, many are watching other people play online. Nearly 60 percent of global gamers watch others play online each week, with 10 percent watching for more than seven hours. For younger gamers, watching others play online is more popular than watching traditional sports on television. In fact, gamers age 18 to 25 spend nearly four hours each week watching online video gaming, 77 percent more time than they spend watching traditional br

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