Business Wire

Biogen and Samsung Bioepis Agree to Settlement with AbbVie Allowing Commercialization of IMRALDI™ (Adalimumab Biosimilar) in Europe

Jaa

Biogen Inc. (Nasdaq: BIIB) and its partner Samsung Bioepis announced today an agreement with AbbVie (NYSE: ABBV) for the commercialization of IMRALDI, a biosimilar referencing HUMIRA® (adalimumab). Under terms of the agreement, AbbVie will grant patent licenses for the use and sale of IMRALDI in Europe, on a country-by-country basis, and Biogen and Samsung Bioepis will make royalty payments to AbbVie. The companies have agreed to dismiss all pending patent litigation.

Biogen expects to launch IMRALDI in Europe on October 16, 2018, which will complement its existing portfolio of anti-TNF therapies, BENEPALI™ (etanercept) and FLIXABI™ (infliximab).

“Biogen is a leader in the emerging field of biosimilars through Samsung Bioepis, our joint venture with Samsung BioLogics,” said Ian Henshaw, Global Head of Biosimilars at Biogen. “Biogen already markets two biosimilars in Europe and the planned introduction of IMRALDI on October 16 could potentially expand patient choice by offering physicians more options to meet the needs of patients while delivering significant savings to healthcare systems.”

The precise terms of the agreement with AbbVie are confidential.

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 Weissmann, Heinz Schaller, Kenneth Murray, 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, 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 – Twitter, LinkedIn, Facebook, YouTube.

Safe Harbor

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits, safety, and efficacy of IMRALDI, planning and timing for commercial launch, and the potential of Biogen’s commercial business and pipeline programs, including IMRALDI, BENEPALI, and FLIXABI. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “except,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “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. 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, problems with the manufacturing process for 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.

Contact information

Biogen Inc.
MEDIA CONTACT:
David Caouette, +1 617-679-4945
public.affairs@biogen.com
or
INVESTOR CONTACT:
Matt Calistri, +1 781-464-2442
IR@biogen.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

American Airlines Announces Nonstop Philadelphia (PHL) to Orlando Melbourne (MLB)22.9.2018 01:13Tiedote

Glorious beaches by day and theme park fireworks by night just got more convenient for Philadelphia travelers. American Airlines announced today that it will begin nonstop flights to Orlando Melbourne International Airport (MLB) starting February 16, 2019. The Central Florida airport is conveniently located in the heart of the tourism region and is the closest airport to NASA rocket launches, Port Canaveral’s cruises and what critics call “some of the most beautiful beaches Florida has to offer.” The flights will depart Saturdays from Philadelphia at 8:05 a.m., arriving in Florida at 10:48 a.m. The Embraer 175 jet arrival time syncs perfectly with cruise ship noon early boarding. Melbourne Airport Express offers nonstop shuttle service to the port, and all major rental car companies are onsite. The return flight to PHL departs at 11:24 a.m. and arrives in PHL at 1:55 p.m., with enough time to connect to some of American’s largest international destinations, including recently announced

Amy Palladino Joins BCW as Executive Vice President, Managing Director, Corporate Practice21.9.2018 20:43Tiedote

BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Amy Palladino has joined the agency as Executive Vice President, Managing Director in the agency’s U.S. Corporate Practice. Based in New York, Palladino will focus on senior client counsel and executive positioning for the agency’s largest corporate clients. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005507/en/ Amy Palladino Joins BCW (Burson Cohn & Wolfe) “Amy is a talented and highly experienced communications executive with a track record of solving clients’ complex challenges and building business through smart, integrated communications approaches,” said Chris Foster, President, North America, BCW. “Her creativity and judgement will be enormously valuable to our current and prospective clients.” Palladino has more than 20 years of experience advising global clients across numerous industries, including technology, healthcar

Heidelberg Engineering Announces the CE-Marking of ANTERION21.9.2018 19:41Tiedote

Heidelberg Engineering, the leader in diagnostic imaging known for the internationally-acclaimed SPECTRALIS ® retina and glaucoma platform, announces the CE-marking of ANTERION ® – an innovative platform designed to transform anterior segment diagnostics and workflow. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005442/en/ The new Heidelberg Engineering ANTERION® provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. (Graphic: Business Wire) The new ANTERION provides the most important anterior segment examinations and measurements in one modular, upgradeable platform. It is a single, workflow-efficient solution that brings together corneal topography and tomography, anterior segment metrics, axial length measurement and IOL calculation to transform the day-to-day routine of busy practices and clinics. Heidelberg Engineering has leveraged its core OCT technolo

Florian Winterstein Becomes New CEO of Jedox21.9.2018 18:46Tiedote

The supervisory board of Jedox AG, a leading vendor of business intelligence and enterprise planning software, has appointed Florian Winterstein as Chief Executive Officer (CEO) effective October 2, 2018. This nomination will support Jedox’s international growth and a new development phase initiated by its latest fund raising in April 2018 with Iris Capital, eCAPITAL entrepreneurial Partners AG and Wecken & Cie. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005416/en/ Florian Winterstein (Photo: Business Wire) With 25 years of experience in strategy consulting and leadership in software and service organizations, Winterstein brings to the company a valuable combination of expertise in cloud solutions, business development, and value creation for customers and partners. As former Chief Strategy Officer of BravoSolution, he positioned the software-as-a-service company as trendsetting digitalization partner, extending it

Avinor to Test Autonomous Snowploughs at Oslo Airport This Winter21.9.2018 17:37Tiedote

Since 2010 Avinor has had a vision and a desire to automate winter maintenance. In March autonomous snow clearing was demonstrated at Fagernes Airport, and this winter Avinor is taking this a step further by testing two autonomous snowploughs at Oslo Airport. The project is one of the first globally where large machinery will operate autonomously to keep snow away from airport areas. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180921005363/en/ Avinor to Test Autonomous Snowploughs at Oslo Airport This Winter (Photo: Business Wire) “Innovation is important to Avinor. In the future, many tasks in aviation will be resolved in other ways than today. Avinor wants to test autonomy, and does of course see a potential for rationalization in the future through new solutions for winter operations and in other areas. Avinor is at the forefront of testing this technology, but it is essential that safety is ensured in all such testing

Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib21.9.2018 16:30Tiedote

Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food. The randomized, global Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG in patients with locally advanced or metastatic ALK+

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