Biogen and Samsung Bioepis Agree to Settlement with AbbVie Allowing Commercialization of IMRALDI™ (Adalimumab Biosimilar) in Europe
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.
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.
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.
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 jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.
Lue lisää julkaisijalta Business Wire
Koza Altin Welcomes Court’s Rejection of Akin Ipek’s Share Purchase Agreement13.7.2018 18:58 | Tiedote
A Turkish Court has found against businessman Akin Ipek this week – ruling that a share purchase agreement, which he had submitted as vital evidence in support of his case against the Turkish state, is null and void. The matter was brought to the Ankara Commercial Court in March 2017 by Koza Holding (parent company of Koza Altin) which, according to Mr Ipek’s share purchase agreement, purportedly transferred all of its shares to Ipek Investment Limited. Koza Holding filed the lawsuit for legal recognition that the share purchase agreement is void. The ruling in Turkey follows on from an earlier judgment set down by the English High Court, which rejected Mr Ipek’s attempt to use up to £3m of UK subsidiary Koza Ltd’s money to fund a claim against the Turkish State at the International Centre for Settlement of Investment Disputes (ICSID). In the English ruling, Deputy Judge Richard Spearman QC declared the “authenticity” of the share purchase agreement as “open to very serious doubt”. The
Mindbreeze Positioned in the Leaders Quadrant of the Gartner’s 2018 Magic Quadrant for Insight Engines13.7.2018 18:27 | Tiedote
Mindbreeze, a leading global provider of appliances and cloud services for information insight and applied artificial intelligence with a focus on knowledge management for leading international companies, announced today that Gartner, Inc. has positioned Mindbreeze in the Leaders quadrant of the 2018 Magic Quadrant for Insight Engines. Mindbreeze is positioned highest on the ability to execute axis. The research and advisory firm Gartner, Inc. evaluated 13 different providers from all over the world. “Understanding the meaning of information is a key priority for today’s customers. Mindbreeze InSpire leverages the full power of our sophisticated AI engine to provide actionable insights and answers ̶ not just more data. Seeing our position in the Magic Quadrant, my first reaction was ‘AWESOME’. Insight Engine was positioned the highest on the ability to execute axis and we believe that's exactly what sets us apart from our competitors. We made the bold move to focus on product innovatio
H.I.G. Capital Announces the Sale of Kondor13.7.2018 17:06 | Tiedote
H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €20 billion of equity capital under management, announced today that one of its affiliates has sold Kondor Limited, a specialist provider of category management solutions for audio and mobile accessory products into the retail and mobile network channels in the UK and Europe, to DCC Technology (which principally trades under the Exertis brand), part of DCC plc, the leading international sales, marketing and support services group. Terms of the transaction were not disclosed. Headquartered in Dorset, England, Kondor distributes audio and mobile accessory products to a broad range of e-tail, retail and mobile operator customers. H.I.G. invested in Kondor in 2014, and has since overseen a full reorganisation of the business. H.I.G. worked in partnership with Kondor to professionalise back office systems, develop Kondor’s access to market data, optimise the company’s product range, improve stock manag
Contactless Technology Powers Fifty Percent of Purchases at 2018 FIFA World Cup Russia™13.7.2018 12:00 | Tiedote
Visa (NYSE: V), the Official Payment Services Partner of FIFA, today released an analysis of spending inside the 2018 FIFA World Cup Russia™ stadiums from the opening match on June 14 through the semi-finals on July 11. The data highlights the increased consumer adoption of innovative payment technology, as fifty percent of purchases with Visa in tournament venues utilized contactless transactions, including cards, mobile devices and wearables. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180713005025/en/ For the 2018 FIFA World Cup Russia™, Visa is the exclusive payment service in all stadiums where payment cards are accepted. In-stadium, fans can pay with contactless Visa credit and debit cards and mobile payment services at the more than 3,500 point-of-sale terminals and 1,000 mobile concessionaires that have been equipped with the latest in payment innovation. (Photo: Business Wire) Visa cardholders on average spent 1,
Brazil Approves AerSafe for Airbus 321 Aircraft to Comply with Fuel Tank Flammability Reduction Rule12.7.2018 22:18 | Tiedote
AerSale ® announced today that the National Civil Aviation Agency of Brazil (ANAC) has approved the Federal Aviation Administration’s (FAA’s) Supplemental Type Certificate (STC) for the company’s AerSafe™ system on Airbus 321 aircraft (ST04010NY), that complies with the Fuel Tank Flammability Reduction (FTFR) rule. This is the second ANAC STC approval for AerSafe, following approval on Boeing 737 CL aircraft in 2017. In the coming months, AerSafe will be expanded to cover additional aircraft types, to meet the September 2019 deadline of the ANAC regulation, Regulamento Brasileiro da Avaiação Civil (RBAC) nº 121.1117, that applies specifically to passenger aircraft that fly within or into Brazil. AerSale’s STCs for the Boeing 737 CL and NG series (ST02980NY) and Boeing 767 series (ST03599NY) have already been approved by the FAA. “We are pleased that our Latin American customers operating A320 family aircraft are now able to immediately benefit from AerSafe’s numerous advantages,” said
Blockchain-based Adents NovaTrack Issues Token to Standardize Access to Comprehensive Supply Chain Traceability12.7.2018 21:20 | Tiedote
Adents, leading serialization and track & trace solutions provider, announces the issue of tokens that, combined with its NovaTrack platform, will standardize access to full supply chain traceability. Adents recently released Adents NovaTrack, a marriage of technologies co-developed with Microsoft. The solution utilizes Blockchain, A.I., IoT and serialization functionalities that, when combined, bring comprehensive visibility throughout product distribution chains & life cycles. The result is a solution highly mindful not only in terms of performance and security, but also governance and scalability. With NovaTrack, Adents aims to create an ecosystem of consortium-based blockchains independent from each other, and individually launched on-demand by various supply chain stakeholders (brands, manufacturers, logistics professionals, etc.). Each consortium-based blockchain will provide a secure environment to its participants to share supply chain data and processes. From brands, manufactu
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