Business Wire

The UK High Court of Justice (Patents) Rules in Fujifilm Kyowa Kirin Biologics' Favor on Rheumatoid Arthritis, Psoriasis and Psoriatic Arthritis Dosing Regimens for Adalimumab Are Obvious and Unpatentable

Del

FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. (President and CEO: Hideaki Nomura; “Fujifilm Kyowa Kirin Biologics”) today announced that on March 3, 2017, the UK High Court of Justice ruled in Fujifilm Kyowa Kirin Biologics’ favor in patent litigation proceedings brought against AbbVie Biotechnology Limited (“AbbVie”) in respect of the validity of certain adalimumab dosing regimens for rheumatoid arthritis, psoriasis and psoriatic arthritis. Fujifilm Kyowa Kirin Biologics brought the action in relation to FKB327, its adalimumab biosimilar candidate of the fully human anti-TNF-α*1 monoclonal antibody referencing Humira®, which Fujifilm Kyowa Kirin Biologics has been developing.

On October 29, 2015, Fujifilm Kyowa Kirin Biologics commenced patent revocation proceedings against AbbVie seeking a declaration that AbbVie’s dosing regimen patents for rheumatoid arthritis, psoriasis and psoriatic arthritis were invalid in the light of certain prior art*2. Although, following the commencement of the proceedings, AbbVie abandoned and/or withdrew the patents in the UK, the Court permitted Fujifilm Kyowa Kirin Biologics to continue the proceedings so as to obtain the UK High Court declaration that the dosing regimens were known and/or obvious, and are therefore not eligible for patent protection.

Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President & COO: Kenji Sukeno; “Fujifilm”) and Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai; “Kyowa Hakko Kirin”) on March 27, 2012 as a company for developing, manufacturing, and marketing biosimilars. The company has achieved major objectives in the Phase 3 global clinical study of FKB327 in October 2016 and is preparing to file its application for marketing authorization for FKB327.

The company also has been developing a biosimilar candidate of the anti-VEGF humanized monoclonal antibody “Bevacizumab”(Code No.: FKB238), a drug used to treat a range of cancers including colorectal and non-small cell lung cancer. A Phase 3 global clinical study of FKB238 is being conducted by Centus Biotherapeutics Ltd, a joint venture established by Fujifilm Kyowa Kirin Biologics and AstraZeneca plc for the development and commercialization of FKB238.

Fujifilm Kyowa Kirin Biologics creates revolutionary production processes and reduces costs for the production of biosimilars by merging the technologies in advanced production, quality control and analysis which Fujifilm has developed over many years through its photographic film business, with the proprietary technologies and know-how which Kyowa Hakko Kirin has accumulated through its biopharmaceutical R&D and manufacturing. Through this partnership, the company will develop and manufacture reliable, high quality, cost-competitive biosimilar products and commercialize these products in a timely manner. With this strategy, Fujifilm Kyowa Kirin Biologics aims to hold a leading position in the expanding biosimilar market.

*1   TNF-α (tumor necrosis factor alpha) is a cytokine that is involved in inhibition of tumorigenesis and defense against infection. Overexpression of TNF-α is implicated in a range of inflammatory diseases, including rheumatoid arthritis and psoriasis.
*2 About 5 months after commencement of Fujifilm Kyowa Kirin Biologics’ revocation action, third parties filed a similar action against the Patents on March 24, 2016, which further to a court order was consolidated with Fujifilm Kyowa Kirin Biologics’ action.

Contact information

Fujifilm Corporation
Kana Matsumoto, +81-3-6271-2000
Corporate Communications Division
or
Kyowa Hakko Kirin Co., Ltd.
Hiroki Nakamura
Corporate Communications Department
media@kyowa-kirin.co.jp

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

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

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

Edgewater Networks Announces Event Sponsorship of BroadSoft Connections 201720.10.2017 21:00Pressemelding

Edgewater Networks, Inc., the industry leader in Network Edge Orchestration, announced today that it is an event sponsor of the BroadSoft Connections 2017 user conference, which takes place October 22-25 at the JW Marriott Phoenix Desert Ridge Resort & Spa in Phoenix, AZ. During the event, Edgewater Networks will feature demonstrations of the latest end-to-end network interoperability capabilities, including Zero Touch Provisioning, UC Analytics from the core to the endpoint, SD-WAN optimized for BroadSoft, and much more. Continuing a long-standing partnership with BroadSoft, Edgewater Networks has completed another level of BroadCloud certification, this time for local survivability which is critical for business continuity for SMB and Enterprise customers. BroadSoft’s PacketSmart is available on all EdgeMarc Intelligent Edges. All elements of the Network Edge Orchestration are

More than 70 Companies to Showcase Top Tech at CES Unveiled Paris20.10.2017 15:08Pressemelding

The Consumer Technology Association (CTA) today announced that more than 70 exhibitors will showcase their latest innovations at the now sold-out fifth annual CES Unveiled Paris The event will focus on the Internet of Things (IoT), connectivity and smart cities, and draw more than 600 attendees. CES Unveiled Paris will run from 2-7:30 PM on Tuesday, October 24, 2017 at the Palais Brongniart. Regional technology companies, top-tier media outlets, buyers and key industry influencers will come together at CES Unveiled Paris to get a direct look at the latest industry developments. The day kicks off with a CES news conference and CTA market trends presentation. Conference programming is followed by a tabletop exhibition & networking reception. Curated exhibitors will be there to showcase top tech from robotics and audio to smart home and augmented and virtual reality. Notable

Westinghouse Receives Regulatory Approval for Analysis Methodologies20.10.2017 12:15Pressemelding

Westinghouse Electric Company today announced that it has received approval from the U.S. Nuclear Regulatory Commission (NRC) for two new important analysis methodologies that will be used to upgrade Westinghouse- and Combustion Engineering-based nuclear steam supply system (NSSS) safety analyses. The approvals granted are for the new FULL SPECTRUMTM Loss of Coolant Accident (FSLOCATM) methodology and the Performance Analysis and Design Model software code update, PAD5. FSLOCA is capable of improved modeling of the transient response in a pressurized water reactor to the full spectrum of LOCA break sizes that could occur, and PAD5 is the next generation of the Westinghouse fuel rod design performance code. “These codes were developed to work in concert with each other to maximize analytical margin for nuclear utilities,” said Michele DeWitt, senior vice preside

Gilead Announces Multiple Scientific Presentations Demonstrating High Cure Rates in Difficult-to-Cure HCV Patients and Improved Long-Term Bone and Renal Safety of Vemlidy® in HBV Patients Switched from Viread®20.10.2017 12:03Pressemelding

Gilead Sciences, Inc. (NASDAQ: GILD) today announced results from Phase 2 and Phase 3 studies of its approved medicines for chronic hepatitis C virus (HCV) and hepatitis B virus (HBV) infection, adding to the body of evidence supporting Gilead’s viral hepatitis therapies in diverse patient populations. These and other data from more than 25 abstracts will be presented this week at The Liver Meeting® 2017, which begins today in Washington, D.C. Positive results from studies of Harvoni® (ledipasvir 90mg/sofosbuvir 400mg) in HCV-infected patients with severe renal impairment, Epclusa® (sofosbuvir 400mg/velpatasvir 100mg) in HCV-infected liver transplant recipients and Vosevi® (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg) in NS5A-inhibitor experienced HCV-infected patients will be presented during poster sessions on October 21 and October 22. In addition, updated results f

SP3H Announces That It Has Obtained a €1.2 Million European Union Grant for Its Intelligent and Clean Vehicle (VIP) Project20.10.2017 10:47Pressemelding

SP3H is proud to announce joining the very select circle of the 10 French winners of the H2020 SME Instrument Phase 2 program since 2014. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171020005325/en/ Last summer VIP received the very prestigious SME instrument phase 2 H2020 label in the "transport & smart cities mobility" category. With an overall budget of € 1.7 million, VIP is subsidized by the European Union at a rate of 70% or €1.2 million. The framework contract was officially signed early October. VIP is the pre-industrialization program for Fuelbox sensors, the world's first miniaturized scanner capable of analyzing the quality of fuels on board vehicles. The heart of the program remains closely linked to the reduction of CO2 and pollutant emissions from vehicle

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom