Business Wire

Fujifilm Kyowa Kirin Biologics Partners with Mylan to Commercialize Biosimilar to Humira® (adalimumab)

Jaa

Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced the company will partner with Mylan N.V. (NASDAQ:MYL) to commercialize FKB327, a biosimilar to Humira® (adalimumab) developed by Fujifilm Kyowa Kirin Biologics. It has entered into an agreement with Mylan to grant an exclusive commercialization right of FKB327 in Europe.

Humira is a TNF-α1 inhibitor aimed at treating multiple chronic inflammatory conditions. The product is indicated in Europe for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Humira is the world’s best-selling biologic medication and had brand sales of approximately $4.1 billion in Europe for the 12 months ending Dec. 31, 2017, according to IQVIA.

“I am delighted that we entered into partnership with Mylan for an adalimumab biosimilar, FKB327 in Europe," said Dr. Yoshifumi Torii, President and CEO of Fujifilm Kyowa Kirin Biologics. “I believe that the establishment of this agreement with Mylan attests to the value of Fujifilm Kyowa Kirin Biologics' proprietary technology in biosimilars space and Mylan’s significant experience and expertise in regulatory commercialization with Fujifilm Kyowa Kirin Biologics’ scientific expertise will ensure patients across Europe benefit from the treatment option.”

Under the terms of the agreement between two companies, Fujifilm Kyowa Kirin Biologics grants Mylan an exclusive license to commercialize FKB327 in Europe and will receive an up-front fee. In addition, Fujifilm Kyowa Kirin Biologics is eligible to receive a subsequent commercialization milestone payment and sales royalties. Mylan will be responsible for the sales activity of the product in European countries.

The two companies continue to negotiate for commercializing the product in additional territories.

The European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application for its proposed biosimilar to Humira on May 18, 2017. The companies expect to receive a decision from EMA in the second half of 2018.

Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President: Kenji Sukeno; hereinafter “Fujifilm”) and Kyowa Hakko Kirin Co., Ltd. (President and COO: Masashi Miyamoto, hereinafter “Kyowa Hakko Kirin”) on March 27, 2012 as a company for developing, manufacturing, and marketing biosimilars. Its pipeline includes an adalimumab biosimilar and a biosimilar of the anti-VEGF humanized monoclonal antibody bevacizumab (Development No. FKB238), a drug used to treat a range of cancers including colorectal and non-small cell lung cancer. Fujifilm Kyowa Kirin Biologics established Centus Biotherapeutics Ltd., a joint venture for the development and commercialization of FKB238 with AstraZeneca plc.

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, Fujifilm Kyowa Kirin Biologics creates revolutionary production processes and reduces costs for the production of biosimilars. 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.

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

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 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

2018 Healthcare+ Expo Taiwan: Where Tech Meets Medicine15.8.2018 16:03Tiedote

From November 29th to December 2nd 2018, global-leading biomedical and technology institutes will gather in Taipei for the top healthcare and technology event in Asia - The Healthcare+ Expo - Taiwan. In line with the theme “Med X Tech”, a lineup of global leaders in technology will share the latest technology advancements and how technology create better solutions for future medical applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005001/en/ This year, the expo gathers 400 + world-class medical institutes and multi-national IT/ICT/electronic giants. The IT giants will showcase medical innovations of AI, IoT and robotic technologies. The medical institutes will demonstrate advanced medical technologies, smart hospital designs, products, and services while bio-pharmaceutical, medical device, and genetic enterprises will provide the most current updates in precision medicine. In all, more than 1,400 booths wil

PEI-Genesis Names Kris Haggstrom Senior Director of E-Commerce and EMS15.8.2018 14:07Tiedote

PEI-Genesis, a global leader in the design and assembly of custom engineered connectors and cable solutions, has named Kris Haggstrom Senior Director of E-Commerce and Electronic Manufacturing Services (EMS), it was announced today by Peter Austin, Corporate Vice President, PEI-Genesis. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180815005021/en/ PEI-Genesis names Kris Haggstrom Senior Director of E-Commerce and Electronic Manufacturing Services (EMS). (Photo: Business Wire) “As PEI-Genesis has grown into a stronger, larger, global company capable of providing services across all markets, our customers have always considered us to be their connector solutions provider,” said Austin. “We have moved from being known as the fastest custom assembler of connectors, to having the largest available-to-sell connector inventory, to making finished cable assemblies, to providing total custom engineering and design capabilities. Wit

Quanergy Signs Oprema as Distribution Partner for UK and Ireland15.8.2018 13:00Tiedote

Quanergy Systems, Inc., a global leader in the design and development of solid state LiDAR sensors and smart sensing solutions, today announced a partnership with Oprema, the fastest growing U.K. security distributor. Through the partnership, Oprema will provide full distribution support for Quanergy’s QORTEX™ for Security system across the United Kingdom and Ireland. Oprema will be Quanergy’s first distributor in the U.K. and Ireland, and will provide access to Quanergy’s LiDAR-based security system QORTEX for Security, an intelligent 3D perimeter fencing system that combines LiDAR hardware and software to enable real-time 3D detection, tracking and classification of security breaches. The solution was developed for use across various industries in which large-scale perimeter monitoring is essential. Tim Duggan, technical director at Oprema commented: “We are delighted to have signed a distribution agreement with Quanergy and are extremely excited about the technological advancements

itslearning and Google for Education Strike New Education Partnership, Deliver Major New Integrations to Improve Learning Outcomes15.8.2018 09:00Tiedote

itslearning today announced its collaboration with Google for Education, delivering the first phase of a comprehensive technology roadmap. This initial milestone aligns with the itslearning mission to improve the efficacy of technology in education. The collaboration will involve significant work across R&D, Sales, and Marketing functions. With phase one complete, these capabilities are now available: Use of Google assignment templates to quickly ‘make a copy’ of a single Google file for each student with one click Easy administration of assignments within the itslearning environment by uploading from or linking to documents on Google Drive Ability to collaborate and give real-time feedback in Google Docs directly from an itslearning assignment screen Automatic management of file permissions to prevent learners from making post-deadline changes to a submitted file View, annotate, and grade submitted files with a grade or against a rubric, all from within one itslearning screen “We are

Pacific Drilling Announces Second-Quarter 2018 Results15.8.2018 00:38Tiedote

Pacific Drilling S.A. (OTC: PACDQ) today reported results for the second quarter of 2018. Net loss for the second-quarter 2018 was $103.7 million or $4.86 per diluted share, compared to net loss of $96.1 million or $4.50 per diluted share for the first-quarter 2018, and net loss of $138.1 million or $6.48 per diluted share for second-quarter 2017. Pacific Drilling CEO Paul Reese commented, “This quarter we continued to provide outstanding operational services to our clients, delivering revenue efficiency of 98.7 percent. Our strong operating results have been recognized by clients as we successfully secure new work for our high-specification, deepwater drillship fleet. Petronas recently exercised its option to contract Pacific Santa Ana for an additional year of work commencing in mid-2019. In addition, we have a letter of intent from Eni for Pacific Bora to work in Nigeria, as well as two letters of award for drilling services in the U.S. Gulf of Mexico for Pacific Khamsin and Pacific

Gilead Sciences Announces Executive Promotions15.8.2018 00:00Tiedote

Gilead Sciences, Inc. (NASDAQ: GILD) today announced that Gregg Alton has been appointed Chief Patient Officer, a newly created role that will facilitate access to the company’s medicines and increase focus on reaching patients. The company also announced that Diana Brainard, MD, has been promoted to Senior Vice President, HIV and Emerging Viral Infections, and that Andrew Cheng, MD, PhD, Chief Medical Officer, has decided to leave Gilead to pursue another opportunity. Mr. Alton joined the company nearly 20 years ago and was the architect of its access program, which has enabled Gilead’s HIV medicines to reach more than 11 million people in the developing world. He has helped shape the organization in a number of executive positions, including as general counsel, and more recently, leading the company’s international commercial operations and corporate affairs groups. Prior to joining Gilead, he was an attorney at the law firm of Cooley Godward, LLP, where he specialized in mergers and

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