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Re: DewDiligence post# 138608

Wednesday, 03/28/2012 5:37:08 PM

Wednesday, March 28, 2012 5:37:08 PM

Post# of 253225
Fujifilm, Kyowa Hakko Form FoB Collaboration for Humira

[The 50/50 JV has 27 employees and 100 million yen of initial funding. The companies say Humira will be the first of several FoB’s to be developed by the JV, but they are making no claims vis-à-vis interchangeability for the US market.]

http://www.fujifilm.com/news/n120327.html

›March 27, 2012

FUJIFILM Corporation (President and CEO Shigetaka Komori; hereinafter "Fujifilm") and Kyowa Hakko Kirin Co., Ltd. (President and CEO Nobuo Hanai; hereinafter "Kyowa Hakko Kirin") commenced business operations of the "FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd." (President and CEO Hideaki Nomura; hereinafter "Fujifilm Kyowa Kirin Biologics"), a joint-venture for the development, manufacturing and sales of biosimilars.

Fujifilm Kyowa Kirin Biologics will merge Fujifilm's advanced production technology, quality control technology and analysis technology developed through its photographic film business over many years, with Kyowa Hakko Kirin's proprietary technologies and know-how, accumulated through its biopharmaceutical R&D and manufacturing, in order to create revolutionary production processes and to achieve cost reduction for biosimilars. The development and timely introduction of highly reliable, high-quality and cost-competitive biosimilars through this partnership will aim to obtain position as the market leader.

Fujifilm Kyowa Kirin Biologics will first focus on the development of the biosimilar of the fully human anti-TNF-a monoclonal antibody "adalimumab" [Humira], a drug with high therapeutic effects for rheumatoid arthritis. After introducing the producing cell* already produced by Kyowa Hakko Kirin, Fujifilm Kyowa Kirin Biologics plans to start clinical trials in the beginning of 2013. It will then proceed with its development aiming for market introduction 4 to 5 years after the start of clinical trials. The company also plans to start clinical trials of 1 biosimilar every year after 2014.

Fujifilm Kyowa Kirin Biologics also intends to hold talks with other companies for sales collaboration of biosimilars.‹

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