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Fujifilm Kyowa Kirin Biologics establishes joint venture with AstraZeneca to develop and commercialise anti-VEGF biosimilar

July 24, 2015
FUJIFILM Corporation
Kyowa Hakko Kirin Co., Ltd.

FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. (President and CEO: Hideaki Nomura; hereinafter “Fujifilm Kyowa Kirin Biologics”) today announced that it has entered into an agreement with AstraZeneca plc (hereinafter “AstraZeneca”) to establish a joint venture for the development and commercialisation of FKB238 in development for the treatment of multiple solid tumours.

FKB238 is a biosimilar version of bevacizumab, an anti-VEGF1 humanized monoclonal antibody with established efficacy across a range of cancers including colorectal and non-small cell lung cancer2. Fujifilm Kyowa Kirin Biologics commenced its Phase I clinical trial for FKB238 in Europe in November 2014.

Under the terms of the agreement, the new joint venture that is equally co-funded by the two companies and will use FKB238's non-clinical, clinical development data compiled by Fujifilm Kyowa Kirin Biologics thus far. Fujifilm Kyowa Kirin Biologics will transfer the rights to FKB238 to the new joint venture, and will receive a lump-sum payment of USD45 million in return.

Company name	to be determined
Address	UK
Scheduled Start of operation	within 2015
Paid-in capital	USD 90 million (Capitalization ratios: 50% for Fujifilm Kyowa Kirin Biologics and 50% for AstraZeneca)
Business description	Development and marketing of FKB238

Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President and CEO: Shigehiro Nakajima; hereinafter “Fujifilm”) and Kyowa Hakko Kirin Co., Ltd. (President and CEO: Nobuo Hanai, hereinafter “Kyowa Hakko Kirin”) on March 27, 2012 as a company for developing, manufacturing and marketing biosimilars. In its pipeline are FKB238 as well as biosimilar of the fully human anti-TNF-α monoclonal antibody, adalimumab (Development No. FKB327) a drug with dramatic therapeutic effects for rheumatoid arthritis. FKB327 is under Phase III clinical trial in the United States and other countries.

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 VEGF is an abbreviation for Vascular Endothelial Growth Factor. VEGF is a glycoprotein which promotes mitogenic activity in vascular endothelial cells, which in turn stimulates angiogenesis.
*2 Lung cancer can be broadly divided into small cell lung cancer and non-small cell lung cancer, with 85% of lung cancers falling into the latter category. Non-small cell lung cancers include squamous cell cancer, adenocarcinoma and large cell carcinoma