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November 13, 2012

Announcement regarding the Filing in Japan of an Application for Marketing Approval of KW-2246 for Cancer Pain Treatment

Tokyo, Japan, November 13, 2012 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced the application in Japan for the marketing approval of KW-2246 (fentanyl citrate sublingual tablet), which is currently undergoing development for the treatment of cancer pain.

KW-2246, which is to be administered sublingually, is a treatment for sudden pain (breakthrough pain) that occurs during chronic cancer pain management, and its major effect is pain relief due to prompt fentanyl absorption. Although an application was made for marketing approval on February 24, 2010, the application was withdrawn in order to conduct additional clinical trials because it was determined that accumulation of new data, in addition to data used for the original application, was necessary. Since the efficacy and safety of this drug were confirmed in the additional trials, the application for marketing approval was made this time.

KW-2246, which was licensed from Orexo Inc. (Uppsala, Sweden; CEO: Anders Lundstrom), has been sold abroad under several names, including "Abstral®." In Europe, ProStrakan (Galashiels, Scotland, UK; CEO: Thomas Stratford), a subsidiary of Kyowa Hakko Kirin, sells this drug under the name of "Abstral®." As announced on February 1, 2010, this drug will be jointly distributed in Japan with Hisamitsu Pharmaceutical Co., Inc. (Saga Prefecture: 4530, President and CEO, Hirotaka Nakatomi; "Hisamitsu Pharmaceutical") (2 channels for 1 brand).

In the field of treatment for cancer pain, Kyowa Hakko Kirin and Hisamitsu Pharmaceutical have been jointly selling Fentos® Tape (fentanyl citrate transdermal absorption product) since June 2010. We would like to continue to contribute to the improvement of QOL of patients suffering from cancer pain through comprehensive information release to healthcare professionals and information collection from them.



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