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September 20, 2013

Announcement regarding the Marketing Approval of Abstral® sublingual tablets for Cancer Pain Treatment

Tokyo, Japan, September 20, 2013 -- Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced today that Abstral® sublingual tablet 100μg, 200μg and 400μg (nonproprietary name: fentanyl citrate; referred to below as "Abstral®"), has been approved for manufacturing and marketing in Japan.

Abstral®, 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. Since the efficacy and safety of this drug were confirmed in the Clinical trials, the application for marketing approval was made on November 13, 2012 and has been approved in Japan this time.

This drug was licensed from Orexo AB. (Uppsala, Sweden; President and CEO: Nikolaj Sørensen), 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, Japan; 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.


Kyowa Hakko Kirin
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