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March 8, 2013

Announcement of Results from a Japanese Phase 3 Clinical Trial on the Additional Indication of Chronic Pain for Fentos® Tape (Development Code: HFT-290), a Transdermal Long-Acting Cancer Pain Relief Patch

Tokyo, Japan, March 8, 2013 -- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin" ) announced that the Company was informed on March 8, 2013 by Hisamitsu Pharmaceutical Co., Inc. (Tosu, Saga, President and CEO: Hirotaka Nakatomi, "Hisamitsu Pharmaceutical") that results had been announced externally from a Japanese phase 3 clinical trial on the additional indication of chronic pain* for Fentos® Tape (development code: HFT-290), a transdermal long-acting cancer pain relief patch.

Fentos® Tape is a narcotic ethical (Rx) pharmaceutical product developed as a transdermal patch of fentanyl citrate, a synthetic narcotic that exhibits significant analgesic effects, using Hisamitsu Pharmaceutical's transdermal drug delivery system (TDDS). Kyowa Hakko Kirin and Hisamitsu Pharmaceutical have been collaborating on the distribution of this product and the provision and collection of information (one brand, two channels) since June 2010.

The Japanese phase 3 clinical trial was a randomized, double-blind study on the efficacy of once daily use of Fentos® Tape for the additional indication of chronic pain. The results showed that Fentos® Tape was effective for patients with moderate-to-severe chronic pain. Hisamitsu Pharmaceutical aims to file for approval of chronic pain as an additional indication for Fentos® Tape during 2013.

Kyowa Hakko Kirin will continue to market Fentos® Tape jointly with Hisamitsu Pharmaceutical. The companies hope that approval of the additional indication of chronic pain will contribute to improved quality of life in patients suffering from chronic pain.

* Chronic pain
Chronic pain is persistent pain that prevent patients from performing daily activities. Causes include chronic disorders(eg, cancer, arthritis) and low back pain.


Kyowa Hakko Kirin
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