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March 25, 2014

Kyowa Hakko Kirin Submits Application for Approval of REGPARA® Tablets 12.5mg in Japan

Tokyo, Japan, March 25, 2014---Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has filed an application for marketing approval to Japan's Ministry of Health, Labour and Welfare (MHLW) for REGPARA® Tablets 12.5mg(generic name: cinacalcet hydrochloride).

REGPARA® (tablets 25mg and 75mg) acts on calcium receptors on the parathyroid gland to suppress the secretion of parathyroid hormone (PTH). REGPARA® tablets 25mg and 75mg were launched in January 2008 for secondary hyperparathyroidism (HPT) in patients who are undergoing regular dialysis. In February 2014, the drug had received the approval for hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy or who experience recurrent primary HPT.

REGPARA® has been marketed in Japan for six years and used to treat many patients, but individual patients vary in their response to or tolerance of the drug. Therefore, Kyowa Hakko Kirin applied for manufacturing and marketing approval of REGPARA® Tablets 12.5mg to provide a lower dosage form to allow doctors to finely adjust the drug dose.

Kyowa Hakko Kirin is focusing on kidney area, along with three other focused areas as our category-based strategy*. With variety kinds of products, Kyowa Hakko Kirin will contribute for kidney diseases.

*Category-based strategy: Each category (Nephrology; Oncology; Immunology and allergy; and Central Nervous System) will have its own portfolio management from R&D through to sales. We will achieve sustained growth while striving to improve productivity.


Kyowa Hakko Kirin
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