Application Seeking Approval for Additional Indication for REGPARA^® Tablets 25mg and 75mg

Tokyo, Japan, June 27, 2013---Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has been filed an application to Japan's Ministry of Health, Labour and Welfare (MHLW) seeking approval for the additional indication of hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary hyperparathyroidism (HPT) who are unable to undergo parathyroidectomy (PTx) ^*1 or who experience recurrent primary HPT for REGPARA^® Tablets 25mg and 75mg (generic name: cinacalcet hydrochloride, "REGPARA^®"). Kyowa Hakko Kirin currently manufactures and markets REGPARA^® for the treatment of secondary HPT.

REGPARA^® acts on calcium receptors on the parathyroid gland to suppress the secretion of parathyroid hormone (PTH). The drug was approved in Japan for secondary HPT in patients who are undergoing regular dialysis in 2007 and was launched in January 2008. Overseas (except for Asia), Amgen Inc. developed the drug and has obtained approval for the indications of secondary HPT in patients with chronic kidney disease on dialysis in 59 countries (as of February 2013), and severe hypercalcemia in patients with parathyroid carcinoma and primary HPT who are unable to undergo PTx in all but a few of the countries where the Drug is available (Brand name; Sensipar^®/Mimpara^®).

Under these circumstances, the Japan Endocrine Society, Japanese Society of Thyroid Surgery, and Japan Associate of Endocrine Surgeons submitted a letter to the MHLW requesting the development of REGPARA^® to treat hypercalcemia in patients with parathyroid carcinoma in August 2009. As a result of deliberations by the "Review Committee on Unapproved Drugs and Indication with High Medical Needs"^*2, REGPARA^® was determined as being of high medical need and in December 2010 the MHLW requested Kyowa Hakko Kirin to develop the additional indication for hypercalcemia in patients with parathyroid carcinoma.

In response to this request, Kyowa Hakko Kirin started to develop REGPARA^® in Japan for the additional indication of hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary HPT who are unable to undergo PTx or who experience recurrent primary HPT. Based on the results of Phase III study in Japan and overseas clinical studies by Amgen, Kyowa Hakko Kirin filed for approval of this additional indication. REGPARA^® was also granted an orphan drug designation^*3 for this indication by the MHLW.

Kyowa Hakko Kirin expects that the additional indication will significantly contribute to the treatment of hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary HPT who are unable to undergo PTx or who experience recurrent primary HPT.

*1: 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