Approval for Additional Indication of REGPARA ® Tablets 25mg and 75mg

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Tokyo, Japan, February 21, 2014---Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that it has been obtained an approval for additional dosage and administration for hypercalcemia in patients with parathyroid carcinoma, and hypercalcemia in patients with primary hyperparathyroidism (HPT) who are unable to undergo parathyroidectomy (PTx) or who experience recurrent primary HPT*1 of REGPARA® Tablets 25mg and 75mg (generic name: cinacalcet hydrochloride, "REGPARA®") from Japan's Ministry of Health, Labour and Welfare ("MHLW").

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 (Brand name; Sensipar®/Mimpara®) 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 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 approved and available.

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 entered Phase III clinical trial for the additional indication in Japan. Based on the results of clinical trial in Japan and overseas clinical studies by Amgen, Kyowa Hakko Kirin filed for approval of this additional indication in June 2013, and has received the approval today. REGPARA® was also granted an orphan drug designation*3 for this indication by the MHLW.

Kyowa Hakko Kirin expects that the approval for additional indication for administration and dosage 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

Primary HPT involves autonomous oversecretion of parathyroid hormone (PTH), usually by a tumor of the parathyroid gland. Elevated PTH levels result in an increase in serum calcium concentration. Primary HPT can be caused by adenoma, hyperplasia, or parathyroid carcinoma. Parathyroidectomy (PTx) is the only reliable method to treat primary HPT including parathyroid carcinoma. Control of hypercalcemia can prove challenging in cases of primary HPT where PTx is not an option because of concomitant diseases or where primary HPT recur after PTx and parathyroid carcinoma, although patients with such hypercalcemia are very rare. An effective treatment is needed for hypercalcemia, as it causes symptoms of fatigue, polyuria, thirst, and renal impairment and severe hypercalcemia can result in death due to a hypercalcemic crisis.

*2: Review Committee on Unapproved Drugs and Indication with High Medical Needs

The Committee was established for the purpose of enhancing development by the pharmaceutical companies of drugs and indications that have been approved for use in the United States and Europe but not yet approved in Japan, through activities such as evaluating medical needs and confirming the applicability of "Application based on evidence in the public domain" and investigating the need for studies that should be additionally conducted.

*3: Orphan drug designation

A drug must meet the following three conditions in order to be granted an orphan drug designation in Japan.

1) The number of patients who may use the drug is less than 50,000 in Japan.

2) There are high medical needs for the drug (There is no appropriate alternative drug/treatment, or high efficacy or safety is expected compared with existing products).

3) There is high possibility of development (There should be a theoretical rationale for the use of the drug for the target disease, and the development plan should be appropriate). For designated orphan drugs, measures to support the research and development activities are taken (The orphan drug and orphan medical device research and development promotion program).

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