[PDF]Kyowa Hakko Kirin Announces Initiation of the Phase III Clinical Study of KHK7580 (evocalcet) for Hypercalcemia in Patients with Parathyroid Carcinoma or Primary Hyperparathyroidism

On October 30, 2017 Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, “Kyowa Hakko Kirin”) reported the initiation in Japan of a phase III clinical study of KHK 7580 (generic name: evocalcet) for hypercalcemia in patients with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo parathyroidectomy or relapse after parathyroidectomy (Press release, Kyowa Hakko Kirin, OCT 30, 2017, View Source [SID1234521287]).

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This phase III study is an open label study in Japan to evaluate the efficacy and safety of KHK7580 oral administration. “We are delighted to start the phase III study of evocalcet,” said Mitsuo Satoh, Ph.D., Executive Officer, Vice President Head of R&D Division of Kyowa Hakko Kirin.

“We believe evocalcet could provide more efficient treat ment for parathyroid carcinoma and primary hyperparathyroidism, in addition to secondary hyperparathyroidism.”

KHK7580 is a small molecular compound and a novel type of calcimimetics discovered by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, “Mitsubishi Tanabe P harma”). Kyowa Hakko Kirin signed a license agreement of KHK7580 with Mitsubishi Tanabe Pharma for the rights to cooperative research, develop, market and manufacture the product in Japan and some parts of Asia in March 2008. The application for KHK7580 was submitted to Japan’s Ministry of Health, Labor and Welfare in April 2017, seeking approval for secondary hyperparathyroidism in maintenance dialysis patients.

The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.