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August 29, 2014

Kyowa Hakko Kirin Announces Commencement of Phase 2b Clinical Study of KHK7580 in Patients with Secondary Hyperparathyroidism in Japan

Tokyo, Japan, August 29, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") today announced the initiation of a phase 2b clinical study evaluating KHK7580 for secondary hyperparathyroidism patients receiving hemodialysis in Japan.

This randomized, placebo-controlled, double-blind, parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and cinacalcet and initial dose of KHK7580 for secondary hyperparathyroidism patients receiving hemodialysis.

KHK7580 is a small molecular compound produced by Mitsubishi Tanabe Pharma Corporation (President & Representative Director, CEO: Masayuki Mitsuka, "Mitsubishi Tanabe Pharma"). 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 part of Asia on March 2008.

The Kyowa Hakko Kirin Group is contributing to the health and prosperity of the world's people by pursuing advances in life sciences and technology and creating new value.


Outline of this study

ClinicalTrials.gov Identifier New window opensNCT02216656
Target Population Secondary hyperparathyroidism patients receiving hemodialysis
Trial Design Randomized, placebo-controlled, double-blind (included open arm of cinacalcet), parallel-group, multi-center study
Administration Group KHK7580, Placebo, cinacalcet
Target Number of Subjects 150
Primary Objective Efficacy
Trial Location Japan
Trial Duration Jul. 2014 to Jun. 2015

Contact:

Kyowa Hakko Kirin
Media Contact:
+81-3-3282-1903
or
Investors:
+81-3-3282-0009



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