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June 18, 2014

Kyowa Hakko Kirin initiates a Phase I Trial of KHK6640 for Alzheimer's Disease in Europe

Tokyo, Japan, June 18, 2014,---Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") announced today that they would initiate a Phase I trial in Europe for KHK6640, an anti-amyloid beta (Aβ) peptide antibody for treatment of prodromal/mild/moderate Alzheimer's disease.

Kyowa Hakko Kirin obtained exclusive rights to the development, manufacture, and sale of this monoclonal antibody, which selectively binds to pathological aggregates of Aβ peptide, from Immunas Pharma Inc. (Kawasaki-City Kanagawa, Japan President and CEO: Takuya Tsunoda) in December of 2009. Aβ aggregates are thought to be the main cause of Alzheimer's disease, and this antibody is expected to inhibit the progression of the disease.
Kyowa Hakko Kirin submitted a Clinical Trial Application for a Phase I trial to confirm the safety and tolerability of this antibody in patients with prodromal/mild/moderate Alzheimer's disease, and the application has been accepted by the regulatory authority of Belgium.

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.


Overview of the Phase I trial

Target Disease prodromal/mild/moderate Alzheimer's disease
Design Single/repeated doses, randomized, double-blind, placebo-controlled, multinational and multicenter trial
Primary endpoints Safety and tolerability
Sites (planned) 5 European countries

Contact:

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



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