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July 28, 2015

Kyowa Hakko Kirin initiated a Pivotal Phase 3 Trial of Benralizumab (KHK4563) for COPD in Japan

Tokyo, Japan, July 28, 2015 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that they initiated a phase 3 trial (GALATHEA) of Benralizumab (generic name / code name: KHK4563) for chronic obstructive pulmonary disease (COPD) in Japan. GALATHEA is the multi-regional clinical trial that has been already initiated by AstraZeneca (London, UK, CEO: Pascal Soriot).

The goal of GALATHEA is to determine whether Benralizumab reduces the annual COPD exacerbation rate in symptomatic patients with moderate to very severe COPD with exacerbation history.

Benralizumab is a humanized monoclonal antibody which binds to the interleukin-5 receptor α subunit (IL-5Rα) using the POTELLIGENT® technology that enhances ADCC activity of antibodies. Benralizumab rapidly depletes eosinophils, which is considered to be associated with COPD exacerbations.

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.


Outline of the GALATHEA

Target Disease COPD (patients with moderate to very severe COPD with exacerbation history)
Trial Design Multicenter, Randomized, Placebo-controlled, Double-blind Trail
(Multi-Regional Clinical Trial)
Planned Number of Subjects 1,566 globally
Trial Location Global (Kyowa Hakko Kirin is responsible for Japan)
Primary Endpoint Annual COPD exacerbation rate


About GALATHEAs
GALATHEA is one of two trials in pivotal phase III program of benralizumab for COPD (Voyager Program), which is conducted globally by AstraZeneca and MedImmune.

About POTELLIGENT® technology
POTELLIGENT® technology is Kyowa Hakko Kirin's unique technology for the production of antibodies with enhanced ADCC activity. This technique enables production of antibodies with a reduced amount of fucose in their carbohydrate structure. For more information, please visit New window openswww.POTELLIGENT.com.

About ADCC (antibody-dependent cellular cytotoxicity) activity
ADCC activity is one of the body's immune responses, initiated by binding of an antibody to its antigen on target cells, followed by lysis of the antibody-bound target cells by effector cells such as natural killer cells. ADCC is known to be one of the modes of action of therapeutic antibodies.



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