News Release

share on google plus
Text size
view with small font size
view with medium font size
view with large font size

April 16, 2014

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

Tokyo, Japan, April 16, 2014 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced today that they initiated CALIMA 1) in Japan, as one of several trials in the Phase III program for benralizumab (generic name / code name: KHK4563). Kyowa Hakko Kirin will also start SIROCCO 1), another Phase III trial in South Korea. CALIMA and SIROCCO are the multinational trials that have been already initiated by AstraZeneca (London, UK, CEO: Pascal Soriot) and MedImmune (Gaithersburg, USA, President: Bahija Jallal, Ph.D.), the licensee of benralizumab. Kyowa Hakko Kirin is participating in these trials as the In-Country Caretaker 2) in Japan and as the IND Holder 3) in South Korea.

Benralizumab is a humanized monoclonal antibody which binds to the interleukin-5 receptor α subunit (IL-5Rα) using the POTELLIGENT® technology 4) that enhances ADCC activity 5) of antibodies. Benralizumab rapidly depletes eosinophils, which play a critical role in the cause and severity of asthma and asthma exacerbations, also known as asthma attacks.

The goal of CALIMA and SIROCCO is to determine whether benralizumab reduces the number of exacerbations in patients with severe asthma who remain uncontrolled, despite high doses of inhaled corticosteroids in combination with a second controller such as a long-acting beta agonist (LABA).

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 CALIMA

Target Disease/ Population Asthma (patients with severe asthma who remain uncontrolled, despite high doses of inhaled corticosteroids in combination with a long-acting beta agonist (LABA)
Trial Design Multicenter, Randomized, Placebo-controlled, Double-blind Trail (Multinational Trial)
Planned Number of Subjects 2052 globally (including number of patients screened)
Trial Location Global (Kyowa Hakko Kirin is responsible for Japan)
Primary Objective Asthma exacerbation

Outline of the SIROCCO

Target Disease/ Population Asthma (patients with severe asthma who remain uncontrolled, despite high doses of inhaled corticosteroids in combination with a long-acting beta agonist (LABA)
Trial Design Multicenter, Randomized, Placebo-controlled, Double-blind Trail (Multinational Trial)
Planned Number of Subjects 1890 globally (including number of patients screened)
Trial Location Global (Kyowa Hakko Kirin is responsible for South Korea)
Primary Objective Asthma exacerbation


1) CALIMA and SIROCCO
CALIMA and SIROCCO trials are the part of the several trials in pivotal phase III program of benralizumab (Windward Program), which is conducted globally by AstraZeneca and MedImmune. Trials were named after local winds of the world.

2) In-Country Caretaker
A foreign company that does not have a local address in Japan, is required to designate an In-Country Caretaker who has a local address in Japan, when the foreign company intends to conduct a clinical trial in Japan. In-Country Caretaker is responsible for all things related to the trial conducted in Japan on behalf of the foreign company as the study sponsor.

3) IND (Investigational New Drug Application) Holder
IND is the process in which a pharmaceutical company (an IND Holder) must submit necessary documents and obtain permission from the regulatory agency in that country before starting a clinical trial. For SIROCCO trial, AstraZeneca is the study sponsor and Kyowa Hakko Kirin Korea Co., Ltd., a wholly owned subsidiary of Kyowa Hakko Kirin, is the IND Holder in South Korea.

4) 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. Non-clinical studies have demonstrated that antibodies produced using this technology killed target cells more efficiently than conventional antibodies and exhibited stronger antitumor effects. For more information, please visit New window openswww.POTELLIGENT.com.

5) 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.

Contact:

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



To Page Top