News Release

Kyowa Hakko Kirin Announces AstraZeneca Has Exercised the Exclusive Option for Commercialization of Benralizumab (KHK4563) in Japan

October 28, 2016

Tokyo, Japan, October 28th, 2016—Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Nobuo Hanai, "Kyowa Hakko Kirin") announced that AstraZeneca AB(Global Headquarters: Cambridge, UK, CEO: Pascal Soriot) has exercised the option for an exclusive right to commercialize benralizumab (generic name, code name: KHK4563) for asthma and chronic obstructive pulmonary disease (COPD) in Japan.

Benralizumab is an anti-eosinophil monoclonal antibody currently in clinical development for the treatment of severe uncontrolled asthma and COPD. In July 2015, Kyowa Hakko Kirin had entered the agreement with AstraZeneca for an exclusive option to commercialize benralizumab (generic name / code name: KHK4563) for asthma and COPD in Japan. After exercising the option, AstraZeneca will be responsible for filing an application of manufacturing and marketing approval to the regulatory authority and all sales and marketing activity, in Japan.

Masashi Miyamoto, Ph.D., Executive Officer, Director, Strategic Product Portfolio Department of Kyowa Hakko Kirin said: "We are delighted that AstraZeneca, our long-standing strategic partner, has exercised the option. Through the partnership with AstraZeneca, we will be able to maximize the medical benefits that benralizumab could bring to patients in Japan."

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.

About benralizumab (KHK4563)

Benralizumab is an anti-eosinophil monoclonal antibody that binds to the human interleukin-5 receptor alpha subunit (IL-5Rα) expressed on the surface of eosinophils and basophils. In binding to the receptor, benralizumab leads to active, rapid and direct eosinophil depletion (apoptosis by ADCC) through natural killer cells.

About Asthma

Asthma is a common, chronic condition in which inflammation and narrowing of the airways may cause wheezing, breathlessness, chest tightness and coughing. Asthma currently affects the health and day-to-day lifestyles of 315 million individuals worldwide, and by 2020 will likely increase in numbers to as many as 400 million people.

About COPD

COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. Although COPD is widely regarded as a disease of the elderly, 50 percent of patients are estimated to be between 50 and 65 years of age, meaning half of the COPD population is likely to be affected at a stage in their life when they are at the peak of their earning potential and are likely to have major family responsibilities.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca.comNew window opens

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