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2015-07-16

AstraZeneca: AstraZeneca enters option agreement with Kyowa Hakko Kirin for commercialisation of benralizumab in Japan

16 July 2015

AstraZeneca today announced that it has entered an agreement with
Kyowa Hakko Kirin Co. Ltd. (Kyowa Hakko Kirin) for an exclusive
option to commercialise benralizumab for asthma and chronic
obstructive pulmonary disease (COPD) in Japan.

Benralizumab is a monoclonal antibody in Phase III development for the
treatment of severe uncontrolled asthma and COPD. It targets the IL-5
receptor and depletes eosinophils, which play a key role in
inflammatory respiratory disease. The global Phase III results for
benralizumab in severe asthma are expected to read out in 2016, with
regulatory submissions anticipated later that year. Phase III results
and regulatory filing in COPD are expected in 2018.

Currently, Kyowa Hakko Kirin holds exclusive development and
commercialisation rights for benralizumab in Japan and certain
countries in Asia, while AstraZeneca has exclusive rights in all
other countries including the US and Europe.

Under the terms of the agreement, AstraZeneca will pay Kyowa Hakko
Kirin a $45 million up-front option fee and subsequent payments for
regulatory filing, approval and commercial milestones, and sales
royalties. Kyowa Hakko Kirin will continue to be responsible for the
research and development of benralizumab in Japan. On exercising the
option, AstraZeneca will be responsible for all sales and marketing
in asthma and COPD in Japan. Kyowa Hakko Kirin will retain the rights
to participate in certain commercial activities alongside
AstraZeneca.

Marc Dunoyer, Chief Financial Officer, AstraZeneca, said: "Japan is
the second largest pharmaceutical market in the world and one of our
growth platforms. The agreement with Kyowa Hakko Kirin increases our
focus on respiratory diseases, a main therapy area for AstraZeneca,
and provides the opportunity to bring an innovative potential
medicine to patients in Japan who are waiting for new treatment
options."

Masashi Miyamoto, PhD, Executive Officer, Director, Strategic Product
Portfolio Department of Kyowa Hakko Kirin said: "We are delighted to
enter this agreement with our long-standing strategic partner
AstraZeneca. Through this new agreement, we will be able to maximise
the medical benefits that this innovative new drug could bring to
patients in Japan."

The option agreement does not impact AstraZeneca's financial guidance
for 2015.

- ENDS -

NOTES TO EDITORS

About benralizumab

Benralizumab is an investigational humanised monoclonal antibody
directed at the alpha sub-unit of the interleukin-5 receptor (IL-5Rα)
that depletes eosinophils, a key target cell in inflammatory
respiratory disease.

Benralizumab is in-licensed from BioWa, Inc., a wholly-owned
subsidiary of Kyowa Hakko Kirin Co., Ltd.

About Asthma

Asthma is a chronic inflammatory disorder of the airways in which the
bronchi are reversibly narrowed. It affects people of all ages and is
a significant source of morbidity and mortality worldwide. Asthma can
be allergic (induced by an immune response to inhaled allergens such
as pollen, fungal spores or dust mite particles) or non-allergic
(induced by exercise, cough, viral respiratory infection, or
inhalation of smoke or chemicals in the workplace). The airway
narrowing characteristic of asthma is a response of the immune system
to the asthma trigger.

Severe persistent asthma is classified by the frequency of symptoms
throughout the day and night, use of reliever inhalers, interference
with daily activities, peak flow readings and whether asthma
exacerbations require use of inhaled corticosteroids (ICS) more than
twice a year. Asthma treatment usually includes ICS that reduce
inflammation of the airways to prevent asthma symptoms and
exacerbations, combined with long-acting β2-agonist bronchodilators
and a short-acting β2-agonist or other bronchodilator for relief.

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 Kyowa Hakko Kirin

Kyowa Hakko Kirin is a research-based life sciences company with
special strengths in biotechnologies. In the core therapeutic areas
of oncology, nephrology and immunology/ allergy, Kyowa Hakko Kirin
leverages leading-edge biotechnologies centered on antibody
technologies, to continually discover innovative new drugs and to
develop and market those drugs world-wide. In this way, we are
working to realise our vision of becoming a Japan-based global
specialty pharmaceutical company that contributes to the health and
comfort of people around the world. More information can be found at
http://www.kyowa-kirin.com

About AstraZeneca in Respiratory Disease
AstraZeneca has a strong heritage in developing innovative medicines
for respiratory diseases with more than 40 years of experience and a
strong franchise of marketed products. Our strategy is to deliver a
range of differentiated inhaled therapies, including novel
combinations, new devices, and innovative product offerings to treat
respiratory diseases, including asthma, COPD and idiopathic pulmonary
fibrosis (IPF). We believe innovative precision approaches will
ensure the right treatment for the right patient - our vision is to
improve the lives of 25 million patients by 2024.

The AstraZeneca Respiratory portfolio includes asthma and COPD
medicine Symbicort and asthma medicine Pulmicort, as well as COPD
treatments, Eklira Genuair / TudorzaPressair / Tudorza Genuair,
Duaklir Genuair and Daliresp.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business
that focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of
cardiovascular, metabolic, respiratory, inflammation, autoimmune,
oncology, infection and neuroscience diseases. AstraZeneca operates
in over 100 countries and its innovative medicines are used by
millions of patients worldwide. For more information please visit:
www.astrazeneca.com.

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