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.
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NOTES TO EDITORS
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.
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.
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 / Tudorza Pressair / Tudorza Genuair, Duaklir Genuair and Daliresp.
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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