Updated on 24 August 2015
Tokyo: Global pharmaceutical company AstraZeneca has entered into an agreement with Kyowa Hakko Kirin Co. Ltd. for an exclusive option to commercialize 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 commercialization 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.