Date: 2015-07-16
Type of information: Commercialisation agreement
Compound: benralizumab
Company: AstraZeneca (UK) Kyowa Hakko Kirin (Japan)
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Type agreement: commercialisation
Action mechanism: monoclonal antibody. Benralizumab is a monoclonal antibody directed at the alpha subunit of the interleukin-5 receptor (IL-5Rα) that depletes eosinophils, a key target cell in inflammatory respiratory disease. Emerging evidence shows that for patients with elevated eosinophil counts, treatment with an IL-5 inhibitor in addition to guideline-based strategies may improve their asthma control and decrease the frequency of asthma attacks.
This antibody is in-licensed from BioWa, Inc., a wholly-owned subsidiary of Kyowa Hakko Kirin Co., Ltd. Under the exclusive license agreement, Kyowa Hakko Kirin/BioWa have exclusive development and commercialisation rights for benralizumab in Japan and certain countries in Asia. AstraZeneca has exclusive rights for benralizumab in all other countries including the US and Europe. BioWa is eligible for milestone payments and royalties related to the development and commercialisation of benralizumab in those countries.
Disease: asthma, chronic obstructive pulmonary disease (COPD)
Details: * On July 16, 2015, AstraZeneca announced that it has entered an agreement with Kyowa Hakko Kirin for an exclusive option to commercialise benralizumab for asthma and chronic obstructive pulmonary disease (COPD) in Japan. 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. 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.
Financial terms: 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. The option agreement does not impact AstraZeneca’s financial guidance for 2015.
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