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AstraZeneca, Kyowa Hakko to commercialize benralizumab...

AstraZeneca and Kyowa Hakko Kirin have entered into an agreement for an exclusive option to commercialize benralizumab, a monoclonal antibody, for the treatment of asthma and chronic obstructive pulmonary disease (COPD) in Japan.


AstraZeneca Headquarters London

Currently, benralizumab is in Phase III development for the treatment of severe uncontrolled asthma and COPD.

Benralizumab targets the IL-5 receptor and reduces eosinophils, which play a major role in inflammatory respiratory disease.

Results from the global Phase III trial of benralizumab in severe asthma are scheduled to be reported in 2016, with regulatory submissions expected later that year.

The Phase III trial results and regulatory filing in COPD are expected in 2018.

At present, Kyowa Hakko Kirin holds exclusive development and commercialization rights for benralizumab in Japan and certain countries in Asia, while AstraZeneca has exclusive rights of the drug in all other countries including the US and Europe.

As part of the deal, AstraZeneca will pay Kyowa Hakko Kirin a $45m up-front option fee and subsequent payments for regulatory filing, approval and commercial milestones, and sales royalties.

The deal will see Kyowa Hakko Kirin to continue to be responsible for the research and development of benralizumab in Japan.

Upon exercising the option, AstraZeneca will be responsible for all sales and marketing of the drug in asthma and COPD in Japan. 
Alongside AstraZeneca, Kyowa Hakko Kirin will retain the rights to participate in certain commercial activities.

AstraZeneca chief financial officer Marc Dunoyer 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."

Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca plc.