AstraZeneca and Kyowa Hakko Kirin have entered into an agreement for an exclusive option to commercialize the antibody benralizumab for the treatment of asthma and COPD in Japan. Presently, 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, according to the Pharmaceutical Business Review.
As part of the new agreement, AstraZeneca will pay Kyowa Hakko Kirin a $45 million up-front option fee as well as subsequent payments for sales royalties, regulatory filing, and approval and commercial milestones. Per the agreement, Kyowa Hakko Kirin will continue to be responsible for the research and development of the drug. The Pharmaceutical Business Review report notes that upon exercising the option, AstraZeneca will be responsible for all sales and marketing of benralizumab for asthma and COPD in Japan.
Kyowa Hakko Kirin, along with AstraZeneca, will retain the rights to participate in certain commercial activities. Results from the global Phase III trial of benralizumab in severe asthma are scheduled to be reported in 2016, with regulatory submissions expected later the same year, according to the Pharmaceutical Business Review. The Phase III trial results and regulatory filing in COPD are expected in 2018.
Marc Dunoyer, AstraZeneca CFO, states, “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.”
Source: Pharmaceutical Business Review