AstraZeneca announced last week it has signed into a partnership with Kyowa Hakko Kirin Co. Ltd. for exclusivity in commercializing benralizumab, a monoclonal antibody currently in Phase III clinical studies as potential treatment for severe uncontrolled asthma and chronic obstructive pulmonary disease (COPD) in Japan. At present, the latter exclusively owns development and commercialization rights for the drug in Japan and select Asian countries, while AstraZeneca owns rights in all other territories, including the US and Europe.
Benralizumab works by specifically acting on the IL-5 receptor while reducing eosinophils, which are known to play a major role in respiratory inflammation. Kyowa Hakko Kirin expects global Phase III study findings for asthma in 2016, which will be followed soon after by regulatory submissions. Study results and subsequent regulatory submissions for COPD are projected for 2018.
As per the licensing agreement, Kyowa Hakko Kirin will be entitled to an up-front payment worth $45 million along with payments for regulatory filing, approval and commercial milestones, and sales royalties. It will also retain responsibility for furthering the drug’s research and development in Japan, and keep hold of rights to participate in some of AstraZeneca’s commercial activities. AstraZeneca will be accountable for all sales and marketing in asthma and COPD in Japan.
Marc Dunoyer, Chief Financial Officer of 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 added: “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.”
In a previous report on asthma, a new study exploring perennial severe allergic asthma entitled “Prevalence of perennial severe allergic asthma in Italy and effectiveness of omalizumab in its management: PROXIMA – an observational, 2 phase, patient reported outcomes study“ was published this July in Clinical and Molecular Allergy. The study consisted of the evaluation of the proportion of patients with severe asthma sensitive to perennial allergens, and to evaluate asthma control and treatment adherence in patients treated with omalizumab in an Italian population.