AstraZeneca advances Medimmune's benralizumab to Phase III in severe asthma

Anglo-Swedish drug major AstraZeneca (LSE: AZN) has started the Phase III Windward program for benralizumab, a potential treatment for severe uncontrolled asthma developed by its USA-based biologics R&D unit MedImmune.

The goal of CALIMA, the first study in the Windward program, is to determine whether benralizumab reduces the number of exacerbations in patients with severe asthma that remains uncontrolled, despite receiving high doses of inhaled corticosteroids in combination with a second controller such as a long-acting beta agonist. Benralizumab is a monoclonal antibody binding to the interleukin-5 receptor (IL-5R alpha) that depletes eosinophils, a type of white blood cell, which play a critical role in the cause and severity of asthma and asthma exacerbations.

Benralizumab is in-licensed from BioWa, a wholly-owned subsidiary of Japanese drugmaker Kyowa Hakko Kirin (TYO: 41521). Under the license agreement, Kyowa Hakko Kirin/BioWa have exclusive development and commercialization rights for benralizumab in Japan and certain countries in Asia. AstraZeneca has exclusive rights for benralizumab in all other countries including the USA and Europe. BioWa is eligible for milestone payments and royalties related to the development and commercialization of benralizumab in those countries.