AstraZeneca Secures Full Asian Rights to Fasenra for All Indications Through New Agreement with Kyowa Hakko Kirin

March 27, 2019 /BioValleyBIOON/ -- Japanese pharmaceutical company Kyowa Hakko Kirin recently announced that it willAstraZeneca(AstraZeneca) has reached a new agreement, granting AstraZeneca exclusive rights to all additional indications of benralizumab (brand name: Fasenra) in Asia (including Japan). Under the previous agreement, AstraZeneca currently holds the rights for benralizumab in Asia for the treatment of chronic obstructive pulmonary disease (COPD) andAsthmaRights to indications. Following the new agreement, AstraZeneca now holds global rights to benralizumab for all current and future indications.

Under the terms of the agreement, AstraZeneca will pay Kyowa Kirin an upfront payment and subsequent regulatory and commercial milestone payments. Other financial terms remain unchanged from the parties’ previous agreement. AstraZeneca will now also be responsible for the development, sales, and marketing of benralizumab for all indications in 14 Asian countries and regions, including Japan.

The active pharmaceutical ingredient of Fasenra is benralizumab, a monoclonal antibody that directly binds to the alpha subunit of the interleukin-5 receptor (IL-5Rα) on eosinophils and uniquely recruits natural killer (NK) cells throughApoptosis(Programmed Cell Death) Induces Rapid and Near-Complete Depletion of Eosinophils.

Fasenra is AstraZeneca’s first respiratory biologic, currently approved in the United States, the European Union, Japan, and several other countries as an add-on maintenance therapy for severe eosinophilicAsthmaPatient Treatment. Regarding medication, Fasenra can be administered as a fixed-dose subcutaneous injection via a pre-filled syringe, with the first three doses given every 4 weeks, followed by subsequent doses every 8 weeks.

Fasenra was licensed to AstraZeneca from BioWa, a wholly owned subsidiary of the Japanese pharmaceutical company Kyowa Hakko Kirin. Currently, AstraZeneca is also evaluating the potential of Fasenra for the treatment of severe nasal polyps. In the United States,FDAFasenra Granted Orphan Drug Designation for the Treatment of Hypereosinophilic Syndrome (HES) and Eosinophilic Granulomatosis with Polyangiitis (EGPA). (Bioon.com)

Original Source:Kyowa Hakko Kirin Enters New Development and Commercialisation Agreements with AstraZeneca for All Benralizumab Indications beyond COPD and Asthma in Asia Inclusive of Japan