Amgen today announced the termination of its co-development and commercialisation agreement with AstraZeneca for brodalumab, an investigational IL-17 receptor inhibitor in development for patients with moderate-to-severe plaque psoriasis, psoriatic arthritis, and axial spondyloarthritis. The announcement follows Amgen’s decision to concentrate on other portfolio priorities after observing suicidal ideation and behaviour events in the brodalumab programme which may result in restrictive labelling.
AstraZeneca will confirm its decision on the future development of brodalumab as soon as possible, based on further review of the data.
Briggs Morrison, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “Data from the three AMAGINE Phase III pivotal studies highlighted that brodalumab has an effective mechanism of action that delivers clinical benefit. We will fully evaluate the data and assess all options before we make our independent decision about the future of this potential medicine.”
About Brodalumab (AMG 827)
Brodalumab is a novel human monoclonal antibody that binds to the interleukin-17 (IL-17) receptor and inhibits inflammatory signaling by blocking the binding of several IL-17 ligands to the receptor. By stopping IL-17 ligands from activating the receptor, brodalumab prevents the body from receiving signals that may lead to inflammation. The IL-17 pathway plays a central role in inducing and promoting inflammatory disease processes. Last November, the companies had reported positive phase III results on brodalumab in moderate-to-severe psoriasis patients and were working on regulatory filings in the U.S. and EU.
About the Amgen and AstraZeneca Collaboration
In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialise five monoclonal antibodies from Amgen’s clinical inflammation portfolio. With oversight from joint governing bodies, Amgen leads clinical development and commercialisation for brodalumab and AMG 557/MEDI5872 (Phase Ib for autoimmune disease, such as systemic lupus erythematosus). AstraZeneca, through its biologics arm MedImmune, leads clinical development and commercialisation for MEDI7183/AMG181 (Phase II for ulcerative colitis and Crohn’s disease), MEDI2070/AMG139 (Phase II for Crohn’s disease) and MEDI9929/AMG157 (Phase II for asthma).
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.