Amgen, AstraZeneca End Brodalumab Pact
Amgen has terminated its co-development and commercialization 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 program that may result in restrictive labeling. AstraZeneca will confirm its decision on the future development of brodalumab as soon as possible, based on further review of the data.
After Amgen transitions the program to AstraZeneca, future decisions on the clinical development and submission of marketing applications for brodalumab will be at the sole discretion of AstraZeneca for all territories, except for certain Asian territories, including Japan, where Kyowa Hakko Kirin has rights to brodalumab.
Brodalumab is a 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.
In April 2012, Amgen and AstraZeneca formed a collaboration to jointly develop and commercialize five monoclonal antibodies from Amgen's clinical inflammation portfolio. With oversight from joint governing bodies, Amgen leads clinical development and commercialization 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 commercialization 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).