AstraZeneca PLC UPDATE ON BRODALUMAB DEVELOPMENT PROGRAMME (1271O)
May 26 2015 - 02:01AM
UK Regulatory
TIDMAZN
RNS Number : 1271O
AstraZeneca PLC
26 May 2015
AstraZeneca Provides Update on Brodalumab Development
Programme
Amgen has 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.
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).
About AstraZeneca
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. For more
information please visit: www.astrazeneca.com
CONTACTS
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Investor Enquiries
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8199
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Inflammation 8233
and Autoimmunity
Nick Stone Cardiovascular +44 17 6326 mob: +44 7717 618834
and Metabolic 3994
Disease
Karl Hård Oncology +44 20 7604 mob: +44 7789 654364
8123
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Neuroscience 8591
and Gastrointestinal
Disease
Christer Gruvris +44 20 7604 mob: +44 7827 836825
8126
26 May 2015
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