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2017-05-23

AstraZeneca: Bydureon EXSCEL trial meets primary safety objective in type-2 diabetes patients at wide range of cardiovascul...

Based on a composite measure of major adverse CV events (MACE),
Bydureon did not increase cardiovascular (CV) risk and showed a
consistent safety profile

Fewer CV events were observed in the Bydureon arm, however, the
efficacy objective of reduction in CV risk did not reach statistical
significance

AstraZeneca today announced top-line results from the Phase IIIb/IV
EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial. The
trial compared the effect of once-weekly Bydureon (exenatide
extended-release) versus placebo, when added to usual type-2 diabetes
care, on the risk of MACE, a composite endpoint of CV death,
non-fatal myocardial infarction or non-fatal stroke, in adults with
type-2 diabetes (T2D) at a wide range of CV risk.

The EXSCEL trial met its primary safety objective of non-inferiority
for MACE. These results address the US Food and Drug Administration
(FDA) requirement that medicines to treat T2D are not associated with
an increase in CV risk. Fewer CV events were observed in the Bydureon
arm of the trial, however, the efficacy objective of a superior
reduction in MACE did not reach statistical significance. Data were
consistent with the known safety profile of Bydureon.

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic
Diseases, Global Medicines Development, AstraZeneca, said: "These
top-line results from the EXSCEL trial provide robust evidence of the
cardiovascular safety profile of Bydureon across a wide range of
patients with type-2 diabetes. Furthermore, the trial design and
broad inclusion criteria of EXSCEL offer physicians relevant data
applicable to clinical practice."

The EXSCEL trial is the largest and most inclusive patient population
of any CV outcomes trial of the glucagon-like peptide-1 (GLP-1)
receptor agonist class conducted to date, having included more than
14,000 patients from 35 countries.

A full evaluation of the EXSCEL data is ongoing. The results will be
presented at the European Association for the Study of Diabetes
(EASD) annual meeting on Thursday, 14 September 2017 in Lisbon,
Portugal.

- ENDS -

NOTES TO EDITORS

About EXSCEL

EXSCEL is a Phase IIIb/IV, double-blind, placebo-controlled, global CV
outcomes trial conducted in 35 countries and enrolled more than
14,000 patients with type-2

diabetes with or without additional CV risk factors or prior CV
events. Participants were randomised to receive exenatide once-weekly
2mg or matching placebo by subcutaneous injections. EXSCEL was run
jointly by two academic research organisations - the Duke Clinical
Research Institute (Durham, NC, US) and the University of Oxford
Diabetes Trials Unit (Oxford, UK).

About AstraZeneca in Diabetes

AstraZeneca is pushing the boundaries of science with the goal of
developing life-changing medicines that aim to reduce the global
burden and complications of diabetes. As a main therapy area for the
company, we are focusing our research and development efforts on
diverse populations and patients with significant co-morbidities,
such as cardiovascular disease, obesity, non-alcoholic
steatohepatitis (NASH), and chronic kidney disease.

Our commitment to diabetes is exemplified by the depth and breadth of
our global clinical research programme. This commitment is advancing
understanding of the treatment effects of our diabetes medicines in
broad patient populations, as well as exploring combination products
to help more patients achieve treatment success earlier in their
disease.

About AstraZeneca in Cardiovascular & Metabolic Diseases (CVMD)

Cardiovascular, renal and metabolic diseases are key areas of focus
for AstraZeneca as part of the company's strategy for achieving
scientific leadership and returning to growth. By collaborating
across therapeutic disciplines within the CVMD therapy area, we are
addressing the underlying disorders that drive CVMD risk, with the
goal of reducing morbidity, mortality and organ damage through
innovative therapies. Recognising the growing unmet needs and
challenges faced by the millions of people worldwide living with
these interrelated diseases, we are determined to understand how they
interact and impact one another - and how they can be treated
together to save more patients' lives.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of Autoimmunity, Neuroscience and Infection. 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 and follow us on Twitter @AstraZeneca.

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