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2017-06-08

AstraZeneca: AstraZeneca to present scientific advances in Cardiovascular and Metabolic Diseases at 2017 ADA Scientific Ses...

Updated safety data on risk-benefit profile of Farxiga
(dapagliflozin), three new analyses from the landmark CVD-REAL study,
including Farxiga vs DPP-4 inhibitors, and a late-breaking oral
presentation reveal further CV evidence across a broad population of
patients with type-2 diabetes

Data from DURATION-7 and DURATION-8 evaluating efficacy and safety of
Bydureon (exenatide extended-release) in combination with basal
insulin and Farxiga, respectively

More than 50 abstracts demonstrate commitment to Cardiovascular and
Metabolic Diseases

AstraZeneca and its global biologics research and development arm,
MedImmune, will present the latest research from the Company's
Cardiovascular and Metabolic Diseases (CVMD) therapy area, including
for Farxiga (dapagliflozin) and Bydureon (exenatide
extended-release), with more than 50 abstracts at the American
Diabetes Association's (ADA) 77th Scientific Sessions in San Diego,
USA, 9-13 June 2017.

Ludovic Helfgott, Vice President, CVMD, said: "Science points to the
need to move beyond lowering blood sugar to treat patients with
type-2 diabetes holistically and earlier in their disease
progression. Through investment in rigorous clinical and real-world
evidence studies in large and diverse patient populations, we are
committed to advancing scientific understanding of the connections
between these highly-prevalent cardiovascular and metabolic diseases
and helping to enhance clinical practice to improve the lives of
patients."

Highlights include a comprehensive updated safety analysis of
dapagliflozin and three additional analyses from the landmark
CVD-REAL real-world evidence study, including CV data for
dapagliflozin, evaluating the risk of hospitalisation for kidney
disease and heart failure (HF), as well as all-cause mortality,
compared to DPP-4 inhibitors, a commonly-used treatment for type-2
diabetes (T2D). Additionally, a late-breaking oral presentation will
explore the rates of HF and death in patients with T2D, both with and
without cardiovascular disease, receiving treatment with SGLT-2
inhibitors (SGLT-2i) versus other T2D medicines.

Also presented will be the baseline characteristics and trial design
of DECLARE, the largest cardiovascular outcomes trial in the SGLT-2i
class. Both CVD-REAL and DECLARE are part of the extensive DapaCare
programme for dapagliflozin, which involves patients with and without
T2D to generate data across established CV disease, CV risk factors
and varying stages of renal disease, providing healthcare providers
with evidence needed to improve patient care.

AstraZeneca will also present analyses from DURATION-8, evaluating the
investigational use of exenatide extended-release in combination with
dapagliflozin, as well as primary data from DURATION-7, examining
exenatide extended-release in combination with basal insulin.

Notable data being presented by AstraZeneca include:

Real-World Evidence on Evaluating CV Outcomes Treatment with SGLT2
inhibitors

· Evaluation of SGLT2i on Risk of Mortality and Heart Failure
Compared to Other Glucose Lowering Drugs: A Three-country Analysis
(Poster 1205-P, Sunday June 11, 12:00 p.m. PDT)[1]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

· Hospitalisation for Heart Failure and Death in New Users of SGLT2
Inhibitors in patients With and Without Cardiovascular Disease -
CVD-REAL Study (Oral 377-OR, Tuesday June 13, 10:45 a.m. PDT)[2]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

· Evaluation of dapagliflozin on Risk of Hospitalization for Kidney
Disease, Heart Failure and All-Cause Death Compared to DPP-4i:
CVD-REAL Nordic (Late-Breaker 165-LB, Sunday June 11, 12:00 p.m.
PDT)[3]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

Comprehensive New Safety Analysis of Dapagliflozin

· Safety Update on dapagliflozin (DAPA) Across the Phase 2b/3
Clinical Trial Program (Poster 1263-P, Sunday June 11, 12:00 p.m.
PDT)[4]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

DECLARE Trial Design and Baseline Characteristics

· DECLARE-TIMI 58: Design and Baseline Characteristics (Poster
1245-P, Sunday June 11, 12:00 p.m. PDT)[5]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

Data Assessing GLP-1 receptor agonists with Other Antidiabetic Agents

· Efficacy and Safety of exenatide QW Versus Placebo Added to
Insulin Glargine in Uncontrolled Basal-Insulin Treated type-2
Diabetes: DURATION-7 Trial (Oral 132-OR, Saturday June 10, 4:45 p.m.
PDT)[6]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

· DURATION-8 Randomized Controlled Trial 1-Year Results: Efficacy
and Safety of Once-Weekly Exenatide (ExQW) Plus Once-Daily
Dapagliflozin (DAPA) Versus ExQW or DAPA Alone (Late-Breaker Poster
141-LB, Sunday June 11, 12:00 p.m. PDT)

· Effects of exenatide Once Weekly Plus dapagliflozin, exenatide
Once Weekly, or dapagliflozin Added to metformin Monotherapy on
Cardiovascular Risk Markers in Patients with type-2 diabetes in the
DURATION-8 trial (Poster 1152-P, Sunday June 11, 12:00 p.m. PDT)[7]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

· DURATION-8: Mechanisms of Glycemic Control for exenatide Plus
dapagliflozin Versus Each Drug Alone (Poster 1074-P, Sunday June 11,
12:00 p.m. PDT)[8]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

· Exenatide Once Weekly (QW) Plus dapagliflozin, exenatide QW, or
dapagliflozin Added to metformin Monotherapy in Subgroups of Patients
with type-2 Diabetes in the DURATION-8 Study (Poster 1115-P, Sunday
June 11, 12:00 p.m. PDT)[9]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)

The full list of AstraZeneca scientific presentations can be accessed
on the ADA website here
(https://professional.diabetes.org/content-page/abstracts).

- ENDS -

NOTES TO EDITORS

About the DapaCare Clinical Programme

AstraZeneca is taking a holistic, patient-centric approach to disease
management by addressing the underlying morbidity, mortality and
organ damage associated with cardiovascular (CV), metabolic and renal
diseases. Due to the interconnectivity of these diseases, AstraZeneca
has developed the DapaCare clinical programme to explore the CV and
renal profile of dapagliflozin in people with and without type-2
diabetes. The clinical programme will enrol nearly 30,000 patients in
randomised clinical trials and is supported by a multinational
real-world evidence study. DapaCare will generate data across a
spectrum of people with established CV disease, CV risk factors and
varying stages of renal disease, both with and without type-2
diabetes, providing healthcare providers with evidence needed to
improve patient outcomes. DapaCare underscores our commitment to
following the science by pursuing a holistic patient approach to
address the multiple risk factors associated with CV, metabolic and
renal diseases.

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.

Media Relations
Esra Erkal-Paler UK/Global +44 7771 740311
Karen Birmingham UK/Global +44 203 749 5634
Rob Skelding UK/Global +44 203 749 5821
Jacob Lund Sweden +46 8 553 260 20
Michele Meixell US +1 302 885 2677

Investor Relations
Thomas Kudsk Larsen +44 203 749 5712
Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Henry Wheeler Oncology +44 203 749 5797
Mitchell Chan Oncology +1 240 477 3771
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Nick Stone Respiratory +44 203 749 5716
Christer Gruvris Autoimmunity, Neuroscience & Infection +44 203 749 5711
US toll free +1 866 381 7277

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[1]
(http://file:///C:/Users/kdzn235/AppData/Local/Microsoft/Windows/Temporar...)
Birkeland K. et al. "SGLT-2i is associated with lower risk of
mortality and heart failure compared to other glucose lowering drugs:
A three-country analysis." American Diabetes Association Scientific
Sessions 2017. Abstract #1205-P

[2]
(http://file:///C:/Users/kdzn235/AppData/Local/M...

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