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2018-09-20

AstraZeneca: AstraZeneca presents further data showing the interconnectivity between cardiovascular and renal risks in diab...

Head-to-head results of Farxiga vs. insulin or sulfonylurea in type-2
diabetes, with

key data on the safety and efficacy of Farxiga in both type-1 and
type-2 diabetes

Results of 10 randomised trials from the DURATION clinical programme
for Bydureon

New data on MEDI0382, a potential first-in-class
oxyntomodulin-like peptide for type-2 diabetes

AstraZeneca and MedImmune, its global biologics research and
development arm, will present more than 50 abstracts from the
Company's Cardiovascular, Renal & Metabolism (CVRM) therapy area at
the 54th Annual Meeting of the European Association for the Study of
Diabetes (EASD) in Berlin, Germany, 1-5 October 2018.

This latest research underscores AstraZeneca's expansive clinical
trial programme and comprehensive approach to advancing clinical
practice in the management of cardiovascular, renal and metabolic
(CaReMe) diseases. Data to be presented from the Company's broad
portfolio include Farxiga (dapagliflozin) and Bydureon (exenatide
extended-release) in type-2 diabetes (T2D), alone and in combination
with other diabetes therapies. Highlights also include data on the
potential of Farxiga in type-1 diabetes (T1D) and additional
pre-clinical and clinical data for MEDI0382, a potential
first-in-class oxyntomodulin-like peptide for type-2 diabetes and the
latest candidate in the Company's CVRM pipeline.

Ludovic Helfgott, Vice President, Cardiovascular, Renal and Metabolism
at AstraZeneca, said: "Our key data at EASD will expand understanding
around the persistent cardiovascular and renal risks in patients with
type-2 diabetes, as well as the unmet need in type-1 diabetes, where
we are at the forefront of advancing treatment for patients. We are
constantly pursuing science to advance the management of
cardiovascular, renal and metabolic diseases to improve patient
outcomes."

New data to highlight the potential of Farxiga in T2D and
interconnectivity between CV and renal diseases

Highlights include several abstracts evaluating the effects of Farxiga
alone and in combination in treating T2D, and in patients with CV
(including heart failure) and renal risk factors. Research into
CaReMe diseases includes a recent trial on CV outcomes and mortality
in people with T2D and associated comorbidities (Poster #1177). The
results will illustrate the importance of identifying novel
protection strategies for various T2D-related comorbidities,
including heart failure and chronic kidney disease, and may have
implications for investigating risk in T2D patients.

A further presentation will include 52-week results of Farxiga as an
add-on therapy to Onglyza (saxagliptin) in addition to metformin,
compared with insulin in patients with or without sulfonylurea
therapy.

For patients with T1D, insulin is the standard therapy with no oral
treatment options approved to date. The latest sub-analysis (Poster
#612) of pooled data from the DEPICT (Dapagliflozin Evaluation in
Patients with Inadequately Controlled Type-1 Diabetes) clinical trial
programme (DEPICT-1 and DEPICT-2) features an evaluation on the
effect of Farxiga in T1D patients taking adjustable insulin
treatment. The analysis will look at two composite endpoints,
including those determining instances of weight gain, severe
hypoglycaemia and diabetic ketoacidosis (DKA). Farxiga is currently
not approved in T1D.

AstraZeneca will also present an analysis from the CVD-REAL study
(Poster #635) which evaluated the efficacy and safety of SGLT2
inhibitors vs. other glucose-lowering medicines. This additional
analysis will look at data across a larger number of countries and
patients, with a longer duration of follow up than previously
evaluated.

Comprehensive new analyses of the safety and efficacy of Bydureon

Results will also be presented from 10 randomised Phase III,
24-to-30-week clinical trials within the DURATION programme (Poster
#737), which evaluated the safety and efficacy of glucagon-like
peptide-1 (GLP-1) receptor agonist Bydureon, administered once-weekly
either subcutaneously or with an autoinjector, in patients with T2D.

Advancing a potential first-in-class approach to T2D with MEDI0382

From the Company's promising CVRM pipeline, there will be an oral
presentation of data from a Phase IIa trial on the observed effects
of MEDI0382 on glucose control and weight loss in patients with T2D
(Presentation #164). MEDI0382 is an oxyntomodulin-like peptide and
potential new medicine designed to simultaneously activate the GLP-1
and glucagon (GLU) receptors, with the goal of achieving glucose
control, reduced body weight and increased energy expenditure in
patients with T2D.

Details of the key abstracts from AstraZeneca/MedImmune at EASD 2018:

+--------------+---------------------------------------------------------------+
|Abstract title|Presentation details |
+--------------+---------------------------------------------------------------+
|Farxiga |
+--------------+---------------------------------------------------------------+
|Effects of |Poster #653 |
|dapagliflozin |Tuesday Oct 2, 12:00 PM - 1:00 PM |
|on urine and |Poster Session: PS 049 Novel aspects of SGLT2 inhibitors |
|plasma | |
|metabolome in | |
|patients with | |
|type 2 | |
|diabetes: | |
|preliminary | |
|results | |
+--------------+---------------------------------------------------------------+
|Pooled data |Poster #612 |
|analysis of |Tuesday Oct 2, 1:15 PM - 2:15 PM |
|composite |Poster Session: PS 044 Are SGLT2 inhibitors effective and safe |
|endpoints from|in type 1 diabetes? |
|the DEPICT-1 | |
|and DEPICT-2 | |
|studies using | |
|dapagliflozin | |
|compared to | |
|placebo added | |
|to adjustable | |
|insulin in | |
|type 1 | |
|diabetes | |
+--------------+---------------------------------------------------------------+
|Pooled |Poster #613 |
|analysis of |Tuesday Oct 2, 1:15 PM - 2:15 PM |
|the duration |Poster Session: PS 044 Are SGLT2 inhibitors effective and safe |
|of type 1 |in type 1 diabetes? |
|diabetes in | |
|dapagliflozin | |
|vs placebo on | |
|adjustable | |
|insulin | |
|therapy from | |
|DEPICT 1 and | |
|2: effects on | |
|glycaemia, | |
|weight and | |
|insulin dosage| |
+--------------+---------------------------------------------------------------+
|Dapagliflozin |Poster #617 |
|preserves |Wednesday Oct 3, 12:00 PM - 1:00 PM |
|renal function|Poster Session: PS 045 Microvascular effects of SGLT2 |
|in patients |inhibitors: focus on kidneys and eyes |
|with T2DM: a | |
|longitudinal | |
|meta-analysis | |
|of eGFR in | |
|clinical | |
|trials | |
+--------------+---------------------------------------------------------------+
|Effect of |Poster #619 |
|dapagliflozin |Wednesday Oct 3, 12:00 PM - 1:00 PM |
|on renal and |Poster Session: PS 045 Microvascular effects of SGLT2 |
|cardiac |inhibitors: focus on kidneys and eyes |
|function in | |
|patients with | |
|type 2 | |
|diabetes and | |
|albuminuria - | |
|a randomized | |
|study | |
+--------------+---------------------------------------------------------------+
|Efficacy of |Poster #775 |
|dapagliflozin |Wednesday Oct 3, 12:00 PM - 1:00 PM |
|plus |Poster Session: PS 063 DPP4 inhibitors: new regiments and new |
|saxagliptin vs|comparisons |
|insulin | |
|glargine at 52| |
|weeks in | |
|patients w...

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