AZ reports results from Brilinta stroke trial


ASTRAZENECA REPORTS TOP-LINE RESULTS FROM THE BRILINTA SOCRATES TRIAL IN STROKE

Missed primary efficacy endpoint; fewer events observed in the Brilinta arm but
trend did not reach statistical significance

Consistent safety profile

AstraZeneca today announced the top-line results of the SOCRATES trial,
assessing the efficacy of Brilinta/Brilique (ticagrelor) 90mg tablets twice
daily, when compared to aspirin 100mg once daily in patients with acute
ischaemic stroke or transient ischaemic attack (TIA). The primary efficacy
endpoint of time to first occurrence of any event from the composite of stroke
(ischaemic or haemorrhagic), myocardial infarction (MI, also known as heart
attack) and death was not met. Fewer events were observed on Brilinta/Brilique
versus the comparator in the overall trial population but the trend did not
reach statistical significance.

Based on preliminary analyses, safety data is consistent with the known safety
profile of Brilinta/Brilique.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief
Medical Officer at AstraZeneca, said: "We will present the full analysis of the
trial results, including  subgroups, at a forthcoming stroke congress and will
engage with regulatory agencies on the interpretation of the data. The SOCRATES
trial enrolled a patient population that differs from the currently-approved
indications for Brilinta/Brilique."

The SOCRATES trial evaluated the efficacy and safety of 90-day treatment with
Brilinta/Brilique versus aspirin for the prevention of major vascular events in
patients > 40 years of age with an acute ischaemic stroke (National Institutes
of Health Stroke Scale (NIHSS) < 5) or TIA (ABCD² score ≥4). Patients randomised
into the trial needed to have symptom onset within 24 hours.

In the second half of 2016, data are expected from the ongoing EUCLID trial in
peripheral arterial disease (PAD). EUCLID is the fourth trial to read-out from
the PARTHENON programme, assessing the potential of Brilinta/Brilique in
additional high-risk patient populations.



About Stroke

Stroke is the second leading cause of death worldwide, with 16.9 million first
strokes and 5.9 million stroke-related deaths in 2010. Patients who experience
an acute ischemic stroke or TIA are at high risk of developing subsequent
ischemic events, with particularly high risks of stroke in the first 90-days
after the index event.

About SOCRATES

SOCRATES (Acute Stroke Or Transient IsChaemic Attack TReated with Aspirin or
Ticagrelor and Patient OutcomES) is an event-driven global clinical trial
involving patients in 33 countries. SOCRATES assessed the efficacy of
Brilinta/Brilique compared to acetylsalicylic acid (ASA or aspirin) in reducing
atherothrombotic events (a composite of stroke, myocardial infarction and death)
in patients with acute ischaemic stroke NIHSS (≤ 5) and TIA (ABCD2 score ≥4).

SOCRATES is one of the largest international randomised controlled trials to
enrol both stroke and TIA patients within 24 hours of the primary event
occurring.

About the PARTHENON programme

The SOCRATES trial is part of PARTHENON, the largest ever AstraZeneca CV
outcomes programme, involving nearly 80,000 patients at high risk of CV events
(MI, stroke and/or CV death) due to their underlying disease. Through the
PARTHENON programme, AstraZeneca aims to address unmet patient needs by
enhancing scientific understanding of the potential role of Brilinta/Brilique in
the treatment of atherothrombotic conditions. It includes five key studies
covering broad patient populations across varying timescales. The trials
encompass a wide range of CV disorders, including coronary artery disease
(PEGASUS-TIMI 54), peripheral arterial disease (EUCLID) and patients with type-2
diabetes at high risk of CV events (THEMIS).

About Brilinta/Brilique

Brilinta/Brilique is a direct-acting P2Y12 receptor antagonist in a chemical
class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Brilinta/Brilique works
by inhibiting platelet activation and has been shown to reduce the rate of
thrombotic CV (cardiovascular) events, such as heart attack or CV death, in
patients with ACS.

Brilinta/Brilique 90mg is indicated to reduce the rate of thrombotic CV events
in patients with ACS (unstable angina (UA), non-ST-elevation myocardial
infarction (NSTEMI), or ST-elevation myocardial infarction (STEMI)).
Brilinta/Brilique 60mg is indicated for the treatment of patients who have
suffered a heart attack at least one year prior and are at high risk of
developing a further atherothrombotic event. Treatment with Brilinta/Brilique
60mg may be started as continuation therapy after an initial one-year treatment
with Brilinta/Brilique 90mg and aspirin or other dual anti-platelet therapy.

Brilinta/Brilique has been shown to reduce the rate of a combined end point of
CV death, MI, or stroke compared to clopidogrel. The difference between
treatments was driven by CV death and MI with no difference in stroke. In
patients treated with percutaneous coronary intervention, it also reduces the
rate of stent thrombosis.

Brilinta and Brilique are registered trademarks of the AstraZeneca group.

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 diseases in three main therapy areas -
respiratory, inflammation, autoimmune disease (RIA), cardiovascular and
metabolic disease (CVMD) and oncology - as well as in infection and
neuroscience. 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

Media Enquiries
Neil Burrows          UK/Global            +44 20 7604 8032
Vanessa Rhodes        UK/Global            +44 20 7604 8037
Karen Birmingham      UK/Global            +44 20 7604 8120
Jacob Lund            Sweden               +46 8 553 260 20
Michele Meixell       US                   +1 302 885 2677
Investor Enquiries
UK
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Christer Gruvris      Consensus Forecasts  +44 7827 836825
US
Lindsey Trickett        Oncology, ING      +1 240 543 7970
Mitch Chan              Oncology           +1 240 477 3771
Dial / Toll-Free                            +1 866 381 7277

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and
Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal

23 March 2016

-ENDS-

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