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2016-03-31

AstraZeneca: Brilinta preferred over clopidogrel in updated American College of Cardiology and American Heart Association guideline in acute coronary syndrome

First major US guideline to include expanded indication for Brilinta
in patients with a heart attack beyond one year

AstraZeneca today confirmed that the American College of Cardiology
(ACC) and American Heart Association (AHA) have released a treatment
guideline on the duration of dual antiplatelet therapy (DAPT).
Brilinta (ticagrelor) is now preferred over clopidogrel for the
management of patients with acute coronary syndrome (ACS) who have
received a coronary stent and in non-ST Elevation Acute Coronary
Syndrome (NSTE-ACS) patients treated with medical therapy alone
(Class IIa LoE: B-R). This update is the first time the ACC/AHA has
recommended Brilinta over clopidogrel for patients who have
experienced an ST-elevation myocardial infarction (STEMI).

The update is also the first US guideline to provide the medical
community with insights drawn from the PEGASUS-TIMI 54 trial. The
guideline supports continuation of P2Y12therapy beyond 12 months in
prior MI patients who are not at high bleeding risk (Class IIb LoE:
A). Full details of the updated guideline are available on the ACC
website
(http://www.acc.org/latest-in-cardiology/features/dual-antiplatelet-thera...).

Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic
Diseases, Global Medicines Development, AstraZeneca said: "We are
pleased that the ACC/AHA have further recognised the role of Brilinta
across a broad spectrum of ACS. This update reflects the clinical
confidence in Brilinta as a treatment option for heart attack
patients in the acute setting and in the longer-term."

The US Food and Drug Administration approved Brilinta at a 60mg dose
for patients with a history of heart attack in September 2015.
Brilinta is the only P2Y12 inhibitor that has been approved by the
FDA in the past 10 years, for long-term use in patients with a
history of MI. In the US, Brilinta is indicated to reduce the rate of
CV death, MI, and stroke in patients with ACS or a history of MI. For
at least the first 12 months following ACS, it has been proven
superior to clopidogrel. Brilinta also reduces the rate of stent
thrombosis in patients who have been stented for treatment of ACS.

This update comes ahead of the American College of Cardiology's
65thAnnual Scientific Sessions. Data will be presented on two new
sub-analyses from the PEGASUS-TIMI 54 trial. The sub-analyses include
prior MI patients with either peripheral artery disease (PAD) or
diabetes. The data will be presented on 3 April and 4 April
respectively.

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

- ENDS -

Notes to Editors

About the ACC/AHA Guidelines

The ACC/AHA Focused Update on the Duration of Dual Antiplatelet
Therapy (DAPT) impacts six already released ACC/AHA Clinical Practice
Guidelines. The scope of the update is limited to the duration of
DAPT, as well as the effectiveness of DAPT compared to aspirin alone
in patients with coronary artery disease.

Within the updated guideline, it is recommended that in patients with
ACS (NSTE-ACS or STEMI) treated with DAPT after coronary stent
implantation and in patients with NSTE-ACS treated with medical
therapy alone (without revascularization), it is reasonable to use
ticagrelor in preference to clopidogrel for maintenance P2Y12
inhibitor therapy.

Regarding longer-term use of DAPT beyond 12 months, the guidelines
recommend that in patients with ACS (NSTE-ACS or STEMI) treated with
coronary stent implantation who have tolerated DAPT without a
bleeding complication and who are not at high bleeding risk (e.g.,
prior bleeding on DAPT, coagulopathy, oral anticoagulant use),
continuation of DAPT (clopidogrel, prasugrel, or ticagrelor) for
longer than 12 months may be reasonable (Class IIb). A new risk score
(the "DAPT score"), derived from the Dual Antiplatelet Therapy study,
may be useful for decisions about whether to continue (prolong or
extend) DAPT in patients treated with coronary stent implantation. To
access the full ACC/AHA guideline, visit
http://www.acc.org/latest-in-cardiology/features/dual-antiplatelet-thera....

About PEGASUS-TIMI 54

PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic
Events in High-RiSk Patients with Prior AcUte Coronary Syndrome -
Thrombolysis In Myocardial Infarction Study Group) is one of
AstraZeneca's largest ever outcomes trials with more than 21,000
patients from over 1,100 sites in 31 countries in Europe, the
Americas, Africa and Australia/Asia. It is being conducted in
collaboration with the Thrombolysis in Myocardial Infarction (TIMI)
Study Group from Brigham and Women's Hospital (Boston, MA, USA).

The PEGASUS-TIMI 54 study investigated the efficacy and safety of both
Brilique 60mg and 90mg, twice daily, compared to placebo on a
background of low dose aspirin, for the long-term prevention of
atherothrombotic events in patients who suffered a heart attack one
to three years prior to enrolment. The primary efficacy endpoint is
time to first occurrence of any event from the composite endpoint of
cardiovascular (CV) death, non-fatal myocardial infarction or
non-fatal stroke.

About BRILINTA® (ticagrelor) tablets

Brilinta is an oral antiplatelet treatment for ACS or prior-MI.
Brilinta is a direct-acting P2Y12 receptor antagonist in a chemical
class called cyclo-pentyl-triazolo-pyrimidines (CPTPs) and 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 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 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 60mg may be started as continuation therapy after an
initial one-year treatment with Brilinta 90mg and aspirin or other
dual anti-platelet therapy.

Brilinta 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 is a registered trademark 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
Thomas Kudsk Larsen +44 7818 524185
Eugenia Litz RIA +44 7884 735627
Nick Stone CVMD +44 7717 618834
Craig Marks Finance +44 7881 615764
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

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Författare WKR

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