ASTRAZENECA PLC ANNOUNCES BRILIQUE (TICAGRELOR) APPROVED IN EU FOR EXTENDED TREATMENT OF PATIENTS WITH HISTORY OF HEART ATTACK

Approval of new 60mg dose expands current indication to include long-term
treatment beyond the first year
AstraZeneca today announced that the European Commission has granted marketing
authorisation for Brilique (ticagrelor) at a new 60mg dose 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 may be
started as continuation therapy after an initial one-year treatment with
Brilique 90mg and aspirin or other dual anti platelet therapy.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief
Medical Officer at AstraZeneca, said: "A growing body of evidence continues to
show that the risk of experiencing a subsequent cardiovascular event continues
beyond the first year after a patient has a heart attack. We are committed to
finding new treatment solutions for these patients who remain at risk, and
today's approval is an important step forward in meeting this need."

Brilique is an oral antiplatelet treatment that works by inhibiting platelet
activation. Brilique 90mg is already approved in the EU for the prevention of
atherothrombotic events in adults with acute coronary syndrome (ACS). In the
management of ACS, the recommended maintenance dose of Brilique is 90mg twice
daily during the first year after an ACS event.

Now, after the first year, patients with a history of heart attack can continue
to be treated with the lower dose Brilique 60mg twice daily, which should be
taken with a daily maintenance dose of aspirin of 75-150mg.

The EU approval was based on the results from the PEGASUS TIMI-54 study, a large
-scale outcomes trial involving more than 21,000 patients, presented at American
College of Cardiology Congress (ACC) in March 2015 and simultaneously published
in the New England Journal of Medicine. PEGASUS TIMI-54 investigated ticagrelor
tablets plus low-dose aspirin, compared to placebo plus low dose aspirin, for
the long-term prevention of cardiovascular (CV) death, heart attack and stroke
in patients who had experienced a heart attack one to three years prior to study
enrollment. The study showed that Brilique significantly reduced the primary
endpoint of CV death, MI or stroke compared to placebo. The rates at 3 years
were 7.77% in the ticagrelor 60mg arm and 9.04% in the placebo arm.

This approval is applicable to all 28 European Union member countries plus
Iceland, Norway and Liechtenstein.

Today's announcement follows the approval on 3 September
2015 (https://www.astrazeneca.com/our-company/media-centre/press
-releases/2015/us-fda-approves-brilinta-long-term-use-heart-attack-history
-patients-03092015.html) of Brilinta (ticagrelor) 60mg by the US Food and Drug
Administration, to be used in patients with a history of heart attack beyond the
first year.

NOTES TO EDITORS

About BRILIQUE

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

BRILIQUE is a registered trademark of the AstraZeneca group.

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 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

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

ING - Infection, Neuroscience and Gastrointestinal



19 February 2016

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