US DOJ Closes Investigation into Plato

UNITED STATES DEPARTMENT OF JUSTICE CLOSES INVESTIGATION INTO PLATO CLINICAL
TRIAL FOR BRILINTA

AstraZeneca today announced that it has received confirmation from the United
States Department of Justice that it is closing its investigation into PLATO, a
clinical trial with Brilinta (ticagrelor). The government is not planning any
further action.

Pascal Soriot, Chief Executive Officer, said: "We welcome the Department of
Justice's decision not to pursue further action. We have always had absolute
confidence in the integrity of the PLATO trial and we are proud of the important
benefit Brilinta offers to patients around the world suffering from acute
coronary syndrome. As one of AstraZeneca's growth platforms, we are committed to
delivering the full potential of this important medicine."

AstraZeneca recently announced the start of the SOCRATES trial, studying
Brilinta for patients with acute ischemic stroke or transient ischemic attack,
and the THEMIS study in patients with Type 2 diabetes and coronary
atherosclerosis. These studies form part of PARTHENON, AstraZeneca's largest
ever clinical trial programme, involving more than 80,000 patients worldwide.
The programme also includes two trials that have recently completed recruitment;
EUCLID for patients with Peripheral Artery Disease and PEGASUS, studying
Brilinta for secondary prevention in patients with previous myocardial
infarction. Headline results for PEGASUS are expected in the first quarter of
2015.

In 2011, the US Food and Drug Administration approved Brilinta for the treatment
of patients with acute coronary syndrome (ACS). Brilinta has been approved by
regulatory authorities in over 100 countries and is included in 11 major ACS
treatment guidelines globally, including six established US treatment
guidelines. The trial manuscript from the PLATO Executive Committee was first
published in the New England Journal of Medicine. Following additional rigorous
peer-review, over 30 PLATO sub-analyses articles have subsequently been
published. The combination of these global reviews makes the PLATO data set one
of the most widely analysed clinical trials.

About the civil investigative demand

On 21 October 2013, AstraZeneca received a civil investigative demand from the
US Department of Justice seeking documents and information related to the PLATO
trial. AstraZeneca has cooperated with the government enquiry, which focused on
questions that have been raised previously in public about the trial. Similar
questions have been responded to by the independent PLATO Executive Committee
which led the clinical trial.

About the PLATO trial

PLATO was a large (18,624 patients in 43 countries), head-to-head patient
outcomes study of BRILINTA vs. clopidogrel, both given in combination with
aspirin and other standard therapy. The trial was designed to establish whether
BRILINTA plus aspirin could achieve a clinically meaningful reduction in
cardiovascular (CV) events in acute coronary syndrome (ACS) patients, above and
beyond that afforded by clopidogrel plus aspirin. Patients were treated for at
least 6 months and up to 12 months.

BRILINTA plus aspirin has been proven clinically superior to clopidogrel plus
aspirin, in reducing thrombotic CV events, including CV death, at 12 months,
based on data from the PLATO trial.

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 cardiovascular, metabolic,
respiratory, inflammation, autoimmune, oncology, infection and neuroscience
diseases. 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

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19 August 2014

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