AstraZeneca reports top-line EUCLID results in PAD

This announcement contains inside information

04 October 2016 07:00

ASTRAZENECA REPORTS TOP-LINE RESULTS FROM THE BRILINTA EUCLID TRIAL IN PATIENTS
WITH PERIPHERAL ARTERY DISEASE

Brilinta did not demonstrate a benefit over clopidogrel in a symptomatic
peripheral artery disease patient population

AstraZeneca today announced top-line results from the EUCLID trial. Brilinta
(ticagrelor) did not demonstrate a benefit over clopidogrel in a symptomatic
peripheral artery disease (PAD) patient population and therefore did not meet
the primary endpoint of the trial.

The EUCLID trial included 13,885 patients in 28 countries and is the largest
cardiovascular (CV) outcomes trial to date conducted exclusively in symptomatic
patients with PAD. It evaluated the treatment of Brilinta 90mg tablets twice
daily versus clopidogrel 75mg once daily for the prevention of atherothrombotic
events (a composite of cardiovascular death, heart attack or ischaemic stroke).
The primary endpoint of the trial was the time to first occurrence of any such
event.

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

Sean Bohen, Executive Vice President, Global Medicines Development and Chief
Medical Officer at AstraZeneca, said: "The proven benefits of Brilinta in acute
coronary syndrome and post-myocardial infarction patients are established and
remain unchanged. We are disappointed that the EUCLID trial results showed
Brilinta did not demonstrate a benefit over clopidogrel in this specific
symptomatic PAD population."

Full results from the EUCLID trial are expected to be presented at the American
Heart Association Scientific Sessions in New Orleans, Louisiana in November
2016.

About Peripheral Artery Disease (PAD)
PAD is the third most common cause of cardiovascular complications (largely
myocardial infarction and stroke) in the world. PAD is a chronic and progressive
clinical manifestation of a systemic atherosclerotic vascular disease and a
predictor of future vascular events. However, only a limited number of PAD
patients receive the recommended treatment advocated in international
guidelines. There is no cure and patients endure a high risk of serious
cardiovascular morbidity and mortality.

About EUCLID
EUCLID (Examining Use of tiCagreLor In paD) is a global, event-driven, double
-blind, parallel group trial involving approximately 13,800 patients in 28
countries, and was run for AstraZeneca by The Duke Clinical Research Institute
(DCRI), part of the Duke University School of Medicine, Durham, North Carolina.
The EUCLID trial evaluated the efficacy and safety of long-term treatment with
Brilinta 90mg twice daily compared to clopidogrel 75mg once daily for the
prevention of atherothrombotic events (a composite of ischaemic stroke,
myocardial infarction and CV death) in patients ≥50 years of age with
symptomatic PAD, defined by ankle-brachial index (ABI) ≤0.80 (at enrolment) and
lower extremity symptoms, or by prior lower extremity revascularisation more
than 30 days prior.

About the PARTHENON programme
PARTHENON is the largest-ever AstraZeneca CV outcomes programme, involving
nearly 85,000 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 in the treatment of atherothrombotic conditions. It
includes five key trials covering broad patient populations across varying
timescales. The trials encompass a wide range of CV disorders, including
coronary artery disease (PEGASUS-TIMI 54), acute coronary syndrome (PLATO),
stroke (SOCRATES) and patients with type 2 diabetes at high risk of CV events
(THEMIS).

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

Brilinta 90mg is indicated to reduce the rate of atherothrombotic 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.

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on
the discovery, development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three therapy areas - Respiratory,
Cardiovascular & Metabolic Diseases, and Oncology. The Company is also
selectively active in Neuroscience and Autoimmunity. 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                            +44 203 749 5637
Vanessa Rhodes       UK/Global                            +44 203 749 5736
Karen Birmingham     UK/Global                            +44 203 749 5634
Rob Skelding         UK/Global                            +44 203 749 5821
Jacob Lund           Sweden                               +46 8 553 260 20
Michele Meixell      US                                   +1 302 885 2677
Investor Relations
UK
Thomas Kudsk Larsen                                       +44 203 749 5712
Craig Marks          Finance, Fixed Income, M&A           +44 7881 615 764
Nick Stone           Respiratory                          +44 203 749 5716
Henry Wheeler        Oncology                             +44 203 749 5797
Christer Gruvris     Neuroscience & Autoimmunity          +44 203 749 5711
US
Lindsey Trickett     Cardiovascular & Metabolic Diseases  +1 240 543 7970
Mitchell Chan         Oncology                            +1 240 477 3771
Toll free                                                 +1 866 381 7277

Adrian Kemp
Company Secretary
AstraZeneca PLC

-ENDS-