Blueprint
FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of October 2016
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1. AstraZeneca
reports top-line EUCLID results in PAD dated 04th October
2016
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
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AstraZeneca
PLC
-ENDS-
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
AstraZeneca
PLC
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Date:
04 October 2016
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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