<SEC-DOCUMENT>0001654954-20-006139.txt : 20200601
<SEC-HEADER>0001654954-20-006139.hdr.sgml : 20200601
<ACCEPTANCE-DATETIME>20200601062934
ACCESSION NUMBER:		0001654954-20-006139
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20200601
FILED AS OF DATE:		20200601
DATE AS OF CHANGE:		20200601

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		20930852

	BUSINESS ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA
		BUSINESS PHONE:		011 44 20 7304 5000

	MAIL ADDRESS:	
		STREET 1:		1 FRANCIS CRICK AVENUE
		STREET 2:		CAMBRIDGE BIOMEDICAL CAMPUS
		CITY:			CAMBRIDGE
		STATE:			X0
		ZIP:			CB2 0AA

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	ZENECA GROUP PLC
		DATE OF NAME CHANGE:	19930422
</SEC-HEADER>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a5007o.htm
<DESCRIPTION>BRILINTA APPROVED IN THE US TO REDUCE THE RISK OF A FIRST HEART ATTACK OR STROKE IN HIGH-RISK PATIENTS WITH CORONARY ARTERY DISEASE
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<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
</font><font style="color: rgb(0, 0, 0);">Brilinta&#xA0;approved in
the US to reduce the risk of a first heart attack or stroke in
high-risk patients with coronary artery disease</font></font></div>
</div>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<font style="font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
1 June 2020 07:00 BST</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;approved in the US to reduce the risk of a
first heart</font></font> <font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
attack or stroke in high-risk patients with coronary artery
disease</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
New Brilinta indication expands treatment to high-risk coronary
patients without a history of stroke or heart attack</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;(ticagrelor) has been approved in the US to
reduce the risk of a first heart attack or&#xA0;stroke&#xA0;in
high-risk patients with coronary artery disease (CAD),
the&#xA0;most common type of heart disease.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The approval by the US Food and Drug Administration (FDA) was based
on positive results from the Phase III THEMIS trial. The trial
showed a statistically significant reduction in the primary
composite endpoint of major adverse cardiovascular (CV) events at
36 months with aspirin plus&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;60mg versus aspirin alone in patients with
CAD and type-2 diabetes (T2D) at high-risk of a first heart attack
or stroke.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;The
primary composite endpoint was driven by a reduction in heart
attack and stroke</font><font style="font-style: italic; color: #000000">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
This is the first regulatory approval for aspirin
plus&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;dual antiplatelet therapy in patients who
have a high CV risk, but without a history of heart attack or
stroke.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Deepak L. Bhatt, MD, MPH, THEMIS trial Co-Chair, Executive Director
of Interventional Cardiovascular Programs at Brigham and Women's
Hospital, and Professor of Medicine at Harvard Medical School,
Boston, US said: "Coronary artery disease is a potentially
life-threatening condition that causes significant morbidity in
many people. The addition of ticagrelor to aspirin offers a new
therapeutic option to decrease the likelihood of both heart attack
and stroke, a significant advance in our ability to treat these
high-risk patients."</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Gabriel Steg, MD, THEMIS trial Co-Chair and Professor at
Universit&#xE9; de Paris, said: "THEMIS for ticagrelor was a large,
multi-national trial of more than 19,000 patients with coronary
artery disease and type-2 diabetes. Around one third of patients
with coronary artery disease have type-2 diabetes, putting them at
higher risk of heart attack or stroke, than patients without
diabetes. Today's approval brings new hope to patients at risk of
experiencing a first heart attack or stroke."</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Ruud Dobber, Executive Vice President, BioPharmaceuticals Business
Unit, said: "Today's approval of&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;is important news for patients with coronary
artery disease who will now have a new therapy option to reduce the
risk of a first heart attack or stroke. This new indication is a
further testament to&#xA0;the overwhelming science
supporting&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;in the management of patients with coronary
artery disease at high risk for cardiovascular
events."</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The THEMIS trial demonstrated the relative risk reduction of the
composite endpoint of heart attack, stroke and CV death by 10%
(absolute risk reduction; 0.8%, 7.7% vs 8.5%) with aspirin plus
long-term&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;compared to aspirin alone in patients who
had CAD and T2D without a history of heart attack or
stroke.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;While
this indication is not limited to this setting, the efficacy
of&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;was established in a population with T2D in
the THEMIS trial.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;The
safety profile for&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;was consistent with the known profile of the
medicine with an increased risk of bleeding events
observed.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The data from the THEMIS trial and the THEMIS-PCI sub-analysis were
published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
New England Journal of Medicine</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
Lancet</font><font style="color: #000000">&#xA0;respectively.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Regulatory submissions to expand the approved indication
for&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;based on the THEMIS trial are also under
regulatory review in the EU, Japan and China.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca also recently announced the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">high-level
results</font><font style="color: #000000">&#xA0;from the Phase III
THALES trial that showed aspirin plus&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;90mg reduced the risk of the composite of
stroke and death at 30 days after an acute ischaemic stroke or
transient ischaemic attack, compared to aspirin
alone.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Brilinta&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">is approved in more
than 110 countries for the prevention of atherothrombotic events in
adult patients with acute coronary syndrome (ACS), and in more than
70 countries for the secondary prevention of CV events among
high-risk patients who have experienced a prior myocardial
infarction.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
CAD and T2D</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
CAD is the most common type of heart disease. Ischaemic heart
disease is the leading cause of healthy life years lost due to
disability in men and the second cause in women
worldwide.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3,4</font><font style="color: #000000">&#xA0;The
disease burden of atherosclerosis is significantly higher in
patients with CAD and T2D than in CAD patients without
T2D.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font></font></div>
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THEMIS</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
THEMIS is an AstraZeneca-sponsored, multi-national, randomised,
double-blinded&#xA0;Phase III&#xA0;trial in patients with CAD and
T2D with no prior heart attack or stroke. More than 19,000 patients
were randomised across 42 countries in Europe, Asia, Africa, North
and South America.&#xA0;THEMIS was designed to test the hypothesis
that&#xA0;aspirin plus&#xA0;</font><font style="font-style: italic; color: #000000">Brilinta</font><font style="color: #000000">&#xA0;60mg twice daily would reduce MACE (major
adverse cardiac events), compared with aspirin alone. CAD was
defined as a percutaneous coronary intervention (PCI), bypass
surgery, or at least a 50% narrowing of a coronary artery.
Additionally,&#xA0;THEMIS-PCI is a clinically meaningful and
prespecified sub-analysis of patients (11,154 which is 58% of total
patients) who had previously undergone percutaneous coronary
intervention (PCI).</font></font></div>
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Brilinta</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Brilinta</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;(ticagrelor) is
an oral, reversible, direct-acting P2Y12 receptor antagonist that
works by inhibiting platelet activation.&#xA0;</font><font style="font-style: italic; color: #000000; background-color: #FFFFFF">Brilinta</font><font style="color: #000000; background-color: #FFFFFF">,
together with aspirin, has been shown to significantly reduce the
risk of MACE defined as&#xA0;myocardial infarction (MI, heart
attack), stroke or CV death, in patients with ACS or a history of
MI.</font></font></div>
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Brilinta</font><font style="color: #000000; background-color: #FFFFFF">, co-administered with
aspirin is indicated for the prevention of atherothrombotic events
in adult patients with ACS, or for patients with a history of MI
and a high risk of developing an atherothrombotic
event.</font></font></div>
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AstraZeneca</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca&#xA0;(LSE/STO/NYSE: AZN)&#xA0;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 -
Oncology, Cardiovascular, Renal &amp; Metabolism, and Respiratory
&amp; Immunology. Based in Cambridge, UK, AstraZeneca operates in
over 100 countries and its innovative medicines are used by
millions of patients worldwide. Please
visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
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Contacts</font></div>
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For details on how to contact the Investor Relations Team, please
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References</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
1. Bhatt D.L et al. Ticagrelor in patients with diabetes and stable
coronary artery disease with a history of previous percutaneous
coronary intervention (THEMIS-PCI): A phase 3, placebo-controlled,
randomised trial.&#xA0;</font><font style="font-style: italic; color: #000000">Lancet</font><font style="color: #000000">&#xA0;2019; 394:1169-1180</font><font style="font-style: italic; color: #000000">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
2. Brilinta (ticagrelor) prescribing information. AstraZeneca
Pharmaceuticals LP.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">
3. NIH National Heart, Lung, and Blood Institute. Ischemic heart
disease: Also known as coronary artery disease, coronary heart
disease, coronary microvascular disease [cited 2019 Feb 4].
Available from: URL:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.nhlbi.nih.gov/health-topics/ischemic-heart-disease</font><font style="color: #000000; font-size: 13px">.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
4. Kyu HH et al. Global, regional, and national disability-adjusted
life-years (DALYs) for 359 diseases and injuries and healthy life
expectancy (HALE) for 195 countries and territories, 1990-2017: A
systematic analysis for the Global Burden of Disease Study
2017.&#xA0;</font><font style="font-style: italic; color: #000000">Lancet</font><font style="color: #000000">&#xA0;2018;
392(10159):1859-922.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
5. Arnold S.V.&#xA0; et al.&#xA0; Clinical management of stable
coronary artery disease in patients with type 2 diabetes mellitus:
A scientific statement from the American Heart
Association.&#xA0;</font><font style="font-style: italic; color: #000000">Circulation.</font><font style="color: #000000">&#xA0;2020;
141:e779-e806.</font></font></div>
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Adrian Kemp</font></div>
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Company Secretary</font></div>
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AstraZeneca PLC</font></div>
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SIGNATURES</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">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.</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
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<font style="font-family: Times New Roman; font-size: 13px">Date:
01 June 2020</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
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<font style="font-family: Times New Roman; font-size: 13px">Name:
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