<SEC-DOCUMENT>0001654954-19-010072.txt : 20190828
<SEC-HEADER>0001654954-19-010072.hdr.sgml : 20190828
<ACCEPTANCE-DATETIME>20190828082605
ACCESSION NUMBER:		0001654954-19-010072
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20190828
FILED AS OF DATE:		20190828
DATE AS OF CHANGE:		20190828

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:		191059263

	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>a3736k.htm
<DESCRIPTION>BREZTRI AEROSPHERE PHASE III ETHOS TRIAL MET ITS PRIMARY ENDPOINT IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE
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TO EXHIBITS</font></div>
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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">Breztri
Aerosphere Phase III ETHOS trial met its primary endpoint in
chronic obstructive pulmonary disease</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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&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
This announcement contains inside information</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
28 August 2019 07:00 BST</font></div>
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&#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">Breztri
Aerosphere&#xA0;</font><font style="color: #000000">Phase III ETHOS
trial met its primary endpoint in chronic obstructive pulmonary
disease</font></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">
&#xA0;</font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
At both standard and low budesonide doses, the triple-combination
therapy showed a statistically-significant reduction in the rate of
moderate or severe exacerbations compared with dual-combination
therapies</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">
&#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">
First time the benefit of two doses of a fixed triple-combination
therapy has been established in a Phase III chronic obstructive
pulmonary disease trial</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">
&#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 today announced positive results from the Phase III
ETHOS trial for triple-combination therapy&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">, formerly PT010, in
patients with moderate to very severe chronic obstructive pulmonary
disease (COPD).</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">
At the standard budesonide dose,&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">&#xA0;(budesonide/glycopyrronium/formoterol
fumarate 320/14.4/9.6mcg)&#xA0;demonstrated a
statistically-significant reduction in the rate of
moderate&#xA0;or&#xA0;severe exacerbations compared with
dual-combination therapies&#xA0;</font><font style="font-style: italic; color: #000000">Bevespi
Aerosphere</font><font style="color: #000000">(glycopyrronium/formoterol fumarate 14.4/9.6mcg)
and PT009 (budesonide/formoterol fumarate
320/9.6mcg).</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-style: italic; 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">
At half of the budesonide dose,&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">&#xA0;(budesonide/glycopyrronium/formoterol
fumarate 160/14.4/9.6mcg) also&#xA0;demonstrated a
statistically-significant reduction in the rate of moderate or
severe exacerbations compared with&#xA0;</font><font style="font-style: italic; color: #000000">Bevespi
Aerosphere</font><font style="color: #000000">&#xA0;and
PT009.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-style: italic; 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 dual-combination therapies used as comparators in the trial
represent recommended&#xA0;therapeutic classes for the treatment of
COPD.</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">
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&amp;D, said: "Exacerbations are devastating events for patients
and&#xA0;can lead to a permanent loss of lung function. The Phase
III ETHOS trial builds on the Phase III KRONOS data which together
show&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere's</font><font style="color: #000000">ability to reduce
exacerbation risk in a broad range of patients with COPD,
irrespective of whether they have had an exacerbation in the
previous twelve months. We look forward to sharing these results
with health authorities as soon as possible."</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">
Klaus Rabe, Professor of Pulmonary Medicine at the University of
Kiel, Director of the Department of Pneumology at Clinic
Grosshansdorf, Germany, and Lead Investigator of the ETHOS trial,
said: "The Phase III ETHOS trial results are exciting and
demonstrate that&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">significantly reduces
the rate of exacerbations. This is also the first time we have seen
the benefit of fixed-dose triple-combination therapy at two inhaled
corticosteroid doses, which could transform treatment practice by
allowing physicians to select the optimal dose for individual
patients."</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 safety and tolerability of&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">&#xA0;were consistent
with the known profiles of the dual comparators. In the trial, all
combination therapies were administered in a pressurised
metered-dose inhaler (pMDI) using&#xA0;</font><font style="font-style: italic; color: #000000">Aerosphere</font><font style="color: #000000">&#xA0;delivery technology.</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 ETHOS trial results will be presented at an upcoming medical
meeting.&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">has been approved in
Japan and is under regulatory review in China, where it has been
granted Priority Review by the National Medical Products
Administration. It is also under regulatory review in the US and
EU.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About ETHOS</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">
ETHOS is a randomised, double-blinded, multi-centre,
parallel-group, 52-week trial to assess the efficacy and safety
of&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">&#xA0;in symptomatic
patients with moderate to very severe COPD and a history of
exacerbation(s) in the previous year.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;Outcomes
in the ETHOS trial included, as a primary endpoint, the rate of
moderate or severe exacerbations. Full trial design details are
published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">Respiratory
Medicine</font><font style="font-style: italic; color: #000000">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</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">
Bevespi Aerosphere</font><font style="color: #000000">&#xA0;is a
fixed-dose dual bronchodilator in a pMDI, combining glycopyrronium,
a&#xA0;long-acting&#xA0;muscarinic antagonist&#xA0;(LAMA), and
formoterol fumarate, a long-acting beta2-agonist (LABA). PT009 is a
single inhaler, fixed-dose dual-combination therapy of budesonide,
an inhaled corticosteroid (ICS), and formoterol fumarate, a LABA.
It was developed as a relevant comparator in clinical trials
for&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4,5</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">
ETHOS involved more than 8,500 patients who had&#xA0;experienced
&#x2265;1 moderate/severe exacerbation in the previous year and were
receiving at least two inhaled maintenance treatments at entry into
the trial.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3</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>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About the ATHENA clinical trial programme</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">
ATHENA is AstraZeneca's Phase III clinical trial programme
for&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">, which includes more
than 15,500 patients globally across 11 trials.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3,4,5,6</font><font style="color: #000000">&#xA0;The
four key trials are ETHOS, KRONOS,&#xA0;TELOS and
SOPHOS.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3,4,5,6</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-size: 70%; vertical-align: top; color: #000000; font-family: Times New Roman">
&#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">
KRONOS is a Phase III randomised, double-blinded, parallel-group,
24-week, chronic-dosing, multi-centre trial that assessed the
efficacy and safety of&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">. The trial
compared&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">&#xA0;with&#xA0;</font><font style="font-style: italic; color: #000000">Bevespi
Aerosphere</font><font style="color: #000000">,&#xA0;</font><font style="font-style: italic; color: #000000">Symbicort
Turbuhaler</font><font style="color: #000000">&#xA0;(budesonide/formoterol fumarate) and PT009.
Patients were given two inhalations twice a day
of&#xA0;</font><font style="font-style: italic; color: #000000">Breztri
Aerosphere</font><font style="color: #000000">,&#xA0;</font><font style="font-style: italic; color: #000000">Bevespi
Aerosphere</font><font style="color: #000000">,&#xA0;</font><font style="font-style: italic; color: #000000">Symbicort
Turbuhaler</font><font style="color: #000000">&#xA0;or PT009.
KRONOS involved approximately 1,900 patients with moderate to very
severe COPD.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</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: 16px"><font style="color: #000000; font-size: 13px">
In the KRONOS trial,&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Breztri</font><font style="color: #000000; font-size: 13px">&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Aerosphere</font><font style="color: #000000; font-size: 13px">&#xA0;met
six of seven primary endpoints versus dual comparators, and PT009
met two non-inferiority endpoints to support the qualification of
PT009 as an active comparator. As published
in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF; font-size: 13px">The
Lancet Respiratory Medicine</font><font style="color: #000000; font-size: 13px">, in a key secondary
endpoint,&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Breztri</font><font style="color: #000000; font-size: 13px">&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Aerosphere</font><font style="color: #000000; font-size: 13px">&#xA0;showed
a statistically-significant 52% reduction in the rate of moderate
or severe COPD exacerbations compared with&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Bevespi
Aerosphere</font><font style="color: #000000; font-size: 13px">&#xA0;in a patient population
that was not required to have had an exacerbation in the previous
12 months.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font><font style="color: #000000; font-size: 13px">&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Breztri
Aerosphere</font><font style="color: #000000; font-size: 13px">&#xA0;also demonstrated
reductions in the rate of moderate or severe COPD exacerbations
versus PT009 and&#xA0;</font><font style="font-style: italic; color: #000000; font-size: 13px">Symbicort
Turbuhaler</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; font-size: 13px">(18%
and 17% respectively), which were numerically but not
statistically-significant improvements. The incidence of
adjudicated pneumonia was low and comparable in all treatment
arms.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font><font style="color: #000000; font-size: 13px">&#xA0;The
primary and secondary endpoints and treatment comparisons in the
KRONOS trial differed according to regional regulatory
requirements.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</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-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">About&#xA0;</font><font style="font-style: italic; color: #000000">Breztri</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Aerosphere</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="font-style: italic; color: #000000">
Breztri Aerosphere</font><font style="color: #000000">&#xA0;has
been approved in Japan and is under regulatory review for approval
in China, where it has been granted Priority Review by the National
Medical Products Administration. It is also under review in the US
and EU.</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">
Under the terms of the agreement to acquire Pearl Therapeutics
Inc., AstraZeneca anticipates making a $150m milestone payment upon
US regulatory approval of&#xA0;</font><font style="font-style: italic; color: #000000">Breztri</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Aerosphere</font><font style="color: #000000">&#xA0;for COPD. This payment would be the final
development and regulatory milestone under that
agreement.</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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About COPD</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">
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;It
affects an estimated 384 million people worldwide and is predicted
to be the third leading cause of death by 2020.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,7</font><font style="color: #000000">&#xA0;Improving
lung function, reducing exacerbations and managing daily symptoms
such as breathlessness are important treatment goals in the
management of COPD.</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="font-weight: bold; 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-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About AstraZeneca in respiratory diseases</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">
Respiratory is one of AstraZeneca's main therapy areas, and our
medicines reached more than 18 million patients as maintenance
therapy in 2018. AstraZeneca's aim is to transform asthma and COPD
treatment&#x202F;through inhaled combinations at the core of care,
biologics for the unmet needs of specific patient populations, and
scientific advancements in disease modification.</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 Company is building on a 40-year heritage in respiratory
disease and AstraZeneca's capability in inhalation technology spans
pressurised metered-dose inhalers and dry powder inhalers, as well
as the&#xA0;</font><font style="font-style: italic; color: #000000">Aerosphere</font><font style="color: #000000">&#xA0;delivery technology. The company also has a
growing portfolio of respiratory biologics
including&#xA0;</font><font style="font-style: italic; color: #000000">Fasenra</font><font style="color: #000000">&#xA0;(anti-eosinophil, anti-IL-5 receptor alpha),
now approved for severe, eosinophilic asthma and in development for
severe nasal polyposis and other potential indications, and
tezepelumab (anti-TSLP), which has been granted Breakthrough
Therapy Designation by the US Food and Drug Administration in
patients with severe asthma and is in Phase III trials.
AstraZeneca's research aims at addressing underlying disease
drivers by focusing on the lung epithelium, lung immunity, lung
regeneration and neuronal functions.</font></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: 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">
About AstraZeneca</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 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, CVRM and Respiratory. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide. For more information,
please visit</font><font style="text-decoration: underline; color: #0000FF">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #0000FF">&#xA0;</font><font style="color: #000000">and
follow us on Twitter</font><font style="color: #0000FF">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="color: #0000FF">.</font></font></div>
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References</font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">1.&#xA0;&#xA0; GOLD. Global
Strategy for the Diagnosis, Management and Prevention of COPD,
Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2019.
[Online]. Available at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">http://goldcopd.org</font><font style="color: #000000; font-size: 13px">.
Last accessed: August 2019.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">2.&#xA0;&#xA0;
Clinicaltrials.gov. Study to Assess the Efficacy and Safety of
PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very
Severe COPD (ETHOS). [Online]. Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://clinicaltrials.gov/ct2/show/NCT02465567</font><font style="font-size: 13px">.</font><font style="color: #000000; font-size: 13px">&#xA0;Last
accessed: August 2019.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">3.&#xA0;&#xA0;&#xA0;Rabe K, Martinez F, Ferguson
G,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">.&#xA0;A Phase III study of
triple therapy with budesonide/glycopyrrolate/formoterol fumarate
metered dose inhaler 320/18/9.6&#xB5;g and 160/18/9.6&#xB5;g using
co-suspension delivery technology in moderate-to-severe COPD: The
ETHOS study protocol.&#xA0;</font><font style="font-style: italic; color: #000000">Respir Med.</font><font style="color: #000000">&#xA0;2019; Epub ahead of print
(DOI:https://doi.org/10.1016/j.rmed.2019.08.010).</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">4.&#xA0;&#xA0;
Clinicaltrials.gov. Study to Assess Efficacy and Safety of PT009
Compared to PT005, PT008, and Symbicort</font><font style="font-size: 70%; vertical-align: top; color: #000000">&#xAE;</font><font style="color: #000000; font-size: 13px">&#xA0;Turbuhaler</font><font style="font-size: 70%; vertical-align: top; color: #000000">&#xAE;</font><font style="color: #000000; font-size: 13px">&#xA0;on
Lung Function Over 24-Weeks in Subjects With Moderate to Very
Severe COPD (TELOS). [Online]. Available
at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://clinicaltrials.gov/ct2/show/NCT02766608</font><font style="color: #000000; font-size: 13px">.
Last accessed: August 2019.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">5.&#xA0;&#xA0;
Clinicaltrials.gov. A Study to Assess the Efficacy and Safety of
PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period
in Subjects With Moderate to Very Severe COPD (SOPHOS). [Online].
Available at:&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://clinicaltrials.gov/ct2/show/NCT02727660</font><font style="color: #000000; font-size: 13px">.
Last accessed: August 2019.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">6.&#xA0;&#xA0;&#xA0;Ferguson GT, Rabe KF, Martinez
FJ,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">.&#xA0;Triple combination of
budesonide/glycopyrrolate /formoterol fumarate using co-suspension
delivery technology versus dual therapies in chronic obstructive
pulmonary disease (KRONOS): a double-blind, parallel-group,
randomised controlled trial.&#xA0;</font><font style="font-style: italic; color: #000000">Lancet Respir
Med</font><font style="color: #000000">. 2018; 6:
747-758.</font></font></div>
<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">7.&#xA0;&#xA0; Adeloye D, Chua S, Lee
C,&#xA0;</font><font style="font-style: italic; color: #000000">et
al.</font><font style="color: #000000">&#xA0;Global Health
Epidemiology Reference Group (GHERG). Global and regional estimates
of COPD prevalence: Systematic review and
meta-analysis.&#xA0;</font><font style="font-style: italic; color: #000000">J Glob
Health</font><font style="color: #000000">. 2015; 5:
020415.</font></font></div>
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<font style="text-decoration: underline; font-family: Times New Roman; font-size: 13px">
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:
<font style="font-weight: bold; font-size: 13px">28 August
2019</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
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