<SEC-DOCUMENT>0001654954-22-010018.txt : 20220725
<SEC-HEADER>0001654954-22-010018.hdr.sgml : 20220725
<ACCEPTANCE-DATETIME>20220725084355
ACCESSION NUMBER:		0001654954-22-010018
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20220725
FILED AS OF DATE:		20220725
DATE AS OF CHANGE:		20220725

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			ASTRAZENECA PLC
		CENTRAL INDEX KEY:			0000901832
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			X0
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		221101306

	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>a5305t.htm
<DESCRIPTION>TEZSPIRE RECOMMENDED FOR EU APPROVAL IN ASTHMA
<TEXT>
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AstraZeneca PLC</font></div>
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TO EXHIBITS</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Tezspire recommended for EU approval in asthma</font></div>
</div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
25 July 2022 07:10 BST</font></div>
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&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; font-style: italic; color: #000000; font-size: 13px">
Tezspire</font><font style="color: #000000">&#xA0;</font><font style="font-weight: bold; color: #000000; font-size: 13px">recommended
for approval in the EU by CHMP for the treatment
of</font><font style="color: #000000">&#xA0;</font><font style="font-weight: bold; color: #000000; font-size: 13px">severe
asthma</font></font></div>
<div style="text-align: left; 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>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
First and only biologic recommended for EU approval in patients
with severe asthma with no phenotype or biomarker
limitations</font></div>
<div style="text-align: left; 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-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca's&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;(tezepelumab) has been recommended for
marketing authorisation in the European Union (EU) as an add-on
therapy in patients 12 years and older with severe asthma who are
inadequately controlled with high dose inhaled corticosteroids plus
another medicinal product for maintenance
treatment.</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 Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on results
from the PATHFINDER clinical trial programme. The marketing
authorisation&#xA0;application included results from the pivotal
NAVIGATOR Phase III trial in which&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;demonstrated superiority across every
primary and key secondary endpoint in patients with severe asthma,
compared to placebo, when added to standard
therapy.</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="font-style: italic; color: #000000">
Tezspire</font><font style="color: #000000">&#xA0;is the first and
only biologic for severe asthma that acts at the top of the
inflammatory cascade by blocking thymic stromal lymphopoietin
(TSLP), an epithelial cytokine.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1-4</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;consistently
and significantly reduced asthma exacerbations across Phase II and
III clinical trials, which included a broad population of severe
asthma patients irrespective of key biomarkers, including blood
eosinophil counts, allergic status and fractional exhaled nitric
oxide (FeNO).</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</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">
Dr. Stephanie Korn, Senior Physician in Pneumology and Respiratory
Medicine at IKF Pneumologie Mainz and Thoraxklinik Heidelberg,
Germany, and investigator for the NAVIGATOR trial&#xA0;said: "Due
to the complexity of severe asthma, about&#xA0;60% of patients have
multiple drivers of inflammation.&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;is&#xA0;a&#xA0;first-in-class&#xA0;biologic
acting at the top of the inflammation cascade and a much-needed
potential treatment for patients who continue to struggle with
severe, uncontrolled asthma</font><font style="color: #000000; background-color: #FFFFFF">."</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, AstraZeneca, said: "Despite recent advances in treatment,
many asthma patients continue to experience debilitating symptoms,
an increased risk of hospitalisation, and even death. The only
biologic recommended for EU approval in severe asthma patients with
no phenotype or biomarker limitation,&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;has consistently and significantly reduced
exacerbations in clinical trials, and has the potential to
transform care for a broad population of severe asthma
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">
Results from the NAVIGATOR Phase III trial 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;in May 2021. There were no clinically
meaningful differences in safety results between
the&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;and placebo groups in the NAVIGATOR
trial.</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">
In clinical trials, the most common adverse events in patients who
received&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;were pharyngitis, rash, arthralgia and
injection site reactions.</font><font style="font-size: 70%; vertical-align: top; color: #000000">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="font-style: italic; color: #000000">
Tezspire</font><font style="color: #000000">&#xA0;was
approved&#xA0;as an add-on maintenance treatment of adult and
paediatric patients&#xA0;aged 12 years and older with severe
asthma&#xA0;in the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">US</font><font style="color: #000000">&#xA0;in December 2021 and&#xA0;is under
regulatory review in Japan and&#xA0;many other countries around the
world.</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="text-decoration: underline; color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Notes</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">
Severe asthma</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">
Asthma is a heterogeneous disease affecting approximately 14
million people living with the disease in the European Union and an
estimated 339 million people worldwide.</font><font style="font-size: 70%; vertical-align: top; color: #000000">7,8</font><font style="color: #000000">&#xA0;Up
to 10% of asthma patients have severe asthma.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9,10</font><font style="color: #000000">&#xA0;Despite
the use of inhaled asthma controller medicine, currently available
biologic therapies and oral corticosteroids (OCS), many severe
asthma patients remain uncontrolled.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9-11</font><font style="color: #000000">&#xA0;Due
to the complexity of severe asthma, many patients have unclear or
multiple drivers of inflammation and may not qualify for or respond
well to a current biologic medicine.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10-13</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">
Severe, uncontrolled asthma is debilitating with patients
experiencing frequent exacerbations, significant limitations on
lung function and a reduced quality of life.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9,10,14</font><font style="color: #000000">&#xA0;Patients
with severe asthma are at an increased risk of mortality and
compared to patients with persistent asthma have twice the risk of
asthma-related hospitalisations.</font><font style="font-size: 70%; vertical-align: top; color: #000000">15-17</font><font style="color: #000000">&#xA0;There
is also a significant socio-economic burden, with these patients
accounting for approximately 50% of asthma-related
costs.</font><font style="font-size: 70%; vertical-align: top; color: #000000">18</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">
Clinical trials</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">
In addition to the Phase IIb PATHWAY trial, the PATHFINDER
programme included two Phase III trials,
NAVIGATOR</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,19</font><font style="color: #000000">&#xA0;and
SOURCE.</font><font style="font-size: 70%; vertical-align: top; color: #000000">20,21</font><font style="color: #000000">&#xA0;The
programme also includes additional mechanistic and long-term safety
trials.</font><font style="font-size: 70%; vertical-align: top; color: #000000">22,23</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
NAVIGATOR is a Phase III, randomised, double-blinded,
placebo-controlled trial in adults (18-80 years old) and
adolescents (12-17 years old) with severe, uncontrolled asthma, who
were receiving standard of care (SoC). SoC was treatment with
medium- or high-dose inhaled corticosteroids plus at least one
additional controller medication with or without daily OCS
treatment. The trial population included approximately equal
proportions of patients with high (&#x2265;300 cells per microlitre)
and low (&lt;300 cells per microlitre) blood eosinophil counts. The
trial comprised a five-to-six-week screening period, a 52-week
treatment period and a 12-week post-treatment follow-up period. All
patients received their prescribed controller medications without
change throughout the trial.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The primary efficacy endpoint was the annualised asthma
exacerbation rate (AAER) during the 52-week treatment period. Key
secondary endpoints included the effect of&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;on lung function, asthma control and
health-related quality of life.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
As part of prespecified analyses, the AAER over 52 weeks was also
assessed in patients grouped by baseline blood eosinophil count,
FeNO level and serum specific immunoglobin E (IgE) status
(perennial aeroallergen sensitivity positive or
negative).</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;These
are inflammatory biomarkers used by clinicians to inform treatment
options and involve tests analysing a patient's blood
(eosinophils/IgE) and exhaled air (FeNO).</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
There were no clinically meaningful differences in safety results
between the&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;and placebo groups in the NAVIGATOR
trial.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;The
most frequently reported adverse events
for&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;were
nasopharyngitis, upper respiratory tract infection and
headache.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
NAVIGATOR is the first Phase III trial to show benefit in severe
asthma irrespective of eosinophils by targeting
TSLP.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;These
results support the FDA Breakthrough Therapy Designation granted
to&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;in September 2018 for patients with severe
asthma, without an eosinophilic phenotype. In July
2021,&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;was the first and only biologic to be
granted&#xA0;</font><font style="text-decoration: underline; color: #0000FF">Priority
Review</font><font style="color: #000000">&#xA0;in the US for the
treatment of asthma by the FDA.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Patients who participated in our Phase III trials were eligible to
continue in DESTINATION, a Phase III extension trial assessing
long-term safety and efficacy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">22</font></font></div>
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<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
Tezspire</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Tezspire</font><font style="color: #000000">&#xA0;(tezepelumab) is
being developed by AstraZeneca in collaboration with Amgen as a
first-in-class human monoclonal antibody that inhibits the action
of TSLP, a key epithelial cytokine that sits at the top of multiple
inflammatory cascades and is critical in the initiation and
persistence of allergic, eosinophilic and other types of airway
inflammation associated with severe asthma, including airway
hyperresponsiveness.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3</font><font style="color: #000000">&#xA0;TSLP
is released in response to multiple triggers associated with asthma
exacerbations, including allergens, viruses and other airborne
particles.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,3</font><font style="color: #000000">&#xA0;Expression
of TSLP is increased in the airways of patients with asthma and has
been correlated with disease severity.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,4</font><font style="color: #000000">&#xA0;Blocking
TSLP may prevent the release of pro-inflammatory cytokines by
immune cells, resulting in the prevention of asthma exacerbations
and improved asthma control.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2,4</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;acts
at the top of the inflammation cascade and has the potential to
help address a broad population of severe asthma patients
irrespective of biomarker levels.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font></font></div>
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<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">
Tezspire</font><font style="color: #000000">&#xA0;is approved in
the US for the add-on maintenance treatment of adult and paediatric
patients aged 12 years and older with severe
asthma.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;is
also in development for other potential indications including
chronic obstructive pulmonary disease (COPD), chronic
rhinosinusitis with nasal polyps, chronic spontaneous urticaria and
eosinophilic esophagitis (EoE). In October 2021, tezepelumab was
granted&#xA0;</font><font style="text-decoration: underline; color: #0000FF">Orphan Drug
Designation</font><font style="color: #000000">&#xA0;by the FDA for
the treatment of EoE.</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Amgen collaboration</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In 2020, Amgen and AstraZeneca updated a&#xA0;</font><font style="text-decoration: underline; color: #0000FF">2012 collaboration
agreement</font><font style="color: #000000">&#xA0;for&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">. Both companies will continue to share costs and
profits equally after payment by AstraZeneca of a mid single-digit
inventor royalty to Amgen. AstraZeneca continues to lead
development and Amgen continues to lead manufacturing. All aspects
of the collaboration are under the oversight of joint governing
bodies. Under the amended agreement, Amgen and AstraZeneca will
jointly commercialise&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;in North America. Amgen will record product
sales in the US, with AZ recording its share of US profits as
Collaboration Revenue. Outside of the US, AstraZeneca will record
product sales, with Amgen recording profit share as
Other/Collaboration revenue.</font></font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in Respiratory &amp; Immunology</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Respiratory &amp; Immunology, part of BioPharmaceuticals, is one of
AstraZeneca's main disease areas and is a key growth driver for the
Company.</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca is an established leader in respiratory care with a
50-year heritage. The Company aims to transform the treatment of
asthma and COPD by focusing on earlier biology-led treatment,
eliminating preventable asthma attacks, and removing COPD as a
top-three leading cause of death. The Company's early respiratory
research is focused on emerging science involving immune
mechanisms, lung damage and abnormal cell-repair processes in
disease and neuronal dysfunction.</font></div>
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&#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">
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immunology-driven disease areas. The
Company's growing presence in immunology is focused on five mid- to
late-stage franchises with multi-disease potential, in areas
including rheumatology (including systemic lupus erythematosus),
dermatology, gastroenterology, and systemic eosinophilic-driven
diseases. AstraZeneca's ambition in Respiratory &amp; Immunology is
to achieve disease modification and durable remission for millions
of patients worldwide.</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000; font-size: 13px">
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
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; font-size: 13px">astrazeneca.com</font><font style="color: #000000; font-size: 13px">&#xA0;and
follow the Company on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">@AstraZeneca</font></font></div>
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References</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; background-color: #FFFFFF; font-weight: bold; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">5.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">European
Medicines Agency. Tezspire Summary of Committee for Medicinal
Products for Human Use Opinion Available at:</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF; background-color: #FFFFFF">https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tezspire</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">[Last
accessed: July 2022].</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">6.&#xA0;&#xA0;&#xA0;</font><font style="font-style: italic; color: #000000">Tezspire</font><font style="color: #000000">&#xA0;(tezepelumab) US prescribing information;
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">9.&#xA0;&#xA0; Chung KF,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">et
al</font><font style="font-style: italic; color: #000000">.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">International
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">10.&#xA0; Wenzel S. Severe asthma in
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">11.&#xA0; Peters SP,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">et
al</font><font style="font-style: italic; color: #000000">.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Uncontrolled
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Med</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">2006:100:1139-1151.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">12.&#xA0; Hyland ME</font><font style="font-style: italic; color: #000000">, et al.</font><font style="color: #000000">&#xA0;A Possible Explanation for Non-responders,
Responders and Super-responders to Biologics in Severe
Asthma.&#xA0;</font><font style="font-style: italic; color: #000000">Explor Res Hypothesis
Med.</font><font style="color: #000000">&#xA0;2019;4:35-38.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">13.&#xA0; Tran TN</font><font style="font-style: italic; color: #000000">, et al.</font><font style="color: #000000">&#xA0;Overlap of atopic, eosinophilic, and
TH2-high asthma phenotypes in a general population with current
asthma.&#xA0;</font><font style="font-style: italic; color: #000000">Ann Allergy Asthma
Immunol</font><font style="color: #000000">.
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