<SEC-DOCUMENT>0001654954-19-008191.txt : 20190712
<SEC-HEADER>0001654954-19-008191.hdr.sgml : 20190712
<ACCEPTANCE-DATETIME>20190712063700
ACCESSION NUMBER:		0001654954-19-008191
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20190712
FILED AS OF DATE:		20190712
DATE AS OF CHANGE:		20190712

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:		19952035

	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>a3075f.htm
<DESCRIPTION>IMFINZI GRANTED US ORPHAN DRUG DESIGNATION FOR SMALL CELL LUNG CANCER
<TEXT>
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<font style="font-family: Times New Roman; font-size: 13px">SECURITIES
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<font style="font-family: Times New Roman; font-size: 13px">Washington,
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<font style="font-family: Times New Roman; font-size: 13px">For the
month of <font style="font-size: 13px">July
2019</font></font></div>
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AstraZeneca PLC</font></div>
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Francis Crick Avenue</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Cambridge
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CB2 0AA</font></div>
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assigned to the Registrant in connection with Rule 12g3-2(b):
82-_____________</font></div>
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AstraZeneca PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</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">Imfinzi
granted US Orphan Drug Designation for small cell lung
cancer&#xA0;</font></div>
<div style="text-align: left; 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">12 July
2019 07:00 BST</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">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; font-style: italic; color: #000000">
Imfinzi</font><font style="font-weight: bold; color: #000000">&#xA0;granted US Orphan Drug
Designation for</font><font style="color: #000000">&#xA0;</font><font style="font-weight: bold; color: #000000">small cell lung
cancer</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 today announced that the US Food and Drug
Administration (FDA) has granted Orphan Drug Designation (ODD)
to&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;(durvalumab) for the treatment of small cell
lung cancer (SCLC).</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">&#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">
SCLC constitutes about 15% of all lung cancer diagnoses. It is the
most aggressive type of lung cancer with only 6% of patients alive
after five years. The FDA grants ODD status to medicines and
potential new medicines intended for the treatment, diagnosis or
prevention of rare diseases or disorders that affect fewer than
200,000 people in the US.</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 June 2019, the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">Phase III CASPIAN
trial</font><font style="color: #000000">&#xA0;met its primary
endpoint with&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;by showing a statistically-significant and
clinically-meaningful improvement in overall survival for patients
with extensive-stage SCLC. These patients were treated
with&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;in combination with&#xA0;standard-of-care
etoposide and&#xA0;platinum-based chemotherapy vs. chemotherapy
alone. Results will be shared at a forthcoming medical
meeting.&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is also being tested following concurrent
chemoradiation therapy in limited-stage SCLC in the Phase III
ADRIATIC trial.</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">
Jos&#xE9; Baselga, Executive Vice President, R&amp;D Oncology said:
"This Orphan Drug Designation comes on the heels of positive
results from the Phase III CASPIAN trial,&#xA0;which is the first
trial to offer the flexibility of combining immunotherapy with
different platinum-based regimens in small cell lung cancer. We are
eager to&#xA0;expand treatment options&#xA0;for
patients&#xA0;facing such a devastating diagnosis&#xA0;and look
forward to&#xA0;working with regulatory authorities to bring
forward new options as soon as possible."</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">
Imfinzi</font><font style="color: #000000">&#xA0;is currently
approved for unresectable, Stage III non-small cell lung cancer
(NSCLC) after chemotherapy and radiation therapy in more than 45
countries including the US, EU, and Japan based on the Phase III
PACIFIC trial.</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 small cell lung cancer</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">
Lung cancer is the leading cause of cancer death among both men and
women and accounts for about one-fifth of all cancer
deaths.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;Lung
cancer is broadly split into NSCLC and SCLC, with about 15%
classified as SCLC.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;About
two-thirds of SCLC patients are diagnosed with extensive-stage
disease, in which the cancer has spread widely through the lung or
to other parts of the body.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font><font style="color: #000000">&#xA0;SCLC
is an aggressive, fast-growing cancer that recurs and progresses
rapidly despite initial response to platinum-based
chemotherapy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4</font><font style="color: #000000">&#xA0;Prognosis
is particularly poor, as only 6% of all SCLC patients will be alive
five years after diagnosis.</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-weight: bold; font-family: Times New Roman; font-size: 13px">
<font style="color: #000000">About&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</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">
Imfinzi</font><font style="color: #000000">&#xA0;(durvalumab) is a
human monoclonal antibody that binds to PD-L1 and blocks the
interaction of PD-L1 with PD-1 and CD80, countering the tumour's
immune-evading tactics and releasing the inhibition of immune
responses.</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">
Imfinzi</font><font style="color: #000000">&#xA0;is also approved
for previously-treated patients with advanced bladder cancer in the
US, Canada, Brazil, Australia, Israel, India, United Arab Emirates,
Qatar, Macau and Hong Kong.</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">
As part of a broad development programme,&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;is also being tested as a monotherapy and in
combination with tremelimumab, an anti-CTLA4 monoclonal antibody
and potential new medicine, as a treatment for patients with NSCLC,
small-cell lung cancer (SCLC), bladder cancer, head and neck
cancer, liver cancer, cervical cancer, biliary tract cancer and
other solid tumours.</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 AstraZeneca in lung cancer</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 has a comprehensive portfolio of approved and potential
new medicines in late-stage clinical development for the treatment
of different forms of lung cancer spanning several stages of
disease and lines of therapy. We aim to address the unmet needs of
patients with EGFR-mutated tumours as a genetic driver of disease,
which occur in 10-15% of NSCLC patients in the US and EU and 30-40%
of NSCLC patients in Asia, with our approved
medicines&#xA0;</font><font style="font-style: italic; color: #000000">Iressa</font><font style="color: #000000">&#xA0;(gefitinib) and&#xA0;</font><font style="font-style: italic; color: #000000">Tagrisso</font><font style="color: #000000">&#xA0;(osimertinib) and ongoing Phase III trials
FLAURA, ADAURA and LAURA as well as the Phase II exploratory
combination trials SAVANNAH and ORCHARD.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5-7</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">
Our extensive late-stage Immuno-Oncology programme focuses on lung
cancer patients without a known genetic mutation which represents
up to 50% of all patients with lung
cancer.&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;(durvalumab),
an anti-PDL1 antibody is in development as monotherapy (Phase III
trials ADJUVANT BR.31, PACIFIC-4, PACIFIC-5, and PEARL) and in
combination with tremelimumab and/or chemotherapy (AEGEAN,
PACIFIC-2, NEPTUNE, POSEIDON, ADRIATIC and CASPIAN Phase III
trials).</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's approach to Immuno-Oncology (IO)</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">
IO is a therapeutic approach designed to stimulate the body's
immune system to attack tumours. Our IO portfolio is anchored by
immunotherapies that have been designed to overcome anti-tumour
immune suppression. We believe that IO-based therapies offer the
potential for life-changing cancer treatments for the clear
majority of 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="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
We are pursuing a comprehensive clinical-trial programme that
includes&#xA0;</font><font style="font-style: italic; color: #000000">Imfinzi</font><font style="color: #000000">&#xA0;(anti-PDL1) as monotherapy and in
combination with tremelimumab (anti-CTLA4) in multiple tumour
types, stages of disease, and lines of therapy, using the PD-L1
biomarker as a decision-making tool to define the best potential
treatment path for a patient. In addition, the ability to combine
our IO portfolio with small, targeted molecules from across our
Oncology pipeline, and from our research partners, may provide new
treatment options across a broad range of
tumours.</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">
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AstraZeneca has a deep-rooted heritage in Oncology and offers a
quickly-growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, we
are committed to advance Oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to our core capabilities, we actively pursue innovative
partnerships and investments that accelerate the delivery of our
strategy as illustrated by our investment in Acerta Pharma in
haematology.</font></div>
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By harnessing the power of four scientific platforms -
Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates - and by championing the development
of personalised combinations, AstraZeneca has the vision to
redefine cancer treatment and one day eliminate cancer as a cause
of death.</font></div>
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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, Cardiovascular, Renal &amp;
Metabolism 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;astrazeneca.com</font><font style="color: #000000">&#xA0;and
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References</font></div>
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1. World Health Organization. International Agency for Research on
Cancer. Available at</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">http://globocan.iarc.fr/Pages/fact_sheets_population.aspx</font><font style="color: #000000; font-size: 13px">.
Accessed May 2019.</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; font-size: 13px">
2. LUNGevity Foundation. Types of Lung Cancer. Available
at&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer</font><font style="color: #000000; font-size: 13px">.
Accessed May 2019.</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; font-size: 13px">
3. Cancer.Net. Lung Cancer - Small Cell. Available
at&#xA0;</font><font style="text-decoration: underline; color: #0000FF; font-size: 13px">https://www.cancer.net/cancer-types/33776/view-all</font><font style="color: #000000; font-size: 13px">.
Accessed May 2019.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
4. Kalemkerian GP,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;Treatment Options for Relapsed Small-Cell
Lung Cancer: What Progress Have We Made?</font><font style="font-style: italic; color: #000000">Journal of Oncology
Practice</font><font style="color: #000000">, volume 14, issue no.
6 (June 1 2018) 369-370.</font></font></div>
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5. Szumera-Cie&#x107;kiewicz A,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;EGFR Mutation Testing on Cytological and
Histological Samples in Non-Small Cell Lung Cancer: a Polish,
Single Institution Study and Systematic Review of European
Incidence.&#xA0;</font><font style="font-style: italic; color: #000000">Int J Clin Exp
Pathol</font><font style="color: #000000">. 2013:6;2800-12.
Accessed May 2019.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
6. Keedy VL,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;American Society of Clinical Oncology
Provisional Clinical Opinion: Epidermal Growth Factor Receptor
(EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell
Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor
Therapy.&#xA0;</font><font style="font-style: italic; color: #000000">J Clin
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Accessed May 2019.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
7. Ellison G,&#xA0;</font><font style="font-style: italic; color: #000000">et al.</font><font style="color: #000000">&#xA0;EGFR Mutation Testing in Lung Cancer: a
Review of Available Methods and Their Use for Analysis of Tumour
Tissue and Cytology Samples.&#xA0;</font><font style="font-style: italic; color: #000000">J Clin
Pathol</font><font style="color: #000000">. 2013:66;79-89. Accessed
May 2019.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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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
PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold; font-size: 13px">12 July
2019</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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