<SEC-DOCUMENT>0001654954-19-013275.txt : 20191121
<SEC-HEADER>0001654954-19-013275.hdr.sgml : 20191121
<ACCEPTANCE-DATETIME>20191121145224
ACCESSION NUMBER:		0001654954-19-013275
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20191121
FILED AS OF DATE:		20191121
DATE AS OF CHANGE:		20191121

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:		191237232

	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>a2857u.htm
<DESCRIPTION>CALQUENCE APPROVED IN THE US FOR ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKAEMIA
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AstraZeneca PLC</font></div>
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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-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;approved in the US for adult patients with
chronic lymphocytic leukaemia</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">
21 November 2019 18:10&#xA0;GMT</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">Calquence</font><font style="color: #000000">&#xA0;approved in the US</font></font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
for adult patients with chronic lymphocytic leukaemia</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: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 16px">
<font style="font-style: italic; color: #000000">Two Phase III
Calquence</font><font style="color: #000000">&#xA0;</font><font style="font-style: italic; color: #000000">trials demonstrated superior
progression-free survival across multiple settings while
maintaining favourable tolerability</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #00B050; 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="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Calquence combined with obinutuzumab and as monotherapy
reduced</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">
the risk of disease progression or death by 90% and
80%,</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">
respectively in ELEVATE-TN</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 approved&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;(acalabrutinib) for adult patients with
chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma
(SLL).</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;The
US approval was granted under the FDA's Real-Time Oncology Review
and newly established Project Orbis programmes.</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&#xA0;is&#xA0;based on positive results from the
interim analyses of two Phase III clinical trials,&#xA0;ELEVATE-TN
in patients with previously untreated CLL and ASCEND in patients
with relapsed or refractory CLL. Together, the trials showed
that&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;in combination with obinutuzumab or as a
monotherapy significantly reduced the relative risk of disease
progression or death versus the comparator arms in both 1st-line
and relapsed or refractory CLL. Across both trials, the safety and
tolerability of&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;were consistent with its established
profile.</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">
Dave Fredrickson, Executive Vice President, Oncology Business Unit
said: "With over 20,000 new cases anticipated this year in the US
alone,&#xA0;today's approval of&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;provides new hope for patients with one of
the most common types of adult leukaemia, offering outstanding
efficacy and a favourable tolerability profile.&#xA0;The chronic
lymphocytic leukaemia patient population is known to face multiple
comorbidities, and tolerability is a critical factor in their
treatment."&#xA0;</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 Jeff Sharman, Director of Research at Willamette Valley Cancer
Institute, Medical Director of Hematology Research for The US
Oncology Network, and &#xA0;a lead author of the ELEVATE-TN trial,
said: "Tolerability remains an issue in the current treatment
landscape of chronic lymphocytic leukaemia, which may require
ongoing therapy for many years. In the ELEVATE-TN and ASCEND trials
comparing&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;to commonly used treatment
regimens,&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;demonstrated a clinically meaningful
improvement in progression-free survival in patients across
multiple settings, while maintaining its favourable tolerability
and safety profile."</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 results of the interim analysis of the ELEVATE-TN trial will be
presented at the upcoming American Society of Hematology
congress.</font><font style="font-size: 70%; vertical-align: top; color: #000000">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">
The trial showed a statistically significant and clinically
meaningful improvement in progression-free survival (PFS) for
patients treated with either&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;in combination with obinutuzumab
or&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;monotherapy versus chlorambucil chemotherapy
plus obinutuzumab, a current standard-of-care combination used in
the control arm.</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 the&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;combination arm, risk of disease progression
or death was reduced by 90% (HR 0.10; 95% CI, 0.06-0.17,
p&lt;0.0001) and in the monotherapy arm it was reduced by 80% (HR
0.20; 95% CI, 0.13-0.30, p&lt;0.0001).</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 median time to disease progression for patients treated
with&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;in combination with obinutuzumab or as a
monotherapy has not yet been reached versus 22.6 months (95% CI,
20-28) for chlorambucil plus obinutuzumab.</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-weight: bold; color: #000000">
ELEVATE-TN safety overview (most common ARs,
&#x2265;15%):</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></font></div>
<div style="text-align: left">
<table cellpadding="0" cellspacing="0" style="text-align: left; width: 100%; font-family: Times New Roman; font-size: 13px; margin: 0px auto 0px 0px;">
<tr>
<td rowspan="2" style="vertical-align: bottom; width: 22%; border-left: 0.5pt solid #000000; border-top: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">Adverse
reaction</font></div>
</td>
<td colspan="2" style="vertical-align: top; width: 24%; border-left: 0.5pt solid rgb(0, 0, 0); border-top: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: left; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; font-style: italic">Calquence</font>&#xA0;<font style="font-weight: bold">plus
obinutuzumab(n=178)</font></font></div>
</td>
<td colspan="2" style="vertical-align: top; width: 24%; border-left: 0.5pt solid rgb(0, 0, 0); border-top: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: left; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; font-style: italic">Calquence</font>&#xA0;<font style="font-weight: bold">monotherapy(n=179)</font></font></div>
</td>
<td colspan="2" style="vertical-align: top; width: 24%; border-color: rgb(0, 0, 0); border-style: solid; border-width: 0.5pt 0.5pt 2px;">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">
Chlorambucil plus obinutuzumab(n=169)</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: left; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Any</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: left; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Grade
&#x2265;3</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: left; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Any</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: left; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Grade&#x2265;3</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Any</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Grade&#x2265;3</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Infection<font style="font-size: 70%; vertical-align: top">&#x2020;</font></font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">69%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">22%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">65%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">14%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">46%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">13%</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Neutropenia<font style="font-size: 70%; vertical-align: top">&#x2020;</font></font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">53%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">37%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">23%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">13%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">78%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">50%</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Anemia<font style="font-size: 70%; vertical-align: top">&#x2020;</font></font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">52%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">12%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">53%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">10%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">54%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">14%</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Thrombocytopenia<font style="font-size: 70%; vertical-align: top">&#x2020;</font></font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">51%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">12%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">32%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">3.4%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">61%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">16%</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Headache</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">40%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1.1%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">39%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1.1%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<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%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Diarrhoea</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">39%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">4.5%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">35%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0.6%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">21%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1.8%</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Musculoskeletal
pain<font style="font-size: 70%; vertical-align: top">&#x2020;</font></font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">37%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">2.2%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">32%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1.1%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">16%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">2.4%</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Fatigue</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">34%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">2.2%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">23%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1.1%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">24%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1.2%</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Bruising<font style="font-size: 70%; vertical-align: top">&#x2020;</font></font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">31%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">21%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">5%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Rash<font style="font-size: 70%; vertical-align: top">&#x2020;</font></font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">26%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">2.2%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">25%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0.6%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">9%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0.6%</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Arthralgia</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">22%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">16%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0.6%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">4.7%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1.2%</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Dizziness</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">20%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">12%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">7%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Hemorrhage<font style="font-size: 70%; vertical-align: top">&#x2020;</font></font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">20%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1.7%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">20%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">1.7%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">6%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Nausea</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">20%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">22%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">31%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 22%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Lymphocytosis<font style="font-size: 70%; vertical-align: top">&#x2020;</font></font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">12%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid #000000; border-bottom: 2px solid #000000">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">11%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">16%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">15%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0.6%</font></div>
</td>
<td style="vertical-align: middle; width: 12%; border-left: 0.5pt solid rgb(0, 0, 0); border-right: 0.5pt solid rgb(0, 0, 0); border-bottom: 2px solid rgb(0, 0, 0);">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">0.6%</font></div>
</td>
</tr></table>
</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-size: 70%; vertical-align: top; color: #000000">
&#x2020;</font><font style="color: #000000">Includes multiple ADR
terms.</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 patients treated with the combination
of&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;plus
obinutuzumab, adverse reactions (ARs) led to treatment
discontinuation in 11% of patients and a dose reduction
of&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;in 7% of patients. In the monotherapy arm,
ARs led to discontinuation in 10% and dose reduction in 4% of
patients.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;In
the control arm, ARs led to regimen discontinuation in 14% of
patients with a dose reduction of chlorambucil in 28% of
patients.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font><font style="color: #000000">&#xA0;There
were no dose reductions for obinutuzumab.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,3</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">
In 1,029 patients with haematologic malignancies who were treated
with&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;100mg approximately every 12 hours across
multiple clinical trials, where 88% received treatment for at least
six months and 79% received treatment for at least one
year,&#xA0;serious or Grade &#x2265;3 infections occurred in 19%,
and Grade 3 atrial fibrillation and flutter occurred in 1.1% of
patients.&#xA0;&#xA0;In the same patient population, major
haemorrhage occurred in 3.0% (serious or Grade &#x2265;3 bleeding or
any central nervous system bleeding), with fatal haemorrhage
occurring in 0.1% of patients. Second primary malignancies (all
grades) including skin cancers occurred in 12% of
patients.</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 US approval is among the first to be granted under Project
Orbis, an initiative of the US FDA Oncology Center of Excellence,
which provides a framework for concurrent submission and review of
oncology medicines among international partners.&#xA0;The FDA, the
Australian Therapeutic Goods Administration, and Health Canada
collaborated on this review.</font><font style="font-size: 70%; vertical-align: top; color: #000000">&#xA0;4</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="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">Calquence</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">
In the US,&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;(acalabrutinib) is indicated for the
treatment of adult patients with chronic lymphocytic leukaemia
(CLL)/small lymphocytic lymphoma (SLL). In the US, Canada,
Australia, Brazil, Qatar, the United Arab Emirates, Mexico,
Argentina, Singapore, Chile, and recently
India,&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;is indicated for adult patients with mantle
cell lymphoma (MCL) who have received at least one prior therapy.
Approved under accelerated review in the US, continued approval for
previously treated MCL is contingent upon verification and
confirmation of clinical benefit in confirmatory
trials.</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="font-style: italic; color: #000000">
Calquence</font><font style="color: #000000">&#xA0;is a
next-generation selective inhibitor of Bruton's tyrosine kinase
(BTK).&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;binds covalently to BTK, thereby inhibiting
its activity.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,5,6,7</font><font style="color: #000000">&#xA0;In
B-cells, BTK signalling results in activation of pathways necessary
for B-cell proliferation, trafficking, chemotaxis, and
adhesion.</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">
As part of an extensive clinical development programme, AstraZeneca
and Acerta Pharma are currently evaluating&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;in 23 company-sponsored clinical
trials.&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;is being developed for the treatment of
multiple B-cell blood cancers including CLL, MCL, diffuse large
B-cell lymphoma, Waldenstr&#xF6;m macroglobulinaemia and follicular
lymphoma and other haematologic malignancies. Several Phase III
clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN,
ELEVATE-RR (ACE-CL-006) evaluating&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;versus ibrutinib in patients with previously
treated high-risk CLL, and ACE-CL-311
evaluating&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;in combination with venetoclax and
with/without obinutuzumab versus chemoimmunotherapy in patients
with previously untreated CLL without 17p deletion
or&#xA0;</font><font style="font-style: italic; color: #000000">TP53</font><font style="color: #000000">&#xA0;mutation.</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 ELEVATE-TN</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">
ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label
Phase III trial evaluating the safety and efficacy
of&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;in combination with obinutuzumab, a CD20
monoclonal antibody, or&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;alone versus chlorambucil, a chemotherapy,
in combination with obinutuzumab in previously untreated patients
with CLL. In the trial, 535 patients</font><font style="color: #00B050">&#xA0;</font><font style="color: #000000">were
randomised (1:1:1) into three arms. Patients in the first arm
received chlorambucil in combination with obinutuzumab. Patients in
the second arm received&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;(100mg twice daily until disease progression
or unacceptable toxicity) in combination with obinutuzumab.
Patients in the third arm received&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;monotherapy (100mg twice daily until disease
progression or unacceptable toxicity).</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,8</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="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The primary endpoint is PFS in the&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;and obinutuzumab arm compared to the
chlorambucil and obinutuzumab arm, assessed by an independent
review committee (IRC), and a key secondary endpoint is
IRC-assessed PFS in the&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;monotherapy arm compared to the chlorambucil
and obinutuzumab arm. Other secondary endpoints include objective
response rate, time to next treatment and overall
survival.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,8</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="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About ASCEND</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">
ASCEND (ACE-CL-309) is a global, randomised, multicentre,
open-label Phase III trial evaluating the efficacy
of&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;in previously treated patients with CLL. In
the trial, 310 patients were randomised (1:1) into two arms.
Patients in the first arm received&#xA0;</font><font style="font-style: italic; color: #000000">Calquence</font><font style="color: #000000">&#xA0;monotherapy (100mg twice daily until disease
progression or unacceptable toxicity). Patients in the second arm
received investigator's choice of either rituximab, a CD20
monoclonal antibody, in combination with idelalisib, a PI3K
inhibitor, or rituximab in combination with bendamustine, a
chemotherapy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,9</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 primary endpoint is PFS assessed by an IRC, and key secondary
endpoints include physician-assessed PFS, IRC- and
physician-assessed overall response rate and duration of response,
as well as overall survival, patient-reported outcomes and time to
next treatment.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,9</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 CLL</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">
Chronic lymphocytic leukaemia (CLL) is one of the most common types
of leukaemia in adults, with an estimated 105,000 new cases
globally each year and 20,720 new cases in the US in 2019, and the
number of people living with CLL is expected to grow with improved
treatment as patients live longer with the
disease.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10,11,12,13</font><font style="color: #000000">&#xA0;In
CLL, too many blood stem cells in the bone marrow become abnormal
lymphocytes and these abnormal cells have difficulty fighting
infections.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font><font style="color: #000000">&#xA0;As
the number of abnormal cells grows there is less room for healthy
white blood cells, red blood cells and
platelets.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font><font style="color: #000000">&#xA0;This
could result in anaemia, infection and bleeding.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font><font style="color: #000000">&#xA0;B-cell
receptor signalling through BTK is one of the essential growth
pathways for CLL.</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 haematology</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">
Leveraging its strength in oncology, AstraZeneca has established
haematology as one of four key oncology disease areas of focus. The
Company's haematology franchise includes two US FDA-approved
medicines and a robust global development programme for a broad
portfolio of potential blood cancer treatments. Acerta Pharma
serves as AstraZeneca's haematology research and development arm.
AstraZeneca partners with like-minded science-led companies to
advance the discovery and development of therapies to address unmet
need.</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 oncology</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">
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, the
Company is committed to advance oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to AstraZeneca's main capabilities, the Company is
actively pursuing innovative partnerships and investments that
accelerate the delivery of our strategy, as illustrated by the
investment in Acerta Pharma in haematology.</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="font-family: Times New Roman; font-size: 13px">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>
<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 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, Cardiovascular, Renal and
Metabolism, and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide.&#xA0;Please visit&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #000000">&#xA0;and
follow the Company on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="text-decoration: underline; color: #0000FF">.</font></font></div>
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13. Jain N, et al. Prevalence and Economic Burden of Chronic
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&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Adrian Kemp</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Company Secretary</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
AstraZeneca&#xA0;</font><font style="font-weight: bold; color: #000000">PLC</font></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
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">21 November
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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<div><font style="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">Name:
Adrian Kemp</font></div>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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