<SEC-DOCUMENT>0001654954-19-003428.txt : 20190327
<SEC-HEADER>0001654954-19-003428.hdr.sgml : 20190327
<ACCEPTANCE-DATETIME>20190327080120
ACCESSION NUMBER:		0001654954-19-003428
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20190327
FILED AS OF DATE:		20190327
DATE AS OF CHANGE:		20190327

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:		19706669

	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
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<FILENAME>a1400u.htm
<DESCRIPTION>FORXIGA APPROVED IN JAPAN FOR TYPE-1 DIABETES
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<font style="font-size: 13px; font-family: Times New Roman">1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">Forxiga
approved in Japan for type-1 diabetes</font></div>
</div>
</div>
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<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">&#xA0;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#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">27
March 2019 07:00 GMT</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">
&#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: 13px">
<font style="font-style: italic; color: #000000">Forxiga</font><font style="color: #000000">&#xA0;approved in Japan for type-1
diabetes</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">The
Japanese Ministry of Health, Labour and Welfare (MHLW) has
approved&#xA0;<font style="font-style: italic">Forxiga</font>(dapagliflozin) as an oral
adjunct treatment to insulin for adults with type-1 diabetes
(T1D).</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">
Elisabeth Bj&#xF6;rk, Senior Vice President, Head of late
Cardiovascular, Renal and Metabolism, R&amp;D BioPharmaceuticals,
said: "This approval of&#xA0;</font><font style="font-style: italic; color: #000000">Forxiga</font><font style="color: #000000">&#xA0;in Japan means that people with type-1
diabetes whose glucose levels are not adequately controlled with
insulin alone now have a new oral treatment option available to
them.&#xA0;</font><font style="font-style: italic; color: #000000">Forxiga</font><font style="color: #000000">&#xA0;will help address a significant unmet need
in this patient population, and this approval in type-1 diabetes
builds on the well-established clinical profile
of&#xA0;</font><font style="font-style: italic; color: #000000">Forxiga</font><font style="color: #000000">."</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">The
approval is&#xA0;based on data from the Phase III
DEPICT&#xA0;clinical programme and a dedicated trial in Japanese
patients (D1695C00001). Results showed that&#xA0;<font style="font-style: italic">Forxiga,</font>&#xA0;when given as an oral
treatment in addition to adjustable insulin in patients with
inadequately-controlled T1D, demonstrated significant and
clinically-meaningful reductions from baseline in average blood
glucose levels HbA1c (primary endpoint), weight and total daily
insulin dose (secondary endpoints) at 24 weeks<font style="font-size: 70%; vertical-align: top">1,2,3</font>, at both 5mg and
10mg doses.</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">The
safety profile of&#xA0;<font style="font-style: italic">Forxiga</font>&#xA0;in these T1D trials was
consistent with its well-established profile in type-2 diabetes
(T2D), with the exception of a higher number of diabetic
ketoacidosis (DKA) events in&#xA0;<font style="font-style: italic">Forxiga</font>-treated patients versus
placebo. DKA is a known complication for adults with T1D that
affects those with T1D more frequently than with
T2D.&#xA0;<font style="font-style: italic">Forxiga</font>&#xA0;is
already indicated as a monotherapy and as part of combination
therapy in adults with T2D to improve glycaemic control as an
adjunct to diet and exercise.</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="font-style: italic">
Forxiga</font>&#xA0;was approved by the European Commission on 20
March as an adjunct treatment to insulin in adults with T1D, and
the medicine is under regulatory review in the US for the same
indication, with a decision expected in the second half of
2019.</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 type-1 diabetes</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">
T1D is a chronic disease in which the pancreas produces little or
no insulin. Approximately five percent of people living with
diabetes have type-1. The condition is caused by an autoimmune
reaction that destroys the beta cells in the pancreas which make
insulin.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4&#xA0;</font><font style="color: #000000">Different
factors, including genetics and some viruses, may contribute to
type-1 diabetes.</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About the DEPICT clinical programme</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The DEPICT (</font><font style="font-weight: bold; text-decoration: underline; color: #000000">D</font><font style="color: #000000">apagliflozin&#xA0;</font><font style="font-weight: bold; text-decoration: underline; color: #000000">E</font><font style="color: #000000">valuation
in&#xA0;</font><font style="font-weight: bold; text-decoration: underline; color: #000000">P</font><font style="color: #000000">atients
with&#xA0;</font><font style="font-weight: bold; text-decoration: underline; color: #000000">I</font><font style="color: #000000">nadequately&#xA0;</font><font style="font-weight: bold; text-decoration: underline; color: #000000">C</font><font style="color: #000000">ontrolled&#xA0;</font><font style="font-weight: bold; text-decoration: underline; color: #000000">T</font><font style="color: #000000">ype
1 Diabetes) clinical trial programme consists of two trials:
DEPICT-1 and DEPICT-2 which are 24-week, randomised,
double-blinded, parallel-controlled trials designed to assess the
effects of&#xA0;</font><font style="font-style: italic; color: #000000">Forxiga</font><font style="color: #000000">&#xA0;5mg or 10mg on glycaemic control in patients
with T1D inadequately controlled by insulin. All patients were
evaluated at week 24 and after a 28-week extension (52 weeks in
total).</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">Forxiga</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">
Forxiga</font><font style="color: #000000">&#xA0;(dapagliflozin)</font><font style="font-weight: bold; color: #000000">&#xA0;</font><font style="color: #000000">is a first-in-class, oral once-daily selective
inhibitor of human sodium-glucose co-transporter 2 (SGLT2)
indicated as both monotherapy and as part of combination therapy to
improve glycaemic control, with the additional benefits of weight
loss and blood pressure reduction, as an adjunct to diet and
exercise in adults with T2D.&#xA0;</font><font style="font-style: italic; color: #000000">Forxiga</font><font style="color: #000000">&#xA0;has a robust clinical trial programme of
more than 35 completed and ongoing Phase IIb/III trials in over
35,000 patients, as well as more than 1.8 million patient-years'
experience. Outside T2D,&#xA0;</font><font style="font-style: italic; color: #000000">Forxiga</font><font style="color: #000000">&#xA0;is also approved in T1D in the
EU.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
About AstraZeneca in Cardiovascular, Renal &amp; Metabolism
(CVRM)</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">
Cardiovascular, renal and metabolism together form one of
AstraZeneca's main therapy areas and a key growth driver for the
Company. By following the science to understand more clearly the
underlying links between the heart, kidneys and pancreas,
AstraZeneca is investing in a portfolio of medicines to protect
organs and improve outcomes by slowing disease progression,
reducing risks and tackling co-morbidities. Our ambition is to
modify or halt the natural course of CVRM diseases and potentially
regenerate organs and restore function, by continuing to deliver
transformative science that improves treatment practices and
cardiovascular health for millions of patients
worldwide.</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
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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 &amp;
Metabolism and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide.&#xA0;For more information, please
visit</font><font style="text-decoration: underline; color: #0000FF">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com</font><font style="color: #0000FF">&#xA0;</font><font style="color: #000000">and
follow us on Twitter</font><font style="text-decoration: underline; color: #0000FF">@</font><font style="text-decoration: underline; color: #0000FF">AstraZeneca</font><font style="color: #0000FF">.</font></font></div>
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Vi&#xF1;a</font></div>
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<td style="vertical-align: middle; width: 45%">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">UK/Global</font></div>
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<td style="vertical-align: middle; width: 21%">
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">+44 203
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<font style="font-family: Times New Roman; font-size: 13px">+1 302
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<font style="font-family: Times New Roman; font-size: 13px">+44 203
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</td>
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<font style="font-family: Times New Roman; font-size: 13px">BioPharma
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Stone</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">+44 203
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<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
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<font style="font-family: Times New Roman; font-size: 13px">+44 203
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<font style="font-family: Times New Roman; font-size: 13px">Craig
Marks</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Finance;
Fixed Income</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">+44
7881 615 764</font></div>
</td>
</tr><tr>
<td style="vertical-align: middle; width: 34%">
<div style="text-align: justify; margin-left: 12px; margin-right: 0px; text-indent: -12px">
<font style="font-family: Times New Roman; font-size: 13px">Jennifer
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<font style="font-family: Times New Roman; font-size: 13px">Retail
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<font style="font-family: Times New Roman; font-size: 13px">+44 203
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<font style="font-family: Times New Roman; font-size: 13px">US
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<font style="font-family: Times New Roman; font-size: 13px">+1 866
381 72 77</font></div>
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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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AstraZeneca PLC</font></div>
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<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">
References</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">1.&#xA0;&#xA0;
Dandona P, Mathieu C, Phillip M, et al. Efficacy and safety of
dapagliflozin in patients with inadequately controlled type 1
diabetes (DEPICT-1): 24-week results from a randomised controlled
trial. Lancet Diabetes and Endocrinol. 2017:5;846-17</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">2.&#xA0;&#xA0;&#xA0;Mathieu
C, Dandona, P, Gillard, P, et al.&#xA0;Ef&#xFB01;cacy and Safety of
Dapagli&#xFB02;ozin in Patients With Inadequately Controlled Type 1
Diabetes (the DEPICT-2 Study): 24-Week Results From a Randomized
Controlled Trial. Diabetes Care 2018;41:1938-1946</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">3.&#xA0;&#xA0;
Dandona P, Mathieu C, Phillip M, et al. Efficacy and safety of
dapagliflozin in patients with inadequately controlled type 1
diabetes: The Depict-1 52 week study. Diabetes Care 2018 Dec;
41(12): 2552-2559</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">4.&#xA0;&#xA0;
"Diabetes Home."&#xA0;Centers for Disease Control and Prevention,
Centers for Disease Control and Prevention, 15 Aug. 2018,
www.cdc.gov/diabetes/basics/type1.html.</font></div>
<div style="text-align: justify; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">5.&#xA0;&#xA0;
"Type 1 Diabetes."&#xA0;Mayo Clinic, Mayo Foundation for Medical
Education and Research, 7 Aug. 2017,
www.mayoclinic.org/diseases-conditions/type-1-diabetes/symptoms-causes/syc-20353011.</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><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="text-decoration: underline; font-family: Times New Roman; font-size: 13px">
SIGNATURES</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<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>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div>
<table cellpadding="0" cellspacing="0" style="width: 100%; font-family: Times New Roman; font-size: 13px">
<tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">AstraZeneca
PLC</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">&#xA0;</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Date:
<font style="font-weight: bold; font-size: 13px">27 March
2019</font></font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
<div>
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<tr>
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<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
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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">By: /s/
Adrian Kemp</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
</td>
</tr><tr>
<td style="vertical-align: top; width: 71%">
<div><font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
</td>
<td style="vertical-align: top; width: 29%">
<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>
</td>
</tr></table>
</div>
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<font style="font-family: Times New Roman; font-size: 13px">&#xA0;</font></div>
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