<SEC-DOCUMENT>0001654954-22-000297.txt : 20220107
<SEC-HEADER>0001654954-22-000297.hdr.sgml : 20220107
<ACCEPTANCE-DATETIME>20220107060722
ACCESSION NUMBER:		0001654954-22-000297
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20220107
FILED AS OF DATE:		20220107
DATE AS OF CHANGE:		20220107

FILER:

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

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		22516432

	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>a7559x.htm
<DESCRIPTION>ASTRAZENECA AND NEURIMMUNE SIGN DEAL FOR NI006
<TEXT>
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<font style="font-size: 13px; font-weight: bold; font-family: Times New Roman">1.</font>
<font style="font-weight: bold; font-family: Times New Roman; font-size: 13px">AstraZeneca
and Neurimmune sign deal for NI006</font>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
07 January 2022 07:00 GMT</font></div>
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&#xA0;</font></div>
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<font style="color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
AstraZeneca and Neurimmune sign exclusive global collaboration and
licence agreement to develop and
commercialise&#xA0;NI006</font></div>
<div style="text-align: left; 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="color: #000000; font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Investigational human monoclonal antibody in Phase Ib development
for the treatment of transthyretin amyloid cardiomyopathy, a
systemic, progressive and fatal condition</font></div>
<div style="text-align: center; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; font-style: italic; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
Alexion, AstraZeneca's Rare Disease group, has entered into an
exclusive global collaboration and licence agreement with
Neurimmune AG for NI006, an investigational human monoclonal
antibody currently in Phase Ib development for the treatment of
transthyretin amyloid cardiomyopathy (ATTR-CM). NI006 specifically
targets misfolded transthyretin and is designed to directly address
the pathology of ATTR-CM by enabling removal of amyloid fibril
deposits in the heart,</font><font style="color: #FF0000">&#xA0;</font><font style="color: #000000">with the
potential to treat patients with advanced
ATTR-CM.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Under the agreement, Alexion will be granted an exclusive worldwide
licence to develop, manufacture and commercialise
NI006.</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">
ATTR-CM is a systemic, progressive and fatal condition that leads
to progressive heart failure and high rate of fatality within four
years from diagnosis.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;It
remains underdiagnosed and its prevalence is thought to be
underestimated due to a lack of disease awareness and the
heterogeneity of symptoms.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#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="color: #000000; font-family: Times New Roman; font-size: 13px">
Marc Dunoyer, Chief Executive Officer, Alexion, said: "With 30
years of experience in developing medicines for people with rare
diseases, Alexion is uniquely positioned to advance innovative
science for small patient populations who are frequently
underdiagnosed. We look forward to applying this expertise to the
development of NI006, which is designed to clear cardiac amyloid
fibril deposits with the potential to improve cardiac function for
patients living with advanced ATTR-CM, who are currently
underserved by existing treatment options."</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
There is a significant unmet medical need for patients with various
types and levels of severity of amyloidosis that may require
multiple mechanisms of action to address those needs. NI006, an
ATTR depleter, adds&#xA0;a novel and complementary approach&#xA0;to
AstraZeneca and Alexion's pipeline of investigational therapies
focused on amyloidosis and strengthens our broader commitment to
addressing cardiomyopathies that can lead to heart
failure.</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">
Financial considerations</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">
Alexion will pay Neurimmune an upfront payment of $30m with the
potential for additional contingent milestone payments of up to
$730m upon achievement of certain development, regulatory and
commercial milestones, as well as low-to-mid teen royalties on net
sales of any approved medicine resulting from the
collaboration.</font></div>
<div style="text-align: left; 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: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Neurimmune will continue to be responsible for completion of the
current Phase Ib clinical trial&#xA0;on behalf of Alexion, and
Alexion will pay certain trial costs.&#xA0;Alexion will be
responsible for further clinical development, manufacturing and
commercialisation.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
The transaction is expected to close following satisfaction of
customary closing conditions and regulatory
clearances.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="text-decoration: underline; color: #000000; font-weight: bold; font-family: Times New Roman; font-size: 13px">
Notes</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="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">
Heart failure</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">
Heart failure (HF) is a life-threatening chronic disease that
prevents the heart from pumping sufficient levels of blood around
the body. HF affects approximately 64 million people worldwide. HF
remains as fatal as some of the most common cancers in both men
(prostate and bladder cancers) and women (breast
cancer).</font><font style="font-size: 70%; vertical-align: top; color: #000000">5</font><font style="color: #000000">&#xA0;Chronic
HF is the leading cause of hospitalisation for those over the age
of 65 and represents a significant clinical and economic
burden.</font><font style="font-size: 70%; vertical-align: top; color: #000000">6</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="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">
AstraZeneca's ambition is to be the leading company in HF,
expanding from&#xA0;</font><font style="font-style: italic; color: #000000">Forxiga</font><font style="color: #000000">&#xA0;today in heart failure with reduced ejection
fraction (HFrEF), to the full HF spectrum including
cardiomyopathies. AstraZeneca is investing in multiple
investigational therapies with diverse mechanisms of action to
address the spectrum of patient need in this
area.</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
ATTR-CM</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">
Cardiomyopathy due to ATTR is caused by aging or genetic mutations
resulting in misfolded TTR protein and accumulation as amyloid
fibrils in the cardiac myocardium. In patients with ATTR-CM, both
the mutant and wild type TTR protein builds up as fibrils in
tissues, including the heart. The presence of TTR fibrils
interferes with the normal functions of these tissues. As the TTR
protein fibrils enlarge, more tissue damage occurs and the disease
worsens, resulting in poor quality of life and eventually
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>
<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">
Worldwide, there are an estimated 300,000-500,000 patients with
ATTR-CM</font><font style="font-size: 70%; vertical-align: top; color: #000000">3,4</font><font style="color: #000000">;
however, many of those patients remain
undiagnosed.</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">
NI006</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">
NI006 is an investigational human monoclonal antibody that
specifically targets misfolded transthyretin and is designed to
directly address the pathology of ATTR-CM&#xA0;by enabling removal
of amyloid fibril deposits in the heart.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Alexion</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">
Alexion, AstraZeneca Rare Disease, is the group within AstraZeneca
focused on rare diseases, created following the 2021 acquisition of
Alexion Pharmaceuticals, Inc. As a leader in rare diseases for
nearly 30 years, Alexion is focused on serving patients and
families affected by rare diseases and devastating conditions
through the discovery, development and commercialisation of
life-changing medicines. Alexion focuses its research efforts on
novel molecules and targets in the complement cascade and its
development efforts on haematology, nephrology, neurology,
metabolic disorders, cardiology and ophthalmology. Headquartered in
Boston, Massachusetts, Alexion has offices around the globe and
serves patients in more than 50 countries.</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca</font></div>
<div><font style="font-family: Times New Roman; font-size: 10">&#xA0;</font></div>
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AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal &amp; Metabolism, and Respiratory &amp;
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit</font><font style="color: #3C4242">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">astrazeneca.com&#xA0;</font><font style="color: #000000">and
follow the Company on Twitter&#xA0;</font><font style="text-decoration: underline; color: #0000FF">@AstraZeneca</font><font style="color: #3C4242">.</font></font></div>
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Contacts</font></div>
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For details on how to contact the Investor Relations Team, please
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References</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">1.&#xA0;&#xA0;&#xA0;Lauppe
RE,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">. Nationwide prevalence and
characteristics of transthyretin amyloid cardiomyopathy in
Sweden.&#xA0;</font><font style="font-style: italic; color: #000000">Open Heart</font><font style="color: #000000">. 2021 Oct;8(2):e001755. doi:
10.1136/openhrt-2021-001755.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">2.&#xA0;&#xA0;&#xA0;Gonz&#xE1;lez-Duarte
A,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">.&#xA0;Impact of non-cardiac
clinicopathologic characteristics on survival in transthyretin
amyloid polyneuropathy.&#xA0;</font><font style="font-style: italic; color: #000000">Neurol Ther</font><font style="color: #000000">. 2020;9(1):135-149.
doi:10.1007/s40120-020-00183-7.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">3.&#xA0;&#xA0; Mohamed-Salem
L,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">. Prevalence of wild type
ATTR assessed as myocardial uptake in bone scan in the elderly
population.&#xA0;</font><font style="font-style: italic; color: #000000">Int J
Cardiol</font><font style="color: #000000">. 2018 Nov
1;270:192-196. doi:
10.1016/j.ijcard.2018.06.006.</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">4.&#xA0;&#xA0; Cuscaden
C,&#xA0;</font><font style="font-style: italic; color: #000000">et
al</font><font style="color: #000000">. Estimation of prevalence of
transthyretin (ATTR) cardiac amyloidosis in an Australian
subpopulation using bone scans with echocardiography and clinical
correlation.&#xA0;</font><font style="font-style: italic; color: #000000">J Nucl
Cardiol.</font><font style="color: #000000">&#xA0;2020 May 8. doi:
10.1007/s12350-020-02152-x.</font></font></div>
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<div style="text-align: left; margin-left: 24px; margin-right: 0px; text-indent: -24px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">5.&#xA0;&#xA0;
Mamas MA et al. Do Patients Have Worse Outcomes in Heart Failure
than in Cancer? A Primary Care-Based Cohort Study with 10-year
Follow-up in Scotland. Eur J Heart Fail 2017;
19(9):1095-104.</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">6.&#xA0;&#xA0;
Azad N, Lemay G. Management of Chronic Heart Failure in the Older
Population. J Geriatr Cardiol 2014; 11(4):329-37.</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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Company Secretary</font></div>
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AstraZeneca PLC</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-size: 13px">07 January 2022</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px">By: /s/
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Name:
Adrian Kemp</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Title:
Company Secretary</font></div>
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