<SEC-DOCUMENT>0001654954-22-010011.txt : 20220725
<SEC-HEADER>0001654954-22-010011.hdr.sgml : 20220725
<ACCEPTANCE-DATETIME>20220725065123
ACCESSION NUMBER:		0001654954-22-010011
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20220725
FILED AS OF DATE:		20220725
DATE AS OF CHANGE:		20220725

FILER:

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

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-11960
		FILM NUMBER:		221100981

	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>a5302t.htm
<DESCRIPTION>ULTOMIRIS RECOMMENDED FOR EU APPROVAL FOR GMG
<TEXT>
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AstraZeneca PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">Enhertu
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Francis Crick Avenue</font></div>
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AstraZeneca PLC</font></div>
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<font style="font-family: Times New Roman; font-size: 13px">INDEX
TO EXHIBITS</font></div>
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<font style="font-size: 13px; font-weight: bold; font-style: italic; font-family: Times New Roman">
1.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-weight: bold; font-style: italic; font-family: Times New Roman; font-size: 13px">
Ultomiris recommended for EU approval for gMG</font></div>
</div>
</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">&#xA0;</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
25 July 07:05 BST</font></div>
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<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-family: Times New Roman; font-size: 13px"><font style="font-weight: bold; font-style: italic; color: #000000; font-size: 13px">
Ultomiris</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-weight: bold; color: #000000; font-size: 13px">recommended
for approval in the EU by CHMP for the treatment of adults with
generalised myasthenia gravis</font></font></div>
<div style="text-align: left; 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: 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">
First and only long-acting C5 complement inhibitor showed early
effect and demonstrated clinical improvement in activities of daily
living</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #FF0000; 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">
Ultomiris</font><font style="color: #000000">&#xA0;(ravulizumab)
has been recommended for marketing authorisation in the European
Union (EU) as an add-on to standard therapy for the treatment of
adult patients with generalised myasthenia gravis (gMG) who are
anti-acetylcholine receptor (AChR) antibody-positive. If
authorised,&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;would be the first and only approved
long-acting C5 complement inhibitor for the treatment of AChR
antibody-positive gMG 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="color: #000000; font-family: Times New Roman; font-size: 13px">
The Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency based its positive opinion on results
from the CHAMPION-MG Phase III trial.</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 this trial,&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;was superior to placebo in the primary
endpoint of change from baseline in the Myasthenia
Gravis-Activities of Daily Living Profile (MG-ADL) total score at
Week 26, a patient-reported scale that assesses patients' abilities
to perform daily activities.</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">
gMG is a rare, debilitating, chronic, autoimmune neuromuscular
disease that leads to a loss of muscle function and severe
weakness.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;The
diagnosed prevalence of gMG in the EU is estimated at approximately
89,000.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3-9</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="color: #000000; font-family: Times New Roman; font-size: 13px">
Renato Mantegazza, Professor at the Department of Neuroimmunology
and Neuromuscular Diseases, Fondazione IRCCS Istituto Neurologico
Carlo Besta, Milan, Italy, and CHAMPION-MG trial investigator,
said: "gMG is a rare and complex disorder that requires early,
consistent&#xA0;and reliable intervention. This positive
recommendation offers hope to the community for an effective
long-acting option that will require fewer treatments each year and
help improve disease management."</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #FF0000; 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">
Marc Dunoyer, Chief Executive Officer, Alexion, said: "This
recommendation is a major milestone in our
commitment&#xA0;</font><font style="color: #000000; background-color: #FFFFFF">to help
a&#xA0;broader&#xA0;range of gMG&#xA0;patients, including those
with&#xA0;milder symptoms, and</font><font style="color: #000000">&#xA0;expand access to&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">. As we listen to the patient community, we're
focused on understanding and meeting the needs of gMG patients,
providing them with effective and accessible treatment options, and
the positive opinion is a great step
forward."&#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">
In CHAMPION-MG, the safety profile of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;was comparable to placebo and consistent
with that observed in Phase III trials of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;in paroxysmal nocturnal haemoglobinuria
(PNH) and atypical haemolytic uraemic syndrome (aHUS). The most
common adverse drug reactions are diarrhoea, upper respiratory
tract infection, nasopharyngitis and headache.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font></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="color: #000000; font-family: Times New Roman; font-size: 13px">
The CHMP recommended approval as an add-on to standard therapy for
the treatment of adult patients with gMG who are AChR
antibody-positive.&#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">
&#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">
Ultomiris</font><font style="color: #000000">&#xA0;was&#xA0;</font><font style="text-decoration: underline; color: #0000FF">approved in the
US</font><font style="color: #000000">&#xA0;for adults with gMG who
are AChR antibody-positive in April 2022, and regulatory reviews
are ongoing in additional countries, including
Japan.</font></font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: left; 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: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: left; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
gMG</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">
gMG is a rare autoimmune disorder characterised by loss of muscle
function and severe muscle weakness.</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">
Eighty percent of people with gMG are AChR antibody positive
meaning they produce specific antibodies (anti-AChR) that bind to
signal receptors at the neuromuscular junction (NMJ), the
connection point between nerve cells and the muscles they
control.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2,4,5,10,11</font><font style="color: #000000">&#xA0;This
binding activates the complement system, which is essential to the
body's defence against infection, causing the immune system to
attack the NMJ.</font><font style="font-size: 70%; vertical-align: top; color: #000000">2</font><font style="color: #000000">&#xA0;This
leads to inflammation and a breakdown in communication between the
brain and the muscles.</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">
gMG can occur at any age, but it most commonly begins for women
before the age of 40 and for men after the age of
60.</font><font style="font-size: 70%; vertical-align: top; color: #000000">12-14</font><font style="color: #000000">&#xA0;Initial
symptoms may include slurred speech, double vision, droopy eyelids
and lack of balance; these can often lead to more severe symptoms
as the disease progresses such as, impaired swallowing, choking,
extreme fatigue and respiratory failure.</font><font style="font-size: 70%; vertical-align: top; color: #000000">15,16</font></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="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
CHAMPION-MG</font></div>
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The global Phase III randomised, double-blind, placebo-controlled,
multicentre 26-week trial evaluated the safety and efficacy
of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;in adults with gMG. The trial enrolled 175
patients across North America, Europe, Asia-Pacific and Japan.
Participants were required to have a confirmed myasthenia gravis
diagnosis at least six months prior to the screening visit with a
positive serologic test for anti-AChR antibodies, MG-ADL total
score of at least 6 at trial entry and Myasthenia Gravis Foundation
of America Clinical Classification Class II to IV at screening.
Patients could stay on stable standard of care medicines, with a
few exceptions, for the duration of the randomised control
period.</font><font style="font-size: 70%; vertical-align: top; color: #000000">17</font></font></div>
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Patients were randomised 1:1 to receive&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;or placebo for a total of 26 weeks. Patients
received a single weight-based loading dose on Day 1, followed by
regular weight-based maintenance dosing beginning on Day 15, every
eight weeks. The primary endpoint of change from baseline in the
MG-ADL total score at Week 26 was assessed along with multiple
secondary endpoints evaluating improvement in disease-related and
quality-of-life measures.</font></font></div>
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Patients who completed the randomised control period were eligible
to continue into an open-label extension period evaluating the
safety and efficacy of&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">, which is ongoing.</font></font></div>
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Ultomiris</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Ultomiris</font><font style="color: #000000">&#xA0;(ravulizumab),
the first and only long-acting C5 complement inhibitor, offers
immediate, complete and sustained complement inhibition. The
medication works by inhibiting the C5 protein in the terminal
complement cascade, a part of the body's immune system. When
activated in an uncontrolled manner, the complement cascade
over-responds, leading the body to attack its own healthy
cells.&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;is administered intravenously every eight
weeks in adult patients, following a loading
dose.&#xA0;</font></font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Ultomiris</font><font style="color: #000000">&#xA0;is approved in
the US for the treatment of certain adults with
gMG.</font></font></div>
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Ultomiris</font><font style="color: #000000">&#xA0;is also approved
in the US, EU and Japan for the treatment of certain adults and
children with PNH.&#xA0;</font></font></div>
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Additionally,&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;is approved in the US, EU and Japan for
certain adults and children with aHUS to inhibit
complement-mediated thrombotic microangiopathy.</font></font></div>
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As part of a broad development programme,&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000">&#xA0;is being assessed for the treatment of
additional haematology and neurology
indications.</font></font></div>
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Alexion</font></div>
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<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 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>
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AstraZeneca</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&#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">@AstraZeneca</font><font style="color: #000000">.</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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For Media contacts, click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.</font></font></div>
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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;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="font-style: italic; color: #000000">Ultomiris</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">(ravulizumab-cwvz)
US prescribing information; 2022.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">2.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Howard,
J. F., (2017). Myasthenia gravis: the role of complement at the
neuromuscular junction. Annals of The New York Academy of Sciences,
1412(1), 113-128.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">3.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Westerberg
E, Punga AR. Epidemiology of Myasthenia Gravis in Sweden 2006-2016.
Brain Behav. 2020;10:e01819.
https://doi.org/10.1002/brb3.1819</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">4.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Anil,
R., Kumar, A., Alaparthi, S., Sharma, A., Nye, JL., Roy, B.,
O'Connor, KC., Nowak, R., (2020). Exploring outcomes and
characteristics of myasthenia gravis: Rationale, aims and design of
registry - The EXPLORE-MG registry. J Neurol Sci. 2020 Jul
15;414:116830.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">5.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Oh
SJ., (2009). Muscle-specific receptor tyrosine kinase antibody
positive myasthenia gravis current status. Journal of Clinical
Neurology. 2009b Jun 1;5(2):53-64.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">6.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Fang,
F.,</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Sveinsson
O., Thormar G., Granqvist M., Askling J., Lundberg IE., Ye W.,
(2015). The autoimmune spectrum of myasthenia gravis: a Swedish
population-based study. J Intern Med 2015;
277:594-604.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">7.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Lefter,
S., Hardiman, O., Ryan, A., (2017). A population-based
epidemiologic study of adult neuromuscular disease in the Republic
of Ireland. Neurology 2017;88:304-313.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">8.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Pallaver,
F., Riviera, AP., Piffer, S., Ricciardi, R., Roni, R., Orrico, D.,
Bonifati, DM., (2011). Change in Myasthenia Gravis Epidemiology in
Trento, Italy, after Twenty Years.</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #231F20">Neuroepidemiology
2011;36:282-287.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">9.&#xA0;&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Santos,
E., Coutinho, E., Moreira, I., et.al., (2016). Epidemiology of
Myasthenia Gravis in Northern Portugal: Frequency Estimates and
Clinical Epidemiological Distribution of Cases. Muscle Nerve 2016;
54: 413-421.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">10.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Tomschik,
M., Hilger, E., Rath, J., Mayer, EM., Fahrner, M., Cetin, H.,
L&#xF6;scher, W., Zimprich, F., (2020). Subgroup stratification and
outcome in recently diagnosed generalized myasthenia gravis.
Neurology. 2020 Sep 8;95(10):e1426-e1436.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">11.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Hendricks,
TM., Bhatti, MT., Hodge, D., Chen, J., (2019). Incidence,
Epidemiology, and Transformation of Ocular Myasthenia Gravis: A
Population-Based Study. Am J Ophthalmol. 2019
Sep;205:99-105.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">12.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Myasthenia
Gravis. National Organization for Rare Disorders (NORD).
Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
Accessed March 2022.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">13.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Howard,
J. F., (2015). Clinical Overview of MG.
Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
Accessed March 2022.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">14.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Sanders,
D. B., Raja, S. M., Guptill J. T., Hobson-Webb, L. D., Juel, V. C.,
&amp; Massey, J. M., (2020). The Duke myasthenia gravis clinic
registry: I. Description and demographics. Muscle &amp; Nerve,
63(2), 209-216.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">15.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Myasthenia
Gravis Fact Sheet. (2020, April 27). National Institutes of
Neurological Disorders and Stroke. Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
Accessed March 2022.</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">16.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">Ding,
J., Zhao, S., Ren, K., Dang, D., Li, H., Wu, F., Zhang, M., Li, Z.,
&amp; Guo, J., (2020). Prediction of generalization of ocular
myasthenia gravis under immunosuppressive therapy in Northwest
China. BMC Neurology, 20(238).</font></font></div>
<div style="text-align: left; margin-left: 48px; margin-right: 0px; text-indent: -24px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">17.&#xA0;</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="color: #000000">ClinicalTrials.gov.
Safety and Efficacy Study of Ravulizumab in Adults With Generalized
Myasthenia Gravis. NCT Identifier: NCT03920293.
Available</font><font style="color: #000000; font-family: Times New Roman">&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
Accessed March 2022.</font></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">
Adrian Kemp</font></div>
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Company Secretary</font></div>
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AstraZeneca PLC</font></div>
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