<SEC-DOCUMENT>0001654954-21-010452.txt : 20210928
<SEC-HEADER>0001654954-21-010452.hdr.sgml : 20210928
<ACCEPTANCE-DATETIME>20210928062118
ACCESSION NUMBER:		0001654954-21-010452
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		1
CONFORMED PERIOD OF REPORT:	20210928
FILED AS OF DATE:		20210928
DATE AS OF CHANGE:		20210928

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:		211283527

	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>a1891n.htm
<DESCRIPTION>SAPHNELO APPROVED IN JAPAN FOR SLE
<TEXT>
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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="color: #000000; 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">Saphnelo approved
in Japan for SLE</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>
<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">28
September 2021 07:00 BST</font></div>
<div style="text-align: left; margin-left: 480px; margin-right: 0px; text-indent: 0px;">&#xA0;
<font style="color: #000000; font-family: Times New Roman; font-size: 13px"><br>
</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">Saphnelo</font><font style="color: #000000">&#xA0;approved in Japan for systemic lupus
erythematosus</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: 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">
Saphnelo is a first-in-class type I interferon receptor antibody
shown to reduce overall disease activity in patients with systemic
lupus erythematosus</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's&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;(anifrolumab) has been approved in Japan for
the treatment of adult patients with systemic lupus erythematosus
(SLE), a serious autoimmune disease, who show insufficient response
to currently available treatment.</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 by the Japanese Ministry of Health, Labour and Welfare
(MHLW) was based on efficacy and safety data from
the&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;clinical development programme, including
the TULIP Phase III trials and the MUSE Phase II trial. In these
trials, more patients treated with&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;experienced a reduction in overall disease
activity across organ systems, including skin and joints, and
achieved sustained reduction in oral corticosteroid (OCS) use
compared to placebo, with both groups receiving standard
therapy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2,3</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
This decision marks the first regulatory approval by the MHLW for a
type I interferon (type I IFN) receptor antagonist in Japan. Type I
IFN plays a central role in the pathophysiology in lupus
and&#xA0;increased type I IFN signalling has been shown to
be&#xA0;associated with increased disease activity and
severity.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4,5,6,7,8</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">
Dr. Yoshiya Tanaka, Professor in the First Department of Internal
Medicine at the University of Occupational and Environmental
Health, Kitakyushu, Japan and an investigator in the TULIP-2 trial,
said: "Compared with other rheumatic diseases, there are limited
treatments available for systemic lupus erythematosus and outcomes
remain poor for patients in Japan and around the world. Through our
own local experience with anifrolumab in clinical trials, we have
observed impressive efficacy and improved patient
outcomes."</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">
Dr. Tsutomu Takeuchi, Emeritus Professor of Keio University, Tokyo,
Japan and an investigator in the TULIP-2 trial, said: "Our
treatment goals in systemic lupus erythematosus are to reduce
disease activity, improve quality of life and prevent organ damage
from either the disease or the medications used to treat it,
especially corticosteroids. Innovative treatments are needed to
address these goals. The anifrolumab clinical programme provided
compelling evidence that blocking type I interferon is a promising
new strategy in the treatment of systemic lupus erythematosus
reducing both disease activity across organ systems and
corticosteroid use."</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">
Mene Pangalos, Executive Vice President, BioPharmaceuticals
R&amp;D, said: "</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;is the first and only type I interferon
receptor antagonist to receive approval in Japan and represents a
major advance in treating systemic lupus erythematosus, a complex
heterogenous disease that is challenging to treat and often
debilitating for patients. We will now work to bring this medicine
to patients in Japan living with this disease as quickly as
possible."</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 adverse reactions that occurred more frequently in patients who
received&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;in clinical trials included upper
respiratory tract infection, bronchitis, infusion-related
reactions, hypersensitivity reactions and herpes
zoster.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2,3</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
SLE&#xA0; can affect any organ, and people often experience
inadequate disease control, long-term organ damage and poor
health-related quality of life.</font><font style="font-size: 70%; vertical-align: top; color: #000000">9,10,11,12</font><font style="color: #000000">&#xA0;SLE
is designated as an Intractable Disease in Japan through a
programme that incentivises research and development of drugs to
treat rare diseases that lack effective treatments, and also helps
reduce cost burden on patients.</font><font style="font-size: 70%; vertical-align: top; color: #000000">13</font><font style="color: #000000">&#xA0;There
are approximately 60,000 registered patients with SLE in Japan, and
the majority are women diagnosed before age 45.</font><font style="font-size: 70%; vertical-align: top; color: #000000">14,15</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">
Results from the TULIP-2 Phase III trial were published
in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
New England Journal of Medicine</font><font style="color: #000000">, results from the TULIP-1 Phase III trial were
published in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">The
Lancet Rheumatology</font><font style="color: #000000">&#xA0;and
results from the MUSE Phase II trial were published
in&#xA0;</font><font style="font-style: italic; text-decoration: underline; color: #0000FF">Arthritis
&amp; Rheumatology</font><font style="color: #000000">. The
sub-analysis of patients in Japan enrolled in TULIP-2 was presented
at the&#xA0;</font><font style="text-decoration: underline; color: #0000FF">Japan College of
Rheumatology annual meeting</font><font style="color: #000000">&#xA0;in April 2021.&#xA0;Efficacy and safety
results from the sub-analysis were consistent with the overall
trial populations.</font><font style="font-size: 70%; vertical-align: top; color: #000000">16</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="font-style: italic; color: #000000">
Saphnelo</font><font style="color: #000000">&#xA0;is&#xA0;</font><font style="text-decoration: underline; color: #0000FF">approved</font><font style="color: #000000">&#xA0;in
the US for the treatment of moderate to severe SLE and is under
regulatory review for SLE in the EU.&#xA0;A Phase III trial in SLE
using subcutaneous delivery has been initiated and additional Phase
III trials are planned for lupus nephritis, cutaneous lupus
erythematosus and myositis.</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: 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">
Financial considerations</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 acquired global rights to&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;through an exclusive license and
collaboration agreement with Medarex, Inc. in 2004. The option for
Medarex to co-promote the product expired on its acquisition by
Bristol-Myers Squibb (BMS) in 2009. Under the agreement AstraZeneca
will pay BMS a low to mid-teens royalty for sales dependent on
geography.</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="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
Systemic lupus erythematosus</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">
SLE is an autoimmune disease in which the immune system attacks
healthy tissue in the body.</font><font style="font-size: 70%; vertical-align: top; color: #000000">17</font><font style="color: #000000">&#xA0;It
is a chronic and complex disease with a variety of clinical
manifestations that can impact many organs and can cause a range of
symptoms including pain, rashes, fatigue, swelling in joints and
fevers.</font><font style="font-size: 70%; vertical-align: top; color: #000000">10</font><font style="color: #000000">&#xA0;More
than 50% of patients with SLE develop permanent organ damage,
caused by the disease or existing treatments, which exacerbates
symptoms and increases the risk of mortality.</font><font style="font-size: 70%; vertical-align: top; color: #000000">18,19</font><font style="color: #000000">&#xA0;At
least five million people worldwide have a form of
lupus.</font><font style="font-size: 70%; vertical-align: top; color: #000000">20</font></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; color: #000000; font-family: Times New Roman; font-size: 13px">
TULIP-1, TULIP-2 and MUSE</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
All three trials for&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;(TULIP-1, TULIP-2 and MUSE) were randomised,
double-blinded, placebo-controlled trials in patients with moderate
to severe SLE who were receiving standard therapy.&#xA0;Standard
therapy included at least one of the following: OCS, antimalarials
and immunosuppressants (methotrexate, azathioprine
or&#xA0;mycophenolate mofetil).</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2,3</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
The pivotal TULIP (Treatment of Uncontrolled Lupus via the
Interferon Pathway) Phase III programme included two
trials,&#xA0;</font><font style="text-decoration: underline; color: #0000FF">TULIP-1</font><font style="color: #000000">&#xA0;and&#xA0;</font><font style="text-decoration: underline; color: #0000FF">TULIP-2</font><font style="color: #000000">,
that evaluated the efficacy and safety of&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;versus placebo.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1,2</font><font style="color: #000000">&#xA0;TULIP-2
demonstrated superiority across multiple efficacy endpoints versus
placebo with both arms receiving standard therapy. In the trial,
362 eligible patients, including 43 patients in Japan, were
randomised (1:1) and received a fixed-dose intravenous infusion of
300mg&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;or placebo every four weeks. TULIP-2
assessed the effect of&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;in reducing disease activity as measured by
the BILAG-Based Composite Lupus Assessment (BICLA)
scale.</font><font style="font-size: 70%; vertical-align: top; color: #000000">1</font><font style="color: #000000">&#xA0;In
TULIP-1, 457 eligible patients were randomised (1:2:2) and received
a fixed-dose intravenous infusion of 150mg&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">, 300mg&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;or placebo every four weeks, in addition to
standard therapy. The trial did not meet its primary endpoint based
on the SLE Responder Index 4 (SRI4) composite
measure.</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&#xA0;</font><font style="text-decoration: underline; color: #0000FF">MUSE</font><font style="color: #000000">&#xA0;Phase
II trial evaluated the efficacy and safety of two doses
of&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;versus placebo. In MUSE, 305 adults were
randomised and received a fixed-dose intravenous infusion of
300mg&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">, 1,000mg&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;or placebo every four weeks, in addition to
standard therapy, for 48 weeks. The trial showed improvement versus
placebo across multiple efficacy endpoints with both arms receiving
standard therapy.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font></font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
&#xA0;</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
In SLE, along with the pivotal TULIP Phase III
programme,&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;continues to be evaluated in a long-term
extension Phase III trial and a Phase III trial assessing
subcutaneous delivery.</font><font style="font-size: 70%; vertical-align: top; color: #000000">21,22</font><font style="color: #000000">&#xA0;In
addition, AstraZeneca is exploring the potential
of&#xA0;</font><font style="font-style: italic; color: #000000">Saphnelo</font><font style="color: #000000">&#xA0;in a variety of diseases where type I IFN
plays a key role, including lupus nephritis, cutaneous lupus
erythematosus and myositis.</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: 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">
Saphnelo</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">
Saphnelo</font><font style="color: #000000">&#xA0;(anifrolumab) is
a fully human monoclonal antibody that binds to subunit 1 of the
type I IFN receptor, blocking the activity of type I
IFN.</font><font style="font-size: 70%; vertical-align: top; color: #000000">3</font><font style="color: #000000">&#xA0;Type
I IFNs such as IFN-alpha, IFN-beta and IFN-kappa are cytokines
involved in regulating the inflammatory pathways implicated in
SLE.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4,6,7,8,23,24</font><font style="color: #000000">&#xA0;The
majority of adults with SLE have increased type I IFN signalling,
which is associated with increased disease activity and
severity.</font><font style="font-size: 70%; vertical-align: top; color: #000000">4,5</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>
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<font style="font-weight: bold; color: #000000; font-family: Times New Roman; font-size: 13px">
AstraZeneca in Respiratory &amp; Immunology</font></div>
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<font style="color: #000000; font-family: Times New Roman; font-size: 13px">
Respiratory &amp; Immunology, part of BioPharmaceuticals, is one of
AstraZeneca's main disease areas and is a key growth driver for the
Company.</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">
AstraZeneca is an established leader in respiratory care with a
50-year heritage. The Company aims to transform the treatment of
asthma and COPD by focusing on earlier biology-led treatment,
eliminating preventable asthma attacks, and removing COPD as a
top-three leading cause of death. The Company's early respiratory
research is focused on emerging science involving immune
mechanisms, lung damage and abnormal cell-repair processes in
disease and neuronal dysfunction.</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">
With common pathways and underlying disease drivers across
respiratory and immunology, AstraZeneca is following the science
from chronic lung diseases to immunology-driven disease areas. The
Company's growing presence in immunology is focused on five mid- to
late-stage franchises with multi-disease potential, in areas
including rheumatology (including systemic lupus erythematosus),
dermatology, gastroenterology, and systemic eosinophilic-driven
diseases. AstraZeneca's ambition in Respiratory &amp; Immunology is
to achieve disease modification and durable remission for millions
of patients worldwide.</font></div>
<div style="text-align: justify; margin-left: 0px; margin-right: 0px; text-indent: 0px">
<font style="font-weight: bold; color: #FF0000; 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">
AstraZeneca</font></div>
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<font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">
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&#xA0;on how to contact the Investor Relations Team,
please click&#xA0;</font><font style="text-decoration: underline; color: #0000FF">here</font><font style="color: #000000">.
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>
<div style="margin-left: 0px; display: table;">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; 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="color: #000000">Morand E, et al. Trial of Anifrolumab in Active
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">2.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Furie R, et al. Type I interferon inhibitor
anifrolumab in active systemic lupus erythematosus (TULIP-1): a
randomised, controlled, phase 3 trial.&#xA0;</font><font style="font-style: italic; color: #000000">Lancet
Rheumatol</font><font style="color: #000000">. 2019;1(4):e208-e219.
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">3.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Furie R, et al. Anifrolumab, an
Anti-Interferon</font><font style="color: #000000; font-family: Times New Roman">&#x2010;</font><font style="color: #000000">a
Receptor Monoclonal Antibody, in Moderate</font><font style="color: #000000; font-family: Times New Roman">&#x2010;</font><font style="color: #000000">to</font><font style="color: #000000; font-family: Times New Roman">&#x2010;</font><font style="color: #000000">Severe
Systemic Lupus Erythematosus.&#xA0;</font><font style="font-style: italic; color: #000000">Arthritis
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">4.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Lauwerys BR, et al. Type I interferon blockade in
systemic lupus erythematosus: where do we
stand?&#xA0;</font><font style="font-style: italic; color: #000000">Rheumatol</font><font style="color: #000000">. 2014;53:1369-1376. Accessed September
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">5.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Crow MK. Type I Interferon in the Pathogenesis of
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">6.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Sarkar MK, et al. Photosensitivity and type I IFN
responses in cutaneous lupus are driven by epidermal-derived
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Dis</font><font style="color: #000000">. 2018;77:1653-1664.
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">7.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Jefferies CA. Regulating IRFs in IFN Driven
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">8.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Mai L, et al. The baseline interferon signature
predicts disease severity over the subsequent 5 years in systemic
lupus erythematosus.&#xA0;</font><font style="font-style: italic; color: #000000">Arthritis Res
Ther</font><font style="color: #000000">. 2021;23:29. Accessed
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">9.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">Centers
for Disease Control and Prevention. Systemic Lupus Erythematosus
(SLE). Available online. Accessed September 2021.</font></div>
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">10.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">American College of Rheumatology. Guidelines for
referral and management of systemic lupus erythematosus in
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">11.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Touma Z, et al. Current and future therapies for
SLE: obstacles and recommendations for the development of novel
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">12.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Izmirly PM, et al. Prevalence of Systemic Lupus
Erythematosus in the United States: Estimates From a Meta-Analysis
of the Centers for Disease Control and Prevention National Lupus
Registries.&#xA0;</font><font style="font-style: italic; color: #000000">Arthritis
Rheumatol</font><font style="color: #000000">. 2021;73(6):991-996.
Accessed&#xA0;September&#xA0;2021.</font></font></div>
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">13.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Kanatani Y, et al. National Registry of Designated
Intractable Diseases in Japan: Present Status and Future
Prospects.&#xA0;Neurol Med Chir (Tokyo).</font><font style="color: #000000; background-color: #FFFFFF">&#xA0;2017;57(1):1-7.
Accessed September 2021.</font></font></div>
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">14.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">Japan
Intractable Diseases Information Center. The number of specific
stipendiary certificate holders of medical expenses (designation
incurable disease). Available online. Accessed September
2021.</font></div>
</div>
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<div style="display: table-row">
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">15.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Tanaka Y, et al. Disease severity and economic
burden in Japanese patients with systemic lupus erythematosus: A
retrospective, observational study.&#xA0;</font><font style="font-style: italic; color: #000000">Int J Rheum
Dis</font><font style="color: #000000">. 2018;21:1609-1618.
Accessed September 2021.</font></font></div>
</div>
</div>
<div style="margin-left: 0px; display: table;">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">16.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">Tanaka
Y, et al. The efficacy and safety of anifrolumab in Japanese
patients with systemic lupus erythematosus (SLE) (TULIP-2
subanalysis). Oral presentation at the 65th Annual General Assembly
and Scientific Meeting of the Japan College of Rheumatology; April
26-28, 2021; Kobe, Japan.</font></div>
</div>
</div>
<div style="margin-left: 0px; display: table;">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">17.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">The
Lupus Foundation of America. What is Lupus? Available online.
Accessed September 2021.</font></div>
</div>
</div>
<div style="margin-left: 0px; display: table;">
<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">18.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Bruce IN, et al. Factors associated with damage
accrual in patients with systemic lupus erythematosus: results from
the systemic lupus international collaborating Clinics (SLICC)
inception cohort.&#xA0;</font><font style="font-style: italic; color: #000000">Ann Rheum
Dis</font><font style="color: #000000">. 2015;74:1706-1713.
Accessed September 2021.</font></font></div>
</div>
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<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">19.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">Segura BT, et al. Damage accrual and mortality
over long-term follow-up in 300 patients with systemic lupus
erythematosus in a multi-ethnic British
cohort.&#xA0;</font><font style="font-style: italic; color: #000000">Rheumatol</font><font style="color: #000000">. 2020;59(3):524-533. Accessed September
2021.</font></font></div>
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<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">20.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">The
Lupus Foundation of America. Lupus facts and statistics. Available
online. Accessed September 2021.</font></div>
</div>
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<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">21.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">ClinicalTrials.gov.
Long Term Safety of Anifrolumab in Adult Subjects With Active
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<font style="color: #000000; font-size: 13px; font-family: Times New Roman">22.</font></div>
<div style="text-align: justify; display: table-cell"><font style="color: #000000; font-family: Times New Roman; font-size: 13px">ClinicalTrials.gov.
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Erythematosus (Tulip SC). NCT Identifier: NCT04877691. Accessed
September 2021.</font></div>
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<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">23.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">L&#xF3;pez de Padilla CM, et al. The Type I
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<div style="display: table-row">
<div style="text-align: left; display: table-cell; width: 24px">
<font style="color: #000000; font-size: 13px; font-family: Times New Roman">24.</font></div>
<div style="text-align: justify; display: table-cell"><font style="font-family: Times New Roman; font-size: 13px"><font style="color: #000000">R&#xF6;nnblom L, et al. Interferon pathway in SLE:
one key to unlocking the mystery of the
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Med</font><font style="color: #000000">. 2019;6(1):e000270.
Accessed September 2021.</font></font></div>
</div>
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Adrian Kemp</font></div>
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