<SEC-DOCUMENT>0001171843-21-008622.txt : 20211220
<SEC-HEADER>0001171843-21-008622.hdr.sgml : 20211220
<ACCEPTANCE-DATETIME>20211220060509
ACCESSION NUMBER:		0001171843-21-008622
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20211220
FILED AS OF DATE:		20211220
DATE AS OF CHANGE:		20211220

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NOVARTIS AG
		CENTRAL INDEX KEY:			0001114448
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		STATE OF INCORPORATION:			V8
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-15024
		FILM NUMBER:		211503578

	BUSINESS ADDRESS:	
		STREET 1:		LICHTSTRASSE 35
		CITY:			BASEL
		STATE:			V8
		ZIP:			CH 4056
		BUSINESS PHONE:		01141613241111

	MAIL ADDRESS:	
		STREET 1:		LICHTSTRASSE 35
		CITY:			BASEL
		STATE:			V8
		ZIP:			CH 4056
</SEC-HEADER>
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<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>UNITED STATES</B></P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>SECURITIES AND EXCHANGE COMMISSION</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Washington, D.C. 20549</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>FORM 6-K</B></P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>REPORT OF FOREIGN PRIVATE ISSUER</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>PURSUANT TO RULE 13a-16 or 15d-16 OF</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>THE SECURITIES EXCHANGE ACT OF 1934</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><b>Report on Form 6-K dated December
20, 2021</b></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>(Commission File No. 1-15024)</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">____________________</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 18pt; text-align: center; margin: 0pt 0"><B>Novartis AG</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">(Name of Registrant)</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Lichtstrasse 35</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>4056 Basel</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0"><B>Switzerland</B></P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">(Address of Principal Executive Offices)</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">____________________</P>

<P STYLE="font-size: 10pt; text-align: center; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark whether the registrant files or will file annual reports under
cover of Form 20-F or Form 40-F:</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

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<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%; text-align: right; font-size: 10pt"><FONT STYLE="font-size: 10pt"><B>Form 20-F:&nbsp;&#9746;</B></FONT></TD>
    <TD STYLE="width: 3%; font-size: 10pt">&nbsp;</TD>
    <TD STYLE="width: 47%; font-size: 10pt"><FONT STYLE="font-size: 10pt">Form 40-F:&nbsp;&#9744;</FONT></TD></TR>
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<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(1):</P>

<P STYLE="font-size: 10pt; margin: 0pt 0"></P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font-size: 10pt">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%; text-align: right"><FONT STYLE="font-size: 10pt">Yes:&nbsp;&#9744;</FONT></TD>
    <TD STYLE="width: 3%">&nbsp;</TD>
    <TD STYLE="width: 47%"><FONT STYLE="font-size: 10pt"><B>No</B>:&nbsp;<B>&#9746;</B></FONT></TD></TR>
</TABLE>
<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted
by Regulation S-T Rule 101(b)(7):&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font-size: 10pt">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%; text-align: right"><FONT STYLE="font-size: 10pt">Yes:&nbsp;&#9744;</FONT></TD>
    <TD STYLE="width: 3%">&nbsp;</TD>
    <TD STYLE="width: 47%"><FONT STYLE="font-size: 10pt"><B>No</B>:&nbsp;<B>&#9746;</B></FONT></TD></TR>
</TABLE>
<P STYLE="font-size: 10pt; margin: 0pt 0">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark whether the registrant by furnishing the information contained
in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange
Act of 1934.&nbsp;</P>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="width: 100%; font-size: 10pt">
<TR STYLE="vertical-align: top">
    <TD STYLE="width: 50%; text-align: right"><FONT STYLE="font-size: 10pt">Yes:&nbsp;&#9744;</FONT></TD>
    <TD STYLE="width: 3%">&nbsp;</TD>
    <TD STYLE="width: 47%"><FONT STYLE="font-size: 10pt"><B>No</B>:&nbsp;<B>&#9746;</B></FONT></TD></TR>
</TABLE>


<P STYLE="margin: 0">&nbsp;</P>

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<P STYLE="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></P>

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    <TD STYLE="width: 33%"><FONT STYLE="font-size: 10pt"><IMG SRC="logo.jpg" ALT=""></FONT></TD>
    <TD STYLE="width: 34%"><FONT STYLE="font-size: 10pt">&nbsp;</FONT></TD>
    <TD STYLE="width: 33%"><p style="color: rgb(4,96,169); font: 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0"><b>Novartis&nbsp;International&nbsp;AG<BR>
                           Novartis&nbsp;Global Communications</b><BR>
                           <font style="color: windowtext">CH-4002 Basel</font><BR>
                           <font style="color: windowtext">Switzerland</font></P>

<p style="color: #0460A9; font: bold 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">&nbsp;</P>

<p style="font: 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">https://www.novartis.com</P>
<P STYLE="font: 9pt Arial, Helvetica, Sans-Serif; margin: 0pt 0">https://twitter.com/novartisnews</P>



</TD></TR>
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<P STYLE="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><FONT STYLE="font-size: 10pt">&nbsp;</font></p>

<p style="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><font style="font-size: 10pt">&nbsp;</font></p>

<p style="font: 14pt Arial, Helvetica, Sans-Serif; margin: 0pt 0; color: rgb(141,31,27)"><b>MEDIA &amp; INVESTOR RELEASE</b></p>

<P STYLE="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><FONT STYLE="font-size: 10pt"></FONT></P>

<P STYLE="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><font style="font-size: 10pt">&nbsp;</font></p>

<p style="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px">&nbsp;</font></p>

<p style="color: rgb(0, 0, 0); font-size: 12pt; margin-top: 0pt; margin-bottom: 0pt; text-indent: 0px"><font style="font-size: 10pt">&nbsp;</FONT></P>

<P STYLE="margin: 12.05pt 30pt 0 0pt; font-size: 10pt; font-weight: bold"><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 14pt">Novartis
provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU)</FONT></P>

<P STYLE="margin: 12.5pt 0 0 0pt; font-size: 10pt"><B>Ad hoc announcement pursuant to Art. 53 LR</B></P>

<P STYLE="font-size: 10pt; margin: 0.5pt 0 0"><B>&nbsp;</B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0pt"></TD><TD STYLE="width: 10.8pt">&bull;</TD><TD STYLE="text-align: justify; padding-right: 22.1pt"><I>Ligelizumab, a high-affinity anti-IgE antibody, demonstrated superiority compared
with placebo at Week 12 in Phase III PEARL 1 and PEARL 2 trials, but not versus omalizumab<SUP>1</SUP></I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.05pt 0 0"><I>&nbsp;</I></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 0pt"></TD><TD STYLE="width: 10.8pt">&bull;</TD><TD STYLE="padding-right: 33.8pt"><I>Novartis is continuing to evaluate the PEARL data and will provide an update in due course as well
as next steps for the program</I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.25pt 0 0"><I>&nbsp;</I></P>

<P STYLE="margin: 0 21pt 0 0pt; font-size: 10pt; line-height: 103%"><B>Basel, December 20, 2021 </B>&ndash; Novartis today announced
top-line results from PEARL 1 and PEARL 2 Phase III studies in chronic spontaneous urticaria (CSU), which showed that the studies met
their primary endpoints of superiority for ligelizumab versus placebo at Week 12, but not versus omalizumab<FONT STYLE="font-size: 10pt; line-height: 103%"><SUP>1</SUP></FONT>.</P>

<P STYLE="margin: 0.1pt 0 0 -40pt; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0 24.9pt 0 0pt; font-size: 10pt; line-height: 103%">&ldquo;We are disappointed that we have been unable to demonstrate
superior efficacy for ligelizumab versus standard of care in the treatment of CSU,&rdquo; said John Tsai, M.D., Head of Global Drug Development
and Chief Medical Officer, Novartis. &ldquo;We will continue to evaluate the potential for ligelizumab to bring benefit to patients in
the areas of chronic inducible urticaria (CIndU) and food allergy, where there is significant unmet need.&rdquo;</P>

<P STYLE="font-size: 10pt; margin: 0.15pt 0 0">&nbsp;</P>

<P STYLE="margin: 0 30pt 0 0pt; font-size: 10pt; line-height: 103%">Full PEARL 1 and 2 Phase III data will be made publicly available
after study completion in the second half of 2022.</P>

<P STYLE="margin: 0.55pt 0 0 -40pt; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0 24.25pt 0 0pt; font-size: 10pt">CSU is an unpredictable, systemic skin disease, characterized by the spontaneous
and recurrent appearance of itchy, painful hives (wheals) on the skin, angioedema or both for at least 6 weeks<FONT STYLE="font-size: 10pt"><SUP>2,3
</SUP></FONT>and affects up to 1% of the population at any one time<FONT STYLE="font-size: 10pt"><SUP>2</SUP></FONT>. Approximately 60%
of patients do not achieve complete control with first-line treatment antihistamines<FONT STYLE="font-size: 10pt"><SUP>4-7</SUP></FONT>.</P>

<P STYLE="margin: 0.25pt 0 0 -40pt; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0.05pt 5.15pt 0 0pt; font-size: 10pt">Novartis recently began Phase III studies for remibrutinib (LOU064), a highly
selective, potent oral BTK inhibitor that has previously shown rapid and effective CSU disease control<FONT STYLE="font-size: 10pt"><SUP>8,9</SUP></FONT>.</P>




<P STYLE="margin: 3.85pt 0 0 0pt; font-size: 10pt; font-weight: bold"></P>

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<P STYLE="margin: 3.85pt 0 0 0pt; font-size: 10pt; font-weight: bold">Novartis in chronic spontaneous urticaria (CSU)</P>

<P STYLE="margin: 0.5pt 17.15pt 0 0pt; font-size: 10pt; line-height: 103%">Novartis is dedicated to reimagining the care of patients
with diseases that can severely limit quality of life such as CSU, psoriasis, acne and atopic dermatitis. Novartis is committed to developing
medicines that will advance the treatment of CSU, so patients are able to live their lives without the distressing and unpredictable
symptoms of this debilitating disease<FONT STYLE="font-size: 10pt; line-height: 103%"><SUP>10</SUP></FONT>. These include ligelizumab
(QGE031) a high-affinity monoclonal anti-immunoglobulin E antibody and remibrutinib (LOU064), a highly selective, potent oral Bruton&rsquo;s
tyrosine kinase (BTK) inhibitor with a potential best-in-class profile for the treatment of autoimmune disorders. Any new therapies will
add to our portfolio of medicines that already includes Xolair<FONT STYLE="font-size: 10pt; line-height: 103%"><SUP>&reg;</SUP></FONT>
(omalizumab), our existing approved therapy for CSU.</P>

<P STYLE="margin: 0.25pt 0 0 -40pt; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0 0 0 0pt; font-size: 10pt; font-weight: bold">About ligelizumab</P>

<P STYLE="margin: 0.5pt 17.15pt 0 0pt; font-size: 10pt; line-height: 103%">Ligelizumab (QGE031) is a high-affinity, monoclonal anti-immunoglobulin
(Ig) E antibody. In a Phase IIb dose-finding trial, more patients experienced complete resolution of wheals (hives) with ligelizumab
compared with Xolair<FONT STYLE="font-size: 10pt; line-height: 103%"><SUP>&reg;</SUP></FONT> (omalizumab)<FONT STYLE="font-size: 10pt; line-height: 103%"><SUP>11</SUP></FONT>.</P>

<P STYLE="margin: 0.1pt 0 0 -40pt; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0 0 0 0pt; font-size: 10pt; font-weight: bold">About PEARL 1 and PEARL 2</P>

<P STYLE="margin: 0.5pt 18.4pt 0 0pt; font-size: 10pt; line-height: 103%">PEARL 1 and PEARL 2 (NCT03580369 and NCT03580356) are two identically
designed Phase III, multicenter, randomized, double-blind, active- and placebo-controlled, parallel-group studies<FONT STYLE="font-size: 10pt; line-height: 103%"><SUP>12,13</SUP></FONT>.
The twin studies are designed to establish efficacy and safety of ligelizumab in adult and adolescent patients (&ge;12 years of age)
with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1-antihistamine treatment by demonstrating better efficacy over
placebo and Xolair<FONT STYLE="font-size: 10pt; line-height: 103%">&reg;</FONT> (omalizumab)<FONT STYLE="font-size: 10pt; line-height: 103%"><SUP>12,13</SUP></FONT>.
More than 2,000 adult and adolescent patients across 48 countries were randomized to ligelizumab 72 mg, ligelizumab 120 mg, omalizumab
300 mg or placebo with treatment given every 4 weeks for 1 year<FONT STYLE="font-size: 10pt; line-height: 103%">12-14</FONT>. Patients
initially randomized to placebo were switched to ligelizumab 120 mg from Week 24 until the end of the 52-week treatment period. The primary
outcome measured the change from baseline in Urticaria Activity Score over 7 days (UAS7) at Week 12<FONT STYLE="font-size: 10pt; line-height: 103%"><SUP>12-14</SUP></FONT>.</P>

<P STYLE="margin: 0.4pt 0 0 -40pt; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0 0 0 0pt; font-size: 10pt; font-weight: bold">Disclaimer</P>

<P STYLE="margin: 0 16.05pt 0 0pt; font-size: 10pt">This press release contains forward-looking statements within the meaning of the
United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as
&ldquo;potential,&rdquo; &ldquo;can,&rdquo; &ldquo;will,&rdquo; &ldquo;plan,&rdquo; &ldquo;may,&rdquo; &ldquo;could,&rdquo; &ldquo;would,&rdquo;
&ldquo;expect,&rdquo; &ldquo;anticipate,&rdquo; &ldquo;seek,&rdquo; &ldquo;look forward,&rdquo; &ldquo;believe,&rdquo; &ldquo;committed,&rdquo;
&ldquo;investigational,&rdquo; &ldquo;pipeline,&rdquo; &ldquo;launch,&rdquo; &ldquo;dedicated,&rdquo; &ldquo;continuing,&rdquo; or similar
terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for ligelizumab, or regarding
potential future revenues from ligelizumab. You should not place undue reliance on these statements. Such forward-looking statements are
based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties.
Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary
materially from those set forth in the forward-looking statements. There can be no guarantee that ligelizumab will be submitted or approved
for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that ligelizumab
will be commercially successful in the future. In particular, our expectations regarding ligelizumab could be affected by, among other
things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical
data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government,
payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain
or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political,
economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality,
data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information
technology systems, and other risks and factors referred to in Novartis AG&rsquo;s current Form 20-F on file with the
US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information, future events or otherwise.</P>

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<P STYLE="margin: 0.55pt 0 0 -40pt; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0 0 0 0pt; font-size: 10pt; font-weight: bold">About Novartis</P>

<P STYLE="margin: 0.5pt 17.15pt 0 0pt; font-size: 10pt; line-height: 103%">Novartis is reimagining medicine to improve and extend people&rsquo;s
lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in
areas of great medical need. In our quest to find new medicines, we consistently rank among the world&rsquo;s top companies investing
in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access
to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.</P>

<P STYLE="margin: 0.25pt 0 0 -40pt; font-size: 10pt">&nbsp;</P>

<P STYLE="margin: 0 0 0 0pt; font-size: 10pt">Novartis is on Twitter. Sign up to follow @Novartis at <B>https://twitter.com/novartisnews</B></P>

<P STYLE="margin: 0.5pt 0 0 0pt; font-size: 10pt">For Novartis multimedia content, please visit</P>

<P STYLE="margin: 0.55pt 0 0 0pt; font-size: 10pt; font-weight: bold">https://www.novartis.com/news/media-library</P>

<P STYLE="margin: 0.5pt 0 0 0pt; font-size: 10pt"><FONT STYLE="letter-spacing: -0.25pt">For questions about the site or required registration,</FONT>
<FONT STYLE="letter-spacing: -0.2pt">please contact</FONT></P>

<P STYLE="margin: 0.5pt 0 0 0pt; font-size: 10pt; font-weight: bold">media.relations@novartis.com</P>

<P STYLE="margin: 0.4pt 0 0 -40pt; font-size: 10pt"><B>&nbsp;</B></P>

<P STYLE="margin: 0 0 0 0pt; font-size: 10pt"><B>References</B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0.8pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.45pt"><FONT STYLE="letter-spacing: -0.05pt">1.</FONT></TD><TD STYLE="padding-left: -20pt">Novartis Data on File.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 107%; margin-top: 0.8pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">2.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 19.85pt">Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria.
A GA2LEN task force report. <I>Allergy</I>. 2011;66:317-330.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 107%; margin-top: 0.15pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">3.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 23.1pt">Vestergaard C and Deleuran M. Chronic spontaneous urticaria: latest developments in aetiology, diagnosis
and therapy. <I>Ther Adv Chronic Dis</I>. 2015;6:304-13.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 108%; margin-top: 0.05pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">4.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 15.5pt">Zuberbier T, Latiff A, Abuzakouk M, et al. The international EAACI/GA2LEN/EuroGuiDerm/APAAACI guideline
for the definition, classification, diagnosis, and management of urticaria. <I>Allergy</I>. Published 2021 Sept 18. doi:10.1111/all.15090.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 110%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">5.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 44.2pt">Kaplan AP. Chronic Spontaneous Urticaria: Pathogenesis and Treatment Considerations. <I>Allergy Asthma
Immunol Res</I>. 2017;9(6):477-482. doi:10.4168/aair.2017.9.6.477</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 108%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">6.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 36.7pt">Maurer M, Costa C, Gimenez Arnau A, et al. Antihistamine- resistant chronic spontaneous urticaria remains
undertreated: 2-year data from the AWARE study. <I>Clin Exp Allergy</I>. 2020;50(10):1166-1175. doi:10.1111/cea.13716.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 108%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">7.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 30.45pt">Guill&eacute;n-Aguinaga S, J&aacute;uregui Presa I, Aguinaga-Ontoso E, Guill&eacute;n-Grima F, Ferrer
M. Updosing nonsedating antihistamines in patients with chronic spontaneous urticaria: a systematic review and meta-analysis. <I>Br J
Dermatol</I>. 2016;175(6):1153-1165. doi:10.1111/bjd.14768.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 108%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">8.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 32.85pt">Clinical Trials.gov. A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU
in Adults Inadequately Controlled by H1 Antihistamines (REMIX-1). NCT05030311. Available from: https://clinicaltrials.gov/ct2/show/NCT05030311.
[Last accessed: December 2021].</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 108%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -40pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">9.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 32.95pt">Clinical Trials.gov. A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU
in Adults Inadequately Controlled by H1- Antihistamines. NCT05032157. Available from: https://clinicaltrials.gov/ct2/show/NCT05032157.
[Last accessed: December 2021].</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 107%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">10.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 34.45pt">Weller K, Maurer M, Grattan C, et al. ASSURE-CSU: a real-world study of burden of disease in patients
with symptomatic chronic spontaneous urticaria. <I>Clin Transl Allergy</I>. 2015;5:29.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 107%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">11.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 16.95pt">Maurer M, Gim&eacute;nez-Arnau AM, Sussman G, et al. Ligelizumab for Chronic Spontaneous Urticaria.
<I>N Engl J Med</I>. 2019;381:1321-1332.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 108%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">12.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 17.3pt">ClinicalTrials.gov. NCT03580369. A Phase III Study of the Efficacy and Safety of Ligelizumab in the
Treatment of CSU in Adolescents and Adults Inadequately Controlled with H1-antihistamines [online] April 2020. Available from: https://clinicaltrials.gov/ct2/show/NCT03580369
[Last accessed: December 2021].</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 108%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">13.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 17.2pt">ClinicalTrials.gov. NCT03580356. A Phase III Study of the Efficacy and Safety of Ligelizumab in the
Treatment of CSU in Adolescents and Adults Inadequately Controlled with H1-antihistamines [online] March 2020. Available from: https://clinicaltrials.gov/ct2/show/NCT03580356
[Last accessed: December 2021].</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; line-height: 110%; margin-top: 0; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="padding-left: -20pt; width: 0pt"></TD><TD STYLE="padding-left: -20pt; width: 14.4pt"><FONT STYLE="letter-spacing: -0.05pt">14.</FONT></TD><TD STYLE="padding-left: -20pt; padding-right: 35pt">Severin T, Maurer M, Gim&eacute;nez-Arnau A, et al. Ligelizumab versus omalizumab in CSU: Phase 3 design
and rationale. Presented at the 4th GA&sup2;LEN Global Urticaria Forum; December 5&ndash;6 2018; Berlin, Germany.</TD></TR></TABLE>

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    <TD><font style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date: December 20, 2021</font></TD>
    <TD><FONT STYLE="font-family: Times New Roman, Times, Serif; font-size: 10pt">By:</FONT></TD>
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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
