<SEC-DOCUMENT>0001171843-19-006290.txt : 20191002
<SEC-HEADER>0001171843-19-006290.hdr.sgml : 20191002
<ACCEPTANCE-DATETIME>20191002060516
ACCESSION NUMBER:		0001171843-19-006290
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20191002
FILED AS OF DATE:		20191002
DATE AS OF CHANGE:		20191002

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:		191130706

	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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<DESCRIPTION>FORM 6-K
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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 October  2, 2019</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>

<TABLE CELLSPACING="0" CELLPADDING="0" STYLE="font-size: 10pt; width: 100%">
<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>
</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)(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>


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<TR STYLE="vertical-align: top; text-align: left">
    <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">http://www.novartis.com</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-size: 10pt; text-align: center; margin: 0pt 0; background-color: Silver"><FONT STYLE="font-size: 11pt"><B>MEDIA
RELEASE&nbsp;&nbsp;&nbsp; &bull; &nbsp;&nbsp;&nbsp;COMMUNIQUE AUX MEDIAS&nbsp;&nbsp;&nbsp; &bull; &nbsp;&nbsp;&nbsp;MEDIENMITTEILUNG</B></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"></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>

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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 33.6pt; margin-bottom: 0pt; text-align: left"><FONT STYLE="font-size: 12pt"><B>Novartis
positive 52-week PREVENT data confirm Cosentyx</B></FONT><B><FONT STYLE="font-size: 10pt"><SUP>&reg;</SUP> </FONT><FONT STYLE="font-size: 12pt">efficacy
in addressing entire axSpA spectrum</FONT></B></P>

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

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<TD STYLE="width: 23.75pt"></TD><TD STYLE="width: 17.85pt"><FONT STYLE="font-family: Symbol; font-style: normal">&middot;</FONT></TD><TD STYLE="padding-right: 25.75pt">Phase III PREVENT study met 52-week primary endpoint of ASAS40, showing a sustained response
in patients with non-radiographic axial spondyloarthritis (nr- axSpA)<SUP>1</SUP></TD></TR></TABLE>

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

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<TD STYLE="width: 23.75pt"></TD><TD STYLE="width: 17.9pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="padding-right: 71.05pt"><I>Novartis plans FDA submission for nr-axSpA, having submitted to EMA previously<SUP>1</SUP>.
This would be the fourth indication for Cosentyx<SUP>2,3</SUP></I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.2pt 0 0"><I>&nbsp;</I></P>

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<TD STYLE="width: 23.85pt"></TD><TD STYLE="width: 18pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="padding-right: 31.1pt"><I>PREVENT underlines Cosentyx leadership and is a step forward in providing patients with a
treatment that addresses the complete axSpA disease spectrum</I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.55pt 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: 23.85pt"></TD><TD STYLE="width: 18.05pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD><I>There are approximately 1.7 million patients with nr-axSpA in the US and EU<SUP>4</SUP></I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.3pt 0 0"><I>&nbsp;</I></P>

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 20.35pt; margin-bottom: 0pt"><B>Basel, October 02, 2019 &ndash; </B>Novartis,
a leader in rheumatology and immuno-dermatology, today announced additional positive data from the PREVENT trial, evaluating the
efficacy and safety of Cosentyx<FONT STYLE="font-size: 10pt"><SUP>&reg;</SUP> </FONT>(secukinumab) in patients with non-radiographic
axial spondyloarthritis (nr-axSpA). The ongoing Phase III trial met its primary endpoint of ASAS40 at Week 52, showing a significant
and clinically meaningful reduction in disease activity for patients treated with Cosentyx versus placebo. The trial demonstrated
a sustained response and a safety profile consistent with previous clinical trials. No new safety signals were detected<FONT STYLE="font-size: 10pt"><SUP>1,5-10</SUP></FONT>.</P>

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

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 23.8pt; margin-bottom: 0pt">Positive 16-week PREVENT data were announced
mid-September and submitted to EMA for approval in nr-axSpA<FONT STYLE="font-size: 10pt"><SUP>11</SUP></FONT>. These data add
to the five-years of clinical data supporting the long- term efficacy and safety of Cosentyx across ankylosing spondylitis, psoriatic
arthritis and psoriasis<FONT STYLE="font-size: 10pt"><SUP>5-10</SUP></FONT>.</P>

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

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 21.8pt; margin-bottom: 0pt">&ldquo;Non-radiographic axial spondyloarthritis is a chronic debilitating
disease, which left untreated can have a significant impact on patients' quality of life,&rdquo; said Atul Deodhar, MD, professor
of medicine and medical director of Rheumatology Clinics at Oregon Health &amp; Science University, and an investigator in the
secukinumab clinical trial program. &ldquo;These positive results indicate a potential new treatment option to help patients experience
relief from the signs and symptoms of their disease.&rdquo;</P>

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

<P STYLE="font-size: 10pt; text-align: justify; margin-top: 0.05pt; margin-right: 37.8pt; margin-bottom: 0pt">&ldquo;These data are encouraging for people living
with nr-axSpA, where there are only limited treatment options available,&rdquo; said John Tsai, M.D., Head of Global Drug Development
and Chief Medical Officer for Novartis. &ldquo;It&rsquo;s a great example of how we&rsquo;re working to reimagine medicine to help
patients realize early relief from this disease.&rdquo;</P>

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

<P STYLE="font-size: 10pt; margin-top: 0.05pt; margin-right: 0pt; margin-bottom: 0pt">Detailed data is planned to be presented at a future scientific congress.</P>

<P STYLE="font-size: 10pt; margin: 0.3pt 0 0">&nbsp;</P>

<P STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-right: 0pt; margin-bottom: 0pt">About axSpA</P>

<P STYLE="font-size: 10pt; margin-top: 0.6pt; margin-right: 13.8pt; margin-bottom: 0pt">Axial spondyloarthritis (axSpA) is a spectrum
of long-term inflammatory disease characterized by chronic inflammatory back pain<FONT STYLE="font-size: 10pt"><SUP>12</SUP></FONT>.
The axSpA disease spectrum includes ankylosing</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">spondylitis
(AS), in which joint damage is generally visible on x-ray, and non-radiographic axial spondyloarthritis (nr-axSpA), in which joint
damage is not visible on x-ray<SUP>12,13</SUP>. Both parts of the disease spectrum have a similar symptom burden, including nocturnal
pain, fatigue, morning stiffness and functional disability<SUP>14</SUP>. If left untreated, axSpA could impair activity, lead
to lost work time and have a significant impact on quality of life<SUP>14</SUP>.</FONT></P>

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

<P STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-right: 0pt; margin-bottom: 0pt">About PREVENT</P>

<P STYLE="font-size: 10pt; margin-top: 0.6pt; margin-right: 20.2pt; margin-bottom: 0pt">PREVENT is an ongoing two-year randomized,
double-blind, placebo-controlled Phase III study (with a two-year extension phase) to investigate the efficacy and safety of Cosentyx,
in patients with active nr-axSpA. The study enrolled 555 male and female adult patients with active nr-axSpA (with onset before
45 years of age, spinal pain rated as &ge;40/100 on a visual analog scale (VAS) and Bath Ankylosing Spondylitis Disease Activity
Index (BASDAI) &ge;4) and who had been taking at least two different non-steroidal anti-inflammatory drugs (NSAIDs) at the highest
dose up to 4 weeks prior to study start. Patients may have previously taken an TNF inhibitor (not more than one) but had had an
inadequate response. Of the 555 patients enrolled in the study, 501 (90%) were biologic naive. Patients were allocated to one
of three treatment groups: Cosentyx 150 mg subcutaneously with loading dose (Induction: 150 mg Secukinumab subcutaneously weekly
for 4 weeks, then maintenance with 150 mg Secukinumab monthly); Cosentyx 150 mg no loading dose (150 mg Secukinumab subcutaneously
monthly), or placebo (induction of subcutaneously weekly for 4 weeks, followed by maintenance of once-monthly)<FONT STYLE="font-size: 10pt"><SUP>1</SUP></FONT>.</P>

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

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 25.15pt; margin-bottom: 0pt">The primary endpoints are the proportion
of patients achieving an ASAS40 response with Cosentyx 150 mg at weeks 16 and 52. Secondary endpoints include change in BASDAI
over time and change in the Ankylosing Spondylitis Disease Activity Score with CRP (ASDAS- CRP)<FONT STYLE="font-size: 10pt"><SUP>1</SUP></FONT>.</P>

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

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 22.9pt; margin-bottom: 0pt">ASAS40 is achieved when there is a measure
of an improvement of at least 40% and an improvement of at least 10 units on a 0&ndash;100 scale in at least three of the following
domains: Patient global assessment, Pain assessment, Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), and Inflammation
(morning stiffness severity and duration) and no worsening in the remaining domains<FONT STYLE="font-size: 10pt"><SUP>15</SUP></FONT>.
BASDAI assesses a patient&rsquo;s disease activity on six measures: fatigue, spinal pain, joint pain/swelling, enthesitis, morning
stiffness duration and morning stiffness severity<FONT STYLE="font-size: 10pt"><SUP>15</SUP></FONT>.</P>

<P STYLE="font-size: 10pt; margin: 0.2pt 0 0">&nbsp;</P>

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

<P STYLE="font-size: 10pt; margin-top: 0.6pt; margin-right: 24.6pt; margin-bottom: 0pt">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;plans,&rdquo; &ldquo;submitted,&rdquo; &ldquo;would,&rdquo; &ldquo;step forward,&rdquo;
&ldquo;ongoing,&rdquo; &ldquo;supporting,&rdquo; &ldquo;potential,&rdquo; &ldquo;encouraging,&rdquo; &ldquo;planned,&rdquo; &ldquo;could,&rdquo;
&ldquo;to investigate,&rdquo; &ldquo;expectations,&rdquo; or similar terms, or by express or implied discussions regarding potential
new indications or labeling for Cosentyx, or regarding potential future revenues from Cosentyx. 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 Cosentyx will be submitted or approved for any additional indications or labeling in
any market, or at any particular time. Nor can there be any guarantee that Cosentyx will be commercially successful in the future.
In particular, our expectations regarding Cosentyx 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</P>



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<P STYLE="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0">to obtain or maintain proprietary intellectual property protection;
the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality
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>

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

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

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<P STYLE="font-size: 10pt; font-weight: bold; margin-top: 0pt; margin-right: 0pt; margin-bottom: 0pt">References</P>

<P STYLE="font-size: 10pt; margin: 0.2pt 0 0"><B>&nbsp;</B></P>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0.05pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 23.75pt"></TD><TD STYLE="width: 18pt">1.</TD><TD>Novartis data on file. September 2019.</TD></TR></TABLE>

<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: 23.75pt"></TD><TD STYLE="width: 18pt">2.</TD><TD>Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2018.</TD></TR></TABLE>

<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: 23.75pt"></TD><TD STYLE="width: 18pt">3.</TD><TD STYLE="padding-right: 25.7pt">Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics. Available
from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf. Last accessed: September
2019.</TD></TR></TABLE>

<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: 23.75pt"></TD><TD STYLE="width: 18pt">4.</TD><TD STYLE="text-align: justify; padding-right: 22.9pt">DRG Epidemiology Database - Axial Spondyloarthritis: Disease Landscape &amp;
Forecast. August 2019. Available from: https://decisionresourcesgroup.com/report/716950-biopharma-axial-spondyloarthritis-landscape-forecast/.
Last accessed: September 2019.</TD></TR></TABLE>

<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: 23.75pt"></TD><TD STYLE="width: 18pt">5.</TD><TD STYLE="padding-right: 37.4pt">Data on file. CAIN457F2310 (MEASURE 2): 5 Year Report. Novartis Pharmaceuticals Corp; September
15, 2015.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0.05pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 23.75pt"></TD><TD STYLE="width: 18pt">6.</TD><TD STYLE="padding-right: 35.1pt">Data on file. Data Analysis Report: Study CAIN457A2302E1. Novartis Pharmaceuticals Corp; November
30, 2015.</TD></TR></TABLE>

<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: 23.75pt"></TD><TD STYLE="width: 18pt">7.</TD><TD STYLE="padding-right: 0.3in">Data on file. CAIN457F2310 and CAIN457F2305 Summary of 5-Year Clinical Safety in (Ankylosing Spondylitis).
Novartis Pharmaceuticals Corp; May 2019.</TD></TR></TABLE>

<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: 23.75pt"></TD><TD STYLE="width: 18pt">8.</TD><TD>Data on file. CAIN457F2312 (FUTURE 2): 5 Year- Interim Report. Novartis Pharmaceuticals Corp; May 2019.</TD></TR></TABLE>

<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: 23.75pt"></TD><TD STYLE="width: 18pt">9.</TD><TD>Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0.05pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 23.75pt"></TD><TD STYLE="width: 18pt">10.</TD><TD STYLE="padding-right: 20.8pt">Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp;
July 23, 2018.</TD></TR></TABLE>

<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: 23.75pt"></TD><TD STYLE="width: 17.95pt">11.</TD><TD STYLE="padding-right: 18.8pt">Novartis press release. Novartis
                                         Cosentyx<SUP>&reg;</SUP> positive 16-week PREVENT results advance potential new indication
                                         for patients with axial spondyloarthritis. Available from: https://www.novartis.com/news/media-releases/novartis-
                                         cosentyx-positive-16-week-prevent-results-advance-potential-new-indication-patients-axial-spondyloarthritis.
                                         Last accessed: September 2019.</TD></TR></TABLE>

<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: 23.7pt"></TD><TD STYLE="width: 18pt">12.</TD><TD>Strand V, et al. Patient Burden of Axial Spondyloarthritis. <I>J Clin Rheumatol</I>. 2017 Oct;23(7):383&ndash;391.</TD></TR></TABLE>

<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: 23.7pt"></TD><TD STYLE="width: 18pt">13.</TD><TD STYLE="padding-right: 0.4in">Rudwaleit M, van der Heijde D, Landew&eacute; R, et al. The development of Assessment of SpondyloArthritis
International Society classification criteria for axial spondyloarthritis (part II): validation and final selection. Ann Rheum
Dis. 2009;68(6):777-783.</TD></TR></TABLE>

<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: 23.7pt"></TD><TD STYLE="width: 18pt">14.</TD><TD STYLE="padding-right: 48.9pt">Mease PJ, van der Heijde D, Karki C, et al. Characterization of patients with ankylosing spondylitis
and nonradiographic axial spondyloarthritis in the US-based Corrona Registry. <I>Arthritis Care Res (Hoboken). </I>2018;70(11):1661-1670.</TD></TR></TABLE>

<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: 23.7pt"></TD><TD STYLE="width: 18pt">15.</TD><TD>Landewe R, et al. Clinical Tools to Assess and Monitor Spondyloarthritis. <I>Curr Rheumatol Rep</I>. 2015;17(7):47.</TD></TR></TABLE>

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end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
