<SEC-DOCUMENT>0001171843-20-004387.txt : 20200617
<SEC-HEADER>0001171843-20-004387.hdr.sgml : 20200617
<ACCEPTANCE-DATETIME>20200616205622
ACCESSION NUMBER:		0001171843-20-004387
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20200617
FILED AS OF DATE:		20200617
DATE AS OF CHANGE:		20200616

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:		20967909

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

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<P STYLE="font-size: 10pt; margin: 0pt 0 3pt">Indicate by check mark whether the registrant by furnishing the information contained
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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">http://www.novartis.com</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>

<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="margin: 0pt 0; font-size: 14pt; text-align: left"><b>Novartis Cosentyx&reg; receives FDA approval for new indication
to treat active non-radiographic axial spondyloarthritis</b></p>

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

<table cellpadding="0" cellspacing="0" style="width: 100%; font-size: 10pt"><tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px">&#8226;</td><td><i>FDA
approval for Cosentyx<sup>&reg;</sup> is based on the Phase III PREVENT trial, &nbsp;demonstrating efficacy in active non-radiographic
axial spondyloarthritis (nr-axSpA), which is part of the axial spondyloarthritis (axSpA) disease spectrum </i><br> &nbsp;</td></tr></table>


<table cellpadding="0" cellspacing="0" style="width: 100%; font-size: 10pt"><tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px">&#8226;</td><td><i>There
are an estimated 2.7M people living with axial spondyloarthritis (axSpA) in the US; however, it remains significantly underdiagnosed<sup>1,2
</sup></i><br> &nbsp;</td></tr></table>


<table cellpadding="0" cellspacing="0" style="width: 100%; font-size: 10pt"><tr style="vertical-align: top"><td style="width: 20px"></td><td style="width: 20px">&#8226;</td><td><i>nr-axSpA
approval is the fourth indication for Cosentyx, which is backed by five years of clinical data supporting long-term safety and
efficacy across moderate to severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)<sup>3-8</sup></i></td></tr></table>


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

<p style="margin: 0pt 0; font-size: 10pt"><b>Basel, June 17, 2020</b> &mdash; Novartis, a leader in rheumatology and immuno-dermatology,
today announced that the US Food and Drug Administration (FDA) has approved Cosentyx<sup>&reg;</sup> (secukinumab) for the treatment
of active non-radiographic axial spondyloarthritis (nr-axSpA), confirming Cosentyx efficacy in addressing the axial spondyloarthritis
(axSpA) disease spectrum<sup>9</sup>.</p>

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

<p style="font-size: 10pt; margin: 0pt 0">&ldquo;The results from the PREVENT trial show that there was a significant reduction
in disease activity for patients treated with Cosentyx versus placebo,&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 PREVENT clinical
trial. &ldquo;This approval brings a new therapeutic option to people living with non-radiographic axial spondyloarthritis.&rdquo;&nbsp;</p>

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

<p style="font-size: 10pt; margin: 0pt 0">The approval of Cosentyx for nr-axSpA is based on efficacy and safety outcomes from the
PREVENT Phase III study, which included 555 adults with active nr-axSpA that were biologic treatment na&iuml;ve or had an inadequate
response / were intolerant to an anti-tumor necrosis factor-&alpha; therapy (anti-TNFs). Cosentyx met the primary endpoints achieving
statistically significant improvements versus placebo in the signs and symptoms of nr-axSpA, as measured by at least a 40% improvement
in the Assessment of Spondyloarthritis International Society (ASAS40) response criteria in biologic-na&iuml;ve individuals at week
52<sup>10</sup>.</p>

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

<p style="font-size: 10pt; margin: 0pt 0">nr-axSpA patients treated with Cosentyx showed improvement in both load and without load
arms compared to placebo-treated patients at Week 16 in health-related quality of life as measured by the Ankylosing Spondylitis
Quality of Life (ASQoL) questionnaire (Least Squares mean change: Week 16: -3.5 and -3.6 -vs -1.8, respectively). General health
status and quality of life was assessed by the Short Form health survey (SF-36). At Week 16, patients treated with Cosentyx showed
greater improvement from baseline in the SF-36 physical component summary (PCS) score and in the mental component summary (MCS)
score<sup>10</sup>. The safety profile of Cosentyx in the PREVENT trial was shown to be consistent with previous clinical trials.
No new safety signals were detected<sup>3-8,10</sup>.</p>

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

<p style="font-size: 10pt; margin: 0pt 0"></p>

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<p style="margin: 0pt 0; font-size: 10pt">nr-axSpA is part of the axSpA spectrum, which is characterized by inflammatory arthritis
of the spine associated with chronic inflammatory back pain<sup>11</sup>. The axSpA disease spectrum also includes AS, in which
joint damage is visible on x-ray, and nr-axSpA, in which joint damage is generally not visible on x-ray<sup>1,12</sup>. The physical
limitations of axSpA can affect activities of daily living as well as leisure activities causing limitations for patients<sup>13,14</sup>.</p>

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

<p style="font-size: 10pt; margin: 0pt 0">&ldquo;There is a need for additional treatment options. Having a new treatment option
for the axSpA community is truly encouraging,&quot; said Cassie Shafer, Chief Executive Officer of the Spondylitis Association
of America. &ldquo;Helping reduce the burden on people living with non-radiographic axial spondyloarthritis by improving symptoms
that affect their daily lives remains a critical focus for the SAA.&rdquo;</p>

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

<p style="font-size: 10pt; margin: 0pt 0">In April 2020, Novartis received European Medicines Agency approval of Cosentyx for the
treatment of nr-axSpA<sup>15</sup>.</p>

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

<p style="font-size: 10pt; margin: 0pt 0"><b>About Cosentyx (secukinumab)</b><br>
Cosentyx is the first and only fully-human biologic that directly inhibits interleukin-17A (IL-17A), an important cytokine involved
in the inflammation and development of psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis
(AS) and nr-axSpA<sup>16,17</sup>. Cosentyx has been studied clinically for more than 13 years. The medicine is backed by robust
investigational evidence, including five years of clinical data supporting long-term safety and efficacy across moderate to severe
plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS)<sup>3-8</sup>. These data strengthen the unique
position of Cosentyx as a comprehensive treatment across axial spondyloarthritis, psoriatic arthritis and psoriatic disease, supported
by more than 340,000 patients treated worldwide since launch<sup>18-20</sup>.</p>

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

<p style="font-size: 10pt; margin: 0pt 0"><b>About PREVENT</b><br>
PREVENT is a 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 a 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)<sup>10</sup>.</p>

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

<p style="font-size: 10pt; margin: 0pt 0">The primary endpoints are the proportion of biologic-na&iuml;ve 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)<sup>10</sup>.</p>

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

<p style="font-size: 10pt; margin: 0pt 0">ASAS40 is achieved when there is a measure of an improvement of at least 40% and an improvement
of at least 20 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<sup>21</sup>. 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<sup>21</sup>.</p>

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

<p style="font-size: 10pt; margin: 0pt 0"></p>

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<p style="margin: 0pt 0; font-size: 10pt"><b>Disclaimer</b><br>
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;may,&rdquo; &ldquo;could,&rdquo; &ldquo;remains,&rdquo; &ldquo;expectations,&rdquo; &ldquo;encouraging,&rdquo;
investigational,&rdquo; &ldquo;launch,&rdquo; &ldquo;brings,&rdquo; or similar terms, or by express or implied discussions regarding
potential or actual marketing approvals, 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 sale or for any additional indications or labeling in any additional markets, 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 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>

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

<p style="font-size: 10pt; margin: 0pt 0"><b>About Novartis</b><br>
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 109,000 people
of more than 145 nationalities work at Novartis around the world. Find out more at<br>
https://www.novartis.com.</p>

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

<p style="font-size: 10pt; margin: 0pt 0">Novartis is on Twitter. Sign up to follow @Novartis at <b>https://twitter.com/novartisnews</b><br>
For Novartis multimedia content, please visit&nbsp;<b>https://www.novartis.com/news/media-library</b><br>
For questions about the site or required registration, please contact media.relations@novartis.com</p>

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

<p style="font-size: 10pt; margin: 0pt 0"><b>References</b></p>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 6pt; width: 100%"><tr style="vertical-align: top; text-align: justify">
<TD STYLE="width: 2%; text-align: left">1.</td><TD STYLE="width: 1%"></td><TD STYLE="text-align: left; width: 97%">Strand V and Singh JA. Evaluation and Management of the Patient With Suspected Inflammatory
Spine Disease. Mayo ClinProc 2017;92:555&ndash;564.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">2.</td><TD></td><TD STYLE="text-align: left">Spondylitis.org. Overview of Ankylosing Spondylitis Ankylosing. Available from: https://www.spondylitis.org/Ankylosing-Spondylitis
[Last accessed: June 2020].</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">3.</td><TD></td><TD STYLE="text-align: left">Data on file. CAIN457F2310 (MEASURE 2): 5 Year Report. Novartis Pharmaceuticals Corp;
September 15, 2015.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">4.</td><TD></td><TD STYLE="text-align: left">Data on file. Data Analysis Report: Study CAIN457A2302E1. Novartis Pharmaceuticals
Corp; November 30, 2015.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">5.</td><TD></td><TD STYLE="text-align: left">Data on file. CAIN457F2310 and CAIN457F2305 Summary of 5-Year Clinical Safety in (Ankylosing
Spondylitis). Novartis Pharmaceuticals Corp; May 2019.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">6.</td><TD></td><TD STYLE="text-align: left">Data on file. CAIN457F2312 (FUTURE 2): 5 Year- Interim Report. Novartis Pharmaceuticals
Corp; May 2019.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">7.</td><TD></td><TD STYLE="text-align: left">Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November
2008.</td>
</tr>
</table>

<p style="margin: 0">&nbsp;</p>

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    <div style="page-break-before: always; margin-top: 6pt; margin-bottom: 6pt"><P STYLE="margin: 0pt">&nbsp;</P></div>
    <!-- Field: /Page -->

<p style="margin: 0"></p>

<TABLE CELLPADDING="0" CELLSPACING="0" STYLE="font-size: 10pt; margin-top: 0pt; margin-bottom: 6pt; width: 100%">

<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left; width: 2%">8.</td><TD STYLE="width: 1%"></td><TD STYLE="text-align: left; width: 97%">Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals
Corp; July 23, 2018.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">9.</td><TD></td><TD STYLE="text-align: left">Cosentyx [Prescribing Information]. East Hanover, NJ: Novartis Pharmaceuticals Corp;
2020</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">10.</td><TD></td><TD STYLE="text-align: left">Novartis data on file. September 2019.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">11.</td><TD></td><TD STYLE="text-align: left">Strand V, et al. Patient Burden of Axial Spondyloarthritis. J Clin Rheumatol. 2017
Oct; 23(7): 383&ndash;391.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">12.</td><TD></td><TD STYLE="text-align: left">Rudwaleit M, 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;68:777&ndash;783.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">13.</td><TD></td><TD STYLE="text-align: left">Doward LC, Spoorenberg A, Cook SA, et al. Development of the ASQoL: a quality of life
instrument specific to ankylosing spondylitis. Ann Rheum Dis. 2003;62:20-26.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">14.</td><TD></td><TD STYLE="text-align: left">Moncur C. Ankylosing spondylitis measures. Arthritis Rheum (Arthritis Care Res). 2003;49:S197-S209.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">15.</td><TD></td><TD STYLE="text-align: left">Novartis. Novartis Cosentyx gains fourth indication in EU with first-in-class approval
in axial spondyloarthritis spectrum. Available from: https://www.novartis.com/news/media-releases/novartis-cosentyx-gains-fourth-indication-eu-first-class-approval-axial-spondyloarthritis-spectrum&nbsp;[Last
accessed: June 2020].</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">16.</td><TD></td><TD STYLE="text-align: left">Novartis Europharm Limited. Cosentyx (secukinumab): Summary of Product Characteristics.
Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&amp;mid=WC0b01ac058001d124&nbsp;[Last
accessed: June 2020].</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">17.</td><TD></td><TD STYLE="text-align: left">Girolomoni G, et al. Psoriasis: rationale for targeting interleukin-17.&nbsp;<i>Br
J Dermatol</i>&nbsp;2012;167:717&ndash;724.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">18.</td><TD></td><TD STYLE="text-align: left">Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; May 2019.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">19.</td><TD></td><TD STYLE="text-align: left">Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December
2008.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">20.</td><TD></td><TD STYLE="text-align: left">Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; June 2020.</td>
</tr>
<tr style="vertical-align: top; text-align: justify">
<TD STYLE="text-align: left">21.</td><TD></td><TD STYLE="text-align: left">Landewe R, et al. Clinical Tools to Assess and Monitor Spondyloarthritis.&nbsp;<i>Curr
Rheumatol Rep</i>. 2015;17(7):47.</td>
</tr></table>

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<table cellspacing="0" cellpadding="0" style="width: 100%; font-size: 10pt; border-collapse: collapse">
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    <td style="width: 50%; font-size: 10pt"><p style="margin-top: 0; margin-bottom: 0">Antonio Ligi <br> Novartis Global External Communications<br> +41 61 324 1374 (direct)<br> antonio.ligi@novartis.com<br></p>
                                            <p style="margin-top: 0; margin-bottom: 0">&nbsp;<br> Eric Althoff<br> Novartis US External Communications<br> +1 646 438 4335<br> eric.althoff@novartis.com</p></td>
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    <TD><font style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Date:</font> June 17, 2020</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>
