<SEC-DOCUMENT>0001171843-18-006229.txt : 20180823
<SEC-HEADER>0001171843-18-006229.hdr.sgml : 20180823
<ACCEPTANCE-DATETIME>20180823110120
ACCESSION NUMBER:		0001171843-18-006229
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20180823
FILED AS OF DATE:		20180823
DATE AS OF CHANGE:		20180823

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:		181034030

	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 August 23, 2018</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>

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<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>

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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>


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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: #0460A9; font-size: 10pt; font-weight: bold; margin: 0pt 0"><FONT STYLE="font-size: 8pt">Novartis&nbsp;International&nbsp;AG<BR>
                           Novartis&nbsp;Global Communications<BR>
                           <FONT STYLE="font-weight: normal; color: windowtext">CH-4002 Basel</FONT><BR>
                           <FONT STYLE="font-weight: normal; color: windowtext">Switzerland</FONT></FONT></P>

<P STYLE="color: #0460A9; font-size: 10pt; font-weight: bold; margin: 0pt 0"><FONT STYLE="font-size: 8pt">&nbsp;</FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 0"><FONT STYLE="font-size: 8pt">http://www.novartis.com</FONT></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="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-size: 10pt; text-align: center; margin: 0pt 0; background-color: Silver"><FONT STYLE="font-size: 11pt"><B>MEDIA
RELEASE &bull; COMMUNIQUE AUX MEDIAS &bull; MEDIENMITTEILUNG</B></FONT></P>

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

<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 24.9pt; margin-bottom: 0pt; text-align: left"><FONT STYLE="font-size: 14pt"><B>SOLAR-1 trial of Novartis investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) meets primary endpoint
in HR+/HER2- advanced breast cancer with PIK3CA mutation</B></FONT></P>



<P STYLE="font-size: 10pt; margin-top: 0pt; margin-right: 24.9pt; margin-bottom: 0pt; text-align: left"><FONT STYLE="font-size: 12pt"><B></B></FONT></P>

<P STYLE="font-size: 10pt; margin: 0pt 24.9pt 0pt 23.75pt">&nbsp;</P>

<P STYLE="font-size: 10pt; margin: 0pt 24.9pt 0pt 23.75pt"></P>

<P STYLE="margin-top: 0pt; margin-bottom: 0pt"></P>

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<TD STYLE="width: 23.75pt"></TD><TD STYLE="width: 18pt"><FONT STYLE="font-family: Symbol; font-style: normal">&middot;</FONT></TD><TD STYLE="padding-right: 23.55pt">SOLAR-1
                                         evaluated BYL719 plus fulvestrant vs. fulvestrant alone in HR+/HER2- advanced breast
                                         cancer patients with PIK3CA mutations who progressed on or following treatment with an
                                         aromatase inhibitor with or without a CDK4/6 inhibitor<FONT STYLE="font-size: 10pt"><SUP>1</SUP></FONT></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.5pt 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: 23.75pt"></TD><TD STYLE="width: 18pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="padding-right: 53.45pt"><I>Approximately
                                         40% of HR+ advanced breast cancer patients have PIK3CA mutations, and the PI3K pathway
                                         is the most commonly mutated pathway associated with tumor progression in HR+ advanced
                                         breast cancer<FONT STYLE="font-size: 10pt"><SUP>2,3</SUP></FONT></I></TD></TR></TABLE>

<P STYLE="font-size: 10pt; margin: 0.35pt 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: 23.75pt"></TD><TD STYLE="width: 18pt"><FONT STYLE="font-family: Symbol">&middot;</FONT></TD><TD STYLE="padding-right: 29.25pt"><I>Full results will be submitted to an upcoming medical congress and Novartis will initiate
discussions with regulatory authorities worldwide</I></TD></TR></TABLE>

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

<P STYLE="margin-top: 0pt; margin-bottom: 0pt"><B>Basel, August 23, 2018 &ndash;</B> Novartis today announced the global Phase
III SOLAR-1 trial evaluating the investigational alpha-specific PI3K inhibitor BYL719 (alpelisib) has met the primary endpoint
showing an improvement in progression-free survival (PFS). SOLAR-1 is evaluating BYL719 in combination with fulvestrant compared
to fulvestrant alone in postmenopausal women and men with hormone-receptor positive, human epidermal growth factor receptor-2
negative (HR+/HER2-) PIK3CA-mutant advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment
with or without a CDK4/6 inhibitor<FONT STYLE="font-size: 10pt"><SUP>1</SUP></FONT>.</P>

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

<P STYLE="margin-top: 0pt; margin-bottom: 0pt">&ldquo;BYL719 is the only alpha-specific PI3K inhibitor and the first one
to show potential increased benefit and acceptable tolerability for patients,&rdquo; said Samit Hirawat, MD, Head, Novartis Oncology
Global Drug Development. &ldquo;We are encouraged by the results observed in the SOLAR-1 study and look forward to submitting the
data to an upcoming medical congress and starting discussions with health authorities worldwide.&rdquo;</P>

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

<P STYLE="margin-top: 0pt; margin-bottom: 0pt">Currently, there are no approved PI3K inhibitors for HR+ advanced breast cancer.
The PI3K pathway plays an important role in regulating cell processes and is the most frequently altered pathway promoting tumor
growth, disease progression and treatment resistance in HR+ advanced breast cancer<FONT STYLE="font-size: 10pt"><SUP>4,5</SUP></FONT>.</P>

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

<P STYLE="margin-top: 0pt; margin-bottom: 0pt">Adverse events observed with investigational BYL719 in combination with fulvestrant
in SOLAR-1 were generally consistent with those observed in previous BYL719 and fulvestrant studies<FONT STYLE="font-size: 10pt"><SUP>1</SUP></FONT>.
The SOLAR-1 trial will continue to assess data for secondary endpoints. Novartis will begin discussions with global health authorities
based on these results.</P>

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

<P STYLE="margin-top: 0pt; margin-bottom: 0pt"><B>About PI3K inhibition in advanced breast cancer</B></P>

<P STYLE="margin: 0">Studies <FONT STYLE="font-size: 10pt">have established the role of PI3K signaling in several processes critical
for cancer progression, including cell metabolism, growth, survival and motility<SUP>9</SUP>. Activation of the PI3K pathway in
breast cancer is associated with resistance to endocrine therapy, disease progression and poorer prognosis<SUP>4,6</SUP>.&nbsp;</FONT></P>

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

<P STYLE="font-size: 10pt; margin: 0pt 19.85pt 0pt 23.75pt">&nbsp;</P>

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<P STYLE="margin-top: 0pt; margin-bottom: 0pt">Proteins in the PI3K pathway consist of four smaller parts called isoforms<FONT STYLE="font-size: 10pt"><SUP>7</SUP></FONT>.
Approximately 40% of HR+ advanced breast cancer patients have genetic mutations that activate the alpha isoform, called PIK3CA
mutations<FONT STYLE="font-size: 10pt"><SUP>2</SUP></FONT>. Mutations in the three other isoforms are typically not associated
with advanced breast cancer<FONT STYLE="font-size: 10pt"><SUP>7</SUP></FONT>.</P>

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

<P STYLE="margin-top: 0pt; margin-bottom: 0pt"><B>About SOLAR-1</B></P>

<P STYLE="margin: 0">SOLAR-1 is a global, Phase III randomized, double-blind, placebo-controlled trial studying investigational
BYL719 in combination with fulvestrant for postmenopausal women and men with PIK3CA-mutated HR+/HER2- advanced or metastatic breast
cancer that progressed on or following prior aromatase inhibitor treatment with or without a CDK4/6 inhibitor<FONT STYLE="font-size: 10pt"><SUP>10</SUP></FONT>.</P>

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

<P STYLE="margin: 0">The trial randomized 572 patients in a 1:1 ratio to receive continuous oral treatment with BYL719 300mg or
placebo once daily in combination with fulvestrant 500mg intramuscular injections on days 1 and 15 on the first cycle and day
1 of each subsequent 28-day cycle as per fulvestrant prescribing information. Patients were allocated based on tumor tissue assessment
to either a PIK3CA-mutant cohort or a PIK3CA non-mutant cohort. Stratification was based on visceral metastases and prior CDK4/6
inhibitor treatment<FONT STYLE="font-size: 10pt"><SUP>10</SUP></FONT>.</P>

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

<P STYLE="margin: 0">The primary endpoint is PFS for patients with the PIK3CA mutation. Secondary endpoints include but are not
limited to: overall survival, overall response rate, clinical benefit rate, health-related quality of life, efficacy in PIK3CA
non-mutant cohort, safety and tolerability<FONT STYLE="font-size: 10pt"><SUP>10</SUP></FONT>.</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 BYL719 (alpelisib)</P>

<P STYLE="margin: 0">BYL719 is an investigational, orally bioavailable, alpha-specific PI3K inhibitor. In breast cancer cell lines
harboring PIK3CA mutations, BYL719 has been shown to potentially inhibit the PI3K pathway and have antiproliferative effects.
In addition, cancer cell lines with PIK3CA mutations were more sensitive to BYL719 than those without the mutation across a broad
range of different cancers<FONT STYLE="font-size: 10pt"><SUP>11</SUP></FONT>.</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 in Advanced Breast Cancer</P>

<P STYLE="margin: 0">For more than 30 years, Novartis has been tackling
breast cancer with superior science, great collaboration and a passion for transforming patient care. With one of the most diverse
breast cancer pipelines and one of the largest numbers of breast cancer compounds in development, Novartis leads the industry in
discovery of new therapies and combinations, especially in HR+ advanced breast cancer, the most common form of the disease.</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">Disclaimer</P>

<P STYLE="margin: 0">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;expect,&rdquo; &ldquo;encouraged,&rdquo; &ldquo;upcoming,&rdquo;
&ldquo;starting,&rdquo; &ldquo;look forward,&rdquo; &ldquo;investigational,&rdquo; &ldquo;pipeline,&rdquo; &ldquo;launch,&rdquo;
or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for
BYL719 or the other investigational or approved products described in this press release, or regarding potential future revenues
from such products. 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 BYL719 or the other investigational
or approved products described in this press release 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 BYL719 or such other products will be commercially
successful in the future. In particular, our expectations regarding BYL719 and such other products 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</P>



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<P STYLE="font-size: 10pt; margin-top: 3.7pt; margin-right: 6.6pt; margin-bottom: 0pt">government, payor and general public pricing and reimbursement pressures;
our ability 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'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: 0.1pt 0 0">&nbsp;</P>

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

<P STYLE="font-size: 10pt; margin-top: 3.7pt; margin-right: 6.6pt; margin-bottom: 0pt">Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these
needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally
in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&amp;D throughout the Group amounted
to approximately USD 9.0 billion. Novartis Group companies employ approximately 125,000 full-time-equivalent associates. Novartis
products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.</P>

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

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

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 1.8pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 41.75pt"></TD><TD STYLE="width: 18pt">1.</TD><TD>Novartis Data on File.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 1.65pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 41.75pt"></TD><TD STYLE="width: 18pt">2.</TD><TD STYLE="text-align: justify; padding-right: 19.55pt">Sabine V, Crozier C, Brookes C, et al. Mutational analysis of PI3K/AKT
signaling pathway in tamoxifen exemestane adjuvant multinational pathology study. <I>Journal of Clinical Oncology</I>. 2014;32:2951-2958.</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: 41.75pt"></TD><TD STYLE="width: 18pt">3.</TD><TD STYLE="padding-right: 37.3pt">Lee JJX, Loh K, Yap Y-S. PI3K/Akt/mTOR inhibitors in breast cancer. Cancer Biol Med. 2015 ;12(4):342-354.</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: 41.75pt"></TD><TD STYLE="width: 18pt">4.</TD><TD STYLE="text-align: justify; padding-right: 20.3pt">Miller TW, Rexer BN, Garrett JT, Arteaga CL.Mutations in the Phosphatidylinositol
3-Kinase Pathway: Role in Tumor Progression and Therapeutic Implications in Breast Cancer. <I>Breast Cancer Res</I>. 2011.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0.2pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 41.75pt"></TD><TD STYLE="width: 18pt">5.</TD><TD STYLE="padding-right: 13.05pt">Mukohara T. PI3K mutations in breast cancer: prognostic and therapeutic implications. Breast
Cancer Targets Ther. 2015;7:111-123.</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: 41.75pt"></TD><TD STYLE="width: 18pt">6.</TD><TD STYLE="padding-right: 39.2pt">Saal LH, Johansson P, Holm K. Poor prognosis in carcinoma is associated with a gene expression
signature of aberrant PTEN tumor suppressor pathway activity. PNAS. 2007;104(18):7564-7569.</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: 41.75pt"></TD><TD STYLE="width: 18pt">7.</TD><TD STYLE="padding-right: 35.25pt">Thorpe LM, Yuzugullu H, Zhao JJ. PI3K in cancer: divergent roles of isoforms, modes of activation,
and therapeutic targeting. <I>Nature Reviews Cancer</I>. 2015;15(1):7-24.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0.25pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 41.75pt"></TD><TD STYLE="width: 18pt">8.</TD><TD STYLE="padding-right: 23.25pt">Keegan NM, Gleeson JP, Hennessy BT and Morris PG. (2018) PI3K inhibition to overcome endocrine
resistance in breast cancer. <I>Expert Opin on Investig Drugs</I>. 2018(27; 1:1-15).</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0.25pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 41.75pt"></TD><TD STYLE="width: 18pt">9.</TD><TD STYLE="padding-right: 35.25pt">Courtney KD, Corcoran RB, Engelman JA. The PI3K pathway as a drug target in human cancer. <I>J
Clin Oncol.</I> 2010;28(6):1075-1083.</TD></TR></TABLE>

<TABLE CELLPADDING="0" CELLSPACING="0" WIDTH="100%" STYLE="font-size: 10pt; margin-top: 0.25pt; margin-bottom: 0"><TR STYLE="vertical-align: top">
<TD STYLE="width: 41.75pt"></TD><TD STYLE="width: 18pt">10.</TD><TD STYLE="padding-right: 8.9pt">ClinicalTrials.gov. Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men
and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment (SOLAR-1).
https://clinicaltrials.gov/ct2/show/NCT02437318?term=SOLAR-1&amp;rank=1 (link is external). Accessed August 16, 2018.</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: 41.75pt"></TD><TD STYLE="width: 18pt">11.</TD><TD STYLE="padding-right: 6.6pt">Fritsch C, Huang A, Chatenay-Rivauday A et al. Characterization of the novel and specific PI3K
alpha inhibitor NVP BYL719 and development of patient stratification strategy for clinical trials. Molecular Cancer Therapeutics.2014;
13(5):1117-1129.</TD></TR></TABLE>

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