<SEC-DOCUMENT>0001104659-14-003932.txt : 20140124
<SEC-HEADER>0001104659-14-003932.hdr.sgml : 20140124
<ACCEPTANCE-DATETIME>20140124082924
ACCESSION NUMBER:		0001104659-14-003932
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20140124
FILED AS OF DATE:		20140124
DATE AS OF CHANGE:		20140124

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:		14544528

	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>
<DOCUMENT>
<TYPE>6-K
<SEQUENCE>1
<FILENAME>a14-4221_16k.htm
<DESCRIPTION>6-K
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">&nbsp;</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="5" face="Times New Roman" style="font-size:18.0pt;font-weight:bold;">SECURITIES AND EXCHANGE COMMISSION</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Washington, D.C. 20549</font></b></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="5" face="Times New Roman" style="font-size:18.0pt;font-weight:bold;">FORM&nbsp;6-K</font></b></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">REPORT OF FOREIGN PRIVATE ISSUER</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">PURSUANT TO RULE 13a-16 or 15d-16 OF</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="3" face="Times New Roman" style="font-size:12.0pt;font-weight:bold;">THE SECURITIES EXCHANGE ACT OF 1934</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Report on Form&nbsp;6-K dated January 24, 2014</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">(Commission File No.&nbsp;1-15024)</font></b></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="5" face="Times New Roman" style="font-size:18.0pt;font-weight:bold;">Novartis AG</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(Name of Registrant)</font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Lichtstrasse 35</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">4056 Basel</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Switzerland</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(Address of Principal Executive Offices)</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Indicate by check mark whether the registrant files or will file annual reports under cover of Form&nbsp;20-F or Form&nbsp;40-F: </font></p>
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<p align="right" style="margin:0in 0in .0001pt;text-align:right;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Form&nbsp;20-F:&nbsp;   </font></b><font size="2" face="Wingdings" style="font-size:10.0pt;">x</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Form&nbsp;40-F:&nbsp; </font><font size="2" face="Wingdings" style="font-size:10.0pt;">o</font></p>    </td>   </tr>  </table>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Indicate by check mark if the registrant is submitting the Form&nbsp;6-K in paper as permitted by Regulation S-T Rule&nbsp;101(b)(1): </font></p>
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<p align="right" style="margin:0in 0in .0001pt;text-align:right;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Yes:&nbsp; </font><font size="2" face="Wingdings" style="font-size:10.0pt;">o</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">No</font></b><font size="2" style="font-size:10.0pt;">:&nbsp; </font><font size="2" face="Wingdings" style="font-size:10.0pt;">x</font></p>    </td>   </tr>  </table>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Indicate by check mark if the registrant is submitting the Form&nbsp;6-K in paper as permitted by Regulation S-T Rule&nbsp;101(b)(7): </font></p>
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<p align="right" style="margin:0in 0in .0001pt;text-align:right;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Yes:&nbsp; </font><font size="2" face="Wingdings" style="font-size:10.0pt;">o</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">No</font></b><font size="2" style="font-size:10.0pt;">:&nbsp; </font><font size="2" face="Wingdings" style="font-size:10.0pt;">x</font></p>    </td>   </tr>  </table>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">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&nbsp;12g3-2(b)&nbsp;under the Securities Exchange Act of 1934. </font></p>
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<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">No</font></b><font size="2" style="font-size:10.0pt;">:&nbsp; </font><font size="2" face="Wingdings" style="font-size:10.0pt;">x</font></p>    </td>   </tr>  </table>
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<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Novartis&nbsp;International&nbsp;AG</font></b><font size="2" style="font-size:10.0pt;"><br>   Novartis&nbsp;Global Communications<br>   CH-4002 Basel<br>   Switzerland</font><font size="2" style="font-size:10.0pt;"><br>    </font><font size="2" style="font-size:10.0pt;">www.novartis.com</font></p>    </td>   </tr>  </table>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">MEDIA RELEASE&#160; </font></b><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><b><font size="2" style="font-size:10.0pt;font-weight:bold;">&#160; COMMUNIQUE AUX MEDIAS&#160; </font></b><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><b><font size="2" style="font-size:10.0pt;font-weight:bold;">&#160; MEDIENMITTEILUNG</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Novartis to request re-examination of serelaxin (RLX030) in acute heart failure (AHF) for conditional marketing authorization in EU</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt 35.45pt;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><i><font size="2" style="font-size:10.0pt;font-style:italic;">Novartis to submit revised filing package for re-examination with request for conditional approval following CHMP negative opinion</font></i></p>
<p style="margin:0in 0in .0001pt 35.45pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt 35.45pt;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><i><font size="2" style="font-size:10.0pt;font-style:italic;">RLX030 is currently the only drug for which a reduction in mortality has been observed in patients with AHF in a major study; data shows RLX030 is generally well tolerated(1)</font></i></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt .5in;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><i><font size="2" style="font-size:10.0pt;font-style:italic;">Second phase III study RELAX-AHF-2 started enrolment in September&nbsp;2013 with goal to replicate the key findings of RELAX-AHF(1)</font></i></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt .5in;text-indent:-.25in;"><font size="2" face="Symbol" style="font-size:10.0pt;">&#183;</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><i><font size="2" style="font-size:10.0pt;font-style:italic;">On February&nbsp;13</font></i><i><font size="1" style="font-size:6.5pt;font-style:italic;position:relative;top:-3.0pt;">th</font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">&#160;Novartis will present RLX030 efficacy and safety data at the FDA&#146;s Cardiovascular and Renal Drugs Advisory Committee meeting to discuss potential US approval</font></i></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Basel, January&nbsp;24, 2014 &#151; </font></b><font size="2" style="font-size:10.0pt;">Novartis announced today it will shortly submit a revised filing package, including new data analyses, for re-examination for conditional approval of RLX030 (serelaxin) for acute heart failure by the Committee for Medicinal Products for Human Use (CHMP) following a negative opinion issued today. In accordance with CHMP process a revised opinion could be granted in Q2 2014.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">The file for regulatory approval is continuing review by the Food and Drug Administration (FDA) in the United States where RLX030 was granted Breakthrough Therapy designation status in June&nbsp;2013</font><font size="2" style="font-size:10.0pt;">(2)</font><font size="2" style="font-size:10.0pt;">. Reviews are also underway with health authorities in 16 countries around the world.</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&#147;With the results from RELAX-AHF showing significant mortality&#160; benefits&#160; with RLX030 in patients with AHF and recognizing that there had been no treatment breakthroughs in this area for 20 years, Novartis took a decision to file for regulatory approval,</font><font size="2" style="font-size:10.0pt;">&#148; said </font><font size="2" style="font-size:10.0pt;">David Epstein, Division Head of Novartis Pharmaceuticals</font><font size="2" style="font-size:10.0pt;">. &#147;It has become apparent through the review process and in accordance with advice we&#146;ve received that the current evidence package may be more compatible with an application for conditional approval in the EU. We look forward to providing a revised package for review to the CHMP shortly.&#148;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">In September&nbsp;2013 the second phase III study RELAX-AHF-2 started recruitment of the over 6000 patients who are expected to be enrolled. The goal is to replicate the key findings of RELAX-AHF and the study will assess cardiovascular mortality as the primary endpoint. This would be one of the largest and most robust programs undertaken by a company for an AHF drug.</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">RLX030, a relaxin receptor agonist(3), is a form of a naturally occurring hormone (human relaxin 2) present in both men and women which rises in women during pregnancy to</font><font size="2" style="font-size:10.0pt;"> help the body cope with the additional cardiovascular demands(4)</font><i><font size="2" style="font-size:10.0pt;font-style:italic;">,</font></i><font size="2" style="font-size:10.0pt;">(5). RLX030 is thought to have multiple effects including relaxing the blood vessels, reducing fluid buildup and protecting the heart and vital organs from the cascade of damage that occurs during an </font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">AHF episode(3),</font><font size="2" style="font-size:10.0pt;">(6),(7),(8),(9).</font><font size="2" style="font-size:10.0pt;"> More than 1.5 million AHF episodes happen every year in Europe alone</font><font size="2" style="font-size:10.0pt;">(10),</font><font size="2" style="font-size:10.0pt;">(11)</font><font size="2" style="font-size:10.0pt;">, with 1 in 5 patients not surviving a year afterwards</font><font size="2" style="font-size:10.0pt;">(12)</font><font size="2" style="font-size:10.0pt;">,</font><font size="2" style="font-size:10.0pt;">(13)</font><font size="2" style="font-size:10.0pt;">,</font><font size="2" style="font-size:10.0pt;">(14),</font><font size="2" style="font-size:10.0pt;">(15),(16),(17)</font><font size="2" style="font-size:10.0pt;">.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">About RELAX-AHF</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">RLX030 was studied in the phase III RELAX-AHF trial, which showed it had </font><font size="2" style="font-size:10.0pt;">both short and longer-term effects, </font><font size="2" style="font-size:10.0pt;">relieving symptoms </font><font size="2" style="font-size:10.0pt;">and reducing the rate of heart failure worsening(1). In the trial p</font><font size="2" style="font-size:10.0pt;">atients who received RLX030 also had a 37% reduction in mortality at 6 months after an AHF episode compared to&nbsp;those who received conventional treatment(1)</font><font size="2" style="font-size:10.0pt;">. </font><font size="2" style="font-size:10.0pt;">Data from clinical trials has shown that RLX030 was generally well tolerated(1),(18)</font><font size="2" style="font-size:10.0pt;">.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">About acute heart failure</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Heart failure is a debilitating and potentially life-threatening condition where the heart cannot pump enough blood around the body. More than 15 million people suffer from heart failure globally and this number is increasing(10),</font><font size="2" style="font-size:10.0pt;">(19)</font><font size="2" style="font-size:10.0pt;">. </font><font size="2" style="font-size:10.0pt;">The condition is often fatal when patients have one or repeated acute heart failure episodes(19). </font><font size="2" style="font-size:10.0pt;">As an AHF episode approaches, </font><font size="2" style="font-size:10.0pt;">patients become severely breathless and rapidly gain weight due to fluid build-up in the lungs and around the body</font><font size="2" style="font-size:10.0pt;">. This is often compared to the sensation of drowning</font><font size="2" style="font-size:10.0pt;">(20)</font><font size="2" style="font-size:10.0pt;">.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Patients experiencing an AHF episode need to be rushed to the emergency room for urgent treatment, making AHF the most common cause of hospitalization in patients over 65 years(10),(21). Currently 2</font><font size="2" style="font-size:10.0pt;">0 to 30% of patients die within 1 year after experiencing an AHF episode,</font><font size="2" style="font-size:10.0pt;"> and </font><font size="2" style="font-size:10.0pt;">3-4% do not survive the initial episode</font><font size="2" style="font-size:10.0pt;">(12),(13),(14),(15),(16),(17)</font><font size="2" style="font-size:10.0pt;">. This means AHF causes more deaths than some advanced cancers, including breast and bowel cancer(</font><font size="2" style="font-size:10.0pt;">22)</font><font size="2" style="font-size:10.0pt;">.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Disclaimer</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">The foregoing release contains forward-looking statements that can be identified by words such as &#147;to request,&#148; &#147;to submit,&#148; &#147;goal,&#148; &#147;will,&#148; &#147;potential,&#148; &#147;could,&#148; &#147;continuing review,&#148; &#147;expected,&#148; &#147;would,&#148; or similar terms, or by express or implied discussions regarding potential marketing approvals for RLX030 or the timing of any such approvals, or regarding potential future revenues from RLX030. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management 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 RLX030 will be approved for sale in any market, or at any particular time. Nor can there be any guarantee that RLX030 will be commercially successful in the future. In particular, management&#146;s expectations regarding RLX030 could be affected by, among other things, the uncertainties inherent in research and development, including unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results and additional analysis of existing clinical data; the company&#146;s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG&#146;s current Form&nbsp;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.</font></p>
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<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">About Novartis</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">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, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(1)&nbsp;Teerlink <i>et al.</i> Serelaxin, recombinant human relaxin-2, for treatment of acute heart failure (RELAX-AHF): a randomised, placebo-controlled trial. <i>Lancet, </i>2013;381:29-39</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(2)&nbsp;Novartis press release &#145;FDA grants Breakthrough Therapy designation to Novartis&#146; serelaxin (RLX030) for acute heart failure&#146; issued on June&nbsp;21, 2013</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(3)&nbsp;Du X., et al. Cardiovascular effects of relaxin: from basic service to clinical therapy. Nat. Rev. Cardiol. 7, 48&#151;58 (2010);</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(4)&nbsp;Teichman S <i>et al</i>. Relaxin, a pleiotropic vasodilator for the treatment of heart failure. <i>Heart Fail Rev.</i> 2009;14:321-329</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(5)&nbsp;Teichman SL <i>et al.</i> Relaxin: Review of biology and potential role in treating heart failure.</font><i><font size="2" style="font-size:10.0pt;font-style:italic;"> Curr Heart Fail Rep.</font></i><font size="2" style="font-size:10.0pt;"> 2010;7:75-82</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(6)&nbsp;Fijalkowska A&nbsp;&amp; Torbicki A. Role of cardiac biomarkers in assessment of RV function and prognosis in chronic pulmonary hypertension. Eur Heart J Supplements 2007;9(Supplement H):H41&#151;H47</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(7)&nbsp;Shlipak MG, et al. Cystatin C and the risk of death and cardiovascular events among elderly persons. N Engl J Med 2005;352:2049-60</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(8)&nbsp;Metra M, et al. Hemoglobin concentration in acute decompensated heart failure J Am Coll Cardiol 2013;61:196&#151;206.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(9)&nbsp;Waikar SS, et al. Can we rely on blood urea nitrogen as a biomarker to determine when to initiate dialysis. Clin J Am Soc Nephrol 2006;1:903&#151;904</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(10)&nbsp;Gheorghiade M, Pang P, Acute heart failure syndromes, <i>Journal of the American College of Cardiology</i> 2009; 53 (7):557-73</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(11) Novartis data on file, approximately 1.6 million in the top 5 EU markets</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(12) Mosterd A, Hoes, A, Clinical epidemiology of heart failure, <i>Heart</i> 2007;93:1137-1146</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(13) Harrison&#146;s &#145;Principles of Internal Medicine&#146;, Seventeenth Edition pages&nbsp;1442 - 1455</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(14) Hunt S <i>et al</i>. Focused update incorporated into the ACC/AHA 2005 Guidelines for the Diagnosis and Management of Heart Failure in Adults: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines Developed in Collaboration With the International Society for Heart and Lung Transplantation. <i>Circulation</i>. </font><font size="2" style="font-size:10.0pt;">2009;119:e391-e479</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(15) Lloyd-Jones <i>et al.</i> Heart disease and stroke statistics&#151;2010 update: a report from the American Heart Association. <i>Circulation.</i> 2010;121:e46-215</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(16) National heart failure audit: April&nbsp;2010 &#151; March&nbsp;2011, NICOR and The British Society for Heart Failure, commissioned by the Healthcare Quality Improvement Partnership (HQIP)</font></p>
<p style="margin:0in 0in .0001pt;text-indent:3.0pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">3<a name="PB_3_003814_5796"></a></font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(17) O&#146;Connor M <i>et al.</i> Causes of death and rehospitalization in patients hospitalized with worsening heart failure and reduced left ventricular ejection fraction: Results from efficacy of vasopressin antagonism in heart failure outcome study with tolvaptan (EVEREST) program, <i>American Heart Journal</i> 2010;159(5): 842-849</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(18) Teerlink JR, Metra M, Felker GM, et al. Relaxin for the treatment of patients with acute heart failure (Pre-RELAX-AHF): a multicentre, randomised, placebo-controlled, parallel-group, dose-finding phase IIb study. Lancet. 2009;373:1429 -1439</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(19) Zannad F. et al, Heart failure burden and therapy, Europace 2009, 11; v1-v9.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(20) Irish Heart Foundation. Living well with heart failure patient booklet. http://www.irishheart.ie/media/pub/patient_booklets/living_with_heart_failure.pdf. Accessed November&nbsp;2013</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(21) Felker <i>et al.</i> Clinical trial of pharmacological therapies in acute heart failure syndromes, <i>Circ Heart Fail. </i>2010;3:314-325</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(22) Stewart <i>et al.</i> More &#145;malignant&#146; than cancer? Five-year survival following a first admission for heart failure <i>Eur J Heart Fail.</i> 2001;3:315322</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">4<a name="PB_4_003957_2897"></a></font></p>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">SIGNATURES</font></b></p>
<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.</font></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
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<p style="margin:0in 0in .0001pt;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Novartis   AG</font></b></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Date:</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">January   24, 2014</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">By:</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;/s/ MALCOLM B. CHEETHAM</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
<td width="6%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:6.66%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Name:</font></p>    </td>
<td width="43%" valign="top" style="padding:0in 0in 0in 0in;width:43.34%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Malcolm   B. Cheetham</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Title:</font></p>    </td>
<td width="43%" valign="top" style="padding:0in 0in 0in 0in;width:43.34%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Head   Group Financial</font></p>    </td>   </tr>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Reporting   and Accounting</font></p>    </td>   </tr>
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<p align="center" style="margin:0in 0in .0001pt;text-align:center;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
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