<SEC-DOCUMENT>0001104659-12-061211.txt : 20120904
<SEC-HEADER>0001104659-12-061211.hdr.sgml : 20120903
<ACCEPTANCE-DATETIME>20120904060625
ACCESSION NUMBER:		0001104659-12-061211
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20120903
FILED AS OF DATE:		20120904
DATE AS OF CHANGE:		20120904

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:		121069503

	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>a12-19789_16k.htm
<DESCRIPTION>6-K
<TEXT>


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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;">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 September 3, 2012</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 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;">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>
<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 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 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;">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>
<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 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>
<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 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;"><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<br>   http://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><b><font size="2" face="Symbol" style="font-size:10.0pt;font-weight:bold;">&#183;</font></b><b><font size="2" style="font-size:10.0pt;font-weight:bold;">&#160; MEDIENMITTEILUNG</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;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Novartis data at ERS shows efficacy of once-daily COPD portfolio versus comparators, further establishes dual-bronchodilator QVA149</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 .25in;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;">QVA149 demonstrated superior bronchodilation compared to indacaterol 150 mcg, glycopyrronium 50 mcg, </font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">salmeterol/fluticasone 50/500 mcg BID, OL tiotropium 18 mcg</font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;"> and placebo</font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">(1),(2)</font></i></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt .25in;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;">Seebri</font></i><i><font size="1" style="font-size:6.5pt;font-style:italic;position:relative;top:-3.0pt;">&#174;</font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">&#160;Breezhaler</font></i><i><font size="1" style="font-size:6.5pt;font-style:italic;position:relative;top:-3.0pt;">&#174;</font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">&#160;(</font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">g</font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">lycopyrronium bromide) demonstrated rapid, sustained bronchodilation and reduced exacerbations similar to OL tiotropium 18 mcg in GLOW pooled data analysis(3),(4)</font></i></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt .25in;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;">Onbrez</font></i><i><font size="1" style="font-size:6.5pt;font-style:italic;position:relative;top:-3.0pt;">&#174;</font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">&#160;Breezhaler</font></i><i><font size="1" style="font-size:6.5pt;font-style:italic;position:relative;top:-3.0pt;">&#174;</font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">&#160;(indacaterol maleate) was superior to OL tiotropium 18 mcg in improving severe breathlessness symptoms in pooled INERGIZE data(5)</font></i></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><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, September&nbsp;3, 2012</font></b><font size="2" style="font-size:10.0pt;"> &#151; Further data from the Novartis once-daily chronic obstructive pulmonary disease (COPD) clinical trial programs were presented today at the European Respiratory Society (ERS) Congress. Overall, Novartis presented 14 abstracts, including data from the investigational QVA149 (fixed-dose combination of indacaterol maleate / glycopyrronium bromide) IGNITE Phase III clinical trial program, the glycopyrronium bromide (Seebri</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;Breezhaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">) GLOW Phase III clinical trial program and the indacaterol maleate (Onbrez</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;Breezhaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">) INERGIZE Phase III/IV clinical trial program. The data further demonstrated the potential of the Novartis COPD portfolio to provide once-daily, innovative treatment choices for patients and physicians.</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;">Among the data presented, three new studies from the investigational QVA149 IGNITE Phase III clinical trial program (SHINE,&nbsp;ILLUMINATE and ENLIGHTEN) demonstrated that QVA149 significantly improved lung function compared to other COPD therapies(1),(2),(6). Data from the GLOW program showed that glycopyrronium 50 mcg once daily provided rapid and sustained bronchodilation, and reduced exacerbations and symptoms when compared to placebo, similar to the levels observed with open-label (OL) tiotropium 18 mcg(3),(4). Additionally, a new pooled-analysis from the INERGIZE studies showed that Onbrez</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;Breezhaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174; </font><font size="2" style="font-size:10.0pt;">300 mcg was superior to OL tiotropium 18 mcg in improving breathlessness in COPD patients who had more severe breathlessness symptoms on entry to the studies (p&lt;0.05)(5).</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;">&#147;We are very excited that the Novartis data at ERS brings us one step further to delivering on the promise to provide COPD patients and physicians with a range of innovative treatments</font><font size="2" style="font-size:10.0pt;">,&#148; said David Epstein, Head of Novartis Pharmaceuticals. &#147;These products are all being made available in the Breezhaler device which allows patients to hear, feel and see that they have taken the drug correctly.&#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;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">IGNITE data demonstrated the efficacy of the dual-bronchodilator QVA149 (indacaterol maleate / glycopyrronium bromide) and showed a superior effect on lung function and patient-reported outcomes versus comparators(1),(2),(6)</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;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">SHINE met its primary endpoint by demonstrating that once-daily QVA149 110/50 mcg improved lung function as measured by trough FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;compared to once-daily indacaterol</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">maleate 150 mcg (+70mL above indacaterol alone; p&lt;0.001) and once-daily glycopyrronium 50 mcg (+90mL above glycopyrronium alone; p&lt;0.001)(1). QVA149 110/50 mcg is an investigational inhaled dry-powder fixed-dose combination medication that provides the equivalent amount of indacaterol as Onbrez (indacaterol maleate) 150 mcg along with glycopyrronium 50 mcg(7).&#160; QVA149 was also more effective at improving lung function compared to OL tiotropium 18 mcg (+80mL above tiotropium; p&lt;0.001) and placebo (+200mL; p&lt;0.001)(1). Mean peak FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;at Week 26 was also significantly higher with QVA149 compared to placebo (+330mL, p&lt;0.001), indacaterol 150 mcg (+120mL; p&lt;0.001), glycopyrronium 50 mcg (+130mL; p&lt;0.001) and OL tiotropium 18 mcg (+130mL; p&lt;0.001)(1). Mean FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;area under the curve (AUC) for 0&#151;24hr at Week 26 was significantly higher with QVA149 compared to placebo (+320mL, p&lt;0.001), indacaterol 150 mcg (+110mL; p&lt;0.001), glycopyrronium 50 mcg (+110mL; p&lt;0.001) and OL tiotropium 18 mcg (+110mL; p&lt;0.001)(1).</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">The results also showed that QVA149 improved breathlessness measured by the transition dyspnea index or TDI (p&lt;0.001 versus placebo; p&lt;0.05 versus OL tiotropium 18 mcg), increased health-related quality of life (HRQoL) measured by the St George&#146;s Respiratory Questionnaire or SGRQ (p&lt;0.01 versus placebo; p&lt;0.05 versus OL tiotropium 18 mcg) and reduced rescue medication use (p&lt;0.001 versus both placebo and OL tiotropium 18 mcg)(1). QVA149 was superior to indacaterol 150 mcg and glycopyrronium 50 mcg at reducing use of rescue medication (p&lt;0.05 and p&lt;0.001 respectively) and also provided numerically higher improvements in breathlessness and HRQoL compared to indacaterol 150 mcg and glycopyrronium 50 mcg(1).</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">ILLUMINATE </font><font size="2" style="font-size:10.0pt;">compared QVA149 110/50 mcg to the twice-daily LABA/ICS salmeterol/fluticasone 50/500 mcg head-to-head over 26 weeks in patients with COPD </font><font size="2" style="font-size:10.0pt;">(2). </font><font size="2" style="font-size:10.0pt;">The study met its primary endpoint by </font><font size="2" style="font-size:10.0pt;">demonstrating that the mean FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;area under the curve (AUC) for 0&#151;12hr at Week 26 was significantly higher with QVA149 compared to salmeterol/fluticasone 50/500 mcg (+140mL; p&lt;0.001)(2). Mean FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;AUC</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">0-12h</font><font size="2" style="font-size:10.0pt;">&#160;was also significantly higher with QVA149 versus salmeterol/fluticasone 50/500 mcg at Day 1 (+70mL; p&lt;0.001)(2)&nbsp;and Week 12 (+120mL; p&lt;0.001)(2). </font><font size="2" style="font-size:10.0pt;">The ILLUMINATE trial also demonstrated that </font><font size="2" style="font-size:10.0pt;">QVA149, in comparison to salmeterol/fluticasone 50/500 mcg, significantly improved breathlessness measured by TDI (p=0.003) and reduced rescue medication use (p=0.019) over 26 weeks(2).</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">ENLIGHTEN demonstrated the efficacy of QVA149 at improving lung function over a 52-week period by </font><font size="2" style="font-size:10.0pt;">showing that QVA149 increased FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;and forced vital capacity (FVC) versus placebo at Day 1 and Weeks 3, 6, 12, 26, 39 and 52 (p&lt;0.001)(6). At Week 52, the mean difference in FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;compared to placebo at 60 minutes post-dose was +257mL (p&lt;0.001)(6).</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">QVA149 was generally well tolerated in the SHINE,&nbsp;ILLUMINATE and ENLIGHTEN trials with an incidence of adverse events that was similar between respective groups(1),(2),(6).</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;">GLOW pooled analyses demonstrated that investigational glycopyrronium increased lung function, improved patient outcomes compared to placebo(3),(4)</font></b></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Results of the first pooled analysis of GLOW1 and GLOW2 </font><font size="2" style="font-size:10.0pt;">data</font><font size="2" style="font-size:10.0pt;">  demonstrated that patients on<b>  </b></font><font size="2" style="font-size:10.0pt;">glycopyrronium </font><font size="2" style="font-size:10.0pt;">50 mcg experienced rapid, sustained and clinically meaningful bronchodilation over 52 weeks(3). The improvement in FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;was seen within five minutes after the first dose on Day 1 (+90mL at 5 minutes and +144mL at 15 minutes versus placebo; p&lt;0.001) and was sustained throughout the 52-week period (p&lt;0.001 vs. placebo)(3). FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;AUC for 0-4h, 0-12h, 0-24h and 12-24h for glycopyrronium 50 mcg was statistically significantly greater than placebo (p&lt;0.05) and numerically greater than OL tiotropium 18 mcg (an exploratory arm in GLOW2) when compared to placebo on Day 1 and Weeks 12, 26 and 52(3).&#160; When compared to placebo, </font><font size="2" style="font-size:10.0pt;">glycopyrronium </font><font size="2" style="font-size:10.0pt;">50 mcg was also numerically higher than OL tiotropium 18 mcg versus placebo at all-time points for trough FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;(Day 1 and Weeks 12, 26 and 52)(3).</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">The second pooled analysis of GLOW1 and GLOW2 data found that for patients taking </font><font size="2" style="font-size:10.0pt;">glycopyrronium </font><font size="2" style="font-size:10.0pt;">50 mcg, the time to first moderate/severe exacerbation was significantly prolonged compared to placebo at both Week 26 (hazard ratio [HR] 0.64; p&lt;0.001) and Week 52 (HR 0.67; p&lt;0.001)(4). The results were comparable in patients treated with OL tiotropium 18 mcg. </font><font size="2" style="font-size:10.0pt;">Glycopyrronium </font><font size="2" style="font-size:10.0pt;">50 mcg also significantly lowered the rate of moderate/severe exacerbations versus placebo at Weeks 26 and 52 (both rate ratio [RR] 0.66; p&lt;0.005)(4).</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Glycopyrronium </font><font size="2" style="font-size:10.0pt;">50 mcg improved breathlessness measured by TDI (p&lt;0.05) and health-related quality of life measured by SGRQ (p&lt;0.001) at Weeks 26 and 52(4). The results were similar to OL tiotropium 18 mcg compared to placebo(4).</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;">INERGIZE pooled analysis showed indacaterol 300 mcg superior to OL tiotropium 18 mcg in improving breathlessness(5)</font></b></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">New results from a pooled post-hoc sub-group analysis from three studies (INVOLVE,&nbsp;INHANCE and INLIGHT2) showed that indacaterol maleate 300 mcg was statistically significantly more effective than OL tiotropium 18 mcg at improving breathlessness in patients who were more breathless on entry to the studies(5).</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">In patients with less severe breathlessness at the start of the study (mMRC score &lt;2.0), both indacaterol </font><font size="2" style="font-size:10.0pt;">maleate</font><font size="2" style="font-size:10.0pt;"> 150 mcg and 300 mcg were similarly effective at increasing trough FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">, reducing breathlessness and improving health-related quality of life (measured by SGRQ) and were both superior to placebo (all p&lt;0.05)(5). The results for the two indacaterol doses were similar to OL tiotropium 18 mcg compared to placebo(5). In patients with more severe breathlessness at the start of the studies (mMRC score <u>&gt;</u>2.0), treatment with indacaterol maleate 150 mcg was more effective than placebo (p&lt;0.05) at improving breathlessness (measured by TDI). Indacaterol </font><font size="2" style="font-size:10.0pt;">maleate</font><font size="2" style="font-size:10.0pt;"> 300 mcg was also more effective than OL tiotropium 18 mcg at increasing trough FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">&#160;and improving breathlessness (both p&lt;0.05)(5).</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 the study designs</font></b></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;">SHINE</font></b><font size="2" style="font-size:10.0pt;"> was a 26 week, multicenter, randomized, double-blind, parallel-group, placebo and active controlled pivotal trial of 2,144 patients with </font><font size="2" style="font-size:10.0pt;">moderate-to-severe COPD to assess efficacy in terms of </font><font size="2" style="font-size:10.0pt;">trough FEV</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">1</font><font size="2" style="font-size:10.0pt;">(1). Patients were </font><font size="2" style="font-size:10.0pt;">randomized</font><font size="2" style="font-size:10.0pt;"> to receive QVA149, indacaterol </font><font size="2" style="font-size:10.0pt;">maleate</font><font size="2" style="font-size:10.0pt;"> 150 mcg, </font><font size="2" style="font-size:10.0pt;">glycopyrronium 50 mcg</font><font size="2" style="font-size:10.0pt;">, </font><font size="2" style="font-size:10.0pt;">OL tiotropium 18 mcg </font><font size="2" style="font-size:10.0pt;">or placebo.</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;">ILLUMINATE</font></b><font size="2" style="font-size:10.0pt;"> was a 26 week, multi-center, randomized, double-blind, double dummy, parallel-group study to assess the efficacy, safety and tolerability of once-daily QVA149 compared to twice-daily fixed dose combination of salmeterol/fluticasone 50/500 mcg in patients with moderate-to-severe stable COPD(2).</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;">ENLIGHTEN</font></b><font size="2" style="font-size:10.0pt;"> was a 52 week, multicenter, randomized, double-blind, parallel-group, placebo controlled pivotal trial of 339 patients with moderate-to-severe COPD to assess the safety and tolerability of QVA149(6).</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;">GLOW1</font></b><font size="2" style="font-size:10.0pt;"> and <b>GLOW2 </b>were multicenter, randomized, double-blind, placebo controlled,</font><font size="2" style="font-size:10.0pt;">  </font><font size="2" style="font-size:10.0pt;">parallel group studies in patients with moderate-to-severe COPD. </font><font size="2" style="font-size:10.0pt;">GLOW1 was a 26 week study with patients randomized to receive once-daily glycopyrronium 50 mcg or placebo. </font><font size="2" style="font-size:10.0pt;">GLOW2 was a 52 week study with patients randomized to receive</font><font size="2" style="font-size:10.0pt;"> once-daily </font><font size="2" style="font-size:10.0pt;">glycopyrronium 50 mcg or placebo, and included an exploratory arm to compare the effects of once-daily OL tiotropium 18 mcg versus placebo</font><font size="2" style="font-size:10.0pt;">(3),(4).</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 first pooled analysis assessed the efficacy of once-daily </font><font size="2" style="font-size:10.0pt;">glycopyrronium </font><font size="2" style="font-size:10.0pt;">50 mcg versus placebo and once-daily OL tiotropium 18 mcg over 26 to 52 weeks in 1,888 patients with moderate-to-severe COPD from clinical trials (GLOW1 and GLOW2)(3). The second pooled analysis assessed the efficacy of once-daily </font><font size="2" style="font-size:10.0pt;">glycopyrronium </font><font size="2" style="font-size:10.0pt;">50 mcg versus placebo and once-daily OL tiotropium 18 mcg at reducing COPD exacerbations,</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">symptoms and improving health status over 26 to 52 weeks in 1,854 patients from clinical trials (GLOW1 and GLOW2)(4).</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;">INERGIZE </font></b><font size="2" style="font-size:10.0pt;">data analysis compared data from three randomized studies (INVOLVE,&nbsp;INHANCE and INLIGHT2) in the clinical trial program which included 3,176 patients with moderate-to-severe COPD(5). The analysis assessed patients randomized to receive once-daily indacaterol maleate 150 mcg, once-daily indacaterol</font><font size="2" style="font-size:10.0pt;"> maleate</font><font size="2" style="font-size:10.0pt;"> 300 mcg, placebo or once-daily OL tiotropium 18 mcg for six months(5).</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 the Novartis COPD portfolio</font></b></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Novartis is committed to addressing the unmet medical needs of COPD patients and improving their quality of life by providing innovative medicines and devices.</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Onbrez</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;Breezhaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174; </font><font size="2" style="font-size:10.0pt;">(indacaterol maleate) is a long-acting beta</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">2</font><font size="2" style="font-size:10.0pt;">-adrenergic agonist (LABA) that is currently the only COPD treatment on the market to offer clinically relevant 24-hour bronchodilation combined with a rapid onset of action at first dose, </font><font size="2" style="font-size:10.0pt;">as demonstrated in the INERGIZE Phase III/IV trial program</font><font size="2" style="font-size:10.0pt;">(8)-(11). </font><font size="2" style="font-size:10.0pt;">Onbrez</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;Breezhaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;&nbsp; </font><font size="2" style="font-size:10.0pt;">&nbsp;is approved in more than 85 countries around the world. </font><font size="2" style="font-size:10.0pt;">It was first launched in the EU (150 mcg and 300 mcg once-daily doses) and has since received approvals in markets worldwide including Japan (Onbrez</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174; </font><font size="2" style="font-size:10.0pt;">Inhalation Capsules 150 mcg once-daily) and US (Arcapta</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">TM</font><font size="2" style="font-size:10.0pt;">&#160;Neohaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">TM </font><font size="2" style="font-size:10.0pt;">75 mcg once-daily).</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Glycopyrronium bromide is an investigational LAMA developed as a once-daily inhaled maintenance therapy for the treatment of COPD. Phase III data from the GLOW 1, 2 and 3 studies demonstrated that glycopyrronium increased patients&#146; lung function over a 24-hour period compared to placebo with a fast onset of action at first dose, and improved exercise endurance versus placebo(12)-(14). Glycopyrronium bromide was licensed to Novartis in April&nbsp;2005 by Vectura and its co-development partner Sosei. In June&nbsp;2012, </font><font size="2" style="font-size:10.0pt;">the European Medicines Agency&#146;s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the approval of </font><font size="2" style="font-size:10.0pt;">glycopyrronium bromidein Europe under the brand name Seebri</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;Breezhaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">.</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">QVA149 is an investigational inhaled, once-daily, fixed-dose combination of indacaterol maleate and glycopyrronium bromide. QVA149 is being investigated for the treatment of COPD in the Phase III IGNITE clinical trial program. </font><font size="2" style="font-size:10.0pt;">IGNITE </font><font size="2" style="font-size:10.0pt;">is one of the largest international clinical trial programs in COPD comprising 10 studies in total with more than 7,000 patients across 42 countries(1),(2),(6),(15)-(21). The first five studies (ILLUMINATE, SHINE, BRIGHT, ENLIGHTEN, SPARK) have already completed in 2012 with three additional studies (BLAZE, ARISE, BEACON) expected to complete by the end of the year. The studies are designed to investigate efficacy, safety and tolerability, lung function, exercise endurance, exacerbations, breathlessness and quality of life. Initial filings for regulatory approval are expected in Q4 2012 for Europe and Japan. US filing is expected at the </font><font size="2" style="font-size:10.0pt;">end of 2014.</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">All Novartis COPD portfolio products are </font><font size="2" style="font-size:10.0pt;">being developed for delivery via the Breezhaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;device, a single-dose dry powder inhaler (SDDPI), which has low air flow resistance, making it suitable for patients with airflow limitation, such as COPD patients. The Breezhaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;device allows patients to hear, feel and see that they have taken the drug correctly(19).</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 COPD</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;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">COPD is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 210 million people worldwide(22) and is predicted to be the third leading cause of death by 2020(23). Although COPD is often thought of as a disease of the elderly, 50% of patients are estimated to be within the ages of 50 and 65, which means that half of the COPD population are likely to be impacted at the peak of their earning power and family responsibilities(24).</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;">Disclaimer</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;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">The foregoing release contains forward-looking statements that can be identified by terminology such as &#147;potential,&#148; &#147;promise,&#148; &#147;committed,&#148; &#147;positive opinion,&#148; &#147;expected,&#148; &#147;being developed,&#148; or similar expressions, or by express or implied discussions regarding potential marketing submissions or approvals, or new indications or labeling for products in the Novartis COPD portfolio, or regarding potential future revenues from such products. </font><font size="2" style="font-size:10.0pt;">You should not place undue reliance on these statements.&#160; </font><font size="2" style="font-size:10.0pt;">Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that any products in the Novartis COPD portfolio will be submitted or approved for sale in any market, or for any additional indications or labeling in any market. Nor can there be any guarantee that any of these products will achieve any particular levels of revenue in the future. In particular, management&#146;s expectations regarding the COPD portfolio products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; competition in general; government, industry and general public pricing pressures</font><font size="2" style="font-size:10.0pt;">; </font><font size="2" style="font-size:10.0pt;">the company&#146;s ability to obtain or maintain patent or other proprietary intellectual property protection; unexpected manufacturing issues; </font><font size="2" style="font-size:10.0pt;">the impact that the foregoing factors could have on the values attributed to the Novartis Group&#146;s assets and liabilities as recorded in the Group&#146;s consolidated balance sheet</font><font size="2" style="font-size:10.0pt;">, 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. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. 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>
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<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 areas. In 2011, the Group&#146;s continuing operations achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&amp;D throughout the Group. Novartis Group companies employ approximately 126,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit </font><font size="2" style="font-size:10.0pt;">http://www.novartis.com</font><font size="2" style="font-size:10.0pt;">.</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.</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;">References</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 .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(1)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Bateman E et al.</font><font size="2" style="font-size:10.0pt;">  </font><font size="2" style="font-size:10.0pt;">Benefits of dual bronchodilation with QVA149 once daily versus placebo, indacaterol, NVA237 and tiotropium in patients with COPD: the SHINE study</font><font size="2" style="font-size:10.0pt;">. </font><font size="2" style="font-size:10.0pt;">[ERS abstract 700179; Session 306; Monday September&nbsp;3, 2012; 14:45:&#151;16:45]</font><font size="2" style="font-size:10.0pt;">.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(2)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Vogelmeier C et al. Once-daily QVA149 significantly improves lung function and symptoms compared to twice-daily fluticasone/salmeterol in COPD patients: The ILLUMINATE study</font><font size="2" style="font-size:10.0pt;">. </font><font size="2" style="font-size:10.0pt;">[ERS abstract 70045; Session 52; Sunday September&nbsp;2, 2012; 08:30-10:30]</font><font size="2" style="font-size:10.0pt;">.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(3)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Banerji D et al. Once-daily NVA237 improves lung function in COPD patients: pooled results of the GLOW1 and GLOW2 studies. </font><font size="2" style="font-size:10.0pt;">[ERS abstract </font><font size="2" style="font-size:10.0pt;">853239</font><font size="2" style="font-size:10.0pt;">; Session 245; Date: September&nbsp;03, 2012 Time: 12:50-14:40</font><font size="2" style="font-size:10.0pt;">.</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 .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(4)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Banerji D et al. Once-daily NVA237 reduces exacerbations and improves symptoms in COPD patients: a pooled analysis, of the GLOW1 and GLOW2 studies. </font><font size="2" style="font-size:10.0pt;">[ERS abstract </font><font size="2" style="font-size:10.0pt;">853213</font><font size="2" style="font-size:10.0pt;">; Session 314; Date: September&nbsp;03, 2012 Time: 14:45-16:45</font><font size="2" style="font-size:10.0pt;">.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(5)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Mahler</font><font size="2" style="font-size:10.0pt;"> D et al. </font><font size="2" style="font-size:10.0pt;">Effectiveness of indacaterol and tiotropium in patients with severe dyspnoea. </font><font size="2" style="font-size:10.0pt;">[ERS abstract </font><font size="2" style="font-size:10.0pt;">850630</font><font size="2" style="font-size:10.0pt;">; Session 245; Date: September&nbsp;03, 2012 Time: 12:50-14:40</font><font size="2" style="font-size:10.0pt;">.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(6)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Dahl R et al. QVA149 administered once daily provides significant improvements in lung function over 1 year in patients with COPD: the ENLIGHTEN study. </font><font size="2" style="font-size:10.0pt;">[ERS abstract </font><font size="2" style="font-size:10.0pt;">853405</font><font size="2" style="font-size:10.0pt;">; Session 315; Date: September&nbsp;03, 2012 Time: 14:45-16:45</font><font size="2" style="font-size:10.0pt;">.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(7)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Novartis data on file</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(8)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Donohue JF, Fogarty C, L&#246;tvall J, <i>et al</i>. Once-daily bronchodilators for chronic obstructive pulmonary disease: Indacaterol versus tiotropium. <i>Am J Respir Crit Care Med</i> 2010;182:155-162.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(9)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Dahl R, Chung KF, Buhl R, <i>et al</i>. </font><font size="2" style="font-size:10.0pt;">Efficacy of a new once-daily long-acting inhaled beta</font><font size="1" style="font-size:6.5pt;position:relative;top:1.0pt;">2</font><font size="2" style="font-size:10.0pt;">-agonist indacaterol versus twice-daily formoterol in COPD. <i>Thorax</i> 2010;65(6):473-9.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(10)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Kornmann O, Dahl R, Centanni S, <i>et al</i>. </font><font size="2" style="font-size:10.0pt;">Once-daily indacaterol vs twice-daily salmeterol for COPD: a placebo-controlled comparison. <i>Eur Respir J</i> 2011;37:273-279.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(11)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Balint B, Watz H, Amos C, <i>et al.</i> Onset of action of indacaterol in patients with COPD: Comparison with salbutamol and salmeterol-fluticasone. <i>Int J Chron Obstruct Pulmon Dis</i> 2010;5:311-318.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(12)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">D&#146;Urzo A, <i>et al</i>. Efficacy and safety of once-daily NVA237 in patients with moderate-to-severe COPD: the GLOW1 trial. Respiratory Research 2011, 12:156 (7 December&nbsp;2011).</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(13)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Kerwin E, et al. Eur Resp J 2012. </font><font size="2" style="font-size:10.0pt;">Published on July&nbsp;26, 2012 (doi:10.1183/09031936.00040712).</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(14)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Beeh KM, et al A . </font><i><font size="2" style="font-size:10.0pt;font-style:italic;">Int J Chron Obstruct Pulmon Dis</font></i><font size="2" style="font-size:10.0pt;">. 2012;7:503-513.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(15)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">QVA149 2305 (</font><font size="2" style="font-size:10.0pt;">BRIGHT). Data on file, Novartis Pharma AG. </font><font size="2" style="font-size:10.0pt;">ClinicalTrials.gov identifier: NCT01294787.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(16)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">QVA149 A2304 (SPARK).</font><font size="2" style="font-size:10.0pt;"> Data on file, Novartis Pharma AG. </font><font size="2" style="font-size:10.0pt;">ClinicalTrials.gov identifier: NCT01120691.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(17)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">QVA149 2322 (BLAZE).</font><font size="2" style="font-size:10.0pt;"> Data on file, Novartis Pharma AG. </font><font size="2" style="font-size:10.0pt;">ClinicalTrials.gov identifier: NCT01490125.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(18)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">QVA149 1301 (ARISE).</font><font size="2" style="font-size:10.0pt;"> Data on file, Novartis Pharma AG. </font><font size="2" style="font-size:10.0pt;">ClinicalTrials.gov identifier: NCT01285492.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-17.0pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(19)</font><font size="1" style="font-size:3.0pt;">&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Onbrez</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;Breezhaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;(indacaterol) EU Summary of Product Characteristics May&nbsp;31, 2011 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001114/human_med_001219.jsp&amp;mid=WC0b01ac058001d124. Last accessed 20 June&nbsp;2012.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(20)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">FDA Access Data. Spiriva</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;HandiHaler</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">&#160;Medical Review Part&nbsp;2, pages&nbsp;37-38.http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-395_Spiriva.cfm. Last accessed 28 March&nbsp;2012.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(21)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">FDA Access Data. Advair Medical Review Nov.&nbsp;17, 2003, Page&nbsp;133. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021077_S003_ADVAIR_DISKUS.pdf Last accessed 30 March&nbsp;2012.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(22)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Global Alliance Against Chronic Respiratory Diseases (GARD). Global surveillance, prevention and control of chronic respiratory diseases: a comprehensive approach. Available at: http://www.who.int/gard/publications/GARD%20Book%202007.pdf Last accessed 22 May&nbsp;2012.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(23)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2011.</font></p>
<p style="margin:0in 0in .0001pt .25in;text-indent:-.25in;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(24)</font><font size="1" style="font-size:3.0pt;">&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Fletcher MJ <i>et al.,</i> COPD Uncovered: An International survey on the impact of chronic obstructive pulmonary disease (COPD) on a working age population. <i>BMC Public Health</i> 2011;11:612.</font></p>
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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>
<tr>
<td width="50%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:50.0%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>
<td width="50%" colspan="3" valign="top" style="padding:0in 0in 0in 0in;width:50.0%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>   </tr>
<tr>
<td width="5%" valign="top" style="padding:0in 0in 0in 0in;width:5.66%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Date:</font></p>    </td>
<td width="44%" valign="top" style="padding:0in 0in 0in 0in;width:44.34%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">September   3, 2012</font></p>    </td>
<td width="3%" valign="top" style="padding:0in 0in 0in 0in;width:3.92%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">By:</font></p>    </td>
<td width="46%" colspan="2" valign="top" style="border:none;border-bottom:solid windowtext 1.0pt;padding:0in 0in 0in 0in;width:46.08%;">
<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>
<tr>
<td width="50%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:50.0%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>
<td width="50%" colspan="3" valign="top" style="padding:0in 0in 0in 0in;width:50.0%;">
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>    </td>   </tr>
<tr>
<td width="50%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:50.0%;">
<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>
<tr>
<td width="50%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:50.0%;">
<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;">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>
<tr>
<td width="50%" colspan="2" valign="top" style="padding:0in 0in 0in 0in;width:50.0%;">
<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:1.0pt;">&nbsp;</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;">Reporting   and Accounting</font></p>    </td>   </tr>
<tr height="0">
<td width="42" style="border:none;"></td>
<td width="332" style="border:none;"></td>
<td width="29" style="border:none;"></td>
<td width="20" style="border:none;"></td>
<td width="324" style="border:none;"></td>   </tr> </table>
<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;">8<a name="PB_8_022942_8146"></a></font></p>
<div style="margin:0in 0in .0001pt;"><hr size="3" width="100%" noshade color="#010101" align="left"></div>
</div>
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