<SEC-DOCUMENT>0001104659-12-042163.txt : 20120607
<SEC-HEADER>0001104659-12-042163.hdr.sgml : 20120607
<ACCEPTANCE-DATETIME>20120607060026
ACCESSION NUMBER:		0001104659-12-042163
CONFORMED SUBMISSION TYPE:	6-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20120606
FILED AS OF DATE:		20120607
DATE AS OF CHANGE:		20120607

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			NOVARTIS AG
		CENTRAL INDEX KEY:			0001114448
		STANDARD INDUSTRIAL CLASSIFICATION:	PHARMACEUTICAL PREPARATIONS [2834]
		IRS NUMBER:				000000000
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		6-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	001-15024
		FILM NUMBER:		12893165

	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>a12-14225_16k.htm
<DESCRIPTION>6-K
<TEXT>


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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>
<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="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 June 6, 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;"><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="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>
<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;">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>
<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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<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 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)(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;"><font size="2" face="Times New Roman" style="font-size:1.0pt;">&nbsp;</font></p>    </td>
<td width="48%" valign="top" style="padding:0in 0in 0in 0in;width:48.0%;">
<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;"><font size="2" face="Times New Roman"><img width="183" height="35" src="g142251bci001.jpg" alt="GRAPHIC"></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;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">Novartis&nbsp;International&nbsp;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: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;">Novartis&nbsp;Global   Communications</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;">CH-4002   Basel</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;">Switzerland</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;">http://www.novartis.com</font></p>    </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;"><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 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 Phase III study showed 62% of patients with most severe form of childhood arthritis were symptom-free with ACZ885 treatment</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 35.7pt;text-indent:-17.85pt;"><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;">Data also showed one third of patients became steroid-free within five months with ACZ885(1), a fully human monoclonal antibody that inhibits IL-1 beta(2)</font></i></p>
<p style="margin:0in 0in .0001pt 35.7pt;text-indent:-17.85pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<p style="margin:0in 0in .0001pt 35.7pt;text-indent:-17.85pt;"><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;">ACZ885 regulatory submissions on track for 2012 in systemic juvenile idiopathic arthritis (SJIA), a rare, disabling and potentially fatal autoinflammatory disease(3)</font></i></p>
<p style="margin:0in 0in .0001pt 35.7pt;text-indent:-17.85pt;"><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;">A Phase II study of ACZ885 in TNF-receptor associated periodic syndrome (TRAPS) showed substantial symptom relief in this rare, periodic fever </font></i><i><font size="2" style="font-size:10.0pt;font-style:italic;">syndrome(4)</font></i></p>
<p style="margin:0in 0in .0001pt .5in;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, 6 June&nbsp;2012 &#151; </font></b><font size="2" style="font-size:10.0pt;">Novartis announced today new data from two trials with ACZ885 (canakinumab); a pivotal Phase III study in patients with systemic juvenile idiopathic arthritis (SJIA), and a Phase II study in patients with tumor necrosis factor (TNF) receptor-associated periodic syndrome (TRAPS). SJIA and TRAPS are both rare and serious autoinflammatory diseases that usually start in childhood(4-6).</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;">Both studies met their primary endpoints, and the results will be presented on 7 June&nbsp;at the annual congress of the European League Against Rheumatism (EULAR 2012), in Berlin, Germany</font><font size="2" style="font-size:10.0pt;">(1),(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;">In the Phase III study, 62% of SJIA patients treated with ACZ885 had inactive disease status at the end of the placebo-controlled period. In contrast, patients who had received ACZ885 treatment and were then randomized to receive placebo had a 32% rate of inactive disease at this time point. Disease inactivity is a rigorous definition of improvement, comprising absence of symptoms including: no active arthritis, no fever, no rheumatoid rash, as well as normalized blood markers normally associated with inflammation, such as ESR (erythrocyte sedimentation rate) and CRP (C-reactive protein). In addition, one third (33%) of SJIA patients treated with ACZ885 were able to completely discontinue corticosteroids</font><font size="2" style="font-size:10.0pt;">(1)</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;">The aim of SJIA therapy is to suppress systemic inflammation and induce disease inactivity(7).</font><font size="2" style="font-size:10.0pt;">  </font><font size="2" style="font-size:10.0pt;">Long-term corticosteroid use in children is associated with potentially serious adverse effects, including Cushing syndrome, growth suppression, and osteoporosis(7).</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;">Data from this Phase III study support the safety and efficacy profile of ACZ885 in the study population. Side effects observed in this study were similar to those already seen for ACZ885&#146;s approved indication in CAPS (Cryopyrin-Associated Periodic Syndromes), including infections and neutropenia(1). Infections were the most common category of adverse event (AE) in both parts of the study. Cases of macrophage activation syndrome (MAS) were also reported(1).</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;In clinical practice, our aim is to help children with SJIA lead a normal life. It is encouraging to see many patients become free of SJIA symptoms in this trial</font><font size="2" style="font-size:10.0pt;">,&#148; said Prof Alberto Martini, Professor of Pediatrics at the University of Genoa and Head of Pediatric Rheumatology at the G. Gaslini Research Institute,&nbsp;Italy. &#147;It is also positive that a third of</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">patients achieved sufficient symptom control with ACZ885 to allow them to completely discontinue corticosteroid therapy.&#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 the Phase II study, 90% of TRAPS patients treated with ACZ885 experienced clinical remission after only one week of treatment. Clinical remission included a clinically significant improvement of disease symptoms, as assessed by the treating physician. After two weeks of treatment, 95% of patients with TRAPS treated with ACZ885 had achieved a complete or almost complete response (clinical remission as well as reduced levels of CRP and/or serum amyloid A [SAA], a protein associated with acute inflammation), which was maintained until the end of treatment with monthly dosing(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;">Side effects observed in this study were similar to those already seen for ACZ885&#146;s approved indication in CAPS. Infections, mostly upper respiratory tract infections (URIs), were the most commonly</font><font size="2" style="font-size:10.0pt;"> reported category of AE(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;">&#147;It is encouraging to witness that targeting interleukin-1 beta with ACZ885 can result in such marked improvement of symptoms in patients with these rare and debilitating conditions, such as SJIA and TRAPS&#148;, </font><font size="2" style="font-size:10.0pt;">said John Hohneker, Head of Development for Integrated Hospital Care for the Pharmaceuticals Division of Novartis. &#147;We are committed to investigating new treatments that can address the existing unmet medical need in immune-mediated diseases, no matter how rare some of these conditions may be.&#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;">SJIA is a rare systemic </font><font size="2" style="font-size:10.0pt;">interleukin-1 beta (</font><font size="2" style="font-size:10.0pt;">IL-1 beta)-mediated autoinflammatory disease characterized by daily spiking fevers, rash, chronic pain, and arthritis that may result in joint destruction, functional disability and impaired growth(3),(8). Patients can also suffer enlargement of their liver and spleen, as well as inflammation of the lining of their organs(3).</font><font size="2" style="font-size:10.0pt;"> SJIA affects less than one child per 100,000(9).</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;">MAS is a known, potentially fatal condition associated with SJIA that is characterized by liver abnormalities, bleeding disorders, central nervous system dysfunction and multiple organ failure(10),(11). Approximately 10% of SJIA patients are diagnosed with MAS, some of whom suffer repeated episodes(8).</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;">TRAPS is a rare auto-inflammatory disease that can affect both children and adults(12-14). This genetically inherited disease is characterized by long and intermittent attacks that can involve fever, rash, abdominal pain, conjunctivitis, severe skin infection, inflammation around the eyes and severe joint pain(12-14).</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">Amyloidosis is a serious complication of TRAPS and is estimated to occur in 25% of patients(15). This long-term complication involves the production of SAA during inflammation, and can lead to liver and/or kidney failure. In some instances, amyloidosis can be fatal(16).</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;">There are currently no approved treatments for TRAPS. While </font><font size="2" style="font-size:10.0pt;">nonsteroidal anti-inflammatory drugs, steroids and colchicine have been shown to relieve some symptoms, there can be problems with limited and intermittent efficacy, in addition to the side-effects of long-term steroid use, particularly in children(12),(17).</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 studies</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;">ACZ885 in SJIA</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">The pivotal Phase III study in patients with SJIA comprised of an open-label, single-arm active treatment period (Part&nbsp;1) followed by a randomized, double-blind, placebo-controlled, event-driven withdrawal design period (Part&nbsp;2)(1). A total of 177 patients between the ages of <u>&gt;</u>2 and &lt;20 years with active SJIA were enrolled in the study(1). In Part&nbsp;1, patients </font><font size="2" style="font-size:10.0pt;">received a subcutaneous (s.c.) dose of ACZ885 (4 mg/kg, up to 300 mg) every 4 weeks. After 8 weeks, patients who entered the trial using a corticosteroid and who had a minimum adapted American College of Rheumatology (ACR) Pediatric 50</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">criteria began tapering (reducing) their steroid use until either: <b>a)</b> the dose had been tapered by a pre-specified amount depending on the baseline corticosteroid dose(18) while maintaining the adapted ACR Pediatric 30 criteria (successful tapering of steroids); or <b>b)</b> a maximum of 20 weeks passed without reaching this goal (unsuccessful tapering of steroids)(1). In Part&nbsp;2 of the study, patients who had a minimum adapted ACR Pediatric 30 criteria at the end of Part&nbsp;1 were randomized to either continue receiving ACZ885, or to receive placebo every 4 weeks, until a pre-specified number (37) of flare-events (&#147;flares&#148;) had occurred(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 primary endpoints were to: <b>a)</b> assess if ACZ885 allows tapering of steroids in at least 25% of SJIA patients (Part&nbsp;1); and <b>b)</b> demonstrate that time to flare is extended with ACZ885 vs. placebo (Part&nbsp;2)(1).</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;">Both primary endpoints were met, with 45% of patients successfully reducing their use of steroids within 28 weeks of commencing treatment with ACZ885 (p&lt;0.0001)(1). At this time point (end of Part&nbsp;1), 31% of patients had inactive disease. Patients using </font><font size="2" style="font-size:10.0pt;">ACZ885 were nearly three times (0.37 hazard ratio) less likely to suffer a new flare in Part&nbsp;2. Only 22% of ACZ885-treated patients experienced a new flare, vs. 52% of patients on placebo during the study (p=0.0043)(1). </font><font size="2" style="font-size:10.0pt;">In Part&nbsp;1 of the study (representing 58 patient years), 138 of 177 patients (78%) reported an AE, with the most common being nasopharyngitis, headache and cough. Serious adverse events (SAEs) were reported in 15 patients, with the most common being infections, MAS (four cases) or flare-associated events(1). Five SAEs led to discontinuation and one patient died of MAS(1). During Part&nbsp;2, AEs (the most common being arthralgia, cough, nasopharyngitis and pyrexia) were reported by 40 of 50 (80%) ACZ885-treated patients (vs. 35 of 50 [70%] placebo-after-ACZ885-treated patients)(1); and six patients in each arm experienced one or more SAE, which mainly included infections, MAS and flare-associated events(1). Six patients, all in the placebo arm, discontinued the study due to AEs or SAEs during Part&nbsp;2(1). One patient died from MAS after study discontinuation in the placebo group.</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;">ACZ885 in TRAPS</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">The ongoing Phase II, open-label, multicenter study investigating </font><font size="2" style="font-size:10.0pt;">the efficacy and safety of ACZ885 in patients with active TRAPS</font><font size="2" style="font-size:10.0pt;"> involves 20 patients with a median age of 39 years (range, 7&#151;78 years), who receive ACZ885 150 mg (or 300 mg) every four weeks. </font><font size="2" style="font-size:10.0pt;">The primary endpoint of the study, is complete or almost complete response at Day 15.</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;">Complete response was defined as clinical remission and normal </font><font size="2" style="font-size:10.0pt;">CRP </font><font size="2" style="font-size:10.0pt;">and/or </font><font size="2" style="font-size:10.0pt;">SAA</font><font size="2" style="font-size:10.0pt;"> levels</font><font size="2" style="font-size:10.0pt;">. Almost complete response was defined as clinical remission and elevated but <u>&gt;</u>70% reduction of baseline CRP and/or SAA(4). Clinical remission was maintained for all patients from Day 15 onwards in the four month treatment period, except for one patient with a relapse at Day 85 who subsequently responded to the scheduled ACZ885 dose(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;">At least one AE was reported for 95% of patients, and most AEs were mild in severity. One SAE, a URI that lasted two days, was reported(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;"><b><font size="2" face="Times New Roman" style="font-size:10.0pt;font-weight:bold;">About ACZ885</font></b></p>
<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">ACZ885 is a fully human monoclonal antibody that inhibits IL-1 beta, which is an important part of the body&#146;s immune system defenses(2). Excessive production of IL-1 beta plays a major role in certain inflammatory diseases, including SJIA(19) and TRAPS(4). ACZ885 works by neutralizing IL-1 beta for a sustained period of time, thereby inhibiting inflammation(2).</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;">Under the brand name Ilaris</font><font size="1" style="font-size:6.5pt;position:relative;top:-3.0pt;">&#174;</font><font size="2" style="font-size:10.0pt;">, ACZ885 is approved in more than 60 countries, including the EU, US and Switzerland for the treatment of adults and children as young as four years with CAPS, a rare, lifelong, inflammatory disorder with debilitating symptoms(2). ACZ885 is also being studied in other diseases in which IL-1 beta plays a key role in causing inflammation, such as gouty arthritis and cardiovascular disease. ACZ885 is not</font></p>
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<p style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">approved for the treatment of SJIA or TRAPS. Not all potential patients with these diseases would be eligible for treatment with ACZ885, if approved.</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 terminology such as &#147;on track,&#148; &#147;potentially,&#148; &#147;will,&#148; &#147;encouraging,&#148; &#147;committed,&#148; &#147;being studied,&#148; &#147;potential,&#148; or similar expressions, or by express or implied discussions regarding potential submissions or approvals of new indications or labeling for ACZ885 or the timing of any such submissions or approvals, or regarding potential future revenues from ACZ885. </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 with ACZ885 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that ACZ885 will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that ACZ885 will achieve any particular levels of revenue in the future. In particular, management&#146;s expectations regarding ACZ885 could be affected by, among other things, unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; competition in general; government, industry and general public pricing pressures</font><font size="2" style="font-size:10.0pt;">; unexpected manufacturing issues; </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; </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>
<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 124,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.</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;">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 35.45pt;text-indent:-35.45pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Ruperto N, Brunner H, Quartier P<i>, et al.</i>  </font><font size="2" style="font-size:10.0pt;">Efficacy and safety of canakinumab, fully human anti-interleukin-1 beta antibody, in systemic juvenile idiopathic arthritis: Oral presentation at: The European League Against Rheumatism (EULAR) congress: June&nbsp;6-9, 2012, Berlin, Germany.</font></p>
<p style="margin:0in 0in .0001pt 35.45pt;text-indent:-35.45pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Ilaris [precribing information]. Surrey, UK: Novartis Pharmaceuticals UK Ltd; 2011.</font></p>
<p style="margin:0in 0in .0001pt 35.45pt;text-indent:-35.45pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Woo P. Systemic juvenile idiopathic arthritis: diagnosis, management, and outcome. </font><i><font size="2" style="font-size:10.0pt;font-style:italic;">Nat Clin Pract Rheumatol </font></i><font size="2" style="font-size:10.0pt;">2006; 2(1):28-34.</font></p>
<p style="margin:0in 0in .0001pt 35.45pt;text-indent:-35.45pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Gattorno M, Obici L, Meini A<i>, et al</i>. </font><font size="2" style="font-size:10.0pt;">Efficacy and safety of canakinumab patients with TNF Receptor-Associated Syndrome (TRAPS): Poster presentation at: The European League Against Rheumatism (EULAR) congress: June&nbsp;6-9, 2012, Berlin, Germany.</font></p>
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<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Wallace CA, Levinson JE. Juvenile rheumatoid arthritis: outcome and treatment for the 1990s. <i>Rheum Dis Clin North Am </i>1991; 17(4):891-905.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Kimberley FC, Lobito AA, Siegel RM, Screaton GR. Falling into TRAPS&#151;receptor misfolding in the TNF receptor 1-associated periodic fever syndrome. <i>Arthritis Res Ther </i>2007; 9(4):217.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Prince FH, Otten MH, van Suijlekom-Smit LW. Diagnosis and management of juvenile idiopathic arthritis. <i>BMJ </i>2010; 341:c6434.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Mellins ED, Macaubas C, Grom AA. Pathogenesis of systemic juvenile idiopathic arthritis: some answers, more questions. <i>Nat Rev Rheumatol </i>2011; 7(7):416-26.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Ramanan AV, Grom AA. Does systemic-onset juvenile idiopathic arthritis belong under juvenile idiopathic arthritis? <i>Rheumatology (Oxford) </i>2005; 44(11):1350-3.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Kelly A, Ramanan AV. Recognition and management of macrophage activation syndrome in juvenile arthritis. <i>Curr Opin Rheumatol </i>2007; 19(5):477-81.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Weiss JE,&nbsp;Ilowite NT. Juvenile idiopathic arthritis. <i>Pediatr Clin North Am </i>2005; 52(2):413-42, vi.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Fietta P. Autoinflammatory diseases: the hereditary periodic fever syndromes. <i>Acta Biomed </i>2004; 75(2):92-9.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Simon A, van der Meer JW. Pathogenesis of familial periodic fever syndromes or hereditary autoinflammatory syndromes. <i>Am J Physiol Regul Integr Comp Physiol </i>2007; 292(1):R86-98.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Borghini S, Fiore M, Di Duca M<i>, et al.</i> Candidate genes in patients with autoinflammatory syndrome resembling tumor necrosis factor receptor-associated periodic syndrome without mutations in the TNFRSF1A gene. <i>J Rheumatol </i>2011; 38(7):1378-84.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Dode C, Cuisset L, Delpech M, Grateau G. TNFRSF1A-associated periodic syndrome (TRAPS), Muckle-Wells syndrome (MWS) and renal amyloidosis. <i>J Nephrol </i>2003; 16(3):435-7.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Aksentijevich I, Galon J, Soares M<i>, et al.</i> The tumor-necrosis-factor receptor-associated periodic syndrome: new mutations in TNFRSF1A, ancestral origins, genotype-phenotype studies, and evidence for further genetic heterogeneity of periodic fevers. <i>Am J Hum Genet </i>2001; 69(2):301-14.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Doull IJ, Campbell MJ, Holgate ST. Duration of growth suppressive effects of regular inhaled corticosteroids. <i>Arch Dis Child </i>1998; 78(2):172-3.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Novartis data on file. Abrams K, Dimitrov-Kuhl M, Doerr T et al. Clinical Study Protocol (CACZ885G2301): &#946;-SPECIFIC 2: Study of Pediatric EffiCacy wIth FIrst-line use of Canakinumab [A randomized, double-blind, placebo controlled, withdrawal study of flare prevention of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations].&#160; 23 May&nbsp;2011.</font></p>
<p style="margin:0in 0in .0001pt 35.3pt;text-indent:-35.3pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">(19)</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;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160;&#160; </font><font size="2" style="font-size:10.0pt;">Church LD, Cook GP, McDermott MF. Primer: inflammasomes and interleukin 1beta in inflammatory disorders. <i>Nat Clin Pract Rheumatol </i>2008; 4(1):34-42.</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>
<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: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;">June   6, 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 style="margin:0in 0in .0001pt;"><font size="2" face="Times New Roman" style="font-size:10.0pt;">&nbsp;</font></p>
<div style="margin:0in 0in .0001pt;"><hr size="3" width="100%" noshade color="#010101" align="left"></div>
<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>
</div>
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