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Novartis announces start of new secukinumab (AIN457) versus Stelara® (ustekinumab) phase IIIb head-to-head psoriasis study at AAD 2014


March 21, 2014 - London

Novartis International AG /Novartis announces start of new secukinumab (AIN457) versus Stelara® (ustekinumab) phase IIIb head-to-head psoriasis study at AAD 2014 . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

  • Global phase IIIb head-to-head study of secukinumab versus Stelara®* in moderate-to-severe plaque psoriasis has started patient enrollment
     
  • CLEAR is a new head-to-head study initiated following positive phase III FIXTURE study results showing secukinumab superiority to Enbrel®** (etanercept) in clearing patients' skin[1]
     
  • New pivotal phase III psoriasis data for secukinumab, the first IL-17A inhibitor with EU and US regulatory submissions completed, to be revealed at AAD 2014
     
  • Twenty-five secukinumab abstracts from the Novartis specialty dermatology portfolio to be presented at AAD 2014, a leading dermatology congress


Basel, 21 March 2014 - Novartis announced today that a new phase IIIb head-to-head study of IL-17A inhibitor secukinumab (AIN457) versus Stelara® (ustekinumab) in moderate-to-severe plaque psoriasis has started patient enrollment. A total of twenty-five secukinumab abstracts, including two pivotal phase III convenience studies to be presented for the first time, will be unveiled at the 72nd Annual Meeting of the American Academy of Dermatology (AAD), taking place in Denver, Colorado, USA from 21-25 March 2014.

"We are pleased to announce the start of CLEAR, our global phase IIIb head-to-head psoriasis study of secukinumab versus Stelara at the 2014 AAD annual meeting, which will provide further evidence regarding the benefit IL-17A inhibitor secukinumab brings to patients," said Tim Wright, Global Head of Development, Novartis Pharmaceuticals. "We initiated this study following the positive results from the phase III FIXTURE study, which showed secukinumab was significantly superior to Enbrel in clearing skin, and we look forward to presenting additional new phase III data from our specialty dermatology portfolio at AAD."

Nearly 3% of the world's population, or more than 125 million people, are affected by plaque psoriasis[2],[3], with more than one third of these suffering from its moderate-to-severe form[4]. Between 40-50% of patients are dissatisfied with their current psoriasis therapies, indicating an unmet need for convenient therapies that act faster and longer to relieve the debilitating symptoms[3],[5],[6],[7].

About the CLEAR phase IIIb head-to-head study of secukinumab versus Stelara
CLEAR (Comparison to assess Long-term Efficacy, sAfety and toleRability of secukinumab vs. ustekinumab), the new 52-week, multicenter, randomized, double-blind study, is the second head-to-head phase III study initiated with secukinumab, and will compare the long-term safety, tolerability and efficacy of secukinumab versus Stelara, a current standard-of-care therapy, in patients with moderate-to-severe plaque psoriasis[8]. The target enrollment for this global phase IIIb study is approximately 640 patients with sites in 25 countries across North America, Europe, Asia and Australia[8].

The primary endpoint measured at Week 16 is at least 90% reduction in the severity of psoriasis symptoms (redness, thickness and scaling) and the extent of skin affected by the disease, known as Psoriasis Area and Severity Index (PASI) 90[8]. PASI 90 is considered the best evidence of efficacy and is therefore a more robust measure of the extent of skin clearance compared to the standard efficacy measures used in most psoriasis clinical studies[9].

The CLEAR study follows the pivotal phase III head-to-head FIXTURE study, which showed secukinumab was significantly superior to Enbrel® in clearing skin[1]. Enbrel is a current standard-of-care anti-TNF-alpha medication approved to treat moderate-to-severe plaque psoriasis, and results from the FIXTURE study were first announced in October 2013[1].

Secukinumab highlights at AAD 2014
A total of twenty-five secukinumab abstracts will be presented at AAD 2014. Phase III secukinumab results in moderate-to-severe plaque psoriasis that will be presented for the first time at AAD include:

  • Late-breaking oral presentation:
    • An analysis from the FIXTURE study showing secukinumab fast onset of efficacy compared to Enbrel in moderate-to-severe plaque psoriasis (22 March, 9:15am MDT)
  • Electronic posters:
    • Primary efficacy and safety data of secukinumab in chronic plaque-type psoriasis patients from the first secukinumab study in pre-filled syringes (FEATURE)
    • Primary efficacy and safety data in psoriasis patients with the secukinumab autoinjector/pen (JUNCTURE)
    • An analysis of secukinumab pre-filled syringes and patient satisfaction through the Self-Injection Assessment Questionnaire (SIAQ) in the FEATURE study
    • An analysis of secukinumab autoinjector and patient satisfaction through the SIAQ in the JUNCTURE study

Additional secukinumab phase III analyses at AAD 2014 include the influence of previous therapies on patient response, the efficacy and safety of secukinumab retreatment, and patient reported outcomes on the benefit of early secukinumab treatment.

About secukinumab (AIN457) and interleukin-17A (IL-17A)
Secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes interleukin-17A (IL-17A)[10]-[12]. IL-17A is a central cytokine (messenger protein) involved in the development of psoriasis, and is found in high concentration in skin affected by the disease[13],[14]. Research shows that IL-17A plays a key role in driving the body's autoimmune response in disorders such as moderate-to-severe plaque psoriasis and is a preferred target for investigational therapies[10]-[12],[15],[16].

Secukinumab is the first therapy selectively targeting IL-17A with phase III results. Regulatory submissions for secukinumab in the EU and US were completed in 2013, based on the largest phase III program in moderate-to-severe plaque psoriasis completed to date, which involved more than 3,300 patients in over 35 countries.

Phase III results for secukinumab in moderate-to-severe plaque psoriasis were first presented in October 2013, with additional results to be presented in 2014 for both moderate-to-severe plaque psoriasis and arthritic conditions (psoriatic arthritis and ankylosing spondylitis). Phase IIIb studies are also ongoing, including the head-to-head study of secukinumab versus Stelara in moderate-to-severe plaque psoriasis (CLEAR) and studies in palmo-plantar psoriasis, nail psoriasis and palmo-plantar pustulosis. Phase II studies are also ongoing in other areas.

About plaque psoriasis
Nearly 3% of the world's population, or more than 125 million people, are affected by plaque psoriasis[2],[3] with more than one third of these suffering from its moderate-to-severe form[4]. Psoriasis is a chronic autoimmune disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain[17]. This common and distressing disease is not simply a cosmetic problem - even those with very mild symptoms find their condition affects their everyday lives[2],[3]. Psoriasis is also associated with psychosocial effects and those with more severe disease are at a greater risk of death from comorbid diseases such as heart disease and diabetes[18],[19].

About Novartis in specialty dermatology
Novartis is committed to developing innovative, life-changing specialty dermatology therapies, redefining treatment paradigms and transforming patient care in severe skin diseases where there are remaining high unmet medical needs. The Novartis specialty dermatology portfolio includes Xolair® (omalizumab) and secukinumab (AIN457). Xolair is a targeted therapy that is approved as an add-on therapy for the treatment of refractory chronic spontaneous urticaria (CSU) in the EU and in eight other countries. Regulatory reviews are currently ongoing in more than 20 countries for CSU and chronic idiopathic urticaria (CIU), as it is known in the US. Secukinumab (AIN457) is the first IL-17A inhibitor to have completed phase III registration studies in moderate-to-severe plaque psoriasis. There are also more than 10 compounds in early stage development for a wide range of severe skin diseases in the Novartis specialty dermatology portfolio. For more information about the Novartis commitment to severe skin disease care, please visit: www.skintolivein.com.

Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "start," "started," "initiated," "to be," "will," "look forward," "target," "investigational," "ongoing," "committed," "currently," "commitment," or by express or implied discussions regarding potential marketing approvals for AIN457 or any other dermatology products, potential and recently approved new indications or labeling for Xolair, or regarding potential future revenues from such products. You should not place undue reliance on these statements.  Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that AIN457 or any other dermatology products will be submitted or approved for sale in any market, or at any particular time.  Nor can there be any guarantee that Xolair will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Neither can there be any guarantee that AIN457, Xolair or any such other products will achieve any particular levels of revenue in the future. In particular, management's expectations regarding these products 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; global trends toward health care cost containment, including ongoing pricing pressures; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; unexpected manufacturing issues; general economic and industry conditions, and other risks and factors referred to in Novartis AG's current Form 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.

About Novartis
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 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 136,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

*Stelara® is a registered trademark of Janssen Biotech, Inc.
**Enbrel® is a registered trademark of Amgen Inc.

References

[1] Langley R, FIXTURE oral presentation at EADV 2013.
[2] International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis." http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed March 2014.
[3] Stern RS, Nijsten T, Feldman SR, Margolis DJ, Rolstad T. Psoriasis Is Common, Carries a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction. J Investig Dermatol Symp Proc 2004; 9(2):136-9.
[4] Herrier R. Advances in the treatment of moderate-to-severe plaque psoriasis. Am J Health-Syst Pharm 2011; 68:795-806.
[5] Christophers E, Griffiths CEM, Gaitanis G, et al. The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review. J Eur Acad Dermatol Venereol 2006;20:921-925.
[6] Krueger JG, Koo J, Lebwohl M, et al. The impact of psoriasis on quality of life: Results for a 1998 National Psoriasis Foundation patient membership survey. Arch Derm 2001;137:280-284.
[7] Sterry W, Barker J, Boehncke WH, et al. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol 2004;151 Suppl 69:3-17.
[8] ClinicalTrials.gov. http://www.clinicaltrials.gov/ct2/show/NCT02074982. Accessed March 2014.
[9] European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline
/2009/09/WC500003329.pdf. Accessed March 2014.
[10] Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009; 9(8):556-67.
[11] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.
[12] Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010;9(9):703-718.
[13] Johansen C, Usher PA, Kjellerup RB, et al. Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin. Brit J Dermatol. 2009;160:319-24.
[14] Arican O, Aral M, Sasmaz S, et al. Serum levels of TNF-alpha, IFN-gamma, IL-6, IL-8, IL-12, IL-17, and IL-18 in patients with active psoriasis and correlation with disease severity. Mediators Inflamm. 2005;2005(5):273-9.
[15] Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010;129(3):311-321.
[16] Krueger J, Fretzin S, Suárez-Fariñas M, et al. IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis. J Allergy Clin Immunol. 2012;130(1):145-154.
[17] Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009; 361(5):496-509.
[18] Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. Psoriasis causes as much disability as other major medical diseases. J Am Acad Dermatol 1999; 41(3 Pt 1):401-7.
[19] Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb;146(1):9-15.

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