New phase III psoriasis data show rapid, significant skin clearance and convenient administration with Novartis' secukinumab (AIN457)

Novartis International AG / New phase III psoriasis data show rapid, significant skin clearance and convenient administration with Novartis' secukinumab (AIN457) . Processed and transmitted by Nasdaq OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

Pivotal phase III FEATURE and JUNCTURE studies met primary and pre-specified secondary endpoints, showing high efficacy with convenient pre-filled syringe (PFS) and autoinjector/pen (AI)[1],[2]Patient-reported outcomes from FEATURE and JUNCTURE show high patient satisfaction with secukinumab PFS and AI self-administration[3],[4]Data show patients rapidly achieved almost clear skin (PASI 90), consistent with head-to-head phase III FIXTURE psoriasis study where secukinumab showed superiority over Enbrel®* (etanercept)[5]Secukinumab is the first IL-17A inhibitor with phase III data presented and regulatory submissions filed with global health authorities

Basel, 22 March 2014 - Novartis announced results from the pivotal phase III FEATURE and JUNCTURE studies showing secukinumab (AIN457), an interleukin-17A (IL-17A) inhibitor, demonstrated consistent high efficacy when administered with a convenient pre-filled syringe (PFS) or autoinjector/pen (AI)[1],[2].These results, along with patient-reported outcomes showing high patient satisfaction with PFS and AI[3],[4], are being presented for the first time at the 72nd Annual Meeting of the American Academy of Dermatology (AAD) in Denver, USA.

FEATURE and JUNCTURE are the first phase III studies to evaluate secukinumab in clearing patients' skin with the PFS and AI administration[1],[2]. Both methods allow secukinumab self-administration anywhere (including the workplace or home) versus healthcare professional administration, if allowed by local regulations. This is important because many psoriasis patients prioritize easy self-administration at a location of their choice[6].

"It is important that people living with psoriasis, a chronic skin disease, have highly effective and safe treatments they can conveniently self-administer," said Tim Wright, Global Head of Development for Novartis Pharmaceuticals. "These exciting results from our specialty dermatology portfolio show that secukinumab, the first IL-17A inhibitor with regulatory submissions completed, had similar efficacy in clearing skin with a convenient pre-filled syringe and autoinjector pen as in the landmark FIXTURE study, where it was significantly superior to Enbrel, a biologic psoriasis therapy approved 10 years ago."

Importantly, in both studies more secukinumab 300 mg patients experienced almost clear skin, described as Psoriasis Area and Severity Index 90 (PASI 90), at Week 12 (60.3% for FEATURE and 55% for JUNCTURE, p<0.0001) compared to placebo[1],[2]. PASI 90 is considered the best evidence of efficacy, and a more robust measure of the extent of skin clearance compared to standard efficacy measures that have been used in most psoriasis clinical studies, such as PASI 75[7].

The FEATURE and JUNCTURE studies met all primary and pre-specified secondary endpoints[1],[2]. Across the co-primary endpoints in both studies, secukinumab 300 mg demonstrated significant improvements in PASI 75 at Week 12 versus placebo (75.9% vs. 0% for FEATURE; 86.7% vs. 3.3% for JUNCTURE, p<0.0001), and was also superior to placebo according to the Investigator's Global Assessment (IGA mod 2011)[1],[2].

Patients also benefitted from rapid and significant skin clearance with secukinumab in both studies[1],[2]. Already by Week 3, patients taking secukinumab 300 mg experienced superior efficacy in clearing skin compared to placebo[1],[2]. In addition, the 300 mg dose showed numerically and clinically relevant improvements compared to 150 mg[1],[2].

Both studies measured usability and patient satisfaction with secukinumab delivered via PFS and AI[3],[4]. At Week 1, all patients successfully self-injected secukinumab by following instructions, with no administration issues observed[3],[4]. Patient satisfaction scores were consistently high, showing acceptability of the PFS and AI[3],[4]. Satisfaction was assessed using a self-administered Self-Injection Assessment Questionnaire (SIAQ), which measures overall experience, feelings about injections, self-confidence, satisfaction with self-injection, injection-site reactions, ease of use, and self-image before and after treatment[3],[4].

Secukinumab demonstrated a positive safety profile consistent with findings from previous studies, with adverse events (AEs) similar between both secukinumab treatment arms (300 mg and 150 mg)[1],[2]. In FEATURE, the most common AEs in any treatment group were diarrhea, nasopharyngitis and headache[1]. In JUNCTURE, the most common AEs in any treatment group were nasopharyngitis, headache and pruritus[2]. There were no deaths reported during either study, and no new or unexpected safety findings were observed[1],[2].

The FEATURE and JUNCTURE results support the head-to-head phase III FIXTURE data first presented in October 2013, which showed secukinumab cleared skin faster and for longer than Enbrel(etanercept)[5]. Clinically relevant differences were observed as early as Week 2 in FIXTURE, and by Week 16 nearly three quarters (72%) of secukinumab 300 mg patients experienced almost clear skin (PASI 90)[5]. Secukinumab efficacy was also sustained over the full one year study, with significantly more secukinumab 300 mg patients experiencing PASI 90 at Week 52 compared to Enbrel (65% vs. 33%)[5].

About the phase III secukinumab psoriasis studies at AAD
FEATURE and JUNCTURE are the final secukinumab phase III studies to be presented as part of 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.

FEATURE (First study of sEcukinumAb in pre-filled syringes in subjecTs with chronic plaqUe-type psoriasis REsponse) was a randomized double-blind, placebo-controlled, multicenter, phase III study involving 177 subjects with moderate-to-severe plaque psoriasis. In this study, a PFS was introduced into the secukinumab program[1].

JUNCTURE (Judging the efficacy of secUkinumab in patients with psoriasis using autoiNjector: a Clinical Trial evalUating treatment REsults) was a double-blind, placebo-controlled, multicenter, phase III study involving 182 subjects with moderate-to-severe plaque psoriasis. In this study, the AI device was introduced into the secukinumab program[2].

In both studies, the co-primary endpoints, PASI 75 and IGA mod 2011 at Week 12, were used to demonstrate superiority of secukinumab vs. placebo. Secondary endpoints included PASI 90 at Week 12 and patient satisfaction of secukinumab administered via PFS and AI, determined by a self-administered SIAQ. The trials are continuing up to one year (52 weeks).

FIXTURE (the Full year Investigative eXamination of secukinumab vs. eTanercept Using 2 dosing Regimens to determine Efficacy in psoriasis) was a randomized double-blind, placebo-controlled, multicenter, global pivotal phase III registration study involving 1,306 patients[5].

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)[8]-[10]. 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[11],[12]. 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[8]-[10],[13],[14].

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.

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[15],[16], with more than one third of these suffering from its moderate-to-severe form[17]. Psoriasis is a chronic autoimmune disease characterized by thick and extensive skin lesions, called plaques, known to cause itching, scaling and pain[18]. This common and distressing disease is not simply a cosmetic problem - even those with very mild symptoms find their condition affects their everyday lives[15],[16]. 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[19]. Between 40-50% of patients are dissatisfied with their current psoriasis therapies, indicating an unmet need for new therapies that act faster and longer to relieve the debilitating symptoms[6],[20]-[22].

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, and for refractory chronic idiopathic urticaria (CIU) as it is known in the US. Regulatory reviews are currently ongoing in more than 20 countries, including Canada, Australia and Switzerland. Secukinumab 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 "are being presented," "exciting," "continuing," "investigational," "to be," "ongoing," "committed," "early stage development," "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.

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

References
[1] Blauvelt A, Prinz J, Gottlieb AB, et al. Secukinumab Efficacy and Safety: Results From the First Study of Secukinumab in Prefilled Syringes in Subjects with Chronic Plaque-Type Psoriasis Response at 12 Weeks (FEATURE). E-poster presentation at: 72nd AAD Annual Meeting; Denver, Co.; 21-25 March 2014.
[2] Paul C, Lacour JP, Cooper S. Secukinumab Efficacy and Safety: Results From the Judging the Efficacy of Secukinumab in Patients With Psoriasis Using Autoinjector: A Clinical Trial Evaluating Treatment Results (JUNCTURE). E-poster presentation at: 72nd AAD Annual Meeting; Denver, Co.; 21-25 March 2014.
[3] Kingo K, Sofen H, Mallya U, et al. Secukinumab Prefilled Syringes Demonstrate Patient Satisfaction:  Analysis of the Self-Injection Assessment Questionnaire (SIAQ) in the FEATURE Study. E-poster presentation at: 72nd AAD Annual Meeting; Denver, Co.; 21-25 March 2014.
[4] Kreutzer K, You R, Mallya U, et al. Secukinumab Autoinjectors Demonstrate Patient Satisfaction: An Analysis of  the Self-Injection Assessment Questionnaire (SIAQ) in the JUNCTURE Study. E-poster presentation at: 72nd  AAD Annual Meeting; Denver, Co.; 21-25 March 2014.
[5] Langley R, Reich K, Griffiths C, et al. Secukinumab Compared With Placebo and Etanercept: A Head-to-Head Comparison of Two Biologics in a Phase 3 Study of Moderate-to-Severe Plaque Psoriasis (FIXTURE). Oral presentation at: 22nd EADV Congress; Istanbul, Turkey; 2-6 October 2013.
[6] Schaarschmidt ML, Schmieder A, et al. Patient preferences for psoriasis treatments: process characteristics can outweigh outcome attributes. Arch Dermatol 2011 Nov;147(11):1285-94.
[7] 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.
[8] Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009; 9(8):556-67.
[9] Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009;30(2):95-103.
[10] Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010;9(9):703-718.
[11] 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.
[12] 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.
[13] Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010;129(3):311-321.
[14] 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.
[15] Stern RS, Nijsten T, Feldman S, et al. Psoriasis Is Common, Carries a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction. J Investig Dermatol Symp 2004;9(2):136-9.
[16] International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis."http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed March 2014.
[17] Herrier R. Advances in the treatment of moderate-to-severe plaque psoriasis. Am J Health-Syst Pharm 2011; 68:795-806.
[18] Nestle FO, Kaplan DH, Barker J. Psoriasis. N Engl J Med 2009; 361(5):496-509.
[19] Farley E et al. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011 Feb;146(1):9-15.
[20] 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.
[21] 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.
[22] 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.

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