Basel, September 30, 2013 - Novartis announced today that new Phase III results from its expanding specialty dermatology portfolio will be presented at the 22nd Congress of the European Association of Dermatology and Venereology (EADV), taking place in Istanbul, Turkey, from 2-6 October 2013. Pivotal data from Phase III studies of secukinumab (AIN457) in moderate-to-severe plaque psoriasis and omalizumab (Xolair®) in chronic spontaneous urticaria (CSU) are among the landmark Novartis results being presented for the first time at the congress.
"The new Phase III results for secukinumab and omalizumab being presented at EADV show our potential to transform patient care in psoriasis and CSU, with the aim of helping patients to achieve clear skin," said David Epstein, Head of the Pharmaceuticals Division of Novartis Pharma AG. "Specialty dermatology is an emerging area of importance for Novartis, and we are on track to deliver an innovative approach to targeted therapies for people suffering from severe skin diseases in need of new treatment options."
Specifically, results from the pivotal head-to-head Phase III FIXTURE study showing the superiority of the IL-17A inhibitor secukinumab to Enbrel®* (etanercept), part of a group of medications known as anti-TNF inhibitors, in moderate-to-severe plaque psoriasis will be presented for the first time at EADV. Data from three additional Phase III studies from the robust, global secukinumab clinical trial program - the largest undertaken in moderate-to-severe plaque psoriasis to date - will also be revealed at the congress.
In addition, data from ASTERIA I, the final of three pivotal registration studies for omalizumab in CSU, will be presented for the first time at EADV. Positive and consistent results from ASTERIA II and GLACIAL, the two other Phase III studies for omalizumab in CSU, were presented at major medical meetings earlier this year. Omalizumab is currently not approved for the treatment of CSU.
Secukinumab is the first therapy selectively targeting IL-17A to present Phase III results in moderate-to-severe plaque psoriasis. 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[1],[2]. 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[3]-[7]. There is a clear unmet need for new psoriasis therapies that act faster and longer to relieve the debilitating symptoms of the disease[8]-[12].
CSU, also known as chronic idiopathic urticaria (CIU) in the US, is a severe and distressing skin condition characterized by red, swollen, itchy and sometimes painful hives or wheals on the skin[13],[14] that spontaneously present and re-occur for more than six weeks[15]. At any given time the prevalence of CSU is 0.5% to 1% worldwide[16]. There is also a significant unmet need in CSU, as more than 50% of patients do not respond to approved doses of antihistamines, the basis of current symptomatic therapy[17].
Novartis specialty dermatology portfolio highlights at EADV 2013 include:
Oral presentations of secukinumab Phase III studies in psoriasis
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New results from the first head-to-head pivotal Phase III study of secukinumab vs. Enbrel®* (etanercept) (FIXTURE) (abstract FC01.10res; 3 October, 8:00 - 9:30 EEST)
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New pivotal Phase III study of secukinumab for long-term disease treatment (SCULPTURE) (abstract FC01.5; 3 October, 8:00 - 9:30 EEST)
Oral presentations of omalizumab Phase III studies in CSU
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Additional results from a Phase III study of omalizumab in CSU patients (abstract FC03.7; 3 October, 11:30 - 13:00 EEST)
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New Phase III study of omalizumab in CSU patients (ASTERIA I) (abstract FC09.1; 5 October, 11:30 - 13:00 EEST)
Electronic posters available throughout the EADV congress
Novartis-sponsored symposia
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Omalizumab in the management of CSU (3 October, 17:15 - 18:45 EEST)
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IL-17A: A new era for psoriasis patients (4 October, 16:45 - 18:15 EEST)
Healthcare professionals attending EADV will also be able to visit the Novartis booth to learn more about IL-17A, psoriasis and CSU. For more information about the Novartis commitment to specialty dermatology, visit: www.skintolivein.com.
About secukinumab (AIN457)
Secukinumab (AIN457) is a fully human monoclonal antibody that selectively binds to and neutralizes IL-17A, a key pro-inflammatory cytokine[3]-[5]. Proof-of-concept and Phase II studies in moderate-to-severe plaque psoriasis and arthritic conditions (psoriatic arthritis, ankylosing spondylitis and rheumatoid arthritis) have suggested that secukinumab may potentially provide a new mechanism of action for the successful treatment of immune-mediated diseases[18]-[22]. Phase III results are being released in 2013 and 2014 for moderate-to-severe plaque psoriasis, and in 2014 and beyond for arthritic conditions. Phase II studies are also ongoing in other areas, including multiple sclerosis.
About Xolair® (omalizumab)
Omalizumab is a targeted therapy unique in binding to immunoglobulin E (IgE). It is not currently approved or indicated for CSU. Research is ongoing to understand the mechanism of action of omalizumab in CSU, and to investigate its impact on the drivers of CSU. It may suppress histamine-induced skin reactions through its reduction of IgE and downstream effects on cellular activation mechanisms.
Omalizumab is approved for the treatment of severe allergic asthma under the brand-name Xolair® in more than 90 countries, including the US since 2003 and the EU since 2005. In the EU it is approved for the treatment of severe allergic asthma in children (aged six and above), adolescents, and adults. Following approval in the EU, a liquid formulation of Xolair in pre-filled syringes has been launched in most European countries. In the US, Xolair (omalizumab) for subcutaneous use in appropriate allergic asthma patients is co-promoted by Novartis Pharmaceuticals Corporation and Genentech, Inc.
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 two unique targeted products in Phase III development, secukinumab (AIN457) for moderate-to-severe plaque psoriasis and omalizumab (Xolair®) for CSU. 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.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as "to reveal," "to be," "on track," "will," "being presented," "potential," "commitment," "suggested," "may," "potentially," "being released," "ongoing," "committed," or by express or implied discussions regarding potential marketing submissions or approvals for secukinumab (AIN457) or other compounds in development, potential submissions or approvals for 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 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 secukinumab (AIN457) or any other compounds in development 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 such 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; competition in general; government, industry and general public pricing pressures; unexpected manufacturing issues; the company`s ability to obtain or maintain patent or other proprietary intellectual property protection; the impact that the foregoing factors could have on the values attributed to the Novartis Group`s assets and liabilities as recorded in the Group`s consolidated balance sheet, 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 2012, the Group achieved net sales of USD 56.7 billion, while R&D throughout the Group amounted to approximately USD 9.3 billion (USD 9.1 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 131,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
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*Enbrel® is a registered trademark of Amgen Inc.
References
| [1] | 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. |
| [2] | 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; Oct 24;2005(5):273-9. |
| [3] | Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev Immunol. 2009; 9(8):556-67. |
| [4] | Ivanov S, Linden A. Interleukin-17 as a drug target in human disease. Trends Pharmacol Sci. 2009; 30(2):95-103. |
| [5] | Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-718. |
| [6] | Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease. Immunology. 2010; 129(3):311-321. |
| [7] | 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. |
| [8] | 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. |
| [9] | Mason AR, Mason J, Cork M et al. Topical treatments for chronic plaque psoriasis. Cochrane Database Syst Rev. 2009;15;(2):CD005028. |
| [10] | Langley R G B, Krueger G G, Griffiths C E M. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005; 64(Suppl II):ii18-ii23. |
| [11] | Ljosaa TM, Mork C, Stubhaug A, et al. Skin pain and skin discomfort is associated with quality of life in patients with psoriasis. J Eur Acad Dermatol Venereol. 2012;26:29-35. |
| [12] | Sterry W, Barker J, Boehncke WH, Bos JD, Chimenti S, Christophers E, De La Brassinne M, Ferrandiz C, Griffiths C, Katsambas A, Kragballe K, Lynde C, Menter A, Ortonne JP, Papp K, Prinz J, Rzany B, Ronnevig J, Saurat JH, Stahle M, Stengel FM, Van De Kerkhof P, Voorhees J. Biological therapies in the systemic management of psoriasis: International Consensus Conference. Br J Dermatol. 2004 Aug;151 Suppl 69:3-17. |
| [13] | Asthma and Allergy Foundation of America (AAFA) website. "Chronic Urticaria (Hives)." http://www.aafa.org/display.cfm?id=9&sub=23&cont=328. Accessed November 14, 2012. |
| [14] | American Academy of Allergy Asthma & Immunology (AAAAI) website. "Skin Allergy Overview." http://www.aaaai.org/conditions-and-treatments/allergies/skin-allergy.aspx. Accessed November 14, 2012. |
| [15] | Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. NEJM 2013; DOI: 10.1056/NEJMoa1215372. |
| [16] | Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66: 317-330. |
| [17] | Kaplan A, Ledford D, Ashby M, et al. Omalizumab in patients with symptomatic chronic idiopathic/spontaneous urticaria despite standard combination therapy. J Allergy Clin Immunol. 2013 Jul;132(1):101-9. doi: 10.1016/j.jaci.2013.05.013. |
| [18] | Papp KA, Langley RG, Sigurgeirsson B, et al. Efficacy and safety of secukinumab in the treatment of moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled phase II dose-ranging study. BJD 2013; 168, pp412-421. |
| [19] | Rich PA, Sigurgeirsson B, Thaci D, et al. Secukinumab induction and maintenance therapy in moderate-to-severe plaque psoriasis: a randomized, double-blind, placebo-controlled, phase II regimen-finding study. BJD 2013;168: 402-411. |
| [20] | Genovese MC, Durez P, Richards HB, et al. Efficacy and safety of secukinumab in patients with rheumatoid arthritis: a phase II, dose-finding, double-blind, randomised, placebo controlled study. Ann Rheum Dis 2013;72:863-869. |
| [21] | Baeten D, Sieper J, Emery P, et al. The anti-il17a monoclonal antibody secukinumab (AIN457) showed good safety and efficacy in the treatment of active ankylosing spondylitis. At: EULAR 2011, The Annual European Congress of Rheumatology, 25-28 May 2011, London, UK. Abstract 0174. |
| [22] | McInnes IB, Sieper J, Braun J, et al. Efficacy and safety of secukinumab, a fully human anti-interleukin-17A monoclonal antibody, in patients with moderate-to-severe psoriatic arthritis: a 24-week, randomised, double-blind, placebo-controlled, phase II proof-of-concept trial. Ann Rheum Dis 2013 Jan 29; doi:10.1136/annrheumdis-2012-202646. |
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