2013-09-30 07:19:02 -
Novartis International AG /
Novartis to reveal landmark Phase III results from specialty dermatology
portfolio at upcoming EADV 2013 congress
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* Data from head-to-head pivotal study showing secukinumab (AIN457)
superiority to Enbrel(®*) (etanercept) in moderate-to-severe plaque
psoriasis to be revealed
* Results from three additional secukinumab Phase III studies also to be
presented for the first time
* Secukinumab is the first IL-17A inhibitor with Phase III data and is on
track to be the first psoriasis medication filed targeting IL-17A
* New data to be
reported from final omalizumab registration study in
refractory chronic spontaneous urticaria (CSU), a persistent, debilitating
form of hives and chronic itch
Basel, September 30, 2013 - Novartis announced today that new Phase III results
from its expanding specialty dermatology portfolio will be presented at the
22(nd) 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
"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
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,. 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-. There is a clear unmet need for new psoriasis
therapies that act faster and longer to relieve the debilitating symptoms of the
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, that spontaneously present and re-
occur for more than six weeks. At any given time the prevalence of CSU is
0.5% to 1% worldwide. 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.
Novartis specialty dermatology portfolio highlights at EADV 2013 include:
Oral presentations of secukinumab Phase III studies in psoriasis
* 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)
* 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
* Additional results from a Phase III study of omalizumab in CSU patients
(abstract FC03.7; 3 October, 11:30 - 13:00 EEST)
* 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
* Secukinumab pivotal Phase III studies
* Study of safety and efficacy of secukinumab vs. placebo (ERASURE)
* Study assessing the usefulness of up-titration of intravenous
* Secukinumab Phase II extension studies
* Study of long-term safety, tolerability and efficacy of secukinumab
* Study of the distribution secukinumab in skin after a single dose by
dermal open flow microperfusion (dOFM)
* Omalizumab in the management of CSU (3 October, 17:15 - 18:45 EEST)
* 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-. 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-. 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
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
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.
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
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.
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needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
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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
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*Enbrel(®) is a registered trademark of Amgen Inc.
 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.
 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
 Gaffen SL. Structure and signaling in the IL-17 receptor family. Nat Rev
Immunol. 2009; 9(8):556-67.
 Ivanov S, Linden A. Interleukin-17 as a drug target in human disease.
Trends Pharmacol Sci. 2009; 30(2):95-103.
 Kopf M, Bachmann MF, Marsland BJ. Averting inflammation by targeting the
cytokine environment. Nat Rev Drug Discov. 2010; 9(9):703-718.
 Onishi RM, Gaffen SL. Interleukin-17 and its target genes: mechanisms of
interleukin-17 function in disease. Immunology. 2010; 129(3):311-321.
 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.
 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.
 Mason AR, Mason J, Cork M et al. Topical treatments for chronic plaque
psoriasis. Cochrane Database Syst Rev. 2009;15;(2):CD005028.
 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
 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.
 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.
 Asthma and Allergy Foundation of America (AAFA) website. "Chronic
Urticaria (Hives)." www.aafa.org/display.cfm?id=9&sub=23&cont=328
Accessed November 14, 2012.
 American Academy of Allergy Asthma & Immunology (AAAAI) website. "Skin
Allergy Overview." www.aaaai.org/conditions-and-
treatments/allergies/skin-allergy.aspx. Accessed November 14, 2012.
 Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of
chronic idiopathic or spontaneous urticaria. NEJM 2013; DOI:
 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.
 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:
 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.
 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
 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
 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.
 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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