Novartis to reveal landmark Phase III results from specialty dermatology portfolio at upcoming EADV 2013 congress

• 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

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

• 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 (STATURE)

• 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)

Novartis-sponsored symposia

• 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[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.