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Novartis announces Xolair® approved in EU as first and only licensed therapy for chronic spontaneous urticaria (CSU) patients unresponsive to antihistamines


March 6, 2014 - London

Novartis International AG /Novartis announces Xolair® approved in EU as first and only licensed therapy for chronic spontaneous urticaria (CSU) patients unresponsive to antihistamines . Processed and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the content of this announcement.

  • Xolair® (omalizumab) approved by European Commission (EC) as add-on therapy for chronic spontaneous urticaria (CSU) in adult and adolescent patients 12 years and above with inadequate response to H1-antihistamines
     
  • Xolair is the first and only approved therapy in the European Union (EU) for the up to 50% of CSU patients with inadequate response to licensed doses of H1-antihistamines[1]
     
  • CSU is an unpredictable skin disease characterized by a debilitating form of chronic itch, hives and angioedema (deep swelling in the tissue of the skin) that can negatively impact quality of life[2]-[5]
     
  • At any given time, the prevalence of chronic urticaria (CU) is up to 1% of the world's population[5], and up to two thirds of these patients have CSU[5],[6]
     

Basel, 6 March 2014 - Novartis announced today that the European Commission (EC) has approved the use of Xolair® (omalizumab) as an add-on therapy for the treatment of chronic spontaneous urticaria (CSU) in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment. The approved dose is 300 mg by subcutaneous injection every four weeks.

"The EU approval of Xolairin CSU is truly exciting for patients with this chronic and debilitating skin disease," said David Epstein, Division Head of Novartis Pharmaceuticals. "With this new therapeutic option from our specialty dermatology portfolio, our aim is to help ensure that the up to 50% of patients who suffer from CSU and don't respond to approved doses of antihistamines have access to Xolairas quickly as possible in the EU."

At any given time, the prevalence of chronic urticaria (CU) is up to 1% of the world's population[5], and up to two thirds of these patients have CSU[5],[6]. CSU is also known as chronic idiopathic urticaria (CIU) in the US, and 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 reoccur for more than six weeks[2]-[4]. Up to 40% of CSU patients also experience angioedema, a swelling in the deep layers of the skin[1].

The EU approval follows the Committee for Medicinal Products for Human Use (CHMP) positive opinion on Xolair, which was adopted based on positive and consistent results from three pivotal Phase III registration studies (ASTERIA I, ASTERIA II and GLACIAL) that involved nearly 1,000 patients with CSU not responding to H1-antihistamines[7]-[9]. Xolair 300 mg met all primary and pre-specified secondary endpoints across these studies, which showed Xolair significantly improved itch and hives, including rapid itch relief, and in many cases completely cleared symptoms[7]-[9]. Quality of life was also significantly improved for patients treated with Xolair 300 mg[1]-[3]across the Phase III study program. Negative effects of CSU on quality of life may include sleep deprivation and psychological comorbidities such as depression and anxiety[5],[10].

Results from the three pivotal registration studies for Xolair in CSU were announced in 2013. Highlights from these studies that were previously reported include:

  • In all three Phase III studies, a significant proportion of patients became either completely free of itch and hives (range 34-44%; p<0.001 to p<0.0001 at 300 mg) or had their symptoms suppressed to minimal levels (52-66%;p<0.0001 at 300mg)[7]-[9].
  • In the ASTERIA II study, 44% of patients receiving Xolair 300 mg were itch-and hive-free after 12 weeks of treatment (p<0.0001)[9].
  • In the ASTERIA I study, Xolair-treated patients experienced a rapid reduction in itch and hives as early as Week 1, with the therapeutic benefit sustained over 24 weeks of active treatment (p<0.0001)[7].
  • In the GLACIAL study, more than half of patients had failed multiple therapies including H1-antihistamines (at up to four times the approved dose) and H2-antihistamines and/or leukotriene receptor antagonists (LTRAs)[8]. Patient response in GLACIAL was similar to that seen in ASTERIA I and II, leading to elimination or suppression of symptoms to minimal levels within 2 weeks of the start of treatment, and sustained throughout the 24 week treatment period[7]-[9].  
     

In the pivotal Phase III studies, the incidence and severity of adverse events (AEs) was similar between Xolair and placebo recipients[7]-[9].

In addition to the EU, Xolair has been approved for the treatment of CSU in five countries: Egypt, Turkey, Guatemala, El Salvador and Bangladesh. Regulatory reviews are currently ongoing in more than 20 countries, including the US, Canada, Australia and Switzerland.

Xolair is being jointly developed by Novartis and Genentech, Inc.

About the Pivotal Phase III Xolair CSU Studies
Three pivotal Phase III studies, ASTERIA I, ASTERIA II and GLACIAL, evaluated the efficacy and safety of Xolair in nearly 1,000 CSU patients not responding to antihistamines[7]-[9].

ASTERIA I and ASTERIA II were global, multi-center, randomized double-blind studies that evaluated the efficacy and safety of Xolair compared to placebo. The studies enrolled 323 patients and 318 patients respectively, aged between 12 and 75 with moderate to severe CSU[7],[9]. Patients were randomized to Xolair 75 mg, 150 mg or 300 mg or placebo, given subcutaneously every four weeks[7],[9]. ASTERIA I had a 24-week treatment period, with a 16-week follow-up and ASTERIA II had a 12-week treatment period, with a 16-week follow-up period[7],[9].

GLACIAL was a 40-week, global, multi-center, randomized double-blind study that evaluated the safety and efficacy of Xolair compared to placebo[8]. It involved 335 patients aged between 12 and 75 with moderate to severe CSU despite receiving standard-of-care therapy, consisting of concomitant H1-antihistamine therapy (up to four times the approved dose) and other background medications including H2-antihistamines and/or leukotriene receptor antagonists (LTRAs)[8]. Patients were randomized to Xolair 300 mg or placebo (3:1), given subcutaneously every four weeks for a total period of 24 weeks[8].

About Xolair® (omalizumab)
Xolair is a targeted therapy that binds to immunoglobulin E (IgE). Xolair suppresses histamine-induced skin reactions, probably through its reduction of IgE and downstream effects on cellular activation mechanisms[11]. Research is ongoing to understand the mechanism of action of Xolair in CSU, which could lead to a deeper understanding of how the disease develops[1].

In addition to the EU, Xolair is currently approved for the treatment of CSU in five other countries. It is approved for the treatment of moderate to severe persistent allergic asthma in more than 90 countries, including the US since 2003 and the EU since 2005 and has over 400,000 patient years of exposure. In the EU, it is also approved for the treatment of severe persistent allergic asthma in children (aged six and above), adolescents and adults. In addition, a liquid formulation of Xolair in pre-filled syringes has been approved in the EU and launched in most European countries. In the US, Xolair 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 targeted products with Phase III registration studies completed, Xolair for CSU and secukinumab (AIN457) for 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 "unpredictable," "can," "at any given time," "aim," "positive opinion," "may," "currently,"  "ongoing," "could," "committed," "commitment," or by express or implied discussions regarding potential and recently approved new indications or labeling for Xolair, potential marketing approvals for AIN457 or any other dermatology products, 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 Xolair will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that AIN457 or any other dermatology products will be submitted or approved for sale in any market, or at any particular time.  Neither can there be any guarantee that Xolair, AIN457 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; 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 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.

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References
[1] Sánchez-Borges M, Asero R, Ansotegui IJ, et al. Diagnosis and treatment of urticaria and angioedema: a worldwide perspective (position paper). World Allergy Organization Journal. 2012; 5:125-147.
[2] Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. NEJM. 2013; DOI: 10.1056/NEJMoa1215372.
[3] 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.
[4] 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.
[5] 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.
[6] Kulthanan K, Jiamton S, Thumpimukvatana N, et al. Chronic idiopathic urticaria: prevalence and clinical course. J Dermatol. 2007;34:294-301.
[7] Maurer M. Phase III randomized, double-blind, placebo-controlled study evaluating efficacy and safety of omalizumab in H1-antihistamine-refractory chronic idiopathic/spontaneous urticaria. European Academy of Dermatology and Venereology (EADV) annual meeting 2013. Oral Presentation. 5 October 2013, 11:30 a.m.
[8] 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.
[9] Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. NEJM. 2013; 368(10):924-35.
[10] O'Donnell BF et al. The impact of chronic urticaria on the quality of life. Br J Dermatol. 1997; 136(2): 197-201.
[11] European Medicines Agency. Omalizumab (XOLAIR). CHMP opinion (EPAR ref. EMA/CHMP/20684/2014)Available at: www.ema.europa.eu. Accessed February 2014.

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