Novartis International AG : Novartis reports Phase III data showing omalizumab improved itch in patients with a chronic form of

Novartis International AG : Novartis reports Phase III data showing omalizumab
  improved itch in patients with a chronic form of hives who failed standard

Novartis International AG / Novartis reports Phase III data showing omalizumab
improved itch in patients with a chronic form of hives who failed standard
therapy[1] . Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.

  *Study published in NEJM today and presented tomorrow met primary
    endpoint[1] in moderate to severe refractory chronic
    idiopathic/spontaneous urticaria (CIU/CSU)
  *Up to two-thirds (66%) of omalizumab patients had their itch and hives
    well controlled within 12 weeks of initiating treatment, versus 19% for
  *CIU/CSU can be a serious, debilitating form of hives; critical unmet need
    among >50% of patients who don't achieve relief with approved
    antihistamine doses[4]
  *Omalizumab is a biologic therapy that targets the IgE antibody; further
    Phase III studies in CIU/CSU and regulatory submissions on track for 2013

Basel, February 24, 2013- Late-breaking results  from ASTERIA II, a Phase  III 
placebo-controlled study,  demonstrated  that  omalizumab  provided  effective 
treatment in patients  with moderate to  severe refractory chronic  idiopathic 
urticaria (CIU), also referred to as chronic spontaneous urticaria (CSU),  who 
remain symptomatic despite treatment with approved antihistamine doses[1].

At the end of the  treatment period (Week 12), more  than three times as  many 
omalizumab 300 mg  patients had  well controlled disease  compared to  placebo 
(66% and 19% respectively)[2],[3].  The data were published  today in the  New 
England Journal of  Medicine and will  be presented tomorrow  at the  American 
Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in San Antonio,
Texas, USA. Omalizumab is not indicated for CIU/CSU.

CIU/CSU is a distressing skin  condition characterized by red, swollen,  itchy 
and sometimes painful  hives on the  skin[5],[6] spontaneously presenting  and 
reoccurring for more than six  weeks[3]. Angioedema, or deep tissue  swelling, 
also  occurs  in  approximately  40   to  50%  of  these  patients[7].   While 
antihistamines are commonly used to treat  CIU/CSU, there is still a  critical 
unmet need  among patients,  with  more than  50%  not achieving  relief  with 
approved doses[2].

"These results  indicate that  omalizumab could  potentially be  an  important 
addition in the treatment  of chronic idiopathic  or spontaneous urticaria,  a 
disease that can have a significant impact on patients and can be  challenging 
to  manage,"  said   Tim  Wright,   Global  Head   of  Development,   Novartis 
Pharmaceuticals. "We are committed to  helping patients with this disease  and 
look forward to  receiving further results  from ongoing longer-term  clinical 

ASTERIA II is the first Phase III  data to be presented from a clinical  trial 
program in CIU/ CSU, which also includes two additional studies  investigating 
the efficacy and safety of omalizumab over 12 and 24 weeks treatment duration.
Novartis regulatory submissions are on track for 2013.

The ASTERIA  II study  evaluated  the efficacy  and  safety of  omalizumab  in 
patients aged 12 to 75 years of age with moderate to severe refractory CIU/CSU
despite  receiving  concomitant  antihistamine  therapy[1]at  approved  doses, 
within a 12 week treatment period.  The primary endpoint was measured using  a 
21 point scale known as a weekly Itch Severity Score (ISS). The study met  its 
primary endpoint, showing  that omalizumab given  at doses of  150 and 300  mg 
every four weeks for 12 weeks, significantly improved the mean weekly ISS from
baseline (approximately 14 in all treatment  groups) by 8.1 (p=0.001) and  9.8 
(p<0.001),  respectively,  compared  to  a  5.1  improvement  in  patients  on 
placebo[2]. The omalizumab 75  mg dose group  did not demonstrate  statistical 
significance compared to placebo[1].

Patient response,  as  measured by  the  median time  to  Minimally  Important 
Difference (MID), a secondary  endpoint, occurred as early  as Week 1 (300  mg 
dose) and Week 2 (150  mg dose), compared to Week  4 in the placebo  group[1]. 
Sixty-six percent of patients in the omalizumab  300 group and 43% in the  150 
mg group experienced well  controlled disease by Week  12, compared to 19%  in 
the placebo group[2]. In the study,  disease control was assessed by a  weekly 
urticaria activity score  (UAS7), where any  score of 6  or less out  of a  42 
point score is considered to represent well controlled disease[2],[3].

The incidence  and  severity  of  adverse  events  (AEs)  was  similar  across 
treatment groups[1]. There were no major imbalances in any of the system organ
class AEs, with the exception of  headache, where more cases were reported  in 
the 150 mg omalizumab group compared with placebo[2].

CIU/CSU also  has  negative  effects  on quality  of  life,  which  frequently 
includes sleep deprivation and psychiatric comorbidity[4]. At any given  time, 
the prevalence of  CIU/CSU is  0.5% to  1% worldwide[4].There  is no  approved 
treatment for CIU/CSU that is broadly effective in patients who are refractory
to antihistamines, the mainstay of current symptomatic therapy[4].

Study Details
ASTERIA II was a global, multi-center, randomized double-blind study that
evaluated the efficacy and safety of omalizumab compared to placebo and
involved 323 patients aged between 12 and 75 with moderate to severe
CIU/CSU[1]. Patients were randomized to omalizumab 75 mg, 150 mg or 300 mg or
placebo, given subcutaneously every four weeks, for a total of three doses
within a 12-week treatment period, with a 16-week follow-up period^2.
Omalizumab 150 mg and 300 mg dose groups met the pre-specified primary
endpoint and all pre-specified secondary endpoints in the ASTERIA II trial,
except for the 150 mg dose that did not show a significant difference from
placebo in the proportion of angioedema-free days from Week 4 to Week 12 of

Five (6.3%) patients experienced serious AEs  (SAEs) in the omalizumab 300  mg 
dose group, compared to two (2.5%) in the placebo group[2]. In the 150 mg  and 
75 mg dose groups, one patient experienced SAEs in each group (1.1% and  1.3%, 
respectively). No deaths were reported during this study[2].

About Omalizumab
Omalizumab is a biologic therapy unique in targeting immunoglobulin E (IgE).
Research is ongoing to understand the mechanism of action of omalizumab in
CIU/CSU, and to investigate its impact on the drivers of CIU/CSU[7].
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.

Omalizumab is being jointly  developed by Novartis and  Genentech. In the  US, 
Xolair^® (omalizumab)  for subcutaneous  use  in appropriate  allergic  asthma 
patients is co-promoted by Novartis Pharmaceuticals Corporation and Genentech.

The foregoing release contains forward-looking statements that can be
identified by terminology such as "on track," "will," "could," "potentially,"
"committed," "look forward to," or similar expressions, or by express or
implied discussions regarding potential new indications or labeling for
omalizumab or regarding potential future revenues from omalizumab. 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 with omalizumab to be materially different from any future results,
performance or achievements expressed or implied by such statements. There can
be no guarantee that omalizumab will be approved for any additional
indications or labeling in any market. Nor can there be any guarantee that
omalizumab will achieve any particular levels of revenue in the future. In
particular, management's expectations regarding omalizumab 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; the company's ability to obtain or maintain patent or
other proprietary intellectual property protection; competition in general;
government, industry and general public pricing pressures; 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
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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,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
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[1] Casale T, Maurer M, Hsieh HJ, et al. Efficacy and safety of omalizumab in
chronic idiopathic/spontaneous urticarial (CIU/CSU): results from a phase III,
randomized, double-blind, placebo-controlled trial. JACI Vol. 131, No. 2
February, 2013 p 1A-4A-Supplement.
[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] Casale T, Maurer M, Hsieh HJ, et al. Efficacy and safety of omalizumab in
chronic idiopathic/spontaneous urticarial: results from a phase III,
randomized, double-blind, placebo-controlled trial (ASTERIA II). American
Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting. 4611 Late
Breaking Oral Abstract I. 25 March 2013, 2:30 pm.
[4] Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in
chronic spontaneous urticaria. A GA2LEN task force report. Allergy 2011; 66:
[5] Asthma and Allergy Foundation of America (AAFA) website. "Chronic
Urticaria (Hives)."
Accessed November 14, 2012.
[6] American Academy of Allergy Asthma & Immunology (AAAAI) website. "Skin
Allergy Overview."
Accessed November 14, 2012.
[7] 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.
[8] Saini S, Rosen KE, Hsieh HJ, et al. A randomized, placebo-controlled,
dose-ranging study of single-dose omalizumab in patients with
H1-antihistamine-refractory chronic idiopathic urticaria. J Allergy Clin
Immunol 2011;128(3):567-573.

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