2013-02-24 19:03:33 -
Novartis International AG /
Novartis reports Phase III data showing omalizumab improved itch in patients
with a chronic form of hives who failed standard therapy
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* Study published in NEJM today and presented tomorrow met primary endpoint
in moderate to severe refractory chronic idiopathic/spontaneous urticaria
* 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
* 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.
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),. 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, spontaneously presenting and
reoccurring for more than six weeks. Angioedema, or deep tissue swelling,
also occurs in approximately 40 to 50% of these patients. 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
"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 trials."
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 therapyat 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. The
omalizumab 75 mg dose group did not demonstrate statistical significance
compared to placebo.
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.
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. 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,.
The incidence and severity of adverse events (AEs) was similar across treatment
groups. 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.
CIU/CSU also has negative effects on quality of life, which frequently includes
sleep deprivation and psychiatric comorbidity. At any given time, the
prevalence of CIU/CSU is 0.5% to 1% worldwide.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.
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. 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 therapy.
Five (6.3%) patients experienced serious AEs (SAEs) in the omalizumab 300 mg
dose group, compared to two (2.5%) in the placebo group. 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.
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. 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,"
"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.
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 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.
 Maurer M, Rosén K, Hsieh HJ, et al Omalizumab for the treatment of chronic
idiopathic or spontaneous urticaria. NEJM 2013; DOI: 10.1056/NEJMoa1215372.
 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.
 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.
 Asthma and Allergy Foundation of America (AAFA) website. "Chronic Urticaria
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.
 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.
 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
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