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Novartis Seeks European Approval for Xolair as First-in-Class Treatment for Severe Allergic Asthma
BASEL, Switzerland, July 2 (ots/PRNewswire) - Novartis Pharma AG yesterday submitted its application for the European approval of Xolair(R) (omalizumab), a novel therapy which targets a root cause of allergic disease and offers an entirely new approach to the treatment of allergic asthma. The file, submitted to the Committee for Medicinal Products for Human Use (CHMP), is based on clinical trial experience in around 5,500 patients demonstrating Xolair's efficacy in controlling symptoms and reducing asthma exacerbations (or `attacks'), even in patients with severe allergic asthma that is uncontrolled by existing medication.
Allergic asthma is a chronic disorder of the airways that affects
nearly 150 million people worldwide and causes more than 180,000
deaths annually. The symptoms include difficulty in breathing,
wheezing, coughing, chest tightness and shortness of breath.
Allergies are a contributory factor in a majority of cases of asthma.
In these patients, the symptoms are triggered by contact with
allergens such as pollen, house dust mites or particles of animal
Unique mode of action
Xolair is conveniently administered by subcutaneous injection
every two or four weeks, and is unique in blocking the action of IgE
(immunoglobulin E), the antibody responsible for triggering the
cascade of symptoms in patients who suffer from allergy-induced
diseases. Xolair is a humanised monoclonal antibody which is designed
to bind to the IgE circulating in the bloodstream, inhibiting the
release of inflammatory chemicals that cause the symptoms of asthma.
Reducing IgE levels also helps to improve inflammation of the
airways, making Xolair the first non-steroidal therapy that is proven
to have a major anti-inflammatory effect in allergic asthma.
Xolair was developed jointly by Novartis Pharma AG, Genentech,
Inc., and Tanox, Inc., and was approved by the US Food and Drug
Administration in June 2003. To date, more than 15,000 patients
have been prescribed Xolair in the US. In Europe the proposed
indication will focus on the prevention of asthma exacerbations and
control of symptoms in adults and adolescents with severe persistent
allergic asthma, who remain inadequately controlled despite use of
inhaled corticosteroids and long-acting beta-2 agonists.
The submission is supported by a comprehensive programme of more
than 30 clinical trials demonstrating Xolair's efficacy in reducing
asthma exacerbations and the need for emergency medical treatment,
and improving patients' quality of life. Among them is a recently
completed 28-week randomised, double-blind, placebo-controlled study
in 419 adults and adolescents with inadequately-controlled severe
allergic asthma, results from which will be presented at the European
Respiratory Society meeting in September 2004.
Data from a clinical trial published in the latest edition of
`Allergy' show that the number of asthma exacerbations was
significantly lower with Xolair than with best standard care alone
(1.12 and 2.86 per patient-year respectively, p <0.001), equivalent
to a reduction of 60.8%. Significantly more patients treated with
Xolair remained exacerbation-free than those on best standard care
alone (49.5% [102/206] vs. 26.4% [28/106], p = 0.001).
This randomised, open-label, multicentre parallel-group study of
312 patients (aged 12-73) with poorly-controlled moderate-to-severe
allergic asthma was designed to investigate Xolair's efficacy and
tolerability in a `real-life' clinical setting.
Prof. Jean Bousquet of the Service des Maladies Respiratoires,
Hôpital Arnaud de Villeneuve, Montpellier, France, who is the editor
of `Allergy', said: "These results confirm that this therapy has the
potential to transform the way we treat patients with severe allergic
asthma, who remain at risk of serious and sometimes life-threatening
symptoms despite receiving the best treatment currently available.
For patients with severe and uncontrolled disease, Xolair has the
potential to provide a major breakthrough in treatment".
The anti-inflammatory properties of Xolair are highlighted in a
further recently-published study involving 43 patients (aged
19-48) with mild-to-moderate disease, whose airways have not been
modified by treatment with corticosteroids. This 16-week randomised,
double-blind, placebo-controlled, multicentre parallel-group study
showed that Xolair led to a reduction in many types of cells involved
in airway inflammation, especially the white blood cells called
eosinophils. An increase of eosinophils in the sputum is a typical
feature of asthma, and this is associated with a greater risk of
exacerbation and broadly correlates with disease severity.
The study showed that the mean sputum eosinophil count decreased
significantly (p <0.001) from 6.6% to 1.7% in the Xolair group, a
reduction significantly (p 0.05) greater than with placebo (8.5% to
7.0%). The authors conclude: "The findings of the present study are
significant in that they show omalizumab to be the first nonsteroidal
agent with major anti-inflammatory activity in the airways of
Xolair treatment is generally well-tolerated. The most frequent
adverse events included injection site reactions (45%), viral
infections (23%), upper respiratory tract infections (20%), sinusitis
(16%), headache (15%), and pharyngitis (11%). These events were
observed at similar rates in Xolair-treated patients and control
This release contains certain "forward-looking statements",
relating to the Group's business, which can be identified by the use
of forward-looking terminology such as "will focus on", "will be
presented", "has the potential", or similar expressions, or express
or implied discussions regarding potential new indications, marketing
approvals, or future sales of Xolair. Such statements reflect the
current views of the Group with respect to future events and are
subject to certain risks, uncertainties and assumptions. There can be
no guarantee that Xolair will be approved for any additional
indications in any market or that it will reach any particular sales
levels. In particular, management's expectations could be affected
by, among other things, new clinical data; unexpected clinical trial
results; 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; increased government pricing pressures; and
other risks and factors referred to in the Company'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 described herein as 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.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and
consumer health. In 2003, the Group's businesses achieved sales of
USD 24.9 billion and a net income of USD 5.0 billion. The Group
invested approximately USD 3.8 billion in R&D. Headquartered in
Basel, Switzerland, Novartis Group companies employ about 78,500
people and operate in over 140 countries around the world. For
further information please consult http://www.novartis.com.
 World Health Organization
 In the US, Xolair is indicated for adults and adolescents (12
years of age and above) with moderate to severe persistent asthma who
have a positive skin test or in vitro reactivity to a perennial
aeroallergen and whose symptoms are inadequately controlled with
inhaled corticosteroids. Xolair is also approved in Australia.
 J. Ayres, B. Higgins, E. Chilvers, et al. Efficacy and
tolerability of anti-immunoglobulin E therapy with omalizumab in
patients with poorly controlled (moderate-to-severe) allergic asthma.
Allergy 2004 Jul; 59(7): 701-8
 R. DjukanoviÄ, S. Wilson, M. Kraft, N. Jarjour, M. Steel, K.
Fan Chung, W. Bao, A. Fowler-Taylor, J. Matthews, W. Busse, S.
Holgate, J. Fahy. The Effects of Anti-IgE (Omalizumab) Treatment on
Airways Inflammation in Allergic Asthma. Am. J. Respir. Crit. Care
Med. 2004 Jun 1 (published online ahead of print)
ots Originaltext: Novartis Pharma AG
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Lisa Richert, Novartis Global Communications, Tel +41-61-324-3543
firstname.lastname@example.org John Taylor, Novartis Pharma
Communications, Tel: +41-61-324-6715 Mobile: +41-79-593-4279