Novartis Pharma AG

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.[1] 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 hair. 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.[2] 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. Clinical benefits Data from a clinical trial published in the latest edition of `Allergy'[3] 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". Anti-inflammatory effect The anti-inflammatory properties of Xolair are highlighted in a further recently-published study[4] 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 allergic asthmatics." Safety information 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 patients. 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 --------------------------------- [1] World Health Organization [2] 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. [3] 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 [4] 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 Im Internet recherchierbar: Contact: Lisa Richert, Novartis Global Communications, Tel +41-61-324-3543 John Taylor, Novartis Pharma Communications, Tel: +41-61-324-6715 Mobile: +41-79-593-4279

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