BASEL, Switzerland and MUNICH, Germany, July 1, 2005 (PRIMEZONE) -- Data from seven clinical studies presented at the World Allergy Congress in Germany demonstrate that in patients with severe allergic asthma who require treatment with oral corticosteroids -- indicating that they have a more severe form of the disease -- Xolair(r) (omalizumab) significantly reduced the rate of severe asthma attacks and emergency medical visits.(1)
A further analysis of results from two of the studies presented at the congress shows that Xolair improved asthma control in patients with moderate to severe allergic asthma, and reduced their reliance on bursts of oral corticosteroid to manage acute asthma exacerbations (or 'attacks').(2) The need for steroid bursts is an important indicator of asthma control, and high use of systemic steroids, coupled with frequent asthma exacerbations, is associated with increased complications including hospital visits and steroid side-effects.
The data were presented as experts in the field of asthma and allergy met to discuss the ongoing challenge of managing severe allergic asthma, and the potential role of the first-in-class anti-IgE therapy Xolair in offering improved symptom control to patients who live with significant risk of hospitalisation and potentially life-threatening attacks. A file for the approval in Europe is being considered by the Committee for Medicinal Products for Human Use (CHMP), which is expected to announce a decision later this year.
Prof. Ulrich Wahn of the Charite Virchow-Klinikum in Berlin, Germany, and President of the European Academy of Allergology and Clinical Immunology (EAACI), said that anti-IgE therapy could prove a valuable addition to current treatment options. "In some cases it is impossible to control the symptoms of severe allergic asthma, even with recommended treatment regimens. For such patients, asthma can have serious impact on their health and affect their quality of life on a daily basis. These data demonstrate that Xolair offers the potential to achieve a significant improvement in control, and to improve the lives of patients who continue to suffer from this debilitating disease."
Xolair offers a novel therapeutic approach to the control of asthma by targeting a root cause of allergic disease. It blocks the action of the IgE antibody, responsible for initiating the cascade of inflammatory symptoms such as airway constriction, mucous production, wheezing and shortness of breath. Xolair is effective even in the most difficult-to-treat patients whose condition remains poorly-controlled despite receiving the best available therapy.
Clinical study summary
Data were analyzed from seven controlled trials of Xolair in severe allergic asthma patients, 93% of whom met GINA 2002 criteria for severe persistent asthma.(1) A total of 446 patients were receiving maintenance oral corticosteroids, indicative of more severe disease, while 3,862 were not. The severe exacerbation rate (i.e. where lung function measured by PEF or FEV1 was less than 60% of personal best, requiring systemic corticosteroids) and the rate of emergency visits (i.e. hospital admissions, emergency room visits and unscheduled doctor's visits) were calculated during the treatment phase.
The results demonstrated that adding Xolair to current therapy offered an improved level of asthma control, reducing the severe exacerbation rate by 59.2% compared to control (p=0.008) and the rate of emergency visits by 55.9% (p=0.014) in patients treated with oral steroids. In patients not receiving oral steroids, similar but slightly smaller reductions were seen in severe exacerbations (56.9%, p less than 0.0001) and emergency visits (44.7%, p=0.0005).
Xolair significantly reduced the asthma exacerbation rate by 37.2% compared to control in patients receiving oral steroids (p=0.001), and by 38.8% in those not receiving oral steroids (p less than 0.0001). The reduction was greatest in absolute terms in the group receiving steroids as they had higher exacerbation rates, an indication of more severe disease.(1) Individual publications of the studies included in the analysis, including three studies of one year's duration, reported excellent tolerability.(3)
Further data from two of the studies presented at the congress assessed the impact of add-on Xolair on the need for bursts of systemic steroids in patients with moderate to severe allergic asthma.(2) Combined data from two randomised 28-week, double-blind, placebo-controlled studies involving 824 patients demonstrated that patients taking placebo were 1.4 times more likely to use steroid bursts to control their disease than those in the Xolair group (p=0.011). This figure rose to 2.2 times in the most difficult to control group of severe patients with an FEV1 of less than 60% (p=0.0002).
Anti-IgE and severe asthma
Around 300 million people in the world have asthma,(4) of whom an estimated 15 million suffer from severe persistent disease.(5) Their health and quality of daily life are often severely affected, and asthma is estimated to cause more than 180,000 deaths worldwide each year.(6)
Martyn Partridge, Professor of Respiratory Medicine at Imperial College London and Chief Medical Adviser to Asthma U.K., commented: "For a sizable minority of people, their lives are significantly impaired by asthma and they remain at real risk of suffering severe attacks and requiring hospital treatment as a result. Despite this, there is still a totally unjustifiable level of complacency about this disease within the community at large. Severe allergic asthma remains a real challenge and we urgently require a new approach to therapy that offers the chance of reducing attacks and improving quality of life for these patients."
The experts' view on the potential of IgE therapy is now supported by global guidelines. Based on the clinical data, guidelines developed by the Global Initiative for Asthma (GINA) have recommended anti-IgE therapy as add-on treatment for patients with severe allergic asthma that is inadequately controlled by standard clinical options.(7)
In the U.S., Xolair has been available for treating moderate to severe allergic asthma since June 2003, and as of 31 March 2005 it had been prescribed to more than 40,000 patients. In addition to the U.S., Xolair is also approved in Australia, Brazil, Canada, Dominican Republic, Guatemala, Israel, New Zealand and Venezuela. It has been developed under an agreement between Novartis Pharma AG, Genentech, Inc., and Tanox, Inc.
The foregoing release contains certain forward-looking statements that can be identified by terminology such as "expected," "could prove," "potential," or similar expressions, or by express or implied discussions regarding the potential that Xolair will be approved for sale in any additional markets, or regarding any potential future revenues from Xolair. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Xolair 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 approved for sale in any additional market, or that it will achieve any particular sales level. In particular, management's expectations regarding commercialization of Xolair could be affected by, among other things, uncertainties relating to clinical trials; new clinical data, or 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; as well as other risks and factors referred to in the Company's current Form 20-F on file with the U.S. 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 AG (NYSE:NVS) is a world leader in pharmaceuticals and consumer health. In 2004, the Group's businesses achieved sales of USD 28.2 billion and pro forma net income of USD 5.6 billion. The Group invested approximately USD 4.2 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 81,400 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com
(References)
(1) Beasley R, Hedgecock S, Fox H, Blogg M, Surrey K, Reisner C. Add-on omalizumab therapy significantly reduces severe asthma exacerbations and emergency visits in patients with severe persistent asthma requiring oral corticosteroids for maintenance therapy: a pooled analysis. World Allergy Congress, June 2005.
(2) Massanari M, Deniz Y, Lee J, Kianifard F, Blogg M, Reisner C, Geba GP. Omalizumab improved asthma control and reduced rescue steroid bursts in moderate to severe allergic asthma. World Allergy Congress, June 2005.
(3) Bousquet J et al. The effect of treatment with omalizumab, an anti-IgE antibody, on asthma exacerbations and emergency medical visits in patients with severe persistent asthma. Allergy 2005;60:302-308.
(4) GINA. The Global Burden of Asthma Report 2004.
(5) American Thoracic Society. Proceedings of the ATS workshop on refractory asthma. Current understanding, recommendations, and unanswered questions. Am J Respir Crit Care Med 2000; 162:2341-2351.
(6) World Health Organization. http://www.who.int/mediacentre/factsheets/fs206/en/
(7) Global Strategy for Asthma Management and Prevention 2004, p110-115. http://www.ginasthma.com/Guidelineitem.asp?l1=2&l2=1&intId=60