Frimley, Surrey, August 30, 2007 – Novartis today welcomed the decision made by the National Institute for Health and Clinical Excellence (NICE) to recommend the use of Xolair (omalizumab) in adolescents (12 years of age and over) and adults with severe, persistent allergic asthma. Xolair is the first anti-immunoglobulin E (IgE) medication available to such high-risk patients and has been clinically proven to reduce the severe exacerbations associated with the condition and improve quality of life. The decision of the Final Appraisal Determination today will ensure that both clinicians and patients continue to benefit from this medication.
Subhanu Saxena, Chief Executive Officer, Novartis UK said: “We welcome the NICE recommendation to make Xolair available to patients with severe, persistent allergic asthma. For some patients, Xolair is the only effective treatment option as their symptoms cannot be controlled by conventional medications alone, leaving them vulnerable to frightening and life-threatening exacerbations which require hospital treatment. As a result of today’s decision, we hope that more patients will have access to Xolair to alleviate their asthma symptoms and experience an improved quality of life.”
The NICE Appraisal Committee has recommended Xolair, a humanised monoclonal antibody, as add-on therapy for patients who have clinically confirmed severe, persistent, unstable IgE-mediated asthma. Specifically they should have experienced either two or more severe exacerbations of asthma requiring hospital admission within the previous year, or three or more severe exacerbations of asthma within the previous year, at least one of which required admission to hospital, and a further two which required treatment or monitoring in excess of the patient’s usual regimen, in an accident and emergency unit. Each patient must also have had a full trial of and documented compliance with standard treatment. If relevant, patients must also stop smoking.1
Dr Robert Niven, Respiratory Consultant commented: “Xolair is a valuable treatment option for patients with severe, persistent allergic asthma whose condition cannot be optimally controlled despite daily high-dose inhaled corticosteroids and long acting β2 agonists. Today's decision by NICE means that clinicians will be able to use Xolair to improve outcomes in a small but important group of patients with severe, intractable asthma.”
Xolair has a novel therapeutic approach targeting the acute, inflammatory response associated with asthma by blocking the action of IgE. In asthmatics, IgE is released in response to an allergen, prompting the release of histamine and other substances which initiate the cascade of inflammatory symptoms such as bronchoconstriction, mucous production, wheezing and shortness of breath. It is prescribed for patients who have a positive skin test or in-vitro reactivity to a perennial aero-allergen and a confirmed, inadequate response to inhaled corticosteroids and long acting β2 agonists. It is administered as a subcutaneous injection every two to four weeks.1,4
Xolair was developed under an agreement between Novartis Pharma AG, Genetech, Inc., and Tanox, Inc. and launched in the UK in 2005. It is the first treatment of its kind for severe, persistent asthma and is prescribed as add-on therapy alongside a patient’s standard asthma medication. It is currently approved in 53 countries, including the US.
This decision on the use of Xolair is expected to be issued by NICE to the NHS in England and Wales within the next six weeks. The decision will then form the guidance for clinical practice within the NHS.
NOTES TO EDITORS
About the NICE Guidance
Xolair add-on therapy should only be initiated if the patient fulfils the criteria of severe unstable allergic asthma:
* Clinical confirmation of allergic (IgE mediated) asthma
· Either two or more severe exacerbations of asthma requiring hospital admission within the previous year, or three or more severe exacerbations of asthma within the previous year, at least one of which required admission to hospital, and a further two which required treatment or monitoring in excess of the patient’s usual regimen, in an accident and emergency unit.
· A full trial and documented compliance with inhaled high-dose corticosteroids and long acting β2 agonists in addition to leukotriene receptor antagonists, theophyllines, oral corticosteroids and β2 agonist tablets and smoking cessation where applicable.
Xolair add-on therapy should be initiated and monitored by a physician experienced in both allergy and respiratory medicine in a specialist centre
Xolair add-on therapy should be discontinued at 16 weeks in patients who have not shown an adequate response to therapy. Response to treatment should be defined on the basis of a full clinical assessment, comprising:
* Degree of asthma control, quality of life, control of exacerbations
* Global evaluation of treatment effectiveness as assessed by physician
* Reported improvement in daily symptoms and in measurements of peak expiratory flow rate (a test which measures how much air can expelled from the lungs in one exhalation)
* Reduction in unplanned consultations for asthma1
Full details of the NICE guidance can be accessed via the NICE website at www.nice.org.uk
About Xolair® (omalizumab)
Xolair is a humanised monoclonal antibody that targets the root cause of allergic asthma by blocking the action of IgE, the molecule responsible for initiating the inflammatory response in allergic asthma. Eligible patients must have a positive skin or blood test for a perennial aero-allergen, an FEV< 80% as well as frequent day time symptoms and/or night time awakenings. It is administered as a subcutaneous injection every two to four weeks, in doses of 150-375 mg. Doses and frequency are determined by levels of total IgE in the blood, measured before the start of treatment, and will vary according to patient body weight (kg.)
More than 30 clinical studies have been undertaken with Xolair and the clinical development programme is still ongoing. Throughout clinical trials, Xolair has shown consistent benefit for adolescent (12 years old and over) and adult patients with severe, persistent allergic asthma. Clinical research shows that adding Xolair to the best available therapy significantly reduces the rate of emergency visits and halves the number of severe asthma exacerbations. Xolair also improves asthma symptoms and asthma-related quality of life.2
· Asthma is a chronic, inflammatory lung disease that is often triggered by allergies and is characterised by airway obstruction, resulting in the symptoms of chest tightness, wheezing and coughing. 
· Asthma impacts 5.2 million people in the UK. Up to 50% of severe asthma is classified as allergic7, and up to 20% of people with asthma are classified as having severe, persistent asthma.8
· Severe, persistent asthma is characterised as the presence of one or more of the following, despite an optimal level of asthma therapy:
o Continuous daytime symptoms
o Limited physical activity during the day
o Frequent symptoms at night
o PEF or FEV1 ≤60% and PEF variability ≥ 30%5
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.
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 National Institute for Clinical Excellence. Final Appraisal Determination – Omalizumab for severe, persistent allergic asthma. Accessed 29 August 2007 – www.nice.org.uk
 Humbert. M et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy 2005: 60: 309-316
 Holgate S, Casale T, Wenzel S et al. The anti-inflammatory effects of omalizumab confirm the central role of IgE in allergic inflammation. J Allergy Clin Immunol. 2005;115(3): 459-465.
 Xolair SPC, May 2007
 Global Initiative for Asthma (GINA). GINA workshop report: Global Strategy for Asthma Management and Prevention. Available at http://www.ginasthma.com
 Asthma UK. Key facts about asthma for journalists. Accessed August 15th 2007 http://www.asthma.org.uk/news_media/media_resources/for_1.html
7 The ENFUMOSA Study Group. The ENFUMOSA cross-sectional European multicentre study of the clinical phentotype of chronic severe asthma. Eur Respir J 2003;22:470-477
8 European Respiratory Society. European Lung White Book, 2003.
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