NICE Backs Xolair(R)-Delta for Severe, Persistent Allergic Asthma

FRIMLEY, England, August 31 /PRNewswire/ --

- Clinicians Welcome Drug Watchdog's Decision to Grant NHS Patients 
Access to Xolair(R) (Omalizumab) for Severe, Persistent Allergic Asthma.

Novartis today welcomes the decision made by the National
Institute for Health and Clinical Excellence (NICE) to recommend the use of
Xolair(R) (omalizumab) in adolescents (12 years of age and above) and adults
with severe, persistent allergic asthma(1). Evidence shows that, when used as
add-on treatment, Xolair can significantly improve symptom contro(l2) and
quality of life in those patients in whom best current management has failed.

Xolair is the first drug shown to stabilise severe allergic asthma in a
significant proportion of patients by tackling its root cause. Xolair blocks
the body reacting to inhaled particles such as pollen, cat dander and
house-dust mite droppings that cause the symptoms associated with severe
allergic asthma(3,4). Through the alleviation of the severe symptoms that can
be associated with asthma deaths, patients benefit from a reduced risk of
severe exacerbations and the need for emergency treatment.(2)

Asthma is a chronic, inflammatory lung disease which kills
approximately 1,400 people every year (one every six hours)(5), whilst also
leading to 71,000 annual hospital admissions.(6) Up to 50% of severe asthma is
classified as allergic(7) and approximately 20% of people with asthma are
classified as having a severe, persistent asthma(8) meaning their symptoms are
present continuously during the day and frequently at night, and their level
of physical activity is significantly reduced(9).

Dr Robert Niven, Respiratory Consultant commented: "Xolair
offers hope for patients with severe, persistent allergic asthma. In this
small but important group with poorly controlled disease, it is clinically
proven to significantly reduce asthma deteriorations and significantly
improve quality of life. Before Xolair was available, clinicians were very
limited in what they could do to control symptoms in these patients other
than prescribe high doses of conventional medications including oral
steroids".

NICE recommend that patients who are eligible for Xolair
therapy must be diagnosed with severe, persistent allergic asthma and have
severe, unstable disease. 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. NICE have
also stated that each patient must also have had a full trial of and
documented compliance with standard treatment. If relevant, patients must
also stop smoking.(1)

Subhanu Saxena, Chief Executive Officer, Novartis UK said: "We
welcome the NICE recommendation to make Xolair available to patients with
such severe asthma. As a result of today's decision, we hope that more
patients will have access to Xolair to alleviate their asthma symptoms and
experience a better quality of life."

Xolair was developed under an agreement between Novartis
Pharma AG, Genetech, Inc., and Tanox, Inc. and launched in the UK in 2005.
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. It 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 Beta-2 agonists in addition to leukotriene
receptor antagonists, theophyllines, oral corticosteroids and Beta-2 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 be
expelled from the lungs in one exhalation)

- Reduction in unplanned consultations for asthmai

Full details of the NICE guidance can be accessed via the NICE
website at http://www.nice.org.uk

About Xolair(R) (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
allergen on 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.)(3)

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 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)

About Asthma

- 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(2). Up to 50% of asthma is
classified as allergic(7), 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:

- Continous daytime symptoms

- Limited physical activity during the day

- Frequent symptoms at night

- PEF or FEV1 lesser than or equal to 60% and PEF variability 
greater than or equal to 30%(9)

About Novartis

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.

References:

(1) National Institute for Clinical Excellence. Final Appraisal
Determination - Omalizumab for severe, persistent allergic asthma. Accessed
29 August 2007 - http://www.nice.org.uk

(2) 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

(3) Xolair SPC, May 2007.

(4) Asthma UK. Asthma triggers A-Z. Accessed 23 August 2007.
http://www.asthma.org.uk/all_about_asthma/triggers_az/index.html

(5) Asthma UK. Key facts about asthma for journalists. Accessed August
15th 2007 http://www.asthma.org.uk/news_media/media_resources/for_1.html

(6) Patient UK. Acute severe asthma and status asthmaticus. Accessed 23
August 2007. http://www.patient.co.uk/showdoc/40002346

(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.

(9) Global Initiative for Asthma (GINA). GINA workshop report: Global
Strategy for Asthma Management and Prevention. Available at
http://www.ginasthma.com