FRIMLEY, England, June 1, 2010 /PRNewswire/ --

    
    - Just for UK media, not for Ireland

    - This release is intended for consumer media

    - Add-On Omalizumab Reduces the Rate of Asthma Attacks in
      Children Aged 6 to 11 Years With Severe Persistent Allergic Asthma 
      Whose Symptoms Remain Uncontrolled Despite Best Available Current 
      Therapies[2]

    - Today's Decision Made Despite Pivotal Study Showing Omalizumab Halves
      Asthma Attacks at One Year With a Good Overall Safety and Tolerability
      Profile in Children Aged 6 to 11 Years [3,4]

Novartis is disappointed that the National Institute for Health and Clinical Excellence (NICE) has decided against recommending omalizumab for children aged 6 to 11 years with severe, persistent allergic asthma in England and Wales because it does not consider it to be a cost-effective use of NHS resources1. Omalizumab is the first in a generation of drugs for severe, difficult-to-control allergic asthma, where patients have an oversensitive immune system, and is already recommended by NICE for use in patients aged 12 years and older[5].

Last month the Scottish Medicines Consortium (SMC) accepted the use of omalizumab for children in Scotland aged 6 to 11 years with severe, persistent allergic asthma who are prescribed chronic systemic steroids[6].

Asthma is a chronic, inflammatory lung disease which affects approximately 1.1 million children in the UK[7]. Of the 80,000 hospital admissions for asthma in the UK every year, 41% are for children under 14 years[8]. Within this group of paediatric patients, there are a small but significant number of children with severe symptoms in whom asthma control remains poor despite best available therapy. These children are currently treated with frequent or maintenance doses of oral corticosteroids (OCS) together with other controller medications. As such, they are at risk of serious OCS-related side-effects, including growth retardation, osteoporotic fractures, diabetes and cardiovascular events such as hypertension and heart failure[9]. It is estimated that just over 300 of these children may be eligible for treatment with omalizumab[10].

Dr Tim Cave, Medical Director, Novartis UK said: "We are disappointed by NICE's initial decision and concerned that the small number of young children with severe asthma in whom omalizumab would be used will be denied access to this drug. If the initial decision stands, doctors will not be able to give children a treatment which could alleviate their asthma symptoms."

Results from a pivotal study submitted to NICE showed that omalizumab reduced asthma attacks by a third after 24 weeks of treatment[2] and provided an overall reduction of 50% at one year[2].

Omalizumab is the only licensed medicine shown to stabilise severe allergic asthma in a significant proportion of patients by blocking the action of the IgE antibody, a factor in the inflammatory cascade associated with allergic asthma[2]. Omalizumab thereby inhibits the body's reaction to inhaled particles such as cat dander and house-dust mite droppings that cause the symptoms associated with severe allergic asthma[3,4]. By targeting IgE, omalizumab can prevent the onset of debilitating symptoms, such as shortness of breath and wheezing, in severely affected patients.

Omalizumab was approved as add-on therapy in the EU by the European regulator (EMEA) in 2005 for patients 12 years and older with severe persistent allergic asthma. More recently omalizumab was approved by the same regulator as add-on therapy for severe persistent allergic asthma in children aged 6 to 11 years[3].

NICE has invited Novartis and other consultees/commentators in the appraisal process, including patient/carer groups, to comment on the ACD by 5pm on 22nd June. It is also possible for members of the public to comment via the NICE website.

Omalizumab was developed under an agreement between Novartis Pharma AG, Genetech, Inc., and Tanox, Inc. and launched in the UK in 2005.

Notes to editors

Xolair Summary of Product Characteristics

Please see: http://www.medicines.org.uk/emc/medicine/17029

SMC advice for Xolair (Omalizumab) - Children (6 to <12 years age)

ADVICE: following an abbreviated submission omalizumab (Xolair(R)) is accepted for restricted use within NHS Scotland.

Licensed indication under review: add-on therapy to improve asthma control in children (6 to <12 years of age) with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Omalizumab treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma.

SMC restriction: Use is restricted to patients who are prescribed chronic systemic steroids and in whom all other treatments have failed. The response to omalizumab treatment should be assessed in all patients at 16 weeks and treatment should be discontinued in patients who have not shown a marked improvement in overall asthma control.

The Scottish Medicines Consortium has previously accepted this product for restricted use in adults and adolescents (12 years of age and above). Omalizumab is listed in the British National Formulary for Children for the prophylaxis of allergic asthma.

SMC advice for Xolair (Omalizumab) - Adults and adolescents (12 years of age and older)

Omalizumab (Xolair) is accepted for restricted use within NHS Scotland as add-on therapy to improve asthma control in adult and adolescent patients (12 years of age and above) with severe persistent allergic asthma.

It is restricted to initiation and monitoring by hospital physicians experienced in the diagnosis and treatment of severe persistent asthma. It is restricted to patients who are prescribed chronic systemic steroids and in whom all other treatments have failed. The response to omalizumab treatment should be assessed in all patients at 16 weeks and treatment should be discontinued in patients who have not shown a marked improvement in overall asthma control.

Xolair (omalizumab) therapeutic indication - adults and adolescents (12 years of age and older)

Omalizumab is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Omalizumab treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma.

Xolair (omalizumab) therapeutic indication - children (6 to 11 years of age)

Omalizumab is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

Omalizumab treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma.

    
    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.

    - Patients with severe persistent asthma are characterised by
      high morbidity with increased use of healthcare resources. They often 
      require hospital admission and attendance at accident and emergency 
      departments. They take multiple therapies and are considered to be at 
      risk of death from their disease.

About Novartis

Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic pharmaceuticals, preventive vaccines, diagnostic tools and consumer health products. Novartis is the only company with leading positions in these areas. In 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

    
    References

    1. National Institute for Health and Clinical Excellence Appraisal
       consultation document - Omalizumab for the treatment of severe 
       persistent allergic asthma in children aged 6 to 11 years. Issue 
       date: 1st June

    2. Kulus M, Hebert J, Garcia E, et al. Omalizumab in children with
       inadequately controlled severe allergic (IgE-medicated) asthma. 
       Current Medical Research and Opinion 2010: Vol 26, no 6; 1285-1293

    3. Xolair Summary of Product Characteristics (SmPC)

    4. Milgrom H, Fink J, Fowler-Taylor A, et al. Safety of omalizumab in
       children with inadequately controlled moderate-to-severe allergic
       (IgE-mediated) asthma. Poster presented at American Thoracic Society 
       (ATS) International Conference, San Diego, California, USA. May 
       15-20, 2009.

    5. Omalizumab for severe persistent allergic asthma. NICE Technology
       Appraisal Guidance 133. Issue Date: November 2007.
       http://guidance.nice.org.uk/TA133/Guidance/pdf/English. Accessed 
       25th May 2010

    6. Scottish Medicines Consortium. www.scottishmedicines.org.uk. Accessed
       11 May 2010.

    7. Asthma UK. Where do we stand? Asthma in the UK today. Accessed 19 May
       2010. http://www.asthma.org.uk/health_professionals/ordering_materials/where_d...

    8. Asthma UK Key Facts & Statistics for Journalists (2010). Available at
       http://www.asthma.org.uk/news_media/media_resources/for_journalists_key....
       Last Accessed 26 January 2010

    9. Manson et al The cumulative burden of oral corticosteroid side-effects
       and the economic implications of steroid use. Respiratory Medicine. 
       2009: Vol 103; pp. 975 - 994

    10. Novartis Data on File. XOL-0110. May 2010