Novartis Disappointed by Initial NICE Decision on Xolair(R) (omalizumab)[1] and Concerned that Children Suffering from Severe Persistent Allergic Asthma will be Denied Access to Treatment[1]

FRIMLEY, England, June 1, 2010 -

    - 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: 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
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.
       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. www.asthma.org.uk/health_professionals/ordering_materials/where_do_we_stand.html

    8. Asthma UK Key Facts & Statistics for Journalists (2010). Available at
       www.asthma.org.uk/news_media/media_resources/for_journalists_key.html
       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

For more information, please contact: Nikki Roberts, Novartis Press Office, Press Office: +44(0)1276-698691, E-mail: pressoffice-uk.phgbfr at novartis.com ; Kate Aldous, Red Health, Tel: +44(0)7890-178-940, Fax: +44(0)207-025-6499, kate.aldous at redconsultancy.com