Symbicort

AstraZeneca PLC
09 October 2006



      AstraZeneca Successfully Completes Mutual Recognition Procedure For
      Symbicort(R) Maintenance And Reliever Therapy (Symbicort SMART(R))
                                   in the EU

AstraZeneca today announced that it has successfully completed the European
Union Mutual Recognition Procedure (MRP) for Symbicort(R) Maintenance And
Reliever Therapy (Symbicort SMART(R)). This new treatment approach enables
patients to take control of their asthma and use just one inhaler for both
maintenance and relief of asthma symptoms.



Symbicort SMART is licensed for use in adults who need an inhaled corticosteroid
(ICS) and a long acting bronchodilator (LABA) combination treatment.  National
approvals are expected to be issued throughout the EU over the coming months.



Asthma is a chronic inflammatory condition of the airways characterised by
reversible airway obstruction. It is a variable condition that can change both
daily and seasonally.  With Symbicort SMART, patients take a maintenance dose of
Symbicort to keep control of their asthma and if further symptoms occur, can
take additional inhalations 'as needed', to provide symptom relief.  When
compared to traditional gold standard therapy, using multiple separate inhaler
devices, Symbicort SMART is a more effective way to manage asthma, as it
provides a simple way for patients to improve daily symptom control and reduce
the risk of asthma attacks.



Dr John Patterson, Executive Director, Development for AstraZeneca said, 'This
new treatment approach has the potential to improve the lives of many patients
with asthma in Europe.  By reducing both symptoms and the number of attacks they
experience, patients can now achieve excellent asthma control using only one
inhaler rather than the traditional approach of using multiple inhalers.'



Symbicort SMART has been studied in a wide clinical trial programme involving
over 14,000 patients with mild to severe persistent asthma. These studies
consistently show that Symbicort SMART, irrespective of asthma severity, reduces
the risk of patients developing potentially life-threatening asthma attacks
significantly better than fixed dosing with either higher doses of ICS alone or
with an ICS/LABA combination therapy plus a short-acting bronchodilator.

This extensive clinical trial programme includes COMPASS, a large,
double-blinded, head-to-head study involving 3,335 patients with moderate to
severe asthma, comparing Symbicort SMART to a double maintenance dose of
Symbicort and with a similar dose of SeretideTM (fluticasone/salmeterol). When
compared to Seretide, Symbicort SMART was shown to reduce the risk of a severe
asthma attack (primary endpoint) by 33 percent and to significantly reduce the
total number of severe asthma attacks by 39 percent.  Similar effects were
reported with Symbicort SMART when compared to double the maintenance dose of
Symbicort. Symbicort SMART patients had equal levels of daily asthma control
compared to both fixed dose treatment approaches, yet received a lower overall
steroid load during the six-month study period. No differences were seen in the
safety of these treatment approaches.



Further data from the SMILE study, recently published in The Lancet, showed for
the first time a positive effect of giving an inhaled steroid for daily
maintenance and as-needed, i.e. to both prevent and treat symptoms. SMILE
evaluated the benefits of different as needed therapies: budesonide/formoterol,
formoterol or terbutaline on top of Symbicort maintenance therapy, in preventing
asthma attacks. The use of as-needed budesonide/formoterol provided increased
protection from severe attacks compared with terbutaline as-needed on top of
Symbicort maintenance therapy. In addition, the use of budesonide/formoterol
as-needed was significantly more effective than formoterol as-needed on top of
Symbicort maintenance therapy.



Symbicort is currently approved in more than 90 countries and in July 2006
received US Food and Drug Administration (FDA) approval for maintenance
treatment of asthma.    Symbicort SMART is already approved in Argentina,
Australia, Brazil, Mexico, the Philippines, Switzerland and Thailand.  Symbicort
has reached more than 5 million patient years, with sales reaching $585 million
in the first half of 2006.



AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription pharmaceuticals
and the supply of healthcare services. It is one of the world's leading
pharmaceutical companies with healthcare sales of $23.95 billion and leading
positions in sales of gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology and infection products. AstraZeneca is listed in the Dow
Jones Sustainability Index (Global) as well as the FTSE4Good Index.



9 October 2006

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