Symbicort Turbuhaler

RNS Number:1156S
AstraZeneca PLC
17 November 2003


               ASTRAZENECA COMPLETES MUTUAL RECOGNITION PROCEDURE
               FOR HIGH DOSE RANGE OF SYMBICORT(R) TURBUHALER(R)


AstraZeneca announced today that it has successfully completed the European
Union Mutual Recognition Procedure for Symbicort(R) Turbuhaler(R), which
permits the use of an increased dose range in some patients with persistent
asthma.  National licences are expected to be issued throughout the EU over the
coming months and will allow patients to use up to four inhalations twice daily
of the 80/4.5micrograms and 160/4.5micrograms strengths (or two inhalations 
twice daily of the 320/9micrograms strength).  European Union countries include 
Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, 
Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom.

The increased dose range of the 80/4.5micrograms and 160/4.5micrograms strengths 
is already approved in Canada, Switzerland, New Zealand and Mexico, and is 
within the label of the Symbicort(R) Turbuhaler(R) monocomponents, budesonide 
and  formoterol, in many countries.  Upon the granting of national licences, 
prescribers and patients in EU countries will have a wider range of Symbicort(R) 
dosing options.

Asthma is a variable disease. Patients experience periods of good control, but
exposure to external factors can often trigger periods of worsenings, which can
develop into "asthma attacks".  Several recent clinical trials including more
than 2,500 patients have demonstrated that, while regular, fixed doses of
combination products provide good control of persistent asthma, patients can
also prevent asthma attacks more effectively by temporarily increasing their
Symbicort(R) dosage when symptoms increase and reducing it during periods of
good control.

This treatment concept is simple for patients to follow and helps to prevent
worsening of symptoms developing into distressing asthma attacks.  For example,
a prescriber could initiate Symbicort(R) therapy at two inhalations twice
daily. The patient could then reduce to perhaps one inhalation twice daily
during periods of good control and increase the dosage up to four inhalations
twice daily if their condition worsens. The prescriber has the discretion to
adjust the dose of Symbicort(R) within the approved dosing range.

Symbicort(R) is the only combination treatment that allows patients to adjust
their dose with the same single inhaler. Recent studies have also shown that
despite having the option to increase their dose to eight inhalations a day to
prevent these attacks, patients using Symbicort(R) adjustable maintenance dosing
used fewer inhalations than patients on a fixed dose of two inhalations twice
daily.

In a recently published study comparing Symbicort(R) adjustable maintenance
dosing with both Symbicort(R) fixed dosing (160/4.5micrograms) and fixed dosing 
of Seretide(R) (salmeterol/fluticasone) dry powder inhaler (DPI) 
(50/250micrograms bid), all groups were shown to provide an equal number of 
well-controlled asthma weeks. However, the possibility to immediately double or 
quadruple daily doses on signs of asthma worsening using Symbicort(R) adjustable 
maintenance dosing, decreased severe asthma exacerbations by 40 per cent, 
compared with fixed dose Seretide(R) (salmeterol/fluticasone) DPI.  Severe 
exacerbations were defined as exacerbations requiring oral steroid treatment 
for at least three days, an emergency room visit, or hospitalisation. Patients 
in the Symbicort(R) adjustable dosing arm also used 27 per cent less 
short-acting bronchodilator as needed for symptom relief, an additional marker 
of asthma control compared with the two fixed dose groups.  This increased 
control of exacerbations with Symbicort adjustable maintenance dosing was 
achieved, whilst overall Symbicort(R) use was reduced, compared with a fixed 
dose of Symbicort(R) used in the same study.

The current worldwide market for fixed combination asthma products is estimated
to be worth $3.5 billion. To date, Symbicort(R) is launched in over 45 markets
and approved in 78 countries.



17 November 2003



Media Enquiries:                          Investor Enquiries:

Steve Brown, ++44 (0) 207 304 5033        Mina Blair-Robinson, ++44 207 304 5084
Edel McCaffrey, ++44 (0) 207 304 5034     Jonathan Hunt, ++44 207 304 5087


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