Symbicort

AstraZeneca PLC
08 September 2003

NEW STUDY SHOWS SYMBICORT(R) ADJUSTABLE DOSING PROVIDES BETTER ASTHMA CONTROL
THAN SERETIDE(R) FIXED DOSING



AstraZeneca announced today that new data presented at the World Allergy
Organization's International Congress of Allergology and Clinical Immunology
(ICACI) show that the rate of severe exacerbations is 40 per cent lower in
asthma patients on Symbicort(R) adjustable dosing than in patients on Seretide
(R) fixed dosing. These are the first head-to-head data on the two fastest
growing brands in asthma treatment.



This seven-month SUND study involved 658 patients with moderate asthma, who were
taking inhaled steroids (and in most cases a long-acting bronchodilator) at
entry, and remained symptomatic despite their treatment.  Patients were randomly
allocated to one of three groups: Symbicort(R) (budesonide/formoterol) fixed
dosing; Seretide(R) (fluticasone/salmeterol) fixed dosing; or Symbicort(R)
adjustable dosing (the treatment concept unique to Symbicort(R)).



The study was conducted in two phases. First, there was a four-week double-blind
period in which patients received a fixed dose of Symbicort(R) or Seretide(R).
This was followed by a six-month open period in which patients received a fixed
dose of Symbicort(R) (160/4.5microgram, two inhalations twice a day), a fixed
dose of Seretide(R) (50/250microgram, one inhalation twice a day), or an
adjustable dose of Symbicort(R) (160/4.5microgram, one to four inhalations twice
a day, depending on disease severity). All patients could also use a
short-acting bronchodilator as needed.



The results of the study showed that all treatment regimens provided similar
levels of symptom control based on the odds of achieving a 'well controlled
asthma week', but  adjustable dosing with Symbicort(R) provided superior control
to fixed dosing with either Seretide(R) or Symbicort(R)  based on other highly
clinically relevant measures of asthma control. The rate of severe exacerbations
was 40 per cent lower in patients using Symbicort(R) adjustable dosing than in
patients on fixed-dose Seretide(R). This significant reduction in exacerbations
suggests that switching 100 similar patients from Seretide(R) fixed dosing to
Symbicort(R) adjustable dosing would prevent 20 severe exacerbations in the next
year. Severe exacerbations are defined as exacerbations requiring oral steroid
treatment for at least three days, emergency room visit, or hospitalisation.

Patients in the Symbicort(R) adjustable dosing arm also used significantly less
short-acting bronchodilator as needed for symptom relief, which is often used as
a marker of symptom control.



Asthma is a variable disease.  Symbicort(R) is the only combination treatment
for asthma that allows patients to adjust the number of inhalations they take to
provide better control of the disease's fluctuations. This ensures that patients
receive the right level of medication at the right time, providing optimal
asthma control. The unique adjustability of Symbicort(R) is due to the dose
response of both its components: the corticosteroid budesonide and the rapid-
and long-acting bronchodilator formoterol.



People with asthma need to partner with their physician to take control of their
own asthma and find the medication that is best for them. A second study
presented at ICACI showed that 93 per cent of patients allowed to adjust their
Symbicort(R) dose according to disease variation were able to step down their
dose from the traditional two inhalations twice-daily at least once in the
five-month study. Patients in the adjustable dosing group showed better asthma
control than the traditional fixed dosing Symbicort(R) group. Thus adjustable
dosing provided both an increase in asthma control and a reduction in drug load.



Symbicort(R) recorded sales of $299 million in 2002 and has already captured
more than 25 per cent of the market share in 18 launch markets in Europe.  These
study results will help to continue the impressive growth of Symbicort(R) in the
marketplace (+79% CER in the first half of 2003) and establish it as an
excellent choice for the management of a chronic and variable disease like
asthma.   Phase III studies are underway to support the registration in the
United States of the product for asthma.



Asthma is a chronic inflammatory disease of the lungs. The World Health
Organisation estimates that there are 100-150 million asthma sufferers
worldwide.



Symbicort(R) (budesonide/formoterol) is the only combination treatment for
asthma that allows patients to adjust their dose according to disease variation,
without adding or switching inhalers.  Some of the patients in the adjustable
arm used doses of Symbicort(R) (8 inhalations/day for short periods).  This is
within the licensed dose range for the monocomponents - budesonide and
formoterol.  A license variation is underway in the EU to include this higher
dose within the prescribing range for Symbicort.



SUND stands for Symbicort Up aNd Down.



Symbicort(R) received European wide approval for use in chronic obstructive
pulmonary disease (COPD) earlier this year.



8 September 2003



Media Enquiries:

Steve Brown, [phone]

Chris Major, [phone]

Analyst Enquiries:

Mina Blair-Robinson, [phone]

Jonathan Hunt, [phone]



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