Stmnt re MRP Approval

AstraZeneca PLC
4 January 2001


SYMBICORT GAINS EUROPEAN UNION MUTUAL RECOGNITION APPROVAL FOR ASTHMA CONTROL


AstraZeneca announced today that 'Symbicort', a new and innovative treatment
for asthma, has been granted approval through the Mutual Recognition Procedure
(MRP) in 14 European Union (EU) states plus Norway and Iceland.  This follows
initial approval of Symbicort in Sweden in August 2000.  Sweden acted as the
reference member state for the MRP application. In addition to these
approvals, Symbicort has been approved in Switzerland, and applications have
been submitted in both Canada and Australia. 

Symbicort contains the corticosteroid budesonide and the rapid- and
long-lasting bronchodilator, formoterol, in the same single inhaler,
'Turbuhaler'.   Both of these classes of treatments are needed to manage
effectively many patients with asthma.  However, this is the first time these
two successful treatments have been teamed up in one single inhaler, thereby
increasing convenience for patients and potentially increasing adherence to
prescribed therapy. 

Because of the variable nature of chronic asthma, management guidelines
highlight the need to start at a high dose of inhaled corticosteroid in order
to gain control of asthma, then step down to the lowest possible dose - even
including once daily - when the disease is fully controlled.  The need for
adjustable dosing has meant that, up until now, doctors have often had to
prescribe a new inhaler (and patients have had to purchase a new inhaler) with
each new dose or treatment required.  Symbicort is the first and only inhaler
containing a corticosteroid and a rapid- and long-lasting bronchodilator that
provides prescribers with the unique benefit of being able to start at a high
dose and then, depending on how the patient responds, step down or back up
using the same single inhaler.

Symbicort has been shown to improve significantly the rate of exacerbations
and asthma control in patients not fully controlled on inhaled corticosteroids
alone.  These findings corroborate those of the landmark study by Pauwels et
al, published in the New England Journal of Medicine. This study showed that
when budesonide and formoterol are used together in patients with moderate to
severe asthma, the rate of mild and severe asthma attacks can be reduced by as
much as 62 and 63 percent, respectively. In addition, improvements were seen
in patients' lung function and night-time symptoms.  Such benefits provide a
significant and sustained improvement in patients' quality of life.

Symbicort is available in the new Turbuhaler, which has a numerical dose
counter and a redesigned patient-friendly mouthpiece. 

Symbicort is indicated in the regular treatment of asthma where use of a
combination (inhaled corticosteroid and long-acting beta2-agonist) is
appropriate. 

Further enquiries to:

Michael Olsson       Tel [phone]        
Ed Seage             Tel [phone]
Jorgen Winroth       Tel [phone]