AstraZeneca PLC
16 September 2002
NEW SYMBICORT(R) DATA SHOW PROMISE FOR DRUG IN TWO NEW SETTINGS-ADJUSTABLE
DOSING FOR ASTHMA AND
TREATMENT FOR COPD
AstraZeneca announced today that new data presented at the 12th Annual Congress
of the European Respiratory Society (ERS) show that adjustable dosing with
Symbicort(R) provided effective asthma control using less drug overall than a
fixed dosing regimen. An adjustable dosing approach with 'Symbicort' is a
response to many asthma patients' needs and allows them to alter their dose
according to disease variation using the same single inhaler. Additionally,
nine poster presentations highlighted the ability of 'Symbicort' to
significantly reduce the number of exacerbations and improve lung function in
patients with Chronic Obstructive Pulmonary Disease (COPD).
Results from the new asthma study ASSURE show that 'Symbicort' adjustable dosing
combines flexibility and effective asthma control using less medication, thereby
meeting patients' self-reported needs, international guidelines for asthma
management, and the recommendations made in the recently released EFA (European
Federation of Allergy and Airway Diseases Patients Associations) asthma patient
manifesto.
Furthermore, the encouraging results from the one-year study in COPD show that '
Symbicort' significantly reduced the number of exacerbations and improved lung
function in patients. In addition, 'Symbicort' provided rapid and sustained
relief from COPD symptoms including shortness of breath, chest tightness and
related nighttime awakenings. Treatment with 'Symbicort' also resulted in
substantial improvements in Quality of Life and was equally well tolerated
compared to placebo. Interestingly, there is also clear evidence for the role
of budesonide, the inhaled corticosteroid in 'Symbicort', in treating patients
with COPD.
Launched only last year, 'Symbicort' recorded sales of $122 million in the first
half of 2002. 'Symbicort' has already captured approximately 20 per cent of the
market share in sixteen launch markets in Europe. Phase III studies are
underway to support the registration in the United States of the product for
asthma (in a pressurised metered dose inhaler). AstraZeneca has submitted a
regulatory package in the EU and other countries outside the US seeking approval
for 'Symbicort' in COPD. The total estimated market value of asthma is $7.6
billion and is growing at a rate of 7 per cent per annum. For COPD, the market
is worth $2.9 billion, and is growing at a rate of 5 per cent per annum.
'Symbicort' provides the inhaled corticosteroid budesonide (Pulmicort(R)) and
the fast-acting and long-lasting bronchodilator formoterol (Oxis(R)) in a
single inhaler. 'Symbicort' (160 mcg budesonide/4.5 mcg formoterol) is approved
for 1-2 inhalations twice daily, with the possibility to step down to one
inhalation once daily.
In the ASSURE study presented at ERS, 1553 asthma patients from 410 centres in
the UK were randomised to follow an adjustable maintenance plan with 'Symbicort'
(2 inhalations twice a day for 4 weeks, then 1-4 inhalations twice a day
according to symptoms for 12 weeks) or a fixed dosing regimen (2 inhalations
twice a day for 16 weeks). The short-acting bronchodilator terbutaline was used
as needed for symptom relief.
The results showed that there was no difference in symptom severity (GINA
definitions), symptom-free days, or total exacerbations between the groups on
adjustable and fixed dosing. In both groups, patients were well controlled, with
94 per cent experiencing no exacerbations. Patients on adjustable treatment
required 15 per cent fewer 'Symbicort' inhalations (average per day 3.2 versus
3.8) than patients on fixed dosing. The use of reliever medication (terbutaline)
was also significantly lower in the adjustable dosing group than in the fixed
dosing group (average per day 1.1 versus 1.2).
In a separate one-year study in COPD, 812 adults with moderate to severe COPD
were randomized to receive two inhalations of 'Symbicort', budesonide only,
formoterol only or placebo. 'Symbicort' reduced the number of severe
exacerbations/patient/year by 24 per cent compared to placebo, and reduced the
number of mild exacerbations/patient/year by 62 per cent, compared to placebo.
With 'Symbicort', lung function (FEV) was increased by 15 per cent versus
placebo, and these improvements were maintained throughout the 12-month study.
Importantly, 'Symbicort' was well tolerated and had a safety profile similar to
placebo. In addition, 'Symbicort' was able to help relieve the symptoms of COPD
by:
• Increasing the number of symptom controlled days by 7 per cent
• Increasing the number of awakening-free nights by 14 per cent
• Increasing the number of days free from shortness of breath by 12 per cent
• Increasing the number of days free from chest tightness by 7.5 per cent
• Reducing the use of reliever medication by 1.3 inhalations/day
'Symbicort' is a trademark of the AstraZeneca group of companies.
16 September 2002
Media Enquiries:
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair-Robinson, Tel: +44 (0) 207 304 5084
- Ends -
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