"Today's results show that 'Symbicort' continues to provide substantial value to the medical community- it is currently the only asthma medication that gives patients the flexibility to adjust their dose according to disease variation, without adding or switching inhalers," said Dr Colin Reddrop, Vice President and Head of the Respiratory and Inflammation Therapy Area, AstraZeneca. "Additional, exciting new data clearly show great potential for 'Symbicort' as a treatment for COPD--a chronic and debilitating disease. AstraZeneca is committed to developing 'Symbicort' to its full potential and is currently seeking approval for the drug in this disease setting."
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 night-time 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.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of ethical (prescription) pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia including pain management, cardiovascular, central nervous system (CNS) and respiratory products.
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Steve Brown
+44 (0)20 7304 5033
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Mina Blair-Robinson
+44 (0)20 7304 5084
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- 'Symbicort' provides the inhaled corticosteroid budesonide (Pulmicort®) and the fast-acting and long-lasting bronchodilator formoterol (Oxis®) 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
- For further information regarding asthma and 'Symbicort', please visit the 'Symbicort' News Centre at www.symbicort-newscentre.com
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Symbicort is a trademark, property of the AstraZeneca group of companies.