Astrazeneca Launches A Smarter Approach To Asthma Management In Europe

AstraZeneca today announced that 37 countries to date have received approval of Symbicort® Maintenance And Reliever Therapy (Symbicort SMART®), and that a period of world wide launches will now be initiated. This new, smarter approach to asthma is the first to provide patients with both asthma maintenance and reliever therapy together in just one inhaler.

With the Symbicort SMART management approach, patients receive inhaled corticosteroid (ICS) and long acting bronchodilator (LABA) with every inhalation. Thus, with Symbicort SMART it is possible to treat the underlying inflammation with every inhalation, even when used for rapid symptom relief, making it a more effective way to manage asthma. A separate SABA (short acting bronchodilator) inhaler is therefore no longer needed. Symbicort SMART has been proven to reduce exacerbations by 39% compared with salmeterol / fluticasone combination and a separate reliever medication.1

The Symbicort SMART treatment approach is possible only because Symbicort combines two components in one inhaler: budesonide, an ICS to provide an anti-inflammatory effect in the airways, and formoterol, a unique bronchodilator that is both rapid in effect and long lasting (LABA). The other LABA available for maintenance treatment of asthma, salmeterol, does not have the properties that enables it to be used in this way. Consequently, Seretide™ (salmeterol/fluticasone) can not be used in the same way as Symbicort SMART. Patients on Symbicort SMART receive a maintenance dose in line with normal practice to establish asthma control and can then take additional inhalations 'as needed' if symptoms occur, to provide both rapid symptom relief and increased asthma control in the longer term.

"We know that patients tend to over-rely on their symptom relief inhaler when experiencing a worsening of their symptoms," comments Professor Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital Germany, and speaker at the official Symbicort SMART launch event in Lund. "Although patients consistently adjust their medication in response to asthma variations, often the adjustment in maintenance therapy is delayed in response to an exacerbation. With Symbicort SMART, physicians can be sure that patients are receiving their anti-inflammatory treatment with every inhalation, ensuring their asthma is better controlled."

The Symbicort SMART approach is recognised by the Global Initiative for Asthma (GINA) who recently announced revised international treatment guidelines on best practice in the prevention and treatment of asthma. The guidelines support the need for a new management approach - Symbicort SMART.2

"Previous editions of the GINA Guidelines have perhaps led to an impression that mild asthma could be equated to mild symptoms and severe asthma to severe symptoms, which we know is not the case," comments Dr Paul O'Byrne, McMaster University, Ontario, Canada and Chair of the GINA Executive Committee. "Asthma is a variable disease and the GINA Committee felt that a treatment approach based upon effective control of symptoms and exacerbations would better reflect the natural course of the disease. The result will be improved outcomes by allowing treatment to be rapidly increased when symptoms first appear and then brought back down again when control is achieved, and thus let the dosing respond quickly to the patients' asthma control status."

Symbicort SMART has been tested extensively in a wide clinical trial program involving over 14,000 patients with persistent asthma. These studies consistently show that Symbicort SMART, irrespective of asthma severity, reduces the risk of patients developing potentially life-threatening asthma attacks compared with traditional treatment approaches such as fixed dosing with either higher doses of ICS plus a short-acting bronchodilator (SABA) or with an ICS/LABA combination therapy plus a SABA. 1, 3-7

In the EU, Symbicort SMART is licensed for use in adults with a need for ICS / LABA combination treatment. National launches are expected throughout the EU over the coming months.

"We are delighted to announce the launch of Symbicort SMART in Europe," said Dr John Patterson, Executive Director, Development for AstraZeneca. "This new treatment approach will simplify asthma management and has the potential to improve the lives of a great many asthma patients. We now have a management approach that provides the reassurance of instant relief when needed and in the same breath treats the underlying disease for the long term. This is a significant step forward for asthma patients."

To date, Symbicort has been effectively and widely used as a traditional maintenance treatment for asthmatics across the world. With the advent of today's launch of Symbicort SMART, Symbicort is the first maintenance therapy to als

o be proven effective and licensed for maintenance and reliever therapy in one inhaler. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For further updates, news and information on Symbicort, please visit
http://www.astrazenecapressoffice.com

References

1. Kuna P, Peters MJ, Buhl R. Budesonide/formoterol as maintenance and reliever therapy reduces asthma exacerbations versus a higher maintenance dose of budesonide/formoterol or salmeterol/fluticasone. Abstract presented at the ERS Congress 2006.

2. The Global Initiative for Asthma (GINA). GINA Report, Global Strategy for Asthma Management and Prevention, published November 2006. www.ginasthma.com

3. Rabe K, Atienza T, Magyar P et al. Reduction in asthma exacerbations with budesonide in combination with formoterol for reliever therapy: a randomised, controlled, double-blind study. Lancet 2006;368: 744-53.

4. Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819-828.

5. O'Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y, Ekström T, Bateman E. Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma. American Journal of Respiratory and Critical Care Medicine 2005; 171(2): 129-136.

6. Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, Boulet L-P, Naya IP, Hultquist C. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Current Medical Research and Opinion 2004;20(9):1403-18.

7. Klaus F. Rabe, Emilio Pizzichini, Björn Ställberg, Santiago Romero, Ana M. Balanzat, Tito Atienza, Per Arve Lier, and Carin Jorup, Budesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized, Double-Blind Trial, Chest, Feb 2006; 129: 246 - 256

Symbicort SMART -- Symbicort SMART improves daily symptom control and reduces asthma attacks while patients only need one inhaler*. A separate short-acting bronchodilator is no longer needed. Patients prescribed Symbicort SMART, take a maintenance dose of Symbicort every day in line with normal practice to establish asthma control and take additional inhalations 'as needed' of Symbicort if symptoms occur, to provide both rapid symptom relief and improved asthma control. *not indicated for prophylactic use before exercise

-- Symbicort SMART successfully completed the European Union Mutual Recognition Procedure (MRP) in October 2006

-- Symbicort SMART is currently approved in 37 countries worldwide

-- Symbicort is currently approved in more than 90 countries; sales were $585 million in the first half 2006 (up 24 percent on 2005 figures) and have now reached more than five million treatment years

-- Symbicort received FDA approval in the US in July 2006 for maintenance treatment of asthma (in patients from 12 years of age)

Asthma -- Asthma is a chronic inflammatory condition of the airways characterised by reversible airway obstruction. It is a variable condition that can change both daily and seasonally

-- Most asthma patients require maintenance treatment with an inhaled corticosteroid (ICS), which suppresses the underlying airway inflammation, and a bronchodilator, which relaxes the smooth muscle of the airways.