9th Oct 2006 14:03
AstraZeneca PLC09 October 2006 AstraZeneca Successfully Completes Mutual Recognition Procedure For Symbicort(R) Maintenance And Reliever Therapy (Symbicort SMART(R)) in the EU AstraZeneca today announced that it has successfully completed the EuropeanUnion Mutual Recognition Procedure (MRP) for Symbicort(R) Maintenance AndReliever Therapy (Symbicort SMART(R)). This new treatment approach enablespatients to take control of their asthma and use just one inhaler for bothmaintenance and relief of asthma symptoms. Symbicort SMART is licensed for use in adults who need an inhaled corticosteroid(ICS) and a long acting bronchodilator (LABA) combination treatment. Nationalapprovals are expected to be issued throughout the EU over the coming months. Asthma is a chronic inflammatory condition of the airways characterised byreversible airway obstruction. It is a variable condition that can change bothdaily and seasonally. With Symbicort SMART, patients take a maintenance dose ofSymbicort to keep control of their asthma and if further symptoms occur, cantake additional inhalations 'as needed', to provide symptom relief. Whencompared to traditional gold standard therapy, using multiple separate inhalerdevices, Symbicort SMART is a more effective way to manage asthma, as itprovides a simple way for patients to improve daily symptom control and reducethe risk of asthma attacks. Dr John Patterson, Executive Director, Development for AstraZeneca said, "Thisnew treatment approach has the potential to improve the lives of many patientswith asthma in Europe. By reducing both symptoms and the number of attacks theyexperience, patients can now achieve excellent asthma control using only oneinhaler rather than the traditional approach of using multiple inhalers." Symbicort SMART has been studied in a wide clinical trial programme involvingover 14,000 patients with mild to severe persistent asthma. These studiesconsistently show that Symbicort SMART, irrespective of asthma severity, reducesthe risk of patients developing potentially life-threatening asthma attackssignificantly better than fixed dosing with either higher doses of ICS alone orwith an ICS/LABA combination therapy plus a short-acting bronchodilator. This extensive clinical trial programme includes COMPASS, a large,double-blinded, head-to-head study involving 3,335 patients with moderate tosevere asthma, comparing Symbicort SMART to a double maintenance dose ofSymbicort and with a similar dose of SeretideTM (fluticasone/salmeterol). Whencompared to Seretide, Symbicort SMART was shown to reduce the risk of a severeasthma attack (primary endpoint) by 33 percent and to significantly reduce thetotal number of severe asthma attacks by 39 percent. Similar effects werereported with Symbicort SMART when compared to double the maintenance dose ofSymbicort. Symbicort SMART patients had equal levels of daily asthma controlcompared to both fixed dose treatment approaches, yet received a lower overallsteroid load during the six-month study period. No differences were seen in thesafety of these treatment approaches. Further data from the SMILE study, recently published in The Lancet, showed forthe first time a positive effect of giving an inhaled steroid for dailymaintenance and as-needed, i.e. to both prevent and treat symptoms. SMILEevaluated the benefits of different as needed therapies: budesonide/formoterol,formoterol or terbutaline on top of Symbicort maintenance therapy, in preventingasthma attacks. The use of as-needed budesonide/formoterol provided increasedprotection from severe attacks compared with terbutaline as-needed on top ofSymbicort maintenance therapy. In addition, the use of budesonide/formoterolas-needed was significantly more effective than formoterol as-needed on top ofSymbicort maintenance therapy. Symbicort is currently approved in more than 90 countries and in July 2006received US Food and Drug Administration (FDA) approval for maintenancetreatment of asthma. Symbicort SMART is already approved in Argentina,Australia, Brazil, Mexico, the Philippines, Switzerland and Thailand. Symbicorthas reached more than 5 million patient years, with sales reaching $585 millionin the first half of 2006. AstraZeneca is a major international healthcare business engaged in theresearch, development, manufacture and marketing of prescription pharmaceuticalsand the supply of healthcare services. It is one of the world's leadingpharmaceutical companies with healthcare sales of $23.95 billion and leadingpositions in sales of gastrointestinal, cardiovascular, neuroscience,respiratory, oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index. 9 October 2006 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034 Steve Brown, Tel: +44 (0) 207 304 5033 Chris Major, Tel: +44 (0) 207 304 5028 Investor Relations: Mina Blair, Tel: +44 (0) 207 304 5084 Jonathan Hunt, Tel: +44 (0) 207 304 5087 Jorgen Winroth, Tel: +1 (212) 579 0506 Ed Seage, Tel: +1 302 886 4065 - - Ends - - This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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