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Astrazeneca receives European approval for Seroquel; in bipolar mania

Sodertalje, Sweden, 13 October 2003 - AstraZeneca announced today that it has successfully completed the Mutual Recognition Procedure (MRP) involving 14 European countries to extend the use of SEROQUEL (quetiapine) to the treatment of mania associated with bipolar disorder (manic-depressive illness). SEROQUEL is also under review for bipolar mania in the United States with the FDA and in the UK with the MHRA.

"This approval is great news for clinicians involved in the treatment of bipolar disorder," commented Dr. Eduard Vieta, Director of Research, Department of Psychiatry, University of Barcelona. "The results from the clinical trial programme confirm that SEROQUEL holds real benefits for clinicians looking to treat the symptoms of the disease while keeping side effects to a minimum. This is of particular importance when treating patients with bipolar disorder since they can be particularly sensitive to treatment side effects which can in turn have a negative impact on compliance with medication."

Bipolar disorder is a serious mental illness that affects approximately 3-4% of the adult population and is the sixth leading cause of disability in the world.1,2,3,4 More than half of those with bipolar disorder stop taking their medication at some point during their illness, subjecting themselves to a high risk of relapse and an increased risk of suicide.5 This lack of compliance is strongly associated with the occurrence of side effects, therefore, a well tolerated and effective treatment is pivotal to the successful treatment of this condition.

Health authorities involved in the Mutual Recognition Procedure reviewed data from a comprehensive clinical trial programme in bipolar disorder undertaken by AstraZeneca, involving almost 1000 patients in 28 countries. The trials have delivered compelling results which confirm SEROQUEL to be an excellent first line therapy for the treatment of manic episodes associated with bipolar disorder.


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Contact: Rupert Doggett
rupert.doggett@shirehealthinternational.com
44-207-471-1500
Shire Health International
13-Oct-2003


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