Seroquel

AstraZeneca PLC 13 October 2003 ASTRAZENECA RECEIVES EUROPEAN APPROVAL FOR SEROQUEL(TM) IN BIPOLAR MANIA 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 Food and Drug Administration (FDA) and in the UK with the Medicines and Healthcare products Regulatory Agency (MHRA). In 2002, worldwide sales of SEROQUEL grew 67 per cent to $1.14 billion. Bipolar disorder is a serious mental illness that affects approximately 3-4 per cent of the adult population and is the sixth leading cause of disability in the world. 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. 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 MRP 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. Individual licenses in the 14 European countries involved in the MRP will follow from the completion of this procedure. Health Authority approvals also have been received in Mexico and New Zealand. Data from two trials from the clinical trial programme, which examined the efficacy of SEROQUEL as a monotherapy for the treatment of bipolar mania, were presented in May this year at the International Conference on Bipolar Disorder (ICBD), Pittsburgh, USA. The results confirmed that SEROQUEL monotherapy is as effective as current treatments for bipolar disorder and offers improved tolerability benefits. Data from another trial examining SEROQUEL as an adjunctive therapy to mood stabilisers in the treatment of bipolar mania were presented at the 3rd European Stanley Foundation Conference on Bipolar Disorder in Freiburg, Germany, in September 2002. The results found that SEROQUEL is significantly more effective than mood stabilizers alone in the treatment of bipolar mania. The MRP involves Austria, Belgium, Denmark, Finland, Germany, Greece, Iceland, Ireland, Luxembourg, The Netherlands, Norway, Portugal, Spain, and Sweden. 13 October 2003 Media Enquiries: Steve Brown, +44 (0) 207 304 5033 Chris Major, +44 (0) 207 304 5028 Investor Enquiries: Mina Blair-Robinson, +44 (0) 207 304 5084 Jonathan Hunt, +44 (0) 207 304 5087 -Ends- This information is provided by RNS The company news service from the London Stock Exchange

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