Seroquel

AstraZeneca PLC 02 January 2003 ASTRAZENECA FILES sNDA FOR SEROQUEL(R) (QUETIAPINE) IN BIPOLAR DISEASE AstraZeneca today announced that it has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SEROQUEL (R) (quetiapine) for the treatment of acute mania associated with bipolar disorder (manic depressive illness). The application to the FDA follows the completion of a comprehensive bipolar disorder clinical trial programme undertaken by AstraZeneca to examine the efficacy and tolerability of SEROQUEL in this important disease area. The programme has delivered consistently strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm SEROQUEL to be an ideal first line agent. The proposed new indication is expected to expand the market for SEROQUEL, which is currently indicated for the treatment of schizophrenia in adults. Analysts estimate that bipolar disorder alone constitutes a multibillion-dollar market. The illness affects an estimated 2.3 million American adults and is ranked as the second leading cause of disability worldwide among the neuro-psychiatric disorders. To date, over 4 million people have been treated with Seroquel worldwide. SEROQUEL is the fastest-growing atypical antipsychotic on the market, with annualised sales that approached $1 billion in Q3 2002. 2 January 2003 Media Enquiries: Emily Denney, Tel: +44 (0) 207 304 5034 Investor Relations: Mina Blair-Robinson, Tel: +44 (0) 207 304 5084 Jonathan Hunt, Tel: +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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AstraZeneca (AZN)
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