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FDA Approves Seroquel for Mania Associated with Bipolar Disorder

AstraZeneca Receives FDA Approval for Seroquel for Treatment of Mania Associated with Bipolar Disorder

January 13, 2004 - AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has approved Seroquel (quetiapine) as a monotherapy and adjunct therapy for the treatment of mania associated with bipolar disorder (manic-depressive illness).

Seroquel, which in 2002 recorded a 67 per cent worldwide sales increase to $1.14 billion, was first approved for the treatment of schizophrenia in 1997.

The FDA’s latest approval is based on the positive results of a comprehensive bipolar disorder clinical trial programme involving more than 1,000 patients in 28 countries that found Seroquel to be effective across a broad range of symptoms and well-tolerated in treating manic episodes as both a monotherapy and in combination with lithium or divalproex. Seroquel was also found to be fast-acting as improvements in patients’ manic symptoms were seen within the first week of treatment.

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. Side effects associated with treatment, such as extrapyramidal symptoms (EPS) which cause movement disorders or serum prolactin elevation which may cause menstrual irregularities, decreased libido and impotence, can often cause patients great distress and lead to issues with treatment compliance. A lack of compliance results in the patient subjecting themselves to a high risk of relapse and increased risk of suicide, therefore, a well tolerated and effective treatment is pivotal to the successful treatment of this condition.

Seroquel has also recently received approval from the Mutual Recognition Procedure (MRP) involving 14 European countries to extend its use to treat mania associated with bipolar disorder. Health authority approvals have also been received in the UK, Italy, Mexico and New Zealand.

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 top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

Further enquiries to:

Media Enquiries:

Steve Brown, +44 (0) 207 304 5033
Edel McCaffrey, +44 (0) 207 304 5034

Investor Enquiries:

Mina Blair-Robinson, +44 (0) 207 304 5084
Jonathan Hunt, +44 (0) 207 304 5087

Posted: January 2004

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