Seroquel

AstraZeneca PLC
13 January 2004



       ASTRAZENECA RECEIVES FDA APPROVAL FOR SEROQUEL(TM) IN BIPOLAR MANIA


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.


Data from the clinical trial programme was presented in September 2002 at the
3rd European Stanley Foundation Conference on Bipolar Disorder in Freiburg,
Germany, and in June 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. In the adjunct setting, SEROQUEL was found to be
significantly more effective than mood stabilisers alone in the treatment of
bipolar mania. Across the mania trials, SEROQUEL was associated with a
favourable weight profile and an incidence of EPS (including akathisia) no
different from placebo across the full dose range.


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.


13 January 2004.



Media Enquiries

Steve Brown , [phone]
Edel McCaffrey, [phone]


Investor Enquiries:

Mina Blair-Robinson, [phone]
Jonathan Hunt, [phone]

SEROQUEL is a trade mark of the AstraZeneca group of companies


For more information, please visit www.astrazenecapressoffice.com



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