Seroquel

AstraZeneca PLC
06 May 2004



                NEW SEROQUEL DATA SHOWS EFFICACY AND TOLERABLITY

                             IN BIPOLAR DEPRESSION



AstraZeneca announces important new data from its first large-scale clinical
trial to examine SEROQUEL (quetiapine) as a treatment for depressive episodes in
patients with bipolar I and II disorders.  The results, presented at the 157th
American Psychiatric Association (APA) congress, show that SEROQUEL is an
effective and well-tolerated agent for the treatment of bipolar depression and
improves a broad range of anxiety and mood symptoms associated with bipolar
depression.



The BOLDER study showed that SEROQUEL was superior to placebo in reducing
depressive symptoms, as measured by Montgomery-Asberg Depression Rating Scale
(MADRS) scores, in patients with bipolar disorder.  Patients treated with
SEROQUEL exhibited a statistically significant improvement across all efficacy
measures, including those measuring anxiety, as early as week one. The
improvements were noted at every assessment during the eight-week trial. In
addition, approximately 50 percent of patients receiving SEROQUEL achieved
remission from their bipolar depression symptoms.



The study was a double-blind, placebo controlled trial involving 542 patients
with bipolar I and II disorders, who were randomised to receive eight weeks of
treatment with either a fixed dose of SEROQUEL (300mg/d, 600mg/d administered
once-daily) or placebo.  The results of the trial found that patients taking
SEROQUEL achieved a significantly greater improvement (p<0.001) in mean MADRS
and Hamilton Rating Scale for Depression (HAM-D) scores versus placebo at every
time point, starting at week one and through week eight (MADRS: -16.7 and -16.4
vs -10.3 in 600mg, 300mg and placebo group, respectively; HAM-D: -13.8 and -13.4
vs -8.5 in 600mg, 300mg and placebo group, respectively).  Significantly 
(p<0.001) more patients taking SEROQUEL were considered responders 
(greater than or equal to 50 percent decrease from baseline MADRS score) from
week two through to the end of the study.



After eight weeks, significantly more patients taking SEROQUEL achieved
remission from their depressive symptoms compared to the placebo group (53
percent vs 28 percent respectively p<0.001) as evaluated on the MADRS scale.
Patients taking SEROQUEL had significantly greater improvement in mean Hamilton
Rating Scale for Anxiety (HAM-A) score versus placebo at every assessment point
starting at week one through week eight (-8.6 and -8.7 vs -5.5; p<0.05 at 600mg,
300mg and placebo, respectively).



Treatment-emergent mania did not differ between SEROQUEL and placebo (3 percent
vs 4 percent respectively).  Significant improvements were also seen on measures
of quality of life and quality of sleep at all time points throughout the
eight-week study (p<0.001). Bipolar depression and anxiety symptoms were
assessed using the MADRS, HAM-D and HAM-A. The primary endpoint for bipolar
depression was change in baseline on the MADRS scale.



Bipolar disorder is a serious mental illness that affects almost four percent 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. A medication's overall efficacy and
tolerability profile is therefore vital to helping patients comply with their
medication.



SEROQUEL is currently approved worldwide for the treatment of mania associated
with bipolar disorder and schizophrenia. SEROQUEL has been licensed for the
treatment of schizophrenia since 1997 and is available in 81 countries.
Licences for bipolar mania have also been received in 23 other countries.
SEROQUEL is the fastest growing product among the three leading brands in the
atypical antipsychotic market. Sales during 2003 reached $1.5 billion and the
product currently ranks second in the US antipsychotic market for new
prescription share, having recently overtaken olanzapine.





Thursday, 6th May 2004



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