Seroquel

AstraZeneca PLC
21 October 2005

BOLDER II STUDY CONFIRMS THERAPEUTIC POTENTIAL OF SEROQUEL IN BIPOLAR DEPRESSION



Newly released top-line results from the BOLDER II (BipOLar DEpRession) study
have underlined the potential for SEROQUEL (quetiapine fumarate) in the
treatment of patients with major depressive episodes associated with bipolar
disorder.  Based on prior discussions with the US Food and Drug Administration
(FDA) and the results of BOLDER II, AstraZeneca plans to file for a US licence
extension for SEROQUEL in the treatment of depressive episodes associated with
bipolar disorder around the end of this year (2005).



BOLDER II - an eight week, multi-centre, placebo-controlled study - found that
SEROQUEL 300mg and 600mg doses achieved a statistically significant reduction in
levels of bipolar depression compared with placebo (p-value less than or equal
to 0.001), as measured by the change from baseline in Montgomery-Asberg
Depression Rating Scale (MADRS) total score.



The significant reduction in MADRS total score was seen both in patients with
bipolar I and bipolar II disorder, in patients with or without a rapid cycling
course of illness, and as early as week one after randomisation.  Significant
improvements were also seen compared with placebo in the various secondary study
endpoints among SEROQUEL-treated patients, including reduction of anxiety
symptoms.  In addition, more than half (53 per cent) of patients receiving
SEROQUEL achieved remission from their bipolar depression symptoms.



BOLDER II reinforces the findings of the landmark BOLDER I study published in
American Journal of Psychiatry in July 2005, which first indicated a significant
effect for SEROQUEL in treating major depressive episodes associated with
bipolar disorder.  Importantly, SEROQUEL was shown to be well tolerated in
BOLDER II with a similar safety profile seen to that in BOLDER I. The rate of
serious adverse events was low, and comparable in all treated groups.  The most
common adverse events reported in the trial were dry mouth, sedation,
somnolence, dizziness and constipation. There was a low incidence of
treatment-emergent mania in the SEROQUEL-treated groups. As in BOLDER I, there
was a low incidence of EPS (extrapyramidal symptoms) and minimal weight change
reported in the study.



Patients with bipolar depression are underserved and understudied. The findings
from the BOLDER II study are very encouraging and support the findings of BOLDER
I, in showing the potential of SEROQUEL, as monotherapy, for the acute treatment
of bipolar depression. Each of these two studies represent the largest
placebo-controlled short-term studies ever conducted in bipolar depression. The
beneficial risk:benefit profile of Seroquel seen in both studies could offer an
important therapeutic value for both patients and physicians as there is
currently only one FDA approved therapy to treat depressive episodes associated
with bipolar disorder.



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.   Patients with bipolar disorder are symptomatic almost half of their
lives, and approximately two-thirds of that time is spent in the depressed phase
of the illness.



SEROQUEL has been licensed for the treatment of schizophrenia since 1997 and is
available in 85 countries for the treatment of this condition.  It is currently
licensed for the treatment of mania associated with bipolar disorder in 73
countries.  In the first half of 2005, SEROQUEL sales reached $1,300 million.



                                    - Ends -



21st October 2005



Media Enquiries:
Edel McCaffrey, Tel: [phone]
Steve Brown, Tel: [phone]



Investor Enquiries:
Mina Blair, Tel: [phone]
Jonathan Hunt, Tel: [phone]
Ed Seage, Tel: [phone]
Jorgen Winroth, Tel + 1 212 579 0506










                      This information is provided by RNS
            The company news service from the London Stock Exchange