Seroquel

AstraZeneca PLC
03 January 2006

London Stock Exchange Announcement



   AstraZeneca Submits sNDA For Seroquel(R) For Bipolar Depression Treatment



    Filing Seeks Approval of SEROQUEL as a Monotherapy Treatment for Bipolar
                                   Depression



AstraZeneca today announced submission of a supplemental New Drug Application
(sNDA) to the US Food and Drug Administration (FDA) to seek approval for a new
indication for SEROQUEL(R) (quetiapine fumarate) for the treatment of patients
with depressive episodes associated with bipolar disorder.  SEROQUEL is
currently approved for the treatment of acute manic episodes associated with
bipolar I disorder and the treatment of schizophrenia.



This sNDA submission is an important milestone in the history of SEROQUEL. If
SEROQUEL receives approval from the FDA to treat bipolar depression, it would be
the only single agent indicated to treat both the depressive and manic episodes
associated with bipolar disorder.



The sNDA submission is based on results from the clinical trial programme known
as BOLDER (BipOLar DEpRession), which comprises two studies: BOLDER I and BOLDER
II.  Both studies were double-blind, placebo-controlled trials of outpatients (N
=1,045) with bipolar I or II disorder. Patients were randomised to receive eight
weeks' treatment with fixed doses of SEROQUEL (300 mg or 600 mg) or placebo
administered once daily. In both studies, patients receiving SEROQUEL, as
compared to those receiving placebo, showed a statistically significant decrease
in depression scores at week one, and scores continued to decrease throughout
the eight-week study.  More than half of the SEROQUEL treated patients in each
trial met the criteria for remission.



Additionally, SEROQUEL was shown to have similar safety profiles in both BOLDER
I and II.  The most common adverse effects reported in these trials included dry
mouth, sedation, somnolence, dizziness, and constipation.



Bipolar disorder, which affects more than seven million American adults,
consists of recurring episodes of mania and depression.  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.
Prolonged periods of sadness, unexplained loss of energy, persistent lethargy,
and recurring thoughts of death or suicide characterise depressive episodes.  Up
to 50 per cent of patients with bipolar depression attempt suicide, and
approximately 10 to 15 per cent commit suicide. Furthermore, bipolar disorder is
often misdiagnosed, and patients may suffer up to 10 years before a correct
diagnosis is made.



SEROQUEL(R) (quetiapine fumarate) is the number one prescribed atypical
antipsychotic in the United States and has a well-established safety and
efficacy profile.  In 2004, sales for SEROQUEL reached $2 billion.  SEROQUEL has
had more than 13 million patient exposures worldwide since its launch in 1997.



ABOUT BIPOLAR DISORDER

Bipolar I disorder consists of recurring episodes of mania with or without
depression.  Bipolar II disorder consists of recurring episodes of depression
and hypomania, a milder form of mania.  In the long term, patients with bipolar
I disorder spend three times longer in the depressed state than in mania.
Patients with bipolar II disorder have traditionally been difficult to treat as
they spend almost 40 times longer in the depressed state than in mania.  Without
appropriate treatment, patients usually suffer for a lifetime with periods of
wellness and functioning punctuated by severe episodes of illness. Both men and
women are equally at risk for this illness, which most often emerges in
adolescence or young adulthood and recurs throughout life.



ABOUT ASTRAZENECA

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 world's leading
pharmaceutical companies with healthcare sales of over $21.4 billion and leading
positions in sales of gastrointestinal, cardiovascular, respiratory, oncology
and neuroscience products.  AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.



Depression scores were measured by the Montgomery-Asberg Depression Rating Scale
(MADRS).  The MADRS scale measures the severity of a number of depressive
symptoms including mood and sadness, tension, sleep, appetite, energy,
concentration, and suicidal ideation.  The MADRS score decreases as depressive
symptoms improve. Remission was defined as a MADRS score of