Seroquel XR

AstraZeneca PLC
29 February 2008


        AstraZeneca Submits sNDA for Seroquel XR(TM) for the Treatment of 
                             Major Depressive Disorder


AstraZeneca today announced submission of a supplemental New Drug Application
(sNDA) to the U.S. Food and Drug Administration (FDA) for once-daily 
SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets to seek approval 
for the treatment of major depressive disorder (MDD) as monotherapy, adjunct 
therapy, and maintenance therapy in adult patients.

MDD affects 15 million American adults - between 5 and 8 percent of the
population each year - and today it is often treated with generic or branded
antidepressants. Studies have shown that at least one-third of patients with MDD
treated with antidepressants fail to achieve a satisfactory response.  The
American Psychiatric Association Practice Guidelines recommend switching to
another class when two medications from the same class have proven ineffective.
AstraZeneca has investigated the use of SEROQUEL XR, an atypical antipsychotic,
in the treatment of MDD, aiming to develop another potential treatment option,
including treatment for patients who have failed or had an inadequate response
to another antidepressant therapy.

The MDD submission is based on seven Phase III, placebo-controlled studies that
assessed the efficacy and safety of once-daily treatment with SEROQUEL XR in
patients diagnosed with MDD. Studies 1, 2, 3, and 4 were acute monotherapy
studies involving 2,116 patients; Studies 6 and 7 were acute adjunct therapy
studies (with ongoing antidepressant therapy) involving 939 patients who had an
inadequate response to an antidepressant therapy; and Study 5 was a longer-term
(up to 78 weeks) monotherapy maintenance study involving 1,854 patients.  The
acute studies included in this submission used the Montgomery-Asberg Depression
Rating Scale (MADRS) as the primary assessment of depression symptoms. In the
longer term study (Study 5), the primary assessment was time to a depressed
event using criteria including MADRS. Doses of 50 mg, 150 mg and 300 mg of
SEROQUEL XR were studied in the MDD programme. Across the whole programme,
patients entering treatment in these seven clinical studies were drawn from 27
countries - three-quarters of the patients were in North America - a further 10
percent were in Western Europe, 6 percent in Eastern Europe and the remainder
were in Asia, South America, South Africa and Australia.

SEROQUEL XR(TM) is approved in the US and 18 further countries for the treatment
of schizophrenia in adult patients and for maintenance treatment of
schizophrenia in adult patients.  It was launched in the US in 2007 and last
month AstraZeneca announced the submission of two separate sNDAs to the FDA for
SEROQUEL XR seeking approval for the treatment of manic episodes associated with
bipolar disorder and the treatment of depressive episodes associated with
bipolar disorder - these remain under review by the FDA. In addition to the
submission for MDD, the clinical development programme and planned regulatory
filings for Seroquel XR extend to generalised anxiety disorder (GAD).

Launched in 1997, SEROQUEL(R) (quetiapine fumarate) is approved in 88 countries
for the treatment of schizophrenia, in 79 countries for the treatment of bipolar
mania, and in 11 countries including the USA for the treatment of bipolar
depression. Global sales of Seroquel for 2007 passed the $4 billion mark for the
first time, up 15 per cent on the previous year.


About Major Depressive Disorder

Major depressive disorder is a serious medical illness affecting 15 million
American adults, or approximately 5 to 8 percent of the adult population in a
given year. Depression occurs twice as frequently in women as in men. Unlike
normal emotional experiences of sadness, loss, or passing mood states, major
depressive disorder is persistent and can significantly interfere with an
individual's thoughts, behaviour, mood, activity, and physical health. Among all
medical illnesses, major depressive disorder is the leading cause of disability
in the U.S. and many other developed countries.

Symptoms of major depressive disorder characteristically represent a significant
change from how a person functioned before the illness. The symptoms of
depression include: persistently sad or irritable mood; pronounced changes in
sleep, appetite, and energy; difficulty thinking, concentrating, and
remembering; physical slowing or agitation; lack of interest in or pleasure from
activities that were once enjoyed; feelings of guilt, worthlessness,
hopelessness, and emptiness; recurrent thoughts of death or suicide; and
persistent physical symptoms for two or more weeks that do not respond to
treatment, such as headaches, digestive disorders, and chronic pain.
Symptomatically, a major depressive episode in MDD is similar to a depressive
episode of bipolar disorder with the major distinguishing feature between the
disorders being the absence of manic or hypomanic symptoms in MDD. It has been
reported that 69 per cent of patients with bipolar disorder were misdiagnosed,
with the most frequent misdiagnosis being MDD.


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 $29.55 billion and leading
positions in sales of gastrointestinal, cardiovascular, neuroscience,
respiratory, oncology and infection products. AstraZeneca is listed in the Dow
Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit: www.astrazeneca.com


29 February 2008


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