FDA Approves AstraZeneca's Seroquel Maintenance Treatment

FDA Approves AstraZeneca's Seroquel Maintenance Treatment in Bipolar Disorder

For business and financial journalists

AstraZeneca today announced that the U.S. Food and Drug Administration (FDA) has
approved SEROQUEL® (quetiapine fumarate) for the maintenance treatment of
patients with bipolar I disorder, as adjunct to lithium or divalproex. SEROQUEL
is approved by the FDA for the treatment of schizophrenia, and is also the only
single agent approved by the FDA for the treatment of both depressive episodes
in bipolar disorder and acute manic episodes associated with bipolar I disorder.

Considered one of the most severe forms of mental illness, bipolar disorder
currently affects about 8 million adults in the US. Bipolar I disorder is a
lifelong psychiatric condition characterised by manic or mixed mood episodes,
interspersed with episodes of major depression. During their lifetime, between
0.4 per cent to 1.6 per cent of people will suffer from bipolar I disorder.

The FDA approval was based on two multicentre, randomised, double-blind,
placebo-controlled clinical trials that evaluated SEROQUEL when used as an
adjunct therapy to lithium or divalproex in the maintenance treatment of adult
patients with bipolar I disorder (n=703, n=623 respectively). The rigourous
study design included a 12 to 36 week stabilisation phase which was followed by
up to two years of randomised double-blind treatment (mean duration of
randomized quetiapine treatment was 189 days and 240 days respectively).

In both studies, patients with bipolar I disorder whose most recent episode was
manic, depressed or mixed, were treated with either SEROQUEL (flexible dosing
between 400mg and 800mg per day in divided doses) plus lithium-or-divalproex, or
placebo plus lithium-or-divalproex. The primary endpoint, which was time to
recurrence of a depressive, manic, or mixed mood event, compared with placebo,
was significant for SEROQUEL compared with placebo in both studies. Pooled study
results indicated that patients treated with SEROQUEL-plus-lithium-or-divalproex
had a risk reduction of 70 per cent relative to those treated with
placebo-plus-lithium-or-divalproex for time to recurrence of a mood event (HR:
0.30; 95% CI: 0.24, 0.37; p<0.001). This reduction in risk was significant for
both recurrence of manic episodes (HR: 0.30; 95% CI: 0.22, 0.41; p<0.001), and
recurrence of depressive episodes (HR: 0.30; 95% CI: 0.23, 0.40; p<0.001). The
proportion of patients who relapsed when treated with SEROQUEL was 19.3%
[125/646] versus 50.4% [343/680] of patients on placebo.

Seroquel Media Enquiries:
James Read +1 302 885 9944 (Wilmington, US)

Media Enquiries:
Steve Brown +44 207 304 5033 (24 hours)
Chris Sampson +44 20 7304 5130 (24 hours)
Neil McCrae +44 207 304 5045 (24 hours)

Investor Enquiries UK:
Jonathan Hunt +44 207 304 5087 mob: +44 7775 704032
Mina Blair +44 20 7304 5084 mob: +44 7718 581021
Karl Hard +44 207 304 5322 mob: +44 7789 654364

Investor Enquiries US:
Ed Seage +1 302 886 4065 mob: +1 302 373 1361
Jorgen Winroth +1 212 579 0506 mob: +1 917 612 4043
Peter Vozzo (MedImmune) +1 301 398 4358 mob: +1 301 252 7518

About Bipolar Disorder
Approximately eight million American adults are affected by bipolar disorder, a
serious psychiatric condition also known as manicdepressive illness. Bipolar
disorder consists of recurring episodes of mania and depression. Bipolar I
disorder is characterised by one or more manic or mixed episodes, often with
episodes of major depression, whereas bipolar II disorder is distinguished by
one or more major depressive episodes accompanied by at least one hypomanicepisode. In the long term, patients with bipolar I disorder experience
depressive symptoms, including prolonged periods of sadness, loss of energy,
persistent lethargy, and recurring thoughts of death or suicide - three times
longer than manic symptoms. Similarly, patients with bipolar II disorder spend
almost 40-times longer in the depressed state than in hypomania. Bipolar
disorder is often misdiagnosed as unipolar depression. This misdiagnosis can
lead to unfocused treatment that may exacerbate the disease. In fact, many
patients face up to ten years without appropriate treatment before a correct
diagnosis is made. Up to 50 per cent of patients with bipolar disorder attempt
suicide, and approximately 10 to 15 per cent complete suicide. Bipolar Disorder
is typically managed through a treatment strategy with several phases -
including acute and maintenance phases. In the acute phase, the aim is to
improve the acute symptoms of the patient. The maintenance treatment phase aims
to prevent the recurrence of the future episodes.

Adverse events in these trials, which were monitored during both the open-label
stabilization phase and the randomized controlled-phase, were generally
consistent with those reported in short term, placebo-controlled trials for
SEROQUEL. In the pooled data of the two clinical studies, a greater incidence
of blood glucose increases to hyperglycemic levels (> 126mg/dL) was observed in
patients randomized to SEROQUEL plus lithium-or-divalproex than in patients
randomized to placebo plus lithium-or-divalproex. The SEROQUEL prescribing
information was updated in July 2007 to reflect the increases in blood glucose
levels observed in these trials.

About SEROQUEL and SEROQUEL XR
Launched in 1997, it is estimated that SEROQUEL has been prescribed to more than
22 million patients worldwide. It 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 US for the treatment of bipolar depression. Global
sales of Seroquel in 2007 were $4,027 million - an increase of 15 per cent.

Beside today's announcement of the approval of SEROQUEL by the FDA in the US for
the maintenance treatment of patients with bipolar I disorder, as adjunct to
lithium or divalproex, a further submission was recently made seeking a similar
approval in Europe, in line with previously announced clinical development
plans. The European bipolar maintenance submission includes data from a study of
SEROQUEL as monotherapy in the maintenance treatment of patients with bipolar I
disorder.

SEROQUEL XR™ is approved in the US and 25 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 earlier this year
AstraZeneca announced the submission of regulatory applications in both the US
and European Union for SEROQUEL XR in the treatment of manic episodes associated
with bipolar disorder, and the treatment of depressive episodes associated with
bipolar disorder. An sNDA for SEROQUEL XR seeking approval for the treatment of
Major Depressive Disorder in the US was also announced in February. SEROQUEL XR
is not approved for these indications at this time and the applications remain
under review by the regulatory authorities.

About AstraZeneca
AstraZeneca is a major international healthcare business engaged in research,
development, manufacturing and marketing of prescription pharmaceuticals and
supplier for healthcare services. AstraZeneca is one of the world's leading
pharmaceutical companies with healthcare sales of US $29.55 billion and is a
leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology
and infection product sales. AstraZeneca is listed in the Dow Jones
Sustainability Index (Global) as well as the FTSE4Good Index.