Seroquel: New Data Shows Efficacy in Bipolar Depression from Week 1

New data presented today at the American Psychiatric Association Annual
Meeting show that Seroquel (quetiapine) 600mg/day significantly improves
depression ratings* including a significant reduction in suicidal thoughts
as early as Week 11. The findings also demonstrated that Seroquel improved
quality of life2 and adherence to treatment3.


Seroquel is not licensed for bipolar depression. Seroquel is currently
licensed for the treatment of manic episodes associated with bipolar
disorder and for the treatment of schizophrenia.4



The BOLDER (BipOLar DepRession) study is an eight-week, multi-centered,
randomised, double-blind, placebo-controlled study involving 542 patients
with a diagnosis of bipolar I or bipolar II disorder. Seroquel demonstrated
efficacy in the treatment of bipolar depression, significantly improving
core symptoms of depression1 (symptoms include apparent sadness, inability
to feel and suicidal thoughts). The trial found that Seroquel is effective
in improving quality of life as demonstrated by the improvement in Q-LES-Q
SF score**, which was significantly greater in both Seroquel treatment
groups2.


"Suicidal thoughts are a common symptom of bipolar disorder and
astonishingly 25% to 50% of people with untreated or inadequately treated
bipolar disorder attempt suicide", commented Professor Allan Young,
Professor of Psychiatry, Royal Victoria Hospital, Newcastle. "These
findings are highly relevant to patient care as this is the first time we
have seen this level of efficacy in reducing suicidal thinking with an
atypical antipsychotic in bipolar disorder. The results show that those
treated with Seroquel benefit from a strong efficacy profile, combined with
improved compliance and quality of life. The fact that Seroquel is
effective in reducing suicidal thoughts within just 1 week and is well
tolerated over 8 weeks, should inform clinicians looking to treat their
patients both in the here and now and for the future."


Bipolar I disorder is a severe mood disorder where patients swing between
states of depression (low mood and energy) and mania (heightened, elevated,
ecstatic mood and energy). Bipolar II disorder is a variant whereby patients
swing between intense depression and a milder manic state known as
'hypomania'. Patients with both types of bipolar disorder spend
significantly longer depressed than manic or hypomanic6, and yet
historically the treatment of the depressive phase has not been well
studied.7















"There is a major unmet need for effective options for healthcare
professionals treating bipolar depression" commented Michelle Rowett, Chief
Executive, MDF The Bipolar Organisation. "Antidepressants normally take a
number of weeks before they have any effect, and there is also a risk that
they may trigger a manic episode. We welcome research into new treatments
for bipolar depression, and this data indicates that quetiapine may be a
useful addition to treatment options for bipolar depression."


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 FTSE4 Good Index.


In Neuroscience, AstraZeneca is dedicated to providing medicines that have
the potential to change patients' lives. The company already markets several
products including Seroquel, one of the fastest growing global
antipsychotics with proven efficacy and a very favourable side effect
profile; and Zomig, a reliable migraine therapy and a leader within the
triptan market. The Neuroscience pipeline includes leading approaches for
the treatment of depression and anxiety, overactive bladder, dementia and
stroke, pain control and anaesthesia.


* As measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and
the Hamilton Rating Scale for Anxiety (HAM-A)

** The Quality of Life Satisfaction Scale Questionnaire (Q-LES-Q)


Seroquel is a trademark of the AstraZeneca group of companies.
Seroquel has been licensed for the treatment of schizophrenia since 1997 and
is available in 82 countries for the treatment of this condition. SEROQUEL
is also licensed in 63 countries for the treatment of mania associated with
bipolar disorder, including the US, Canada and several European countries.
To date, over 8 million people have been treated with SEROQUEL worldwide.


Results:


Reducing suicidal thinking key to reducing high suicide rates1:

(As measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and
the Hamilton Rating Scale for Anxiety (HAM-A))


These data, from the BOLDER (BipOLar DEpRession) trial, an eight week,
multi-centered, randomised, double-blind, placebo-controlled study involving
542 patients with a diagnosis of bipolar I or II disorder, showed that
SEROQUEL (600 and 300 mg/day) is approximately twice as effective in
reducing suicidal ideation by week eight as placebo. The results were
analysed using standard clinical scales to assess improvements in depressive
and anxiety symptoms. Additional results from the BOLDER study showed:


* SEROQUEL (600 and 300 mg/day) significantly improved the core
symptoms of depression as early as week one onwards (symptoms include
apparent sadness, reported sadness, inability to feel, suicidal thoughts,
and pessimistic thoughts)


* A significant improvement in anxiety symptoms occurred as early as
week one and was maintained to study end (P