SEROQUEL(R) Sustained Release Schizophrenia Data Presented at ECP Congress in Madrid

SEROQUEL(R) Sustained Release Schizophrenia Data Presented at ECP Congress in Madrid

March 19, 2007

    LONDON, March 19 /Xinhua-PRNewswire/ -- AstraZeneca
(NYSE: AZN) today announced SEROQUEL(R) sustained release
formulation (quetiapine fumarate sustained release)
clinical trial data presented at the European Congress of
Psychiatry (ECP) in Madrid.  The data demonstrated that the
SEROQUEL(R) sustained release formulation (quetiapine
fumarate sustained release), administered once daily,
significantly improved symptoms associated with
schizophrenia(1) (measured by PANSS) and increased the time
to psychiatric relapse(2), when administered through a
3-step dose initiation aimed at reaching the effective dose
range on the second day of treatment. 

    SEROQUEL(R) sustained release formulation is under
review by regulatory authorities around the world for the
treatment of schizophrenia and has not been approved in any
market.

    A randomized, double-blind study of 588 patients with
acute schizophrenia (Study 132) compared SEROQUEL(R)
sustained release formulation (400 mg/day, 600 mg/day or
800 mg/day) with placebo and found a significant
improvement in Positive and Negative Syndrome Scale (PANSS)
total scores from baseline for all doses(1). After 6 weeks
of treatment, reductions of 24.8 (p=0.03), 30.9
(p<0.001), and 31.3 (p<0.001) points were seen with
400, 600, and 800 mg doses, respectively, compared with a
reduction of 18.8 points for placebo. Patients on
SEROQUEL(R) sustained release formulation also had
significantly better scores on the Clinical Global
Impression (CGI)-Severity scale and significantly more
patients showed improvement on the CGI-Improvement scale
compared to placebo.

    A second randomized, double-blind placebo controlled
study (Study 004) examined time to first psychiatric
relapse in 197 patients with clinically stable
schizophrenia treated with either SEROQUEL(R) sustained
release formulation (mean dose 669 mg/day) or placebo(2).
Patients treated with SEROQUEL(R) sustained release
formulation experienced a significantly reduced risk of
relapse (risk reduction of 87%, p<0.0001), and a
significantly longer time to relapse, compared with those
on placebo.  Differences in relapse rate between active
treatment and placebo were large enough to require the
study to be stopped early, in accordance with the study
protocol. In the SEROQUEL(R) sustained release group, the
estimated risk of relapse after 6 months was 14.3% versus
68.2% in the placebo group (p<0.0001). Hospitalization
due to worsening of schizophrenia was required by 8.3% of
patients on placebo, but was not needed for any patients
taking SEROQUEL(R) sustained release formulation.

    Professor Rene Kahn, Professor and Chair of the
Department of Psychiatry and Head of the Division of
Neuroscience at the University Medical Center, Utrecht,
said: "In these studies SEROQUEL(R) sustained release
formulation showed its potential as a once-daily treatment
for both acute and clinically stable schizophrenia.
Statistical significance on the primary endpoint was seen
at doses between 400 and 800 mg/day and patients achieved
that range within two days of starting treatment -- that is
an advantage over original formulation quetiapine, where the
initial dose escalation is not so simple.  In mental
healthcare, striving for treatment that is simpler and more
practical is an important objective for patients and
doctors."

    In both studies, somnolence and dizziness were the most
common adverse events with SEROQUEL(R) sustained release
formulation and these were generally mild or moderate,
transient, and did not lead to withdrawal from the trials.
The incidence of extrapyramidal adverse events was similar
to placebo (EPS-related adverse events were seen in 5.1% of
patients taking placebo versus 2.7% [400mg], 8.0% [600mg]
and 4.1% [800mg] of patients taking SEROQUEL(R) sustained
release formulation in the acute study(1)).

    Other new SEROQUEL(R) sustained release formulation
studies presented at the congress show that patients who
are currently receiving original formulation quetiapine, or
who are inadequately treated with another antipsychotic
agent, could be easily switched to SEROQUEL(R) sustained
release formulation. Among clinically stable patients who
switched from original formulation quetiapine, there were
no significant differences between SEROQUEL sustained
release formulation and the original formulation quetiapine
in PANSS total scores after 6 weeks treatment (mean PANSS
total score at day 42 was 55.4 and 54.8 for the sustained
release formulation and the original formulation
respectively) and the incidence of adverse events was
similar (Study 146)(3). Among patients who switched to
SEROQUEL(R) sustained release formulation from other
antipsychotics, 62.8% achieved improved clinical benefit
(based on CGI-CB scores) regardless of the reason for
switching (insufficient efficacy or intolerability of
initial treatment, Study 147)(4).

    Based on these data and data from other trials,
regulatory filings for the treatment of schizophrenia with
SEROQUEL(R) sustained release formulation were submitted to
the authorities in the US, EU and other markets in 2006.
Beyond schizophrenia, ongoing clinical studies of
SEROQUEL(R) sustained release formulation cover bipolar
disorder, major depressive disorder and generalized anxiety
disorder.  SEROQUEL(R) (original formulation quetiapine) is
the number 1 prescribed atypical antipsychotic in the
United States and global sales for SEROQUEL(R) reached
US$3.4 billion in 2006.  It is licensed in 85 countries for
the treatment of schizophrenia, in 73 countries for the
treatment of mania associated with bipolar disorder, and in
October 2006 it was approved in the US by the FDA for the
treatment of bipolar depression.  It is estimated that more
than 19 million patients have used SEROQUEL(R) worldwide
since its launch in 1997.

    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
$26.47 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 FTSE4 Good Index.

    References

    1. Kahn R, et al. Efficacy and tolerability of once
daily quetiapine 
       sustained release in patients with acute
schizophrenia: a randomised, 
       double blind, 6 week, placebo-controlled study.
Presented at the 
       European Congress of Psychiatry, Madrid, Spain,
17-21 March, 2007.

    2. Peuskens J, et al. Randomised, placebo-controlled,
relapse-prevention 
       study with once-daily quetiapine sustained release
in patients with 
       schizophrenia. Presented at the European Congress of
Psychiatry, 
       Madrid, Spain, 17-21 March, 2007.

    3. Moller H-J, et al. Continued efficacy and
tolerability in clinically 
       stable patients switched from quetiapine immediate
release (IR) to 
       quetiapine sustained release (SR). Presented at the
European Congress 
       of Psychiatry, Madrid, Spain, 17-21 March, 2007.

    4. Ganesan S, et al. Clinical benefit of switching
patients with 
       schizophrenia to once-daily quetiapine sustained
release. Presented at 
       the European Congress of Psychiatry, Madrid, Spain,
17-21 March, 2007.

    For further information, please visit
http://www.astrazeneca.com or
http://www.astrazenecapressoffice.com .



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