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2025'02.01.Sat
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2007'09.02.Sun
AstraZeneca's Once-Daily SEROQUEL XR(TM) Extended-Release Tablets Approved in Netherlands for the Acute and Long Term Treatment of Schizophrenia
August 29, 2007




-- For International Medical Journalists Only --

    LONDON, Aug. 29 /Xinhua-PRNewswire/ -- AstraZeneca
today announced the Netherlands regulatory authority MEB
(Medicines Evaluation Board) has approved SEROQUEL XR(TM)
(quetiapine fumarate) Extended-Release Tablets, a
once-daily medicine for the treatment of schizophrenia in
adult patients. With SEROQUEL XR(TM) patients can achieve a
dose within the recommended range as early as the second day
of treatment and the MEB approval also includes relapse
prevention in the long-term treatment of schizophrenia.
AstraZeneca will proceed with a Mutual Recognition
Procedure, seeking similar approvals across Europe.
SEROQUEL XR was approved for the treatment of schizophrenia
in the US in May 2007.

    SEROQUEL XR has been developed with the aim of
improving dosing and titration options for patients and
their doctors as they face the challenge of achieving
successful treatment of schizophrenia. World Health
Organisation (WHO) statistics indicate that schizophrenia
affects about 24 million people worldwide. It subjects
people to social isolation, poor quality of life and
increased mortality -- it is a severe mental disorder,
characterized by profound disruptions in thinking,
affecting language, perception, and the sense of self. It
is estimated that SEROQUEL (original formulation
quetiapine) has been used to treat more than 19 million
patients worldwide since its launch in 1997.

    The MEB approval was based on clinical trials of
SEROQUEL XR(TM) evaluating effectiveness and safety at
doses of 400, 600, and 800 mg/day, in acute treatment,
relapse prevention and also in a non-inferiority study of
acute efficacy and safety when switching from the original
formulation to SEROQUEL XR(TM).

    The data from the clinical studies of SEROQUEL XR
reviewed by MEB have now been published. 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 clinical studies
SEROQUEL XR(TM) showed its potential as a once-daily
treatment for both acute and clinically stable
schizophrenia patients. In the clinical trials, the
effective dose range was reached within two days of
starting treatment -- the data demonstrated that range is
between 400 and 800 mg/day. In mental healthcare, striving
for treatment that is simpler and more practical is an
important objective for patients and doctors. The right
treatment enables patients to begin a path to recovery --
not only in mental and physical terms but in emotional and
social terms also."

    Beyond schizophrenia, ongoing clinical studies of
SEROQUEL XR cover bipolar disorder, major depressive
disorder and generalized anxiety disorder. SEROQUEL(R)
(original formulation quetiapine) is the number one
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.

    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
US$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 FTSE4Good Index.

    SEROQUEL XR is a trademark of the AstraZeneca group of
companies.



    For more information, please contact:

    AstraZeneca

    Medical Media Enquiries: 
     James Read
     Tel:   +1-302-885-9944
 
     Sarah Winkless
     Tel:   +44-7771-757695

    Business Media Enquiries: 
     Edel McCaffrey
     Tel:   +44-207-304-5034

     Steve Brown 
     Tel:   +44-207-304-5033 

    Investor Enquiries: 
     Mina Blair 
     Tel:   +44-207-304-5084

     Jonathan Hunt
     Tel:   +44-207-304-5087

     Karl Hard
     Tel:   +44-207-304-5322

     Ed Seage
     Tel:   +1-302-886-4065
 
     Jorgen Winroth
     Tel    +1-212-579-0506
PR
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