AstraZeneca's Once-Daily SEROQUEL XR(TM) Extend...

LONDON, August 29 /PRNewswire/ --

- For International Medical Journalists Only

    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.