AstraZeneca's Once-Daily SEROQUEL XR(TM) Extended-Release Tablets Approved in Netherlands for the Acute and Long Term Treatment of Schizophrenia

London (ots/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.

ots Originaltext: AstraZeneca
Im Internet recherchierbar: http://www.presseportal.de

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