2007-08-29

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 authorityMEB (Medicines Evaluation Board) has approved SEROQUEL XR(TM)(quetiapine fumarate) Extended-Release Tablets, a once-daily medicinefor the treatment of schizophrenia in adult patients. With SEROQUELXR(TM) patients can achieve a dose within the recommended range asearly as the second day of treatment and the MEB approval alsoincludes relapse prevention in the long-term treatment ofschizophrenia. AstraZeneca will proceed with a Mutual RecognitionProcedure, seeking similar approvals across Europe. SEROQUEL XR wasapproved for the treatment of schizophrenia in the US in May 2007.

SEROQUEL XR has been developed with the aim of improving dosingand titration options for patients and their doctors as they face thechallenge of achieving successful treatment of schizophrenia. WorldHealth Organisation (WHO) statistics indicate that schizophreniaaffects about 24 million people worldwide. It subjects people tosocial isolation, poor quality of life and increased mortality - itis a severe mental disorder, characterized by profound disruptions inthinking, affecting language, perception, and the sense of self. Itis estimated that SEROQUEL (original formulation quetiapine) has beenused to treat more than 19 million patients worldwide since itslaunch in 1997.

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

The data from the clinical studies of SEROQUEL XR reviewed by MEBhave now been published. Professor Rene Kahn, Professor and Chair ofthe Department of Psychiatry and Head of the Division of Neuroscienceat the University Medical Center, Utrecht, said: "In clinical studiesSEROQUEL XR(TM) showed its potential as a once-daily treatment forboth acute and clinically stable schizophrenia patients. In theclinical trials, the effective dose range was reached within two daysof starting treatment - the data demonstrated that range is between400 and 800 mg/day. In mental healthcare, striving for treatment thatis simpler and more practical is an important objective for patientsand doctors. The right treatment enables patients to begin a path torecovery - not only in mental and physical terms but in emotional andsocial terms also."

Beyond schizophrenia, ongoing clinical studies of SEROQUEL XRcover bipolar disorder, major depressive disorder and generalizedanxiety disorder. SEROQUEL(R) (original formulation quetiapine) isthe number one prescribed atypical antipsychotic in the United Statesand global sales for SEROQUEL(R) reached US$3.4 billion in 2006. Itis licensed in 85 countries for the treatment of schizophrenia, in 73countries for the treatment of mania associated with bipolardisorder, and in October 2006 it was approved in the US by the FDAfor the treatment of bipolar depression.

AstraZeneca is a major international healthcare business engagedin the research, development, manufacture and marketing ofprescription pharmaceuticals and the supply of healthcare services.It is one of the world's leading pharmaceutical companies withhealthcare sales of US$26.47 billion and leading positions in salesof gastrointestinal, cardiovascular, neuroscience, respiratory,oncology and infection products. AstraZeneca is listed in the DowJones Sustainability Index (Global) as well as the FTSE4Good Index.

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

ots Originaltext: AstraZenecaIm Internet recherchierbar: http://www.presseportal.de

Contact:Medical Media enquiries: James Read, Tel: +1-302-885-9944; Sarah Winkless, Tel: +44-7771-757695; Business Media enquiries: Edel McCaffrey, Tel: +44-(0)-207-304-5034 (London); Steve Brown, Tel: +44-(0)-207-304-5033 (London); Investor Enquiries: Mina Blair, Tel: +44-(0)-207-304-5084; Jonathan Hunt, Tel: +44-(0)-207-304-5087; Karl Hard, Tel: +44-(0)207-304-5322; Ed Seage, Tel: +1-302-886-4065; Jorgen Winroth, Tel +1-212-579-0506

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

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