AstraZeneca PLC
19 October 2006
AstraZeneca Submits EU and Canadian Regulatory Filings for Sustained Release
Formulation SEROQUEL SR(TM) for the Treatment of Schizophrenia
AstraZeneca today announced further submissions to Regulatory Authorities for
the approval of the sustained release (SR) once-daily formulation of SEROQUEL(R)
for the treatment of patients with schizophrenia, including Canada and a
Marketing Authorisation Application (MAA) in the European Union (EU) under
Mutual Recognition Procedure (MRP). The submission will cover all markets in the
EU where SEROQUEL(R) is currently approved.
This follows the NDA for SEROQUEL SR(TM)submitted in the US earlier this year.
The clinical development programme supporting the SEROQUEL SR(TM) application in
the EU included trials using a titration period aimed at achieving a
therapeutically effective dose by the second day of treatment. Another trial
studied schizophrenia relapse prevention in long-term treatment with SEROQUEL
SR(TM). The SR formulation has patent protection to 2017.
SEROQUEL(R) (quetiapine fumarate) has a well-established safety and efficacy
profile and to date it is estimated that over 19 million people have been
treated worldwide. SEROQUEL(R) has been licensed for the treatment of
schizophrenia since 1997 and it is available in 85 countries for the treatment
of this condition. SEROQUEL(R) is also licensed in 73 countries for the
treatment of mania associated with bipolar disorder. SEROQUEL(R) is the number
one prescribed atypical antipsychotic in the United States, with global sales of
almost $2.8 billion in 2005.
19th October 2006
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Jonathan Hunt, Tel: +44 (0) 207 304 5087
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Jorgen Winroth, Tel +1 (212) 579 0506
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