AstraZeneca PLC
18 July 2006
AstraZeneca Submits an NDA For Sustained Release Formulation SEROQUEL SR(TM)
For the Treatment of Schizophrenia
AstraZeneca today announced the submission of a New Drug Application (NDA) to
the US Food and Drug Administration for a sustained release (SR) once-daily
formulation of SEROQUEL for the treatment of patients with schizophrenia. The
clinical trials to support the US submission of SEROQUEL SR(TM) used a short
titration period aimed at achieving a therapeutically effective dose by the
second day of treatment. The Company also expects to make a SEROQUEL SR(TM)
filing in the European Union towards the end of 2006. The SR formulation has
patent protection to 2017.
SEROQUEL(R) (quetiapine fumarate) has a well-established safety and efficacy
profile and to date over 16 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 is
also licensed in 73 countries for the treatment of mania associated with bipolar
disorder. Following the recent regulatory submissions based on the BOLDER
studies in bipolar depression, SEROQUEL is set to become the first medication to
offer a single treatment effective at both poles of bipolar disease (depression
and mania).
SEROQUEL is the number one prescribed atypical antipsychotic in the United
States, with global sales of almost $2.8 billion in 2005.
Tuesday 18th July 2006
Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033
Investor Relations:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
Ed Seage, Tel: +1 302 886 4065
Jorgen Winroth, Tel +1 (212) 579 0506
-Ends-
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