18th Jul 2006 07:01
AstraZeneca PLC18 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) tothe US Food and Drug Administration for a sustained release (SR) once-dailyformulation of SEROQUEL for the treatment of patients with schizophrenia. Theclinical trials to support the US submission of SEROQUEL SR(TM) used a shorttitration period aimed at achieving a therapeutically effective dose by thesecond 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 haspatent protection to 2017. SEROQUEL(R) (quetiapine fumarate) has a well-established safety and efficacyprofile and to date over 16 million people have been treated worldwide.SEROQUEL(R) has been licensed for the treatment of schizophrenia since 1997 andit is available in 85 countries for the treatment of this condition. SEROQUEL isalso licensed in 73 countries for the treatment of mania associated with bipolardisorder. Following the recent regulatory submissions based on the BOLDERstudies in bipolar depression, SEROQUEL is set to become the first medication tooffer a single treatment effective at both poles of bipolar disease (depressionand mania). SEROQUEL is the number one prescribed atypical antipsychotic in the UnitedStates, with global sales of almost $2.8 billion in 2005. Tuesday 18th July 2006 Media Enquiries: Edel McCaffrey, Tel: +44 (0) 207 304 5034Steve Brown, Tel: +44 (0) 207 304 5033 Investor Relations: Mina Blair, Tel: +44 (0) 207 304 5084Jonathan Hunt, Tel: +44 (0) 207 304 5087Ed Seage, Tel: +1 302 886 4065Jorgen Winroth, Tel +1 (212) 579 0506 -Ends- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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