19th Oct 2006 08:45
AstraZeneca PLC19 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 forthe approval of the sustained release (SR) once-daily formulation of SEROQUEL(R)for the treatment of patients with schizophrenia, including Canada and aMarketing Authorisation Application (MAA) in the European Union (EU) underMutual Recognition Procedure (MRP). The submission will cover all markets in theEU 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 inthe EU included trials using a titration period aimed at achieving atherapeutically effective dose by the second day of treatment. Another trialstudied schizophrenia relapse prevention in long-term treatment with SEROQUELSR(TM). The SR formulation has patent protection to 2017. SEROQUEL(R) (quetiapine fumarate) has a well-established safety and efficacyprofile and to date it is estimated that over 19 million people have beentreated worldwide. SEROQUEL(R) has been licensed for the treatment ofschizophrenia since 1997 and it is available in 85 countries for the treatmentof this condition. SEROQUEL(R) is also licensed in 73 countries for thetreatment of mania associated with bipolar disorder. SEROQUEL(R) is the numberone prescribed atypical antipsychotic in the United States, with global sales ofalmost $2.8 billion in 2005. 19th October 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- This information is provided by RNS The company news service from the London Stock ExchangeRelated Shares:
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