AstraZeneca Announces Two Business Milestones for Seroquel(reg)

Main Category: Bipolar
Article Date: 03 Dec 2004 - 14:00 PDT

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AstraZeneca today announces two new business milestones for SEROQUEL (quetiapine), an atypical antipsychotic for the treatment of schizophrenia and acute manic episodes associated with bipolar disorder (manic-depressive illness).

The company has submitted a regulatory application to the French Health Authorities for a licence to market SEROQUEL in France for the treatment of schizophrenia and acute manic episodes associated with bipolar disorder. Approval has also been received from Health Canada to market SEROQUEL as a monotherapy for the acute management of manic episodes associated with bipolar disorder.

French Regulatory Submission

A dossier has been submitted to the Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) in France to register SEROQUEL by the Mutual Recognition Repeat Use Procedure. SEROQUEL is already approved in 14 European Union territories using the Mutual Recognition Procedure, with the Netherlands as the Reference Member State, for the treatment of schizophrenia and acute manic episodes associated with bipolar disorder. In France, there are currently an estimated 600,000 people suffering from schizophrenia and 1.8 million people suffering from bipolar disorder.

Canadian Approval

Health Canada has approved SEROQUEL as a monotherapy for the management of acute manic episodes associated with bipolar disorder. The approval is based on the results of clinical trials which showed SEROQUEL to be an effective and well-tolerated first line agent in the treatment of manic episodes - excited mental states seen in bipolar disorder that are characterised by impulsive behaviour, racing thoughts, pressured speech, and decreased need for sleep. Patients taking SEROQUEL in the clinical trials showed improvement of their manic symptoms as early as the fourth day of treatment. The improvement was statistically superior to that of placebo as measured by the Young Mania Rating Scale (YMRS), a common psychiatric measurement tool.

In September 2004, SEROQUEL became the market leader in new prescriptions in the US atypical antipsychotic market, with sales reaching $1.9 billion over the past 12 months. SEROQUEL has been licensed in 81 countries for schizophrenia and 47 countries for bipolar disorder since it was launched in 1997. To date, SEROQUEL has been prescribed to over eight million patients worldwide.

Further enquiries to:

Media Enquiries:
Edel McCaffrey, Tel: +44 (0) 207 304 5034
Steve Brown, Tel: +44 (0) 207 304 5033

Investor Enquiries:
Mina Blair, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087

Notes to Editors:
AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of over $18.8 billion and leading positions in sales of gastrointestinal, oncology, cardiovascular, neuroscience and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index

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