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AstraZeneca Submits sNDAs for Seroquel XR for the Treatment of Bipolar Mania and Bipolar Depression

LONDON, Jan. 2, 2008 - AstraZeneca today announced that the company has submitted two separate supplemental New Drug Applications (sNDAs) to the U.S. Food and Drug Administration (FDA) for once-daily Seroquel XR (quetiapine fumarate) Extended-Release Tablets to seek approval for the treatment of manic episodes associated with bipolar disorder and the treatment of depressive episodes associated with bipolar disorder.

The bipolar mania submission is based on a clinical study of once-daily treatment with Seroquel XR, compared to placebo, with a primary endpoint of change in YMRS (Young Mania Rating Scale) total score (week 3), in 316 patients suffering from bipolar mania. The bipolar depression submission is supported by a clinical study of once-daily treatment with Seroquel XR, compared to placebo, with a primary endpoint of change from baseline in MADRS (Montgomery Asberg Depression Rating Scale) total score after eight weeks of treatment, in 280 patients diagnosed with bipolar depression. Doses of Seroquel XR administered in both the bipolar mania (400 mg to 800 mg/day) and bipolar depression (300 mg/day) studies were comparable to the FDA-approved recommended doses for Seroquel (quetiapine fumarate) immediate release tablets in those indications. Both studies met their primary endpoint and it is expected that they will be presented at major scientific congresses in 2008.

Seroquel XR is currently approved in eight countries including US, Canada and The Netherlands, for the acute and maintenance treatment of schizophrenia in adults.

Launched in 1997, it is estimated that Seroquel has been prescribed to more than 25 million patients worldwide. It is approved in 88 countries for the treatment of schizophrenia, in 79 countries for the treatment of bipolar mania, and in 11 countries including the USA for the treatment of bipolar depression. Global sales of Seroquel for the first nine months of 2007 were $2.94 billion, an increase of 15 per cent on the same period of 2006. Seroquel XR was launched for the treatment of schizophrenia in the US in 2007, and its clinical development programme and planned regulatory filings extend through bipolar disorder to major depressive disorder (MDD) and generalised anxiety disorder (GAD).

Seroquel Media Contact:
James Read – Wilmington, USA: +1 302 885 9944

Media Enquiries:
Steve Brown, +44 207 304 5033 (24 hours)
Edel McCaffrey, +44 207 304 5034 (24 hours)

Investor Enquiries:
Jonathan Hunt, +44 207 304 5087
Ed Seage, +1 302 886 4065
Karl Hard, +44 207 304 5322
Jorgen Winroth, +1 212 579 0506
Peter Vozzo, (MedImmune) +1 301 398 4358

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $26.47billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

Posted: January 2008

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