AstraZeneca announced that two analyses from a large-scale study that investigated the efficacy of SEROQUEL XR™ (quetiapine fumarate) Extended-Release Tablets, a once-daily medicine for the treatment of schizophrenia in adult patients, were presented today at the annual meeting of the American Psychiatric Association (APA). In this study of patients with an acute exacerbation of symptoms of schizophrenia, PANSS Total Score decreased significantly more in SEROQUEL XR-treated patients than in those on placebo, SEROQUEL XR was generally well-tolerated, and it was administered once-daily at fixed doses.1,2

On May 17, 2007, the U.S. Food and Drug Administration (FDA) approved SEROQUEL XR for the treatment of schizophrenia in adult patients (link here)

- SEROQUEL XR is not approved in any other country.

"Both analyses show that SEROQUEL XR was superior to placebo, demonstrating it is another viable treatment option for schizophrenia," said Charles Schulz, MD, Professor and Head, Department of Psychiatry, University of Minnesota Medical School. "These analyses are significant because SEROQUEL XR may provide greater convenience and simplicity in patient treatment plans."

About large-scale study: Study 132

This six-week, double-blind, randomized, placebo-controlled study investigated the efficacy and safety of once-daily SEROQUEL XR. In this study, 588 patients with acute schizophrenia were randomized to receive either SEROQUEL XR at 400, 600, or 800 mg/day, the immediate release formulation of SEROQUEL® (quetiapine fumarate) at 400 mg/day (200 mg twice-daily), or placebo. The primary endpoint was assessed using the Positive and Negative Syndrome Scale (PANSS) [†].1,2

In the study, SEROQUEL XR was generally well-tolerated. SEROQUEL XR was administered once-daily at fixed doses, with dose escalation conducted over the initial three days (Day 1 = 300mg, Day 2 = 400 or 600mg, and Day 3 = 400, 600 or 800mg). The immediate-release formulation of SEROQUEL was administered twice-daily and escalated from 50 mg/day to 400 mg/day over a five day period. The most common adverse events seen in the active treatment groups during the trial were somnolence and dizziness. The incidences of adverse events leading to discontinuation were low: 5.3%, 2.7%, and 2.5% in the SEROQUEL XR 400, 600, 800 mg/day groups; 4.9% in the immediate release SEROQUEL group; and 2.5% in the placebo group. Individual extrapyramidal symptoms (EPS)-related adverse events occurred in three patients or less in all treatment groups.1,2

About a poster presentation entitled: Efficacy of Once?Daily Extended Release Quetiapine Fumarate in Patients with Acute Schizophrenia

This first analysis of Study 132 evaluated the efficacy of SEROQUEL XR versus placebo in patients with schizophrenia. The primary endpoint was the change from baseline to Day 42 in PANSS total score.1

After six weeks, the mean PANSS total score decreased significantly with SEROQUEL XR (400 mg: -24.8, p<0.05; 600 mg: -30.9, p<0.001; 800 mg: -31.3, p<0.001) compared with placebo (-18.8). In addition, PANSS response rates for SEROQUEL XR (all doses) were significantly higher than for placebo (p<0.05).1

About a poster presentation entitled: Efficacy of Once-Daily Extended Release Quetiapine Fumarate across Symptom Domains in Schizophrenia

In this second analysis of Study 132, the efficacy of SEROQUEL XR was evaluated across a broad range of symptoms in schizophrenia, including positive and negative symptoms as well as symptoms of general psychopathology, aggression, and depression. Efficacy was assessed from the change from baseline to study endpoint (Day 42) using PANSS total score as well as positive symptom, negative symptom, general psychopathology, aggression, and depression rating scores.2

At Day 42, there were statistically significant reductions versus placebo with all doses of SEROQUEL XR for the change in PANSS total, positive subscale, general psychopathology subscale, and hostility and aggression scores. Changes in negative symptom and depression scores of the PANSS were statistically significant versus placebo for SEROQUEL XR 600 mg/day and 800 mg/day.2

About Schizophrenia

Schizophrenia is a serious brain disorder with symptoms including distorted perceptions of reality, hallucinations and delusions, illogical thinking, and flat or blunted emotions.4 Schizophrenia affects men and women with equal frequency, but the first signs of schizophrenia typically emerge earlier in men (in late teens or early twenties) compared to women (in twenties or early thirties).5 Over 2 million American adults - about 1 percent of the population age 18 and older - suffer from schizophrenia. Medications are important in the management of symptoms. While there is no cure for schizophrenia, it is a highly treatable and manageable illness. Medications are classified into two categories - "conventional" and "atypical" antipsychotics.6

About AstraZeneca

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 $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

In the United States, AstraZeneca is a $12.44 billion healthcare business with more than 12,000 employees. For nearly three decades, AstraZeneca has offered drug assistance programs side by side with its medicines, and over the past five years, has provided over $3 billion in savings to more than 1 million patients throughout the US and Puerto Rico. AstraZeneca has been named one of the "100 Best Companies for Working Mothers" by Working Mother magazine and is the only large pharmaceutical company named to FORTUNE magazine's 2007 list of "100 Best Companies to Work For." In 2006, for the fifth consecutive year, Science magazine named AstraZeneca a "Top Employer" on its ranking of the world's most respected biopharmaceutical employers.

The statements herein include forward-looking statements. By their nature, forward-looking statements and forecasts involve risk and uncertainty. For a discussion of those risks and uncertainties please see the company's Annual Report/Form 20-F for 2006.


1 C Schulz, R Kahn, V Palazov, E Reyes, D Meulien, M Brecher, O Svensson, HM Andersson. "Efficacy of Once-Daily Quetiapine Extended Release in Patients with Acute Schizophrenia." Annual Meeting of the American Psychiatric Association, 2007, San Diego, CA, research poster board NR04.

2 C Schulz, R Kahn, V Palazov, E Reyes, D Meulien, M Brecher, O Svensson, HM Andersson. "Efficacy of Once-Daily Quetiapine Extended Release across Symptom Domains in Schizophrenia." Annual Meeting of the American Psychiatric Association, 2007, San Diego, CA, research poster board NR495.

3 Kay et al. Schizophrenia Bulletin. 1987;13:261-276.

4 American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR). Fourth Edition. Arlington, VA, 2000. 299.

5 National Institutes of Mental Health. The Numbers Count: Mental Disorders in America. NIH Publication No. 06-4584. December 2006.

6 National Alliance for the Mentally Ill: About Mental Illness/Schizophrenia fact sheet. Reviewed by Kenneth Duckworth, M.D.: February 2007.