“Today’s results add to previous clinical studies that show SEROQUEL can provide relief of disease symptoms without the troublesome side effects sometimes associated with other treatments, making it an ideal first-line treatment for bipolar disorder, where patient compliance is paramount,” commented Bill Bastain, Vice President and Head, Neuroscience Therapy Area, AstraZeneca. “SEROQUEL is the fastest growing of the leading atypical antipsychotics on the market, and as we learn more about its use in other patient populations, such as bipolar disorder, we are confident it will continue to grow and add value to the AstraZeneca product portfolio.”

A pooled analysis of the data from two 12-week trials, which tested SEROQUEL monotherapy vs. placebo, showed that after three weeks, SEROQUEL achieved significantly greater improvements in the Young Mania Rating Scale (YMRS) total score from baseline compared to the placebo group (-13.58 and –7.76, respectively, p<0.0001). In patients treated with SEROQUEL, a statistically significant improvement in YMRS total score was observed as early as day four (p=0.021) and at each subsequent time point until day 84 (p<0.001). SEROQUEL was also well tolerated by patients in the trials.

These results support a previous study, which showed that SEROQUEL, in combination with a mood stabiliser (lithium or divalproex), was significantly more effective than a mood stabiliser alone in treating bipolar mania. AstraZeneca announced its submission of a Supplemental New Drug Application to the U.S. Food and Drug Administration in January 2003 and to the 14 European Member States involved in the Mutual Recognition Procedure in February 2003, for SEROQUEL to be granted a licence for the treatment of manic episodes associated with bipolar disorder (manic-depressive illness).

This new indication is expected to expand the market for SEROQUEL, which is currently indicated for the treatment of schizophrenia in adults. Analysts estimate that bipolar disorder alone constitutes a multibillion-dollar market. The illness affects affects approximately 3-4 per cent of the adult population and is ranked as the second leading cause of disability worldwide among the neuro-psychiatric disorders. To date, over 4 million people have been treated with SEROQUEL worldwide. SEROQUEL is the fastest-growing of the leading atypical antipsychotic on the market, with $1.145 billion in sales in 2002, a 67 per cent increase from the previous year.

One of the issues faced by psychiatrists treating this condition are the problems associated with treatment compliance due to tolerability issues with some treatments. More than half of those with bipolar disorder stop taking their medication at some point during their lives, subjecting themselves to a high risk of relapse and an increased risk of suicide.

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 top five pharmaceutical companies in the world with healthcare sales of over $17.8 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global and European) as well as the FTSE4Good Index.

In Neuroscience, AstraZeneca is dedicated to providing medicines that have the potential to change patients' lives. The company already markets several products including SEROQUEL®, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and ZOMIG®, a reliable migraine therapy and a leader within the triptan market. The Neuroscience pipeline includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke, pain control and anaesthesia.