The application to the FDA follows the completion of a comprehensive bipolar disorder clinical trial programme undertaken by AstraZeneca to examine the efficacy and tolerability of SEROQUEL in this important disease area. The programme has delivered consistently strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm SEROQUEL to be an ideal first line agent.

“We are very pleased with the results of the trial programme and are extremely optimistic about the future for SEROQUEL. SEROQUEL is a truly unique compound and its profile is ideal for the treatment of bipolar disorder,” commented Geoff Birkett, Global Vice President, CNS, Pain and Infection. “Success in the market is driven by the impact on patients, and our vision to introduce therapies that truly change patients’ lives for the better. With its expanded indication range, SEROQUEL will continue to help patients and is the cornerstone of our rapidly growing business.”

The proposed 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 an estimated 2.3 million American adults 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 atypical antipsychotic on the market, with global sales that reached $1 billion in 2002.

The trial programme consisted of four studies involving almost 1800 patients in 28 countries. The results from one of the combination therapy studies were presented earlier this year at the 3rd European Stanley Foundation Conference in Bipolar Disorder, in Germany. The results from this trial showed that SEROQUEL, in combination with standard mood stabilizing medication (lithium or divalproex), is significantly more effective at treating the manic symptoms of bipolar disorder than mood stabilizers alone. Importantly, the results also showed that SEROQUEL is well tolerated – a major consideration in the treatment of this disorder. The results from the remaining monotherapy studies will be presented at major psychiatry conferences in 2003.

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 $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In CNS, AstraZeneca is dedicated to providing medicines that offer the potential to change patients' lives. The company already markets 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 in the triptan market. AstraZeneca’s R&D pipeline also includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke.