AstraZeneca has submitted a Supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for Seroquel (quetiapine fumarate) for the treatment of acute mania associated with bipolar disorder. The sNDA is based on a comprehensive package of clinical data for Seroquel, both as monotherapy and as adjunct therapy, for acute mania.

The anticipated 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.

"Submitting our sNDA for Seroquel reflects our continuing commitment to improving the lives of people with mental illnesses," commented James Pusey, vice president and CNS, Pain & Infection therapeutic area leader at AstraZeneca. "Use of Seroquel has been growing at a phenomenal rate, and we expect continued growth in 2003 and beyond. In the treatment of schizophrenia, Seroquel has proven efficacy and an excellent side effect profile including no dose related extrapyramidal symptoms (EPS)."

Since its initial approval in September 1997, there have been approximately 13.7 million prescriptions written for Seroquel, for more than 3.4 million patients in the U.S. Seroquel is the fastest-growing atypical antipsychotic on the market, with annualized global sales that approached $1 billion in the third quarter 2002.