AstraZeneca PLC
02 January 2003
ASTRAZENECA FILES sNDA FOR SEROQUEL(R) (QUETIAPINE)
IN BIPOLAR DISEASE
AstraZeneca today announced that it has submitted a Supplemental New Drug
Application (sNDA) to the U.S. Food and Drug Administration (FDA) for SEROQUEL
(R) (quetiapine) for the treatment of acute mania associated with bipolar
disorder (manic depressive illness).
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.
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 annualised sales that approached $1 billion in Q3 2002.
2 January 2003
Media Enquiries:
Emily Denney, Tel: +44 (0) 207 304 5034
Investor Relations:
Mina Blair-Robinson, Tel: +44 (0) 207 304 5084
Jonathan Hunt, Tel: +44 (0) 207 304 5087
-ENDS -
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