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AstraZeneca Receives FDA Approval for SEROQUEL in Bipolar Mania

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WILMINGTON, Delaware, January 13 /PRNewswire/ -- AstraZeneca announced today that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL(TM) (quetiapine) as a monotherapy and adjunct therapy for the treatment of mania associated with bipolar disorder (manic- depressive illness). SEROQUEL has been indicated for the treatment of schizophrenia since 1997.

The FDA's approval is based on the positive results of a comprehensive bipolar disorder clinical trial programme involving more than 1,000 patients in 28 countries that found SEROQUEL to be effective across a broad range of symptoms and well-tolerated in treating manic episodes as both a monotherapy and in combination with lithium or divalproex.(1,2,3,4) SEROQUEL was also found to be fast-acting as improvements in patients' manic symptoms were seen within the first week of treatment. (1,2,3,4)

"The new indication for SEROQUEL marks an important milestone for the millions of people who suffer from bipolar disorder," said Dr. Trisha Suppes, Bipolar Disorder Clinic and Research Director, University of Texas Southwestern Medical Center. "With its favourable side-effect profile, SEROQUEL offers patients an excellent option to help improve symptoms of manic episodes associated with bipolar disorder."

Bipolar disorder is a serious mental illness that affects approximately 3-4% of the adult population and is the sixth leading cause of disability in the world. (5,6,7,8) Side effects associated with treatment, such as extrapyramidal symptoms (EPS) which cause movement disorders or serum prolactin elevation which may cause menstrual irregularities, decreased libido and impotence, can often cause patients great distress and lead to issues with treatment compliance. A lack of compliance results in the patient subjecting themselves to a high risk of relapse and increased risk of suicide, therefore, a well tolerated and effective treatment is pivotal to the successful treatment of this condition.

SEROQUEL has also recently received approval from the Mutual Recognition Procedure (MRP) involving 14 European countries to extend its use to treat mania associated with bipolar disorder. Health authority approvals have also been received in the UK, Italy, Mexico and New Zealand.

"With this latest approval of SEROQUEL in the U.S., a greater number of patients around the world will be able to benefit from this medication," said Dr. Jamie Mullen, Senior Director of Clinical Research at AstraZeneca. "AstraZeneca is committed to providing medicines that help patients with mental illness and Seroquel is an excellent example of the company's dedication to finding effective treatments that patients can accept."

Data from the clinical trial programme was presented in September 2002 at the 3rd European Stanley Foundation Conference on Bipolar Disorder in Freiburg, Germany and in June this year at the International Conference on Bipolar Disorder (ICBD), Pittsburgh, USA.(1,2,3,4) The results confirmed that SEROQUEL monotherapy is as effective as current treatments for bipolar disorder and offers improved tolerability benefits.(1,2) In the adjunct setting, SEROQUEL was found to be significantly more effective than mood stabilisers alone in the treatment of bipolar mania.(4) Across the mania trials, Seroquel was associated with a favourable weight profile and an incidence of EPS (including akathisia) no different from placebo across the full dose range.(1,2,3,4)

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, cardiovascular, neuroscience 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(TM), 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.

For more information, please visit www.astrazenecapressoffice.com

Notes to Editors

All product names appear in upper case. SEROQUEL is a trade mark of the AstraZeneca group of companies

For an electronic and downloadable version of this press release or for further information about SEROQUEL, please visit the psychiatry resource internet site at: www.psychiatry-in-practice.com This psychiatry resource features educational materials relating to severe mental illness, including background information on schizophrenia as well as epidemiological data and treatment issues clinicians face in everyday practice.

References:

1. Brecher M, Huizar K. Quetiapine monotherapy for acute mania associated with bipolar disorder. International Conference on Bipolar Disorder, Pittsburgh, USA, 2003, abs.

2. Paulsson B, Huizar K. Quetiapine monotherapy for the treatment of bipolar mania. International Conference on Bipolar Disorder, Pittsburgh, USA, 2003, abs.

3. Jones M, Huizar K. Quetiapine monotherapy for mania associated with bipolar disorder. International Conference on Bipolar Disorder, Pittsburgh, USA, 2003, abs.

4. Sachs G, Mullen JA, Devine NA. Quetiapine vs Placebo as Adjunct to Mood Stabilizer for the treatment of acute mania. Stanley Foundation Bipolar Conference, 2002, abs.

5. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington DC, American Psychiatric Association, 2000:385, 395.

6. Hirschfield et al. J Clin Psychiatry. 2003;64:53-59

7. Lisd JD, Dime-Meenan S, Whybrow PC et al. The National Depressive and Manic-Depressive Association (DMDA) survey of bipolar members. J Affect Disord. 1994;31:281-294.

8. World Health Organization and the World Bank. The Global Burden of Disease: Summary. Cambridge, Mass: The Harvard School of Public Health Harvard University Press, 1996.

SOURCE AstraZeneca



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