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Biopharmaceuticals FDA

 News Release - October 20, 2006

FDA Approves AstraZeneca's SEROQUEL(R) For Bipolar Depression Treatment

SEROQUEL is now the first and only single medication approved by the FDA to treat both depressive and manic episodes associated with bipolar disorder

WILMINGTON, Del., Oct. 20 (HSMN NewsFeed) -- AstraZeneca (NYSE: AZN ) today announced that the U.S. Food and Drug Administration (FDA) has approved SEROQUEL® (quetiapine fumarate) for the treatment of patients with depressive episodes associated with bipolar disorder. SEROQUEL already is approved for the treatment of acute manic episodes associated with bipolar I disorder** and for the treatment of schizophrenia. SEROQUEL is now the first and only single medication approved by the FDA to treat both depressive and acute manic episodes associated with bipolar disorder.

More than seven million American adults are affected by bipolar disorder, a serious psychiatric condition also known as manic depressive illness.(1) Patients with bipolar disorder are symptomatic almost half of their lives, and approximately two-thirds of that time is spent in the depressed phase of the illness.(2) For many people with bipolar disorder, the depressive symptoms are significantly more debilitating than the manic symptoms associated with the illness.(3)

"The new indication for SEROQUEL provides physicians and their patients with a single medication to treat both the depressive and manic episodes associated with bipolar disorder," said John Patterson, Executive Director- Development, AstraZeneca. "Treating acute bipolar disorder with a single medication may help patients adhere to their medication regimen."

The FDA approval was based on results from the clinical trial program known as BOLDER (BipOLar DEpRession), which comprises the BOLDER I and BOLDER II studies. In these studies, patients taking SEROQUEL showed an improvement in depressive symptoms* starting at week one compared to those taking placebo, and this improvement continued throughout the eight-week study.(4),(5) In addition, patients treated with SEROQUEL showed significant improvement on other measures of efficacy including overall quality of life and satisfaction related to functioning.***

Both studies in the BOLDER program were double-blind, placebo-controlled trials of outpatients (N=1,045) with bipolar I or II disorder**. Patients were randomized to receive eight weeks of treatment with fixed doses of SEROQUEL® (300 mg or 600 mg) or placebo administered once-daily. Efficacy in bipolar depression was demonstrated in the studies at both 300 mg a day and 600 mg a day. No additional benefit was seen in the 600 mg a day dose groups. Therefore, the recommended dose is 300 mg once-daily, to be achieved by day four of treatment.

SEROQUEL was generally well tolerated, with adverse event types similar to those seen in other clinical trials of SEROQUEL in bipolar mania and schizophrenia.(4),(5) The most frequent adverse events seen in the bipolar depression trials were dry mouth, sedation, somnolence, dizziness and constipation.

"Data from the BOLDER clinical trial program demonstrate that SEROQUEL was safe and effective in treating bipolar depression with significant decrease in depression scores* as early as week one," said Michael E. Thase, MD, lead investigator of BOLDER II and Professor of Psychiatry, University of Pittsburgh School of Medicine. "For many patients with bipolar disorder, the depressive symptoms are significantly more debilitating and frequent than the manic symptoms, and having a medication that effectively treats both acute phases of the illness can be crucial to the overall treatment process."

Because the depressive symptoms associated with bipolar disorder are also seen in major depressive disorder, a proper diagnosis can be difficult to achieve. In fact, studies show that as many as 69% of people with bipolar disorder were misdiagnosed, with the most frequent misdiagnosis being major depressive disorder. This misdiagnosis can lead to unfocused treatment that may exacerbate the disease.(6)

SEROQUEL is the #1 prescribed atypical antipsychotic in the United States.(7) With a well-established safety and efficacy profile, SEROQUEL has had more than 19 million patient exposures worldwide since its launch in 1997. In 2005, global sales for SEROQUEL reached $2.8 billion.


SEROQUEL is indicated for the treatment of depressive episodes in bipolar disorder; acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; and schizophrenia. Patients should be periodically reassessed to determine the need for treatment beyond the acute response. SEROQUEL is not approved for the treatment of major depressive disorder.

Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death compared to placebo (4.5% vs. 2.6% respectively). SEROQUEL is not approved for the treatment of patients with dementia-related psychosis. (see Boxed Warning)

Suicidality in children and adolescents - antidepressants increased the risk of suicidal thinking and behavior (4% vs 2% for placebo) in short-term studies of 9 antidepressant drugs in children and adolescents with major depressive disorder and other psychiatric disorders. Patients started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SEROQUEL® is not approved for use in pediatric patients. (see Boxed Warning)

Prescribing should be consistent with the need to minimize the risk of tardive dyskinesia. A rare condition referred to as neuroleptic malignant syndrome has been reported with this class of medications, including SEROQUEL.

Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics, including SEROQUEL. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing.

Precautions include the risk of seizures, orthostatic hypotension and cataract development.

The most commonly observed adverse events associated with the use of SEROQUEL in clinical trials were dry mouth, somnolence, sedation, dizziness, asthenia, constipation, abdominal pain, postural hypotension, pharyngitis, weight gain, SGPT increase, dyspepsia and lethargy.

Please see the full Prescribing Information including Boxed Warnings for SEROQUEL available at

About Bipolar Disorder**

More than seven million American adults are affected by bipolar disorder, a serious psychiatric condition also known as manic depressive illness.(1) Bipolar disorder consists of recurring episodes of mania and depression. Bipolar I disorder is characterized by one or more manic or mixed episodes, often with episodes of major depression, whereas bipolar II disorder is distinguished by one or more major depressive episodes accompanied by at least one hypomanic episode.(8) In the long term, patients with bipolar I disorder experience depressive symptoms -- including prolonged periods of sadness, loss of energy, persistent lethargy, and recurring thoughts of death or suicide(9) - three times longer than manic symptoms.(2) Similarly, patients with bipolar II disorder spend almost forty times longer in the depressed state than in hypomania.(10) Bipolar disorder is often misdiagnosed as unipolar depression. This misdiagnosis can lead to unfocused treatment that may exacerbate the disease. In fact, many patients face up to ten years without appropriate treatment before a correct diagnosis is made.(6) Up to 50 percent of patients with bipolar disorder attempt suicide, and approximately 10 to 15 percent complete suicide.(11)

About AstraZeneca

AstraZeneca is a major international health care business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $23.95 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. In the United States, AstraZeneca is a $10.77 billion healthcare business with more than 12,000 employees. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For more information about AstraZeneca, please visit:

This press release contains forward-looking statements with respect to AstraZeneca's business. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report/Form 20-F for 2005.


1. Hirschfeld RMA, Calabrese JR, Weissman MM, et al. Screening for Bipolar in the Community. J Clin Psychiatry. 2003; 64:53-59.

2. Judd LL, Akiskal HS, Schettler PJ, et al. The Long-term Natural History of the Weekly Symptomatic Status of Bipolar I Disorder. Arch Gen Psychiatry. 2002; 59:530-537.

3. Calabrese, Hirschfeld et al. Impact of Depressive Symptoms Compared with Manic Symptoms in Bipolar Disorder: Results of a U.S. Community-Based Sample. J Clin Psychiatry. 2004;65(11):1499-504.

4. Calabrese JR, Keck PE, Macfadden W, et al, for the BOLDER Study Group. A randomized, double-blind, placebo-controlled trial of quetiapine in the treatment of bipolar I or II depression. Am J Psychiatry. 2005; 162:1351- 1360.

5. Thase ME, Macfadden W, McCoy R, Chang W, Calabrese JR. Confirmation of the Efficacy of Quetiapine Monotherapy in Bipolar Depression in a Second Double-Blind, Placebo-Controlled Study: The BOLDER II Study. Presented at the Annual Meeting of the American Psychiatric Association, 2006, Toronto, Canada. Poster NR600.

6. Hirschfeld RMA, Lewis L, Vornik LA. Perceptions and Impact of Bipolar Disorder: How Far Have We Really Come? Results of the National Depressive and Manic- Depressive Association 2000 Survey of Individuals With Bipolar Disorder. J Clin Psychiatry. 2003; 64:161-174.

7. All atypical prescriptions: Total prescriptions Jan 06 to August 06. IMS Health. National Prescription Audit.

8. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. Fourth Edition Text Revision. Washington DC: 2000.

9. Introduction to Depression and Bipolar Disorder. Available at: Accessed July 28, 2006.

10. Judd LL, Akiskal HS, Schettler PJ, et al. A Prospective Investigation of the Natural History of the Long-term Weekly Symptomatic Status of Bipolar II Disorder. Arch Gen Psychiatry. 2003; 60:26 -269.

11. Oquendo MA, Chaudhury SR, Mann JJ. Pharmacotherapy of Suicidal Behavior in Bipolar Disorder. Archives of Suicide Research. 2005; 9(3):237- 250.

12. Montgomery-Åsberg Depression Rating Scale (MADRS).

*Depression scores were measured by the Montgomery-Åsberg Depression Rating Scale (MADRS).(4),(5) The MADRS scale measures the severity of a number of depressive symptoms including sadness, tension, sleep, appetite, energy, concentration, and suicidal ideation.(12) The MADRS score decreases as depressive symptoms improve. In BOLDER I, mean change in MADRS scores were (-)16.4 for SEROQUEL 300 mg and (-)16.7 for SEROQUEL 600 mg vs. (-)10.3 for placebo at week eight; (both p's<.001 vs. placebo).4 The corresponding mean changes in BOLDER II were (-)16.9,(-)16.0, and (-)11.9, respectively (both p's<.001 vs. placebo). In BOLDER I and II, improvement in MADRS total score with both doses of SEROQUEL (600 mg/day and 300 mg/day) was significantly greater than placebo at every assessment (p<0.01) including week one.4

***As measured by Quality of Life Enjoyment and Satisfaction Questionnaire (QLES-Q).

Source: AstraZeneca

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