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Updated Bipolar Disorder Guidelines include Seroquel as a first line therapy for Bipolar Depression on strength of BOLDER I and II data

CANMAT (Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder

ALDERLEY PARK, UK -- November 30, 2006 -- Updated CANMAT (Canadian) guidelines have been issued for the management and treatment of patients suffering from bipolar disorder. The guidelines consider Seroquel™ (quetiapine fumarate) as a first-line single medication for bipolar depression and a second-line option for the management of bipolar II depression1. Seroquel is currently licensed for 'the treatment of depressive episodes associated with bipolar disorder', in the United States only.

The updated CANMAT guidelines have today been published in Bipolar Disorders by the Canadian Network for Mood and Anxiety Treatments (CANMAT) and have been updated to ensure that they include all new data that have become available over the past 12 months including Seroquel BOLDER data.

"We felt that the data from BOLDER I and BOLDER II were so strong that it merited inclusion of Seroquel as a first-line option for bipolar depression in these guidelines " said Dr. Lakshmi N Yatham, MD, primary author of the CANMAT Guidelines and Professor of Psychiatry, University of British Columbia, Vancouver, Canada.

Results from the newly published BOLDER II (BipOLar DEpRession) study confirm the findings of BOLDER I Trial and indicate that Seroquel has potential as a single medication to treat major depressive episodes in patients with bipolar disorder. The results, which were recently published in the December issue of the Journal of Clinical Psychopharmacology, reinforce the positive findings of the landmark BOLDER I study, and have led the FDA to approve Seroquel for the treatment of depressive episodes associated with bipolar disorder for patients in the US in October 2006. This means that Seroquel is the first and only single medication approved by the FDA to treat both depressive and manic episodes associated with bipolar disorder.

BOLDER II, an 8-week, multicentre, placebo-controlled trial, found that patients treated with Seroquel 300 mg or 600 mg per day had significant improvements in their depression compared with placebo recipients (P≤0.001) as measured by the Montgomery-┼sberg Depression Rating Scale (MADRS).1 A wide range of patients participated in BOLDER II, including those with rapidly cycling disease and those with bipolar I and bipolar II disorders.

Today's publication of new guidelines follows the recent announcement from the National Institute of Clinical Excellence (NICE) in the UK who updated their guidelines in July 2006 to highlight appropriate treatment options, including Seroquel, when diagnosing patients with bipolar disorder and to ensure that more is done to correctly identify and treat bipolar disorder.

Approximately 3–4% of adults worldwide are affected by bipolar disorder, a serious psychiatric condition which was previously known as manic depressive illness2. Bipolar disorder is characterized by recurrent episodes of mania and, more commonly, depression. The disease is chronic and can create considerable problems for patients, spouses and family members if left untreated.

Beyond schizophrenia, bipolar mania and bipolar depression, the ongoing clinical development programme includes investigations of the use of Seroquel in bipolar maintenance. Regulatory filings for the treatment of schizophrenia with a sustained release formulation of quetiapine fumarate, Seroquel SR™, were submitted this year to regulatory authorities in the US, EU and other markets. Ongoing Seroquel SR™ clinical studies also cover major depressive disorder and generalized anxiety disorder. Seroquel is the number 1 prescribed atypical antipsychotic in the United States. 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.

REFERENCES:
1. Yatham LN et al. Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines for the management of patients with bipolar disorder: update 2006. Bipolar Disorders 2006:8: 1-19
2. Hirschfeld RMA, Calabrese JR, Weissman MM, et al. Screening for bipolar disorder in the community. J Clin Psychiatry. 2003;64:53-59.


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