New data show the efficacy of EQUETRO in patients with Bipolar I Disorder

05/25/05

Patients were previously taking valproate or lithium

Atlanta, Ga May 24, 2005 Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that EQUETROTM (carbamazepine extended-release capsules) are effective in significantly reducing the manic symptoms in patients with Bipolar I Disorder previously taking valproate or lithium, according to a pooled analysis of two phase 3 trials, one of two posters about carbamazepine extended-release capsules presented today at a major medical meeting in Atlanta, Ga.

The FDA approved EQUETRO for the treatment of patients with acute manic and mixed episodes associated with Bipolar I Disorder. Individual studies estimate lifetime prevalence for Bipolar I Disorder at more than 2 million American adults, or between 0.6 to 3.3 percent for lifetime incidence.

"Carbamazepine extended-release capsules are an effective treatment option for patients with bipolar disorder," said Richard H. Weisler, M.D., adjunct professor of psychiatry at the University of North Carolina at Chapel Hill School of Medicine, adjunct assistant professor of psychiatry and behavioral sciences at Duke University Medical Center, and primary investigator of two carbamazepine extended-release capsule trials. "The advent of carbamazepine extended-release capsules as a treatment option is a significant milestone."

In a pooled analysis of placebo-controlled studies, patients taking EQUETRO who had been previously taking valproate or lithium (both with or without improvement of their symptoms) showed significant reduction in manic symptoms based on a standard measure of Young Mania Rating Scale (YMRS). Specifically, patients previously taking valproate had a reduction in their average YMRS scores by 10.8 on EQUETRO vs. 5.7 on placebo (p=0.04), and those previously treated with lithium had a reduction in their average YMRS scores by 11.6 on EQUETRO vs. 4.0 on placebo (p=0.03). The analysis involved 115 patients from the two randomized, double blind placebo-controlled trials. There is a need for further clinical trials that are prospectively designed.

About Bipolar Disorder
Bipolar disorder is one of the six leading mental disorders worldwide, according to the World Health Organization. Bipolar disorder is characterized by episodes of feeling overly "high" and/or irritable, called mania, and of depression, with periods of normal mood in between. Severe changes in energy and behavior go along with these changes in mood. The disorder can have devastating effects on an individual's life, although proper diagnosis and early treatment can usually alter the course of the illness.

Because of the severity of the illness, bipolar disorder is disruptive to patients, their families, friends and colleagues and can damage relationships, cause poor job or school performance and may result in suicide. Although bipolar disorder is not curable, patients are treatable and recovery is possible. Early diagnosis combined with drug therapy is key to optimal treatment.

About EQUETRO
EQUETRO received approval from the Food and Drug Administration on Dec. 10, 2004 for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder. The medication is available in 100 milligram (mg), 200 mg and 300 mg dosage strengths.

Important Safety Information
Physicians should ensure a patient is not taking any other form of carbamazepine before prescribing carbamazepine extended-release capsules. The most frequently reported adverse events for carbamazepine extended-release capsules were dizziness, drowsiness, unsteadiness, nausea and vomiting. Initiating therapy at the lowest possible effective dose can minimize adverse events. Aplastic anemia and agranulocytosis have been reported in association with the use of carbamazepine. Reports of transient or persistent decreased platelet or white blood cell count are not uncommon in association with the use of carbamazepine. Although the vast majority of cases of leukopenia have not progressed to the more serious conditions of aplastic anemia or agranulocytosis, complete pretreatment hematological testing should be obtained as a baseline. If a patient, in the course of treatment, exhibits low or decreased white blood cell or platelet count, the patient should be monitored closely. Patients should be monitored and discontinuation of the drug should be considered if any evidence of bone marrow depression occurs. Carbamazepine should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds. Because the possibility of a suicide attempt is inherent in bipolar disorder, close supervision of high-risk patients should accompany drug therapy.

Notes to editors
APA Poster # 309: Tuesday, May 24, 2005, 12:00 PM ET Georgia World Congress Center, Level 3, Rooms B302-B305 Efficacy of Switching to Carbamazepine Extended-Release Capsules in Bipolar Disorder Richard H. Weisler, MD; Robert Hirschfeld, MD; Thomas Gazda, MD; Terrence A. Ketter, MD; Paul E. Keck, Jr, MD; Alan Swann, MD; and Amir Kalali, MD.

Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

For further information on Shire, please visit the Company's website: www.shire.com.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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