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Repligen Announces Completion of Patient Enrollment in Phase 2b Clinical Trial of RG2417 for Bipolar Depression
Date:9/30/2010

recruited into this study was 31.3 compared to 30.4 in the Phase 2a study and there has been a high degree of fidelity between the MADRS scores determined by the raters and the patient's self-assessment of depression symptoms during the 8-week treatment period.  To date, there have been no serious adverse events determined to be related to RG2417, which continues to support an advantageous tolerability and safety profile for the drug.

"We are very pleased to have completed the patient enrollment phase of this study," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation.  "We believe that this study has been adequately powered to detect a potential benefit of treatment with RG2417 consistent with our Phase 2a results."

This study was designed to confirm and extend the results of a Phase 2a study in which 6 weeks of treatment with RG2417 improved the symptoms of bipolar depression when compared to placebo as measured by the MADRS.  The positive effect of treatment with RG2417 in the Phase 2a study was primarily observed in patients with a significant history of disease as determined by the number of episodes of mania and depression experienced during their lifetime.  The Phase 2a results demonstrated that RG2417 was safe and well tolerated.

Bipolar disorder, also known as manic depression, is an illness marked by extreme changes in mood, thought, energy and behavior in which a person's mood can alternate between the "poles" of mania and depression.  Bipolar disorder is a chronic illness associated with substantial morbidity and mortality, ranking worldwide behind unipolar depression and alcohol abuse among psychiatric illnesses for related disabilities and overall economic burden of illness.  The lifetime financial burden of bipolar disorder in the United States is about $600,000 per patient, depending on resistance to treatment and persistence of symptoms.  Although several the
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