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Repligen Reports Second Quarter Fiscal Year 2011 Financial Results
Date:11/2/2010

d benefit from RG1068, a potential market opportunity of over $100 million.

RG2417 for Bipolar Disorder We have completed enrollment in our Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. The study enrolled 175 patients at 29 clinical sites within the United States.  The primary objective of the Phase 2b study is to assess the efficacy of RG2417 on the symptoms of bipolar depression by demonstrating a greater improvement in the Montgomery-Asberg Depression Rating Scale (MADRS) score of the patients receiving RG2417 when compared to placebo over an 8-week treatment period.  MADRS is a standardized, rater-administered scale, which has been used for numerous drug trials in bipolar disorder.  In addition, the study will assess the safety of RG2417 in patients with bipolar depression including, lack of induction of mania as measured by the Young's Mania Rating Scale.  Additional secondary and exploratory objectives include improvements in the Clinical Global Impression scale, difference in MADRS scores after 8 weeks of therapy, and responder rate as defined as percent of patients with an improvement in MADRS score of greater than 50% from baseline to week 8.  We expect to report top-line results of the Phase 2b study in the first quarter of 2011.  

This study is 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.  In the Phase 2a study, a lower placebo effect was observed in those patients with more numerous episodes of mania and depression experienced during their lifetime resulting in a higher apparent therapeutic effect of RG2417, which will also be assessed in the Phase 2b study.

Bipolar disorder is a chronic illness associated with substantial morbidity and mortality, ranking worldwide behind unipolar depre
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