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Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results
Date:6/12/2008

feedback from the Food and Drug Administration (FDA) we plan to initiate a Phase 2b clinical trial of RG2417, an oral formulation of uridine in patients with bipolar disorder in the fall. This will be a multi-center, parallel arm placebo-controlled, clinical trial in which approximately 150 patients with bipolar disorder will receive either RG2417 or a placebo twice a day for eight-weeks. This study is designed to assess the efficacy and safety of RG2417 on the symptom of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). Gary S. Sachs, M.D., founder and director of the Bipolar Clinic and Research Program at the Massachusetts General Hospital and an Associate Professor of Psychiatry at the Harvard Medical School will be the Principal Investigator of this study.

In addition, we announced today that we have completed our assessment of the data from the previous Phase 2a study and have found that patients with a history of more frequent symptoms demonstrated greater improvements when treated with RG2417 than patients without a history of frequent symptoms. For example, patients with more than 5 episodes of depression over their entire life (n=50) demonstrated greater improvements in their symptoms of depression compared to patients with 5 or fewer lifetime episodes of depression. From weeks 2-6 of treatment, the patients with more than 5 lifetime episodes of depression who received RG2417 had an average improvement on MADRS of 5.5 points over placebo (p<0.001), compared to all patients in the study receiving RG2417 who had an average improvement on MADRS of 3.0 points over placebo (p=0.01) as previously reported. This result may reflect the difficulty in accurately diagnosing bipolar disorder in the absence of frequent symptomatology and will be used in the design and execution of the next study.

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