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Repligen Reports Fourth Quarter and Fiscal Year 2009 Financial Results
Date:6/11/2009

ical need. There are more than 300,000 MRI procedures conducted in the U.S. and Europe each year that could benefit from the use of RG1068.

RG2417 for Bipolar Disorder

We are currently enrolling a Phase 2b clinical trial of RG2417, an oral formulation of uridine, in patients with bipolar depression. This is a multi-center, randomized, double-blind, placebo-controlled clinical trial in which approximately 150 patients with bipolar depression will receive either RG2417 or a placebo twice a day for eight weeks. The study is designed to assess the safety and efficacy of RG2417 on the symptoms of depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and the Clinical Global Impression of Change in Bipolar Disorder scale (CGI-BP-C). The design of the ongoing study is based on the positive results of a Phase 2a study in which 83 patients received either RG2417 or a placebo twice a day for six weeks. Over the six-week treatment period, the study demonstrated a statistically significant improvement in the symptoms of depression in the patients receiving RG2417 when compared to placebo on the MADRS (p=0.01) and the CGI-BP-C (p=0.04). In March, Repligen exclusively licensed worldwide rights to a patent application from McLean Hospital for the use of uridine in the treatment of patients with bipolar disorder. If issued, the patent would remain in force until at least 2025. More than two million adults in the U.S. have bipolar disorder.

HDAC Inhibitors for Friedreich's Ataxia and Huntington's Disease

We are currently developing inhibitors of histone deacetylases (HDACs) for the treatment of inherited neurodegenerative diseases such as Friedreich's ataxia and Huntington's disease. Preclinical studies have shown that HDAC inhibitors have the potential to arrest disease progression in Friedreich's ataxia, a novel approach to treating this debilitating disease. We have identified sever
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