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Repligen Reports Second Quarter Fiscal Year 2009 Financial Results
Date:11/6/2008

signation by the FDA, a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. There are more than 300,000 procedures conducted in the United States and Europe each year that may benefit from enhancement with RG1068.

RG2417 for Bipolar Disorder

We have initiated 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. This study is designed to assess the efficacy and safety 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). This 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).

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

We are currently developing inhibitors of histone deacetylases (HDACs) which may have utility in treating progressive, inherited neurodegenerative diseases such as Friedreich's ataxia and Huntington's disease. We have identified several potential clinical candidates and are further characterizing these leads in animal models for their pharmacologic, toxicologic and pharmacodynamic profiles. Repligen announced receipt of a $1 million research grant from the Muscular Dystrophy Association and a $125,000 grant from the Friedreich's Ataxia Research Alliance and the National Ataxia Foundation. The grants
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1. Repligen Initiates Phase 2b Clinical Trial of RG2417 in Bipolar Disorder
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