Repligen Reports Phase 3 Clinical Trial Results of RG1068 in Pancreatic Imaging

WALTHAM, MA - December 9, 2009 - Repligen Corporation (NASDAQ: RGEN) reported today top-line results from a Phase 3 clinical trial to evaluate the safety and efficacy of RG1068, synthetic human secretin, to improve magnetic resonance imaging (MRI) of the pancreas in patients with a history of pancreatitis. The study's co-primary endpoints were improvements in sensitivity of detection of structural abnormalities of the pancreatic ducts using RG1068 in combination with MRI compared to MRI alone with minimal loss in specificity (<7.5%). The study design used endoscopy as the standard for determination of structural abnormalities. The predetermined criteria for a successful study were achievement of a statistically significant improvement in sensitivity with minimal loss in specificity from two of the three central radiologists reading the MRI images. In this study, one radiologist achieved a statistically significant improvement in sensitivity with RG1068 (p<0.001) while a second radiologist showed a trend but did not achieve statistical significance (p=0.088). There was minimal loss in specificity for all radiologists. While it was not a pre-specified endpoint, pooled data from all three radiologists resulted in a statistically significant improvement in sensitivity with RG1068 (p=0.005) with minimal loss in specificity.

source: Repligen