Repligen Receives FDA Fast Track Designation for RG1068 for Pancreatic Imaging

Repligen Corporation RGEN announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program for RG1068, synthetic human secretin, to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI). Fast track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. Once a drug receives Fast Track designation, frequent communication between the FDA and the sponsor is encouraged throughout the development and review process. In addition, many drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review, under which the time it takes the FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.

"We are very pleased that the FDA has recognized the urgent need for a safe procedure to assess pancreatic abnormalities," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "We expect to complete patient enrollment in our Phase 3 clinical trial this year and, if successful, file an NDA in 2009."

Repligen is currently conducting a Phase 3 clinical trial to evaluate the use of RG1068, synthetic human secretin, to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI). The Phase 3 study is a multi-center, baseline-controlled, single dose study in which approximately 250 patients will receive an unenhanced MRI followed by a secretin-enhanced MRI of the pancreas. The study is designed to assess the sensitivity and specificity of secretin-enhanced MRI to improve the ability to detect pancreatic duct abnormalities relative to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis. The study is being conducted at approximately 30 clinical sites within the United States and Canada.

(Published at: http://www.pharmalive.com/News/index.cfm?articleid=531950&categoryid=56)