Repligen announces completion of RG1068 pre-New Drug Application meeting with U.S. FDA

Repligen Corporation (NASDAQ: RGEN) today announced that the Company has concluded a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, RG1068 for improvement of magnetic resonance imaging (MRI) of the pancreas. The purpose of the meeting was to discuss the positive results of the "re-read" of the radiographic images from the Company's Phase 3 clinical trial and to reach agreement on the content and format of the proposed NDA for RG1068. Based on this meeting, we intend to submit our NDA as previously planned.

"The conclusion of this meeting brings us closer to our objective to obtain FDA approval and commercialize RG1068 in the U.S. to improve pancreatic imaging," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "RG1068 has been granted Fast Track Designation, and we intend to request that the FDA grant our application priority review when we file our NDA later this summer."

RG1068, a synthetic version of human secretin, stimulates the secretion of pancreatic fluid into the pancreatic ducts, thereby filling the ducts with water, which improves the ability to visualize pancreatic abnormalities. Identification of pancreatic duct abnormalities is important in the identification of cause and potential treatment options for diseases such as pancreatitis. The FDA has granted RG1068 Orphan Drug status and Fast Track Designation, a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need based on the need for safer, non-invasive tests to diagnose pancreatic disorders. There are approximately 300,000 MRI procedures conducted in the U.S. and Europe each year that could directly benefit from the addition of RG1068.

We believe that there may be additional uses for RG1068 and we intend to evaluate the ability of RG1068 to improve the detection of pancreatic cancer. Early detection of pancreatic cancer may increase the potential to treat the patient with surgery and improve patient outcomes. We will also seek to acquire products that are complementary to RG1068, which our sales force may be able to sell to gastroenterologists and radiologists.

Source: Repligen Corporation