Repligen Provides Regulatory Update for RG1068 New Drug Application; FDA Cancels Advisory Committee Meeting
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Repligen (NASDAQ:RGEN)
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Today : Thursday 26 April 2012
Repligen Corporation (NASDAQ:RGEN) announced today that midday yesterday, the FDA notified the Company that the FDA Advisory Committee meeting previously scheduled for May 31 to review RG1068 for pancreatic imaging has been cancelled by the FDA. The Company expects to receive a Complete Response letter on the previously announced June 21 PDUFA date requesting additional clinical trial data to support the New Drug Application (NDA).
“While we are disappointed in this result, we continue to believe that RG1068 is a safe and effective agent for imaging of the pancreatic ducts, and that it has the potential to meet a significant unmet patient need,” stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. “We intend to continue our dialogue with the FDA to assess a potential path forward for RG1068.”
RG1068 is a synthetic version of human secretin which was evaluated in a Phase 3 study to improve detection of pancreatic duct abnormalities in combination with MRI in patients with pancreatitis. On December 21, 2011 we filed a NDA, and on February 21, 2012, the FDA accepted the filing of our NDA and granted it priority review based on its prior Orphan Drug and Fast Track designations. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s goal for completing review of the NDA is June 21, 2012.
On March 5, 2012 we submitted an MAA to the EMA, which has been successfully validated for full review by the EMA’s Committee for Medicinal Products for Human Use. The U.S. and EU marketing applications are based on positive outcomes from a re-read of our Phase 3 clinical study, supporting the use of RG1068 in combination with MRI to improve detection of pancreatic duct abnormalities in patients with known or suspected pancreatitis.
About Repligen Corporation
Repligen Corporation is a leading supplier of critical biologic products used to manufacture biologic drugs. Repligen also applies its expertise in biologic product development to RG1068 (SecreFlo™), a synthetic hormone being developed as a novel imaging agent for the diagnosis of a variety of pancreatic diseases. In addition, the Company has two central nervous system (CNS) rare disease programs in Phase 1 clinical trials. Repligen’s corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested at www.repligen.com.
