Repligen Corporation (NASDAQ:RGEN) announced today that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for SecreFlo™ to improve detection of pancreatic duct abnormalities in patients with pancreatitis. SecreFlo™ (synthetic human secretin) is used in combination with magnetic resonance imaging (MRI) and is the Company's lead diagnostic imaging product candidate. The MAA submission for SecreFlo™ follows on the recent grant of Priority Review by the U.S. Food and Drug Administration (FDA) for the Company's new drug application (NDA) for SecreFlo™ in the same indication. Both the MAA and NDA filings are based on positive outcomes from the Company's Phase 3 clinical trial results.
“These accomplishments bring us all one step closer to the goal of providing a safe, reliable and cost-effective alternative to invasive endoscopic procedures for evaluating patients with pancreatitis.”
"This MAA submission in the EU and the recent grant of priority review for our SecreFlo™ NDA in the U.S. are important achievements that reflect the commitment of our employees and clinical investigators to this program," said Walter C. Herlihy, Ph.D., President and Chief Executive Officer of Repligen. "These accomplishments bring us all one step closer to the goal of providing a safe, reliable and cost-effective alternative to invasive endoscopic procedures for evaluating patients with pancreatitis."
"We are pleased to have filed the SecreFlo™ MAA and look forward to working closely with the European regulators to address any questions during the review process," stated Dr. Michael L. Hall, Chief Medical Officer of Repligen. "We believe SecreFlo™ will become an important diagnostic tool to help radiologists and gastroenterologists confidently plan the best course of treatment for their patients with pancreatitis. We also believe that there are significant cost-savings associated with the use of SecreFlo™ and MRI versus endoscopy, which would be well-received by healthcare payers."
We anticipate receiving a response from the EMA by March 21, following validation of completeness of the SecreFlo™ MAA. Pending successful validation, the agency would then require its Committee for Medicinal Products for Human Use (CHMP) to complete a full scientific Assessment and deliver its opinion on marketing approval for SecreFlo™, a process that is expected to conclude in 10 to 12 months.
Clinical Basis for SecreFlo™ NDA
As with the SecreFlo™ NDA in the U.S., the MAA was submitted to the EMA based on positive outcomes from the re-read of the Company's Phase 3 clinical study. This pivotal study was a multi-center, baseline controlled, single dose study in which 258 patients were enrolled at 23 clinical sites in the U.S. and Canada. Each patient in the study received an MRI of the pancreas with and without SecreFlo™ and separately underwent endoscopy (ERCP) as a diagnostic reference. The MRI images were randomized and independently read and reviewed by three central radiologists.
The Phase 3 study's co-primary endpoints were achievement of a statistically significant improvement in sensitivity of detection of abnormalities of the pancreatic ducts with minimal loss in specificity by two of the three central radiologists reading the MRI images. The study met its primary endpoints, demonstrating that the addition of SecreFlo™ to MRI resulted in a highly statistically significant improvement (p<0.0001) in sensitivity of detection of ten prespecified abnormalities of the pancreatic ducts, with minimal loss in specificity (<7.5%). All three secondary endpoints were also met, with each demonstrating highly statistically significant improvements (p<0.0001) in image quality, visualization of the main pancreatic duct and diagnostic confidence when compared to MRI alone. In addition, SecreFlo™ was shown to be safe and well tolerated. A radiologist's ability to safely and more confidently identify and characterize pancreatic duct abnormalities has the potential to substantially improve "next-step" clinical decisions (patient triage) and patient outcomes.
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