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Repligen Announces Submission Of Marketing Authorization Application In EU For SecreFlo™ To Improve Pancreatic Imaging In Patients With Pancreatitis

Stocks in this article: RGEN

Please replace the forward looking statement with the following corrected version.

The corrected release reads:


- Follows on U.S. FDA Grant of Priority Review for SecreFlo™ NDA -

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.

“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.”

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