Repligen Announces FDA Advisory Committee Date for SecreFlo™ NDA
Repligen Corporation (NASDAQ: RGEN) today announced that the U.S. Food and Drug Administration's Gastrointestinal Drugs Advisory Committee will meet on May 31, 2012 to discuss the Company's New Drug Application (NDA) for SecreFlo™ for the improved detection of pancreatic duct abnormalities in combination with magnetic resonance imaging (MRI) in patients with pancreatitis. Publicly available briefing documents for the meeting are expected to be posted to the FDA website two business days in advance of the Committee meeting.
The SecreFlo™ NDA was submitted on December 21, 2011 and was granted Priority Review by the FDA with a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2012. Priority Review designation is given to product candidates that offer a significant improvement in the treatment, diagnosis or prevention of a disease or that address an unmet medical need.
Walter C. Herlihy, President and Chief Executive Officer of Repligen, said, “The Advisory Committee assigned to review the SecreFlo™ NDA will include relevant experts in the field of gastroenterology. The Committee meeting and our preparations for it provide an excellent opportunity to engage with a broader network of thought leaders as we near the potential FDA approval of SecreFlo™.”
Clinical Basis for SecreFlo™ NDA
The SecreFlo™ NDA was submitted to the FDA 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 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 with minimal loss in specificity. 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, 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.
SecreFlo™ is a synthetic version of the human hormone secretin. When used in combination with magnetic resonance imaging (MRI), SecreFlo™ offers a safe, reliable and lower-cost alternative to the diagnostic use of endoscopic retrograde cholangio-pancreatography (ERCP) in examining and evaluating patients with pancreatitis. The medical community has recognized the need for a safer diagnostic approach based on documented morbidity and mortality risks associated with the diagnostic use of ERCP and current practice recommendations issued by the National Institutes of Health (NIH). MRI offers a safer and noninvasive alternative to diagnostic ERCP; however, its utility is currently limited by the lack of an approved agent to clarify MRI images of the pancreatic ducts in order to achieve a definitive diagnosis. SecreFlo™ in combination with MRI is designed to fill this unmet need. There are approximately 300,000 abdominal MRI procedures conducted in the U.S. and Europe each year that may directly benefit from the addition of SecreFlo™.
In addition to priority review designation, SecreFlo™ has also been granted Orphan Drug status in the U.S., which qualifies Repligen to receive seven years of U.S. market exclusivity for SecreFlo™, if approved.
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 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.
This press release contains forward-looking statements, which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, express or implied statements regarding future financial performance and position, the Food and Drug Administration approval of our NDA for SecreFlo™, plans and objectives for future operations, plans and objectives for product development, plans and objectives for regulatory approval, product development, our market share and product sales and other statements identified by words like “believe,” “expect,” “may,” “will,” “should,” “seek,” or “could” and similar expressions, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: our ability to develop and commercialize products and the market acceptance of our products; reduced demand for our products that adversely impacts our future revenues, cash flows, results of operations and financial condition; the ability to obtain, and the timing and receipt of, FDA approval for our NDA; our ability to obtain other required regulatory approvals; the success of current and future collaborative or supply relationships; our ability to compete with larger, better financed bioprocessing, pharmaceutical and biotechnology companies; the success of our clinical trials; new approaches to the treatment of our targeted diseases; our compliance with all Food and Drug Administration and EMEA regulations; our ability to obtain, maintain and protect intellectual property rights for our products; the risk of litigation regarding our intellectual property rights; our limited sales capabilities; our volatile stock price; and other risks detailed in Repligen's annual report on Form 10-K on file with the Securities and Exchange Commission and the other reports that Repligen periodically files with the Securities and Exchange Commission. Actual results may differ materially from those Repligen contemplated by these forward-looking statements. These forward looking statements reflect management's current views and Repligen does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date hereof except as required by law.
Laura L. Whitehouse, 781-419-1812
Vice President, Market Development