Today, Repligen Corp., already leading with a strong presence in critical components used in the manufacture of biologic drugs, announced they are taking development of their SecreFlo™ hormone, designed for use as an imaging enhancer for diagnosing pancreatic diseases, to the next level with the submission of an NDA (new drug application).
SecreFlo (RG1068, synthetic human secretin) is a powerful tool for vastly improving detection rates of abnormalities in the ducts of the pancreas during MRI examination for pancreatitis, which is characterized by such structural abnormalities and related serious abdominal pain. Increased sensitivity, image quality and the overall ability to have total visualization of the entire length of the pancreatic ducts, was validated for SecreFlo in the pivotal Phase 3 study, where MRI examination using the agent generated statistical improvements across all these key factors.
SecreFlo helps to stimulate fluid secretion in the pancreas, thus making visualization by MRI more effective. The multi-center, baseline controlled and single dose Phase 3 study of SecreFlo included 258 patients enrolled via 23 clinical sites throughout the U.S. and Canada. Evaluation for 10 pre-specified abnormalities against image quality, overall visualization and diagnostic capability data points was solid. Review by the team of three independent radiologists of the radiographic image data overturned the original analysis soundly, which was determined to be flawed and therefore inconclusive, amply satisfying the “re-read” agreed to by both FDA and the European Medicines Agency.
The NDA has been filed with a request for priority review, which would mean a 6-month review period if the request is granted. This is great news for radiologists who routinely struggle with limitations of MRI alone, trying to decipher from significantly less combined incoming visuals and instrumentation data whether or not such duct abnormalities are present. Needless to say, the quality of life and care improvement for patients is also immense.
President and CEO of REGN, Walter Herlihy, thanking the dedication and hard work of employees, clinical investigators and consultants, praised this milestone achievement for the Company as having the potential to become a standard tool for gastroenterology/radiology professionals to more competently diagnose and treat their patients.
Chief Medical Officer at RGEN, Dr. Michael Hall, projected a 60-day window for a response from FDA regarding acceptance of the application and priority review status, pledging to continue diligently working hand-in-hand with FDA as the process moves forward. Hall assured investors that every step was being taken to ensure complete success of the Company’s first NDA and pointed to previous fast track designation status granted to SecreFlo as a non-invasive alternative to dangerous diagnosis/treatment procedures like ERCP (endoscopic retrograde cholangiopancreatography; essentially, gastrointestinal endoscopy plus x rays).
The huge market, with over 300k MRIs in the US/Europe alone annually that could benefit from SecreFlo, and obvious potential is underwritten by a previously granted orphan drug designation, qualifying RGEN for seven years of marketing exclusivity if the Company is first to obtain approval for SecreFlo in combination with MRI. Additionally, RGEN is already planning a similar strategic move in Europe with the move to file a marketing authorization application next quarter.
For more information on the NDA, or on Repligen Corp., please visit the Company’s website at: www.Repligen.com
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