WALTHAM, Mass., April 16 /PRNewswire-FirstCall/ -- Repligen Corporation (Nasdaq: RGEN) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the development program for RG1068, synthetic human secretin, to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI). Fast track is a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need. Once a drug receives Fast Track designation, frequent communication between the FDA and the sponsor is encouraged throughout the development and review process. In addition, many drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review, under which the time it takes the FDA to review a new drug application is reduced. The goal for completing a Priority Review is six months.
"We are very pleased that the FDA has recognized the urgent need for a safe procedure to assess pancreatic abnormalities," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "We expect to complete patient enrollment in our Phase 3 clinical trial this year and, if successful, file an NDA in 2009."
Repligen is currently conducting a Phase 3 clinical trial to evaluate the use of RG1068, synthetic human secretin, to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI). The Phase 3 study is a multi-center, baseline-controlled, single dose study in which approximately 250 patients will receive an unenhanced MRI followed by a secretin-enhanced MRI of the pancreas. The study is designed to assess the sensitivity and specificity of secretin-enhanced MRI to improve the ability to detect pancreatic duct abnormalities relative to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis. The study is being conducted at approximately 30 clinical sites within the United States and Canada.
Repligen previously conducted a multi-center, baseline-controlled, single dose Phase 2 study in which 76 patients with a history of pancreatitis received an unenhanced pancreatic MRI followed by a RG1068-enhanced pancreatic MRI. The results of the study showed an improvement in sensitivity of detection of structural abnormalities of the pancreatic duct of approximately 20% with no loss in specificity. In addition, the study showed highly significant increases in physician confidence in their ability to identify structural abnormalities, the number of pancreatic duct segments visualized and improvement in the overall quality of the MRI images.
RG1068 is a synthetic version of human secretin, a natural gastrointestinal hormone involved in the process of digestion. Secretin has been used for many years by gastroenterologists in combination with endoscopy, an invasive procedure to evaluate and treat diseases of the pancreas and gallbladder. There are risks associated with the use of endoscopy, which have generated interest in the development of safer non-invasive tests to diagnose gastrointestinal disorders. The use of secretin in combination with a non-invasive procedure such as MRI can improve the detection of abnormalities and increase the diagnostic quality of the MRI image of the pancreas. The use of MRI is attractive for patient care as it can obviate the need for more risky invasive procedures. There are approximately 150,000 pancreatic MRIs conducted in the U.S. each year that could benefit from enhancement with secretin.
About Repligen Corporation
Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for diseases that affect the central nervous system. In addition, we are the world's leading supplier of recombinant Protein A, the sales of which partially fund the advancement of our development pipeline while supporting our financial stability. Repligen's corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from http://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. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance and position, management's strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market and our other target markets and projected growth in product sales, 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: the success of current and future collaborative relationships, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration 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 and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in Repligen's filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.
SOURCE Repligen Corporation
