Press Release: Repligen Corporation Reports Positive Phase 2 Clinical Trial Results of Secretin
Repligen Corporation Reports Positive Phase 2 Clinical Trial Results of Secretin for MRI Imaging of the Pancreas WALTHAM, Mass., May 10 -- Repligen Corporation announced today positive results from a Phase 2 clinical trial to evaluate the use of RG1068, synthetic human secretin, as an agent to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI). The study showed an improvement in sensitivity of detection of structural abnormalities of the pancreatic duct of approximately 20% with no loss in specificity, consistent with prior data and expectations. In addition, the study showed highly significant increases in the following three assessments: 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. Detailed visual assessment of the pancreatic ducts and identification of structural abnormalities is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis. This was a multi-center, baseline controlled, single dose study in which 80 patients with a history of pancreatitis received a secretin-enhanced MRI and an unenhanced MRI of the pancreas. All study operations and data analyses were conducted with protocols previously discussed with the U.S. Food and Drug Administration (FDA). "We are pleased with the successful outcome of our first prospectively defined, blinded, multi-center clinical study to assess the use of secretin to aid in the detection of structural abnormalities of the pancreas," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. "These quantitative results confirm what has previously been reported by physicians, and establishes a sound basis for discussions with the FDA regarding a clinical plan to receive marketing approval for secretin for MRI imaging of the pancreas. We believe there may be more than 100,000 potential MRI images of the pancreas in the U.S. each year that could benefit from the use of secretin." Secretin is 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 to improve the detection and delineation of normal and abnormal structures of the pancreas and to quantify pancreatic fluid production, harnesses the natural biologic properties of the hormone to increase the diagnostic quality of the MRI image. The use of MRI is attractive for patient care as it can obviate the need for more risky invasive procedures. The use of secretin in abdominal imaging may have application beyond improvements in detection of structural abnormalities. We are conducting several pilot studies to evaluate the use of secretin with MRI to assess among other things, the function of the pancreas. This study is based on the clinical observation that patients with pancreatic diseases have a reduced fluid production response to secretin stimulation and will be designed to confirm and quantify this observation. The Office of Orphan Products Development of the FDA granted Repligen orphan drug designation for RG1068, synthetic human secretin, for use with MRI of the pancreas. Orphan drug designation qualifies Repligen for seven years of exclusive marketing rights in the United States if the company is first to receive marketing approval for RG1068 for MRI imaging of the pancreas. 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 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.