WALTHAM, Mass., Nov. 21 /PRNewswire-FirstCall/ -- Repligen Corporation announced today that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) granted orphan drug designation to RG1068, synthetic human secretin, for use with magnetic resonance imaging (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. The designation also provides for benefit from certain tax credits and waives the company’s obligation to pay the FDA application user fees for this product as required by the Prescription Drug User Fee Act. Repligen is currently conducting a multi-center, Phase 2/3 clinical trial of RG1068 as an agent to improve the detection of structural abnormalities of the pancreatic ducts during MRI imaging of the pancreas as well as a Phase 1 investigator study to assess the utility of secretin for functional imaging of the pancreas. The U.S. Orphan Drug Act provides incentives for companies developing and marketing therapies for rare diseases, defined as those affecting fewer than 200,000 Americans.
“We are very pleased to receive Orphan Drug Designation from the FDA,” stated Walter C. Herlihy, President and Chief Executive Officer of Repligen. “We believe there may be more than 100,000 pancreatic MRI’s 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 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 following secretin administration harnesses the natural biologic properties of the hormone and may improve 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.
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 currently market two commercial products, Protein A and SecreFlo(R), 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.
Repligen Corporation
CONTACT: Walter C. Herlihy, Ph.D., President and Chief Executive Officer,+1-781-419-1900, or Laura Whitehouse, Vice President, Market Development,+1-781-419-1812, both of Repligen Corporation
Web site: http://www.repligen.com//
