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Repligen Concludes Pre-NDA Meeting with FDA for RG1068

^{Published on 2011-06-01 19:40:52 - Market Wire}
 

WALTHAM, Mass.--([ BUSINESS WIRE ])--Repligen Corporation (NASDAQ: RGEN) today announced that the Company has concluded a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, RG1068 for improvement of magnetic resonance imaging (MRI) of the pancreas. The purpose of the meeting was to discuss the positive results of the are-reada of the radiographic images from the Companya™s Phase 3 clinical trial and to reach agreement on the content and format of the proposed NDA for RG1068. Based on this meeting, we intend to submit our NDA as previously planned.

"RG1068 has been granted Fast Track Designation, and we intend to request that the FDA grant our application priority review when we file our NDA later this summer."

aThe conclusion of this meeting brings us closer to our objective to obtain FDA approval and commercialize RG1068 in the U.S. to improve pancreatic imaging,a stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. aRG1068 has been granted Fast Track Designation, and we intend to request that the FDA grant our application priority review when we file our NDA later this summer.a

RG1068, a synthetic version of human secretin, stimulates the secretion of pancreatic fluid into the pancreatic ducts, thereby filling the ducts with water, which improves the ability to visualize pancreatic abnormalities. Identification of pancreatic duct abnormalities is important in the identification of cause and potential treatment options for diseases such as pancreatitis. The FDA has granted RG1068 Orphan Drug status and Fast Track Designation, a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need based on the need for safer, non-invasive tests to diagnose pancreatic disorders. There are approximately 300,000 MRI procedures conducted in the U.S. and Europe each year that could directly benefit from the addition of RG1068.

We believe that there may be additional uses for RG1068 and we intend to evaluate the ability of RG1068 to improve the detection of pancreatic cancer. Early detection of pancreatic cancer may increase the potential to treat the patient with surgery and improve patient outcomes. We will also seek to acquire products that are complementary to RG1068, which our sales force may be able to sell to gastroenterologists and radiologists.

About Repligen Corporation

Repligen Corporation is a biopharmaceutical company focused on building an integrated company by developing and marketing innovative drugs that deliver the benefits of protein therapies in the fields of neurology and gastroenterology. We have a core competency in the development and manufacturing of biologics products, which is the basis for our bioprocessing business and we have out-licensed certain biologics intellectual property, which provide ongoing sources of revenue. Repligena™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. 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 future financial performance and position, managementa™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 protection, product development, manufacturing plans and performance, projected changes in the size of our markets, our market share and product sales and other statements identified by words like abelieve,a aexpect,a amay,a awill,a ashould,a aseek,a or acoulda 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: the success of our clinical trials; our ability to develop and commercialize products; our ability to obtain required regulatory approvals; 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; 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 Repligena™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 managementa™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.