WALTHAM, Mass., Nov. 21 /PRNewswire-FirstCall/ -- Repligen Corporation
(Nasdaq: RGEN) 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.
SOURCE Repligen Corporation
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Related links:
http://www.repligen.com/
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
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