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
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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 L. Whitehouse, Vice
President, Market Development, +1-781-419-1812
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