Repligen Corporation (NASDAQ:RGEN) today announced that it has received
a Complete Response Letter (CRL) from the U.S. Food & Drug
Administration (FDA) regarding the Company’s New Drug Application (NDA)
for RG1068 (synthetic human secretin). RG1068 was evaluated in a Phase 3
study to improve detection of pancreatic duct abnormalities in
combination with MRI in patients with known or suspected pancreatitis.
The CRL indicates that the FDA has completed its review of the RG1068
NDA and has determined that additional clinical efficacy and safety
trial data will be required to support potential approval of the NDA.
There were no specific safety concerns cited in the CRL, although safety
will continue to be monitored in conjunction with any future clinical
trial. No deficiencies were cited in the CRL with respect to the
manufacturing, pharmacology or toxicology sections of the NDA.
“We will continue to engage in dialogue with the FDA to determine the
design and scope of a clinical program that will address the agency’s
requirements for approval of RG1068,” said Walter C. Herlihy, Ph.D.,
President and Chief Executive Officer of Repligen. “We believe that
RG1068, if approved, will provide a safe and effective means to
non-invasively image the pancreas with MRI and will meet an important
unmet medical need for patients with pancreatitis.”
Repligen filed its NDA for RG1068 on December 21, 2011 based on the
re-read of Phase 3 clinical trial data. On February 21, 2012, the FDA
accepted the NDA filing and granted it priority review based on its
prior Fast Track designation. In addition, on March 5, 2012, Repligen
submitted a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) that was successfully validated for full review
by the EMA’s Committee for Medicinal Products for Human Use.
About Repligen Corporation
Repligen Corporation is a leading supplier of critical biologic products
used to manufacture biologic drugs. Repligen also applies its expertise
in biologic product development to RG1068, a synthetic hormone being
developed as a novel imaging agent for the diagnosis of a variety of
pancreatic diseases. In addition, the Company has two central nervous
system (CNS) rare disease programs in Phase 1 clinical trials.
Repligen’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. Investors are cautioned that
statements in this press release which are not strictly historical
statements, including, without limitation, express or implied statements
regarding FDA approval of our NDA for RG1068, EMA approval of our MAA
for RG1068, future financial performance and position, plans and
objectives for future operations, plans and objectives for product
development, and product sales and other statements identified by words
like “believe,” “expect,” “may,” “will,” “should,” “seek,” or “could”
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:
our ability to obtain FDA approval for our NDA for RG1068, including the
design, timing, cost and similar uncertainties related to additional
clinical studies that the FDA may require for approval; whether EMA will
require additional clinical studies before approving our MAA for RG1068
and similar uncertainties regarding such additional clinical studies;
our ability to develop and commercialize products and the market
acceptance of our products; reduced demand for our products that
adversely impacts our future revenues, cash flows, results of operations
and financial condition; our ability to obtain other required regulatory
approvals; the success of current and future collaborative or supply
relationships; our ability to compete with larger, better financed
bioprocessing, pharmaceutical and biotechnology companies; our ability
to successfully integrate Repligen Sweden AB; the success of our
clinical trials; new approaches to the treatment of our targeted
diseases; our compliance with all FDA and EMEA 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 capabilities; our volatile stock price; and
other risks detailed in Repligen’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 management’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.
