News for 'RGEN' - (Repligen Provides Regulatory Update for RG1068 New Drug Application; FDA Cancels Advisory Committee Meeting)
WALTHAM, Mass., Apr 26, 2012 (BUSINESS WIRE) -- Repligen Corporation
(NASDAQ:RGEN) announced today that midday yesterday, the FDA notified the
Company that the FDA Advisory Committee meeting previously scheduled for May 31
to review RG1068 for pancreatic imaging has been cancelled by the FDA. The
Company expects to receive a Complete Response letter on the previously
announced June 21 PDUFA date requesting additional clinical trial data to
support the New Drug Application (NDA).
"While we are disappointed in this result, we continue
to believe that RG1068 is a safe and effective agent for imaging of the
pancreatic ducts, and that it has the potential to meet a significant unmet
patient need," stated Walter C. Herlihy, President
and Chief Executive Officer of Repligen. "We intend to
continue our dialogue with the FDA to assess a potential path forward for
RG1068."
RG1068 is a synthetic version of human secretin which was evaluated in a Phase 3
study to improve detection of pancreatic duct abnormalities in combination with
MRI in patients with pancreatitis. On December 21, 2011 we filed a NDA, and on
February 21, 2012, the FDA accepted the filing of our N DA and granted it
priority review based on its prior Orphan Drug and Fast Track designations.
Under the Prescription Drug User Fee Act (PDUFA), the
FDA's goal for completing review of the NDA is June
21, 2012.
On March 5, 2012 we submitted an MAA to the EMA, which has been successfully
validated for full review by the EMA's Committee for
Medicinal Products for Human Use. The U.S. and EU marketing applications are
based on positive outcomes from a re-read of our Phase 3 clinical study,
supporting the use of RG1068 in combination with MRI to improve detection of
pancreatic duct abnormalities in patients with known or suspected pancreatitis.
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 (SecreFlo(TM)), 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
SecreFlo(TM), EMA approval of our MAA for
SecreFlo(TM), future financial performance and position, plans and
objectives for future operations, plans and objectives for product development,
and product sales and other statem ents 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, including the design, timing, cost and similar uncertainties related to
additional clinical studies that FDA may require for approval; whether EMA will
require additional clinical studies before approving our MAA 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 compete with
larger, better financed bioprocessing, pharmaceutical and biotechnology
companies; the success of our clinical trials; new approaches to the treatment
of our targeted diseases; our compliance with all Food and Drug Administration
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 ci rcumstances that occur after the
date hereof except as required by law.
SOURCE: Repligen Corporation
CONTACT:
Repligen Corporation
Walter C. Herlihy, 781-419-1900
President & CEO
Copyright Business Wire 2012
-0-
KEYWORD: United States
North America
Massachusetts
INDUSTRY KEYWORD: Health
Biotechnology
Pharmaceutical
FDA
SUBJECT CODE: Product/Service
