EVANSTON, Ill.--(BUSINESS WIRE)--Apr. 30, 2009--
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that it has
received a complete response letter from the U.S. Food and Drug
Administration pertaining to the Company’s Biologic License Application
for its investigational product, PolyHeme, indicated for the treatment
of life-threatening hemoglobin levels when blood transfusion is
indicated and red blood cells may not be available.
The letter states that FDA has completed its review of the Company’s BLA
and finds “that the information and data submitted are inadequate for
final approval action.” Specifically, FDA stated that the Company’s
pivotal study “… did not meet the pre-specified primary efficacy
endpoint,” and that “based on the totality of the data in the
application, FDA has determined that the data submitted do not support
the proposed indication.”
FDA also noted that “the safety data of all controlled studies reveal
that the administration of PolyHeme places the patients at a higher risk
of significant adverse events,” and stated that “therefore, in the
absence of clinical benefit, the risk:benefit assessment of the product
in trauma is unfavorable.”
Northfield is evaluating FDA’s response and is considering the options
for the Company going forward.
About Northfield Laboratories
Northfield Laboratories is developing a hemoglobin-based oxygen-carrying
red blood cell substitute, PolyHeme. PolyHeme is a solution of
chemically modified human hemoglobin that requires no cross-matching and
is therefore compatible with all blood types. It has an extended shelf
life in excess of 12 months. For further information, visit http://www.northfieldlabs.com.
Forward Looking Statement
This press release may contain forward-looking statements concerning,
among other things, Northfield's future business plans and strategies
and clinical and regulatory developments affecting our PolyHeme red
blood cell substitute product. These forward-looking statements are
identified by the use of such terms as "intends," "expects," "plans,"
"estimates," "anticipates," "should," "believes" and similar terms.
These forward-looking statements involve inherent risks and
uncertainties. Our actual results may therefore differ materially from
those predicted by the forward-looking statements because of various
factors and possible events, our potential inability to obtain FDA
approval to market PolyHeme commercially based on our BLA, our potential
inability to obtain adequate additional capital to continue our
business, our potential inability to maintain compliance with applicable
Nasdaq listing standards, our potential inability to obtain adequate
supplies of raw materials and to manufacture PolyHeme in commercial
quantities, our potential inability to market PolyHeme successfully, the
possibility that competitors will develop products that will render
PolyHeme obsolete or non-competitive, our potential inability to protect
our intellectual property rights, the outcome of a purported class
action lawsuit as described in our most recently filed quarterly report
on Form 10-Q, the possibility that we may be subject to product
liability claims and other legal actions, our dependency on a limited
number of key personnel, the uncertainty of third party reimbursement
for our product and other risks and uncertainties described from time to
time in our periodic reports filed with the Securities and Exchange
Commission, including our most recently filed annual report on Form 10-K
and quarterly report on Form 10-Q. These forward-looking
statements speak only as of the date of this press release. We do not
undertake any obligation to update or publicly release any revisions to
forward-looking statements to reflect events, circumstances or changes
in expectations after the time such statement is made. All subsequent
written and oral forward-looking statements attributable to Northfield
or any person acting on our behalf are qualified by this cautionary
statement.
Source: Northfield Laboratories Inc.
Northfield Laboratories Inc.
Sophia H. Twaddell, 847-864-3500
Vice
President, Corporate Communications
stwaddell@northfieldlabs.com
or
Fleishman-Hillard
Tom
Laughran, 312-751-3519
laughrant@fleishman.com
