Northfield Laboratories Inc. Announces Submission of BLA for PolyHeme®
October 29 2008 - 10:55AM
Business Wire
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today it has
submitted a Biologics License Application (BLA) to the Food and
Drug Administration (FDA) for PolyHeme�, the Company�s human
hemoglobin-based red cell substitute for the treatment of
life-threatening red blood cell loss when an oxygen-carrying fluid
is required and red blood cells are not available. Northfield also
requested Priority Review, based on the potential for PolyHeme to
address a critical, unmet medical need. �This submission is the
culmination of the development of PolyHeme for its initial clinical
indication,� said Steven A. Gould, M.D., Chairman and Chief
Executive Officer. �We firmly believe in PolyHeme�s potential to
save the lives of patients for whom blood transfusion is not an
option.� By regulation, the FDA has 60 calendar days to review the
BLA for completeness and to make a determination regarding Priority
Review of the application. About Northfield Laboratories Northfield
Laboratories is a leader in developing a hemoglobin-based
oxygen-carrying red blood cell substitute. The initial indication
we are seeking for our product PolyHeme� is the treatment of
life-threatening red blood cell loss when an oxygen-carrying fluid
is required and red blood cells are not available. 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, including the possibility that FDA may reject our BLA
submission as incomplete or otherwise not in compliance with
applicable FDA regulations, the possibility that FDA, even if it
accepts our BLA for filing, will not grant our request for Priority
Review, the possibility that even if Priority Review is granted,
FDA may not meet the required time periods for the review of our
BLA under applicable laws and regulations, our potential inability
to obtain FDA approval to market PolyHeme commercially based on our
BLA, our potential inability to regain compliance with applicable
Nasdaq listing standards, our need to obtain additional capital to
finance our ongoing business operations and the construction of an
expanded commercial-scale manufacturing facility, 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.
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