EVANSTON, Ill.--(BUSINESS WIRE)--May. 15, 2009--
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that it has
determined to wind down its business operations and carry out an orderly
disposition of its assets.
Following its review and analysis of the complete response letter
received from the Food and Drug Administration on April 30, 2009,
Northfield determined that further clinical development of a
reformulated version of its PolyHeme® human red cell substitute product,
including additional clinical trials, would likely be required before it
could again seek to obtain FDA approval. Northfield concluded that the
time and substantial expense required to complete this additional
clinical development, together with significant uncertainty that FDA
approval would ultimately be obtained, made it unlikely that sufficient
additional capital could be raised to support such further product
On May 8, 2009, Northfield announced that it had terminated
substantially all operational and staff employees at its manufacturing
facility and headquarters.
Northfield cautioned that in view of the Company’s obligations to
creditors, expenses expected to be incurred in connection with the wind
down process and uncertainty regarding the realizable value of the
Company’s non-cash assets, no assurance can be given that any amounts
will be available for distribution to shareholders in connection with
the winding down of the Company’s business. Northfield has retained
counsel to explore the options available to wind down its business.
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 Statements
This press release may contain forward-looking statements within the
meaning of the federal securities laws. 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
risks and uncertainties, including those described from time to time in
our periodic reports filed with the Securities and Exchange Commission.
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.
Tom Laughran, 312-932-2834
Northfield Laboratories, 847-864-3500