Northfield Laboratories Inc. Announces Submission Of BLA For PolyHeme(R) - Human Hemoglobin-based Red Cell Substitute

Main Category: Blood / Hematology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 30 Oct 2008 - 7:00 PDT

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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.

Source
Sophia H. Twaddell
Vice President
Northfield Laboratories Inc.
and
Tom Laughran
Fleishman-Hillard

Northfield Laboratories Inc.

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