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Northfield Laboratories Analyst Meeting Highlights; Seeking Fast-Track Designation for PolyHeme

EVANSTON, Ill.--(BUSINESS WIRE)--Aug. 8, 2006--Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that the Company hosted a meeting of financial analysts and institutional investors this morning in New York. The program was made available to all interested Northfield shareholders via live webcast.

The Program

The program, Delivering Trauma Care Today and Tomorrow, included three presentations.

Ellen J. MacKenzie, Ph.D., Fred and Julie Soper Professor & Chair, Department of Health Policy & Management, Johns Hopkins Bloomberg School of Public Health, gave a presentation entitled Trauma Systems in the 21st Century: Current Status and Future Challenges. Dr. MacKenzie discussed access to trauma care in the United States, challenges facing the trauma system and improvements that may be seen in the future. She also discussed the impact trauma has on society, including healthcare costs, productivity losses from injury and death, and advocated for improved patients outcomes.

Christopher B. Colwell, M.D., FACEP, Medical Director, Denver Paramedic Division and Denver Fire Department, Associate Director, Emergency Department, Denver Health Medical Center, Associate Professor, Department of Surgery, Division of Emergency Medicine, University of Colorado Health Sciences Center, gave a presentation on EMS Systems at Work: Rural, Urban, and Everything in Between. Dr. Colwell outlined how trauma care is organized and delivered today and the challenges impacting the overall system. In addition, he discussed the different models of delivery, including hospital-based, third party services, private providers, fire department-based and various combinations. He also provided perspective on the variations in protocols and equipment and the roles of the medical director and other EMS personnel.

Fast-Track Designation

Steven A. Gould, M.D., Chairman and CEO, provided an update on Northfield's recently completed pivotal Phase III trial, the first planned commercial manufacturing facility, and the Company's plans to seek FDA approval for PolyHeme. As previously announced, Northfield looks forward to reporting top-line study results in the fall.

Dr. Gould also reported that the Company has applied for Fast Track designation for PolyHeme, for the treatment of life-threatening blood loss when an oxygen carrying fluid is required and red blood cells are not available. Fast Track is a feature of the FDA Modernization Act of 1997 and is intended to facilitate the development and expedite the review of products intended for the treatment of serious or life-threatening conditions and which demonstrate the potential to address an unmet medical need for such a condition. A product in a Fast Track development program is eligible for consideration for some or all of a number of programs for expediting product development and review. In particular, a BLA for a Fast Track drug development program ordinarily will be eligible for "priority" review by FDA. Priority review is requested at the time the BLA is submitted and FDA makes a decision as to whether to grant it as part of the agency's review of the application for filing.

"Now that the enrollment phase of our Phase III trial is complete, we are focusing on the remaining steps necessary for submission of a BLA," said Dr. Gould. "We believe PolyHeme qualifies for Fast Track designation based on its life-sustaining potential and we hope to be eligible for priority review when we submit our BLA next year."

Interested investors may access a replay of the webcast of the presentation at www.northfieldlabs.com. The replay will be available for two weeks.

About Northfield Laboratories

Northfield Laboratories Inc. is a leader in developing an oxygen-carrying red blood cell substitute for the treatment of life-threatening blood loss, when an oxygen-carrying fluid is required and red blood cells are not available. PolyHeme(R) is a solution of chemically modified human hemoglobin that requires no cross matching and is therefore compatible with all blood types. It has a shelf life in excess of 12 months. For further information, visit www.northfieldlabs.com.

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(R) 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 our ability to obtain FDA approval to market PolyHeme commercially, our ability to obtain Fast Track designation and priority review, the availability of capital to finance our clinical trials and ongoing business operations, our ability to obtain adequate supplies of raw materials and to manufacture PolyHeme in commercial quantities, our ability to market PolyHeme successfully, the possibility that competitors will develop products that will render PolyHeme obsolete or non-competitive, our ability to protect our intellectual property rights, the outcome of certain governmental inquiries and 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 quarterly report on Form 10-Q and annual report on Form 10-K. 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.


    CONTACT: Northfield Laboratories Inc.
             Sophia H. Twaddell, 847-864-3500
             stwaddell@northfieldlabs.com
             or
             Fleishman-Hillard
             Tom Laughran, 312-501-1909
             laughrant@fleishman.com

    SOURCE: Northfield Laboratories Inc.
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