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, Delivering Trauma Care Today and Tomorrow, included
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.
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
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
CONTACT: Northfield Laboratories Inc.
Sophia H. Twaddell, 847-864-3500
Tom Laughran, 312-501-1909
SOURCE: Northfield Laboratories Inc.