EVANSTON, Ill., May 11 /PRNewswire/ -- Management of Northfield
Laboratories Inc. (Nasdaq: NFLD) told investors at the Deutsche Banc
Alex. Brown Healthcare Conference yesterday that it was confident and
optimistic about bringing its blood substitute product, PolyHeme(TM), through
the regulatory review process, once its application is filed. Northfield, a
leading developer of an oxygen-carrying blood substitute for trauma and
elective surgery situations, is currently in the final stages of preparing a
biologic license application (BLA) for FDA review.
"We are extremely pleased with the data from our trauma trials, which we
believe satisfy the criteria for safety and efficacy as outlined in a 1999 FDA
workshop," said Richard DeWoskin, chief executive officer. "We believe that
our approach of ongoing data analysis and interactive dialog with the FDA is
essential to maximize the likelihood of a favorable review and subsequent
approval of the BLA. It is a very challenging task, but we remain confident
that we are proceeding properly and are on the right track."
Dr. Steven A. Gould, president, gave the webcast presentation at
yesterday's investor conference, sharing his enthusiasm for PolyHeme's
clinical data. "According to published reports in the scientific literature,
on average, survival in massive blood-loss situations is less than 20 percent.
Northfield, on the other hand, has observed patient survival of 75 percent in
clinical studies using PolyHeme."
Gould also announced that Northfield's results, outlined in a paper
titled, "The Life-Sustaining Capacity of Human Polymerized Hemoglobin in
Massive Blood Loss when Blood may be Unavailable," were recently selected to
be presented at a paper session at the annual meeting of the American College
of Surgeons in October. "This is important because the ACS is the largest,
most influential surgical meeting each year. Peer approval is both gratifying
and confirming of the strength of our data," Gould told investors. This study
and a separate March 2001 published study in the Journal of Trauma extends the
already large body of published data suggesting that PolyHeme may have
substantial patient benefit compared to blood in urgent situations.
At the close of his presentation, Gould reminded the audience that
Northfield has a unique clinical program in that it is the only sponsor
testing in both trauma and elective surgery; the only sponsor that has been
able to safely and rapidly infuse massive quantities of its product; and the
only sponsor that is assessing survival in a formal protocol for trauma. "We
believe we are successfully addressing the greatest clinical need in today's
marketplace."
PolyHeme is the only blood substitute undergoing clinical trials that has
been tested at large enough dosages to be considered a substitute for acute
blood loss in trauma and surgical settings. As a result of the process used
to manufacture the blood substitute, essentially a solution of polymerized
hemoglobin, PolyHeme has a longer shelf life than blood, requires no cross
matching and does not transmit disease.
Northfield Laboratories was founded in 1985. The company is headquartered
in Evanston, Illinois, and its stock is traded on the Nasdaq National Market
System under the symbol NFLD.
Statements in this release that are not strictly historical are "forward-
looking" statements that are made pursuant to the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995. Forward-looking
statements involve known and unknown risks, which may cause the company's
actual results in the future to differ materially from expected results.
These risks include, among others: competition from other blood substitute
products; the company's ability to obtain regulatory approval to market
PolyHeme commercially; the company's and/or its representative's ability to
successfully market and sell PolyHeme; the company's ability to manufacture
PolyHeme in sufficient quantities; the company's ability to obtain an adequate
supply of raw materials; the company's ability to maintain intellectual
property protection for its proprietary product and to defend its existing
intellectual property rights from challenges by third parties; the
availability of capital to finance planned growth; and the extent to which the
hospitals and physicians using PolyHeme are able to obtain third-party
reimbursement, as described in the company's filing with the Securities and
Exchange Commission.
For more information on Northfield Laboratories Inc. via facsimile at no
cost, simply dial 1-800-PRO-INFO and enter the company code NFLD.
Visit the Northfield website at: http://www.northfieldlabs.com .
SOURCE Northfield Laboratories, Inc.
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Related links:
http://www.northfieldlabs.com
CONTACT:
Richard DeWoskin, Chief Executive Officer of
Northfield Laboratories, 847-864-3500; or General Information,
Leslie Hunziker of The Financial Relations Board, 312-640-6760
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