EVANSTON, Ill., May 9 /PRNewswire-FirstCall/ -- Management of Northfield
Laboratories Inc. (Nasdaq: NFLD), today presented at the Health Care 2002,
Deutsche Banc Alex. Brown Health Care Conference in Baltimore. The meeting
provided investors with an update on the life-saving capability of
Northfield's PolyHeme and the current status of the discussions with the
Center for Biologics Evaluation and Research (CBER) of the U.S. Food & Drug
Administration.
Dr. Steven A. Gould, president, gave the webcast presentation at the
conference. "We remain enthusiastic about PolyHeme's effectiveness with
regard to the survival rate in massive blood-loss situations. We also believe
we are making good progress with regard to our ongoing dialogue with CBER."
Interested investors can access a replay of the webcast at
http://www.northfieldlabs.com . The replay will be available for 30 days.
Northfield Laboratories, founded in 1985, is a leading developer of an
oxygen-carrying blood substitute. Its product, 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.
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.
Northfield cautions that the FDA approval process for PolyHeme continues to be
subject to significant risks and uncertainties. The FDA could refuse to
accept Northfield's BLA in its current form. If Northfield's BLA is accepted,
the FDA could deny its approval for the commercial sale of PolyHeme or could
require additional clinical tests as a condition to its approval. If FDA
approval for the commercial sale of PolyHeme is granted, the indication uses
for which PolyHeme may be marketed could be significantly limited by the FDA.
Other risks may include: 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.
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, +1-847-864-3500, or Investors, Bill
Schmidle, +1-312-640-6753, or Media, Cindy Martin,
+1-312-640-6741, both of FRB Weber Shandwick
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