EVANSTON, Ill., May 15 /PRNewswire-FirstCall/ -- Northfield Laboratories
Inc. (Nasdaq: NFLD), a leading developer of an oxygen-carrying blood
substitute for trauma and elective surgery situations, today responded to the
recent volatility in the company's stock price.
"There has been no news or corporate developments that would merit the
recent weakness in our stock price," said Richard DeWoskin, chief executive
officer. "As we had indicated in our most recent comments at the Deutsche
Banc Alex. Brown Health Care conference, we remain as confident as ever in our
product and continue to make progress in our ongoing discussions with the
Center for Biologics Evaluation and Research (CBER) of the U.S. Food & Drug
Administration."
DeWoskin added, "At this point, we continue to emphasize the fact that
PolyHeme has proven effective in cases of severe trauma. We have infused up
to 20 units in massive hemorrhage situations and have accumulated substantial
evidence of safety and efficacy. With $20 million in cash, we have adequate
funding for the next 18-24 months."
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.
 back to top
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
|
