EVANSTON, Ill., Dec. 21 /PRNewswire/ -- Northfield Laboratories Inc.
(Nasdaq: NFLD), a leading developer of an oxygen-carrying blood substitute for
trauma and elective surgery situations, said today that management is unaware
of any information that would account for the recent share price decline. It
has issued no news announcements recently. "Our outlook for the
commercialization of our product, PolyHeme(TM), for use in urgent, massive
blood-loss situations, remains as positive as ever," said Richard DeWoskin,
chairman and chief executive officer. Northfield also said it hopes to get a
meeting on the FDA's calendar in January to discuss modifications to its
Biologics License Application (BLA).
In mid-November, the company announced that it received comments from the
FDA on its BLA, indicating that the regulatory agency was seeking additional
information before accepting Northfield's application for filing. Since then,
the company and its consultants have been preparing for a meeting with the FDA
to begin the process of addressing the issues.
"As a rule, we don't comment on our stock price as it changes day to day.
Instead, we focus on running the business," said DeWoskin. "However, we've
recently received calls from our shareholders about the stock's movement, and
we believe it's important to reaffirm our confidence in the company's long-
term prospects. Results from our clinical trial data are remarkable. Our
cash position remains sufficient to support operations and ongoing clinical
trials for two years. And we continue to believe the issues and questions
raised by the FDA in its initial response to our BLA are manageable."
On a separate note, the company announced a change in its investor
relations contact information. Leslie Hunziker, senior vice president at
Northfield's agency-of-record, FRB|Weber Shandwick, has accepted a position as
investor relations director at a major NYSE-listed corporation. Bill
Schmidle, a partner with FRB|Weber Shandwick, will replace Leslie as
Northfield's primary investor contact. Please direct inquiries or information
requests to Bill at 312-640-6753.
About the Company
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.
SOURCE Northfield Laboratories Inc.
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Related links:
http://www.northfieldlabs.com
CONTACT:
Richard DeWoskin, Chief Executive Officer of
Northfield Laboratories Inc., +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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