EVANSTON, Ill., Nov. 19 /PRNewswire/ -- Northfield Laboratories Inc.
(Nasdaq: NFLD), a leading developer of an oxygen-carrying blood substitute for
trauma situations, today reported that it received comments from The U.S. Food
and Drug Administration's Center for Biologics Evaluation and Research (CBER)
on its Biologics License Application (BLA), submitted August 2001. CBER
indicated that they are seeking additional information before accepting the
application for filing and issued a Refusal-to-File letter to the company.
"Refusals for first-time submissions are not uncommon," said Richard
DeWoskin, chief executive officer. "We are encouraged by the constructive
information provided in CBER's initial response, and believe that while the
next few months will be busy, there is good reason to expect that
modifications resulting from this feedback will help us to progress to the
next stage of the application process."
The company said the letter included both questions and comments about
Northfield's blood substitute, PolyHeme, from CBER. Management said it will
quickly begin the process of addressing these issues.
"The regulatory review will be a multi-stage process. There now will be a
period of several weeks during which we will interact with CBER to clarify and
come to fully understand the issues in question. This will lead to actions
taken by the company to satisfy some of the agency's inquiries, but we believe
these are manageable. Additionally, through interaction with CBER, we also
believe we will address the agency's remaining issues on certain scientific
and regulatory issues outlined in the letter over the next few months," said
DeWoskin.
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 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 filings 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; General Info., Leslie
Hunziker, +1-312-640-6760, Analysts, Bill Schmidle,
+1-312-640-6753, or Media, Cindy Martin, +1-312-640-6741, all of
FRB Weber Shandwick
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