EVANSTON, Ill., Aug. 16 /PRNewswire/ -- Northfield Laboratories Inc.
(Nasdaq: NFLD), a leading developer of an oxygen-carrying blood substitute,
reported today that it has completed preparation of all of the components of
its Biologics License Application (BLA), including collection and analysis of
its clinical trial data for PolyHeme. The company now is completing the final
clerical compilation and preparation of the document for submission to the
Food and Drug Administration (FDA). Northfield intends to submit the
application before Labor Day.
"We are pleased with the results from our clinical studies and believe the
safety and efficacy data that we will present to the FDA are compelling," said
Richard DeWoskin, chairman and chief executive officer. "We have begun the
administrative challenge of compiling the application, which involves
approximately 40 volumes of information, spanning more than 16,000 pages.
Once the BLA has been submitted to the FDA, we will announce that milestone to
our shareholders."
The company noted that while recent reports have suggested that other
blood substitute sponsors are experiencing problems in elective surgery
trials, Northfield's focus always has been in the trauma, or urgent, acute
blood loss market.
The company will provide more detail on its regulatory progress in its
annual business update on August 31, 2001. This presentation will be webcast
after the close of the market, at 4:30 p.m. central time, that day. Anyone
interested in accessing the presentation should log on to
http://www.northfieldlabs.com or http://www.videonewswire.com , or for those without
Internet access, you may dial in to 888-413-4411 to listen to the call. A
replay of the webcast will be available for 30 days after the presentation.
The telephonic replay will be available for seven days by dialing 888-266-2086
and providing the passcode, 5458560.
Northfield's annual meeting will take place earlier that day at 2:00 p.m.
central time to vote on business matters as outlined in its August 3rd proxy
statement. Only questions related to those business matters will be taken at
the meeting. The business update will not be webcast at corporate
headquarters.
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.
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.
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 General, Leslie
Hunziker of The Financial Relations Board, +1-312-640-6760
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