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SCHEDULE 14A
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INFORMATION REQUIRED IN PROXY STATEMENT
SCHEDULE 14A INFORMATION
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Northfield Laboratories Inc.
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(Name of Registrant as Specified in Its Charter)
Northfield Laboratories Inc.
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PRESS RELEASE
NORTHFIELD INTENDS TO SUBMIT FDA APPLICATION BEFORE LABOR DAY; DATA ANALYSIS FOR
APPLICATION COMPLETE
EVANSTON, Ill., Aug. 16 - 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 www.northfieldlabs.com
or 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,
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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: www.northfieldlabs.com.