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Northfield Laboratories
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NORTHFIELD LABORATORIES INC.
1560 SHERMAN AVENUE, SUITE 1000
EVANSTON, IL 60201
(847) 864-3500
WWW.NORTHFIELDLABS.COM
AT NORTHFIELD LABORATORIES: AT THE FINANCIAL RELATIONS BOARD:
Richard DeWoskin Leslie Hunziker
Chief Executive Officer General Information
(847) 864-3500 (312) 640-6760
FOR IMMEDIATE RELEASE
TUESDAY, AUGUST 28, 2001
NORTHFIELD LABORATORIES SUBMITS BIOLOGICS LICENSE APPLICATION TO FDA FOR
APPROVAL OF ITS BLOOD SUBSTITUTE, POLYHEME(TM)
EVANSTON, ILLINOIS, AUGUST 28, 2001 -- NORTHFIELD LABORATORIES INC. (NASDAQ/NMS:
NFLD), a leading developer of an oxygen-carrying blood substitute, today
reported that it has submitted a Biologics License Application (BLA) to the Food
and Drug Administration (FDA) seeking approval to market its patented blood
substitute product, PolyHeme, as an ideal oxygen-carrying resuscitative fluid
for use in the treatment of urgent, life-threatening blood loss.
"The submission of the BLA for PolyHeme is a significant milestone for
Northfield, and marks a first for a blood substitute for human use in the U.S.,"
said Richard DeWoskin, chairman and chief executive officer. "PolyHeme provides
a remarkable clinical benefit, and represents more than 16 years of product
development, clinical studies and data analysis. More importantly, it addresses
a large market opportunity and fills an important clinical need.
"We plan to continue working with the FDA to support the strength of our
application and to provide any additional information that may be necessary to
achieve a favorable determination," said DeWoskin.
Dr. Steven A. Gould, president, said, "The data from our clinical trials
demonstrate that PolyHeme will support life in seriously injured, bleeding
patients in the virtual absence of circulating red blood cells, and thereby
improve survival in situations when blood cannot be used. We believe these
results demonstrate the ability of PolyHeme to effectively and safely transport
oxygen. This extraordinary survival benefit indicates that PolyHeme is capable
of addressing a critical, unmet medical need, and has led us to file for
priority review and fast-track status with the FDA, which we hope will lead to
accelerated approval of PolyHeme."
PolyHeme is the only blood substitute that has been safely infused rapidly and
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
this product, essentially a solution of polymerized hemoglobin, PolyHeme has a
longer shelf life than blood, requires no cross matching and does not transmit
disease.
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NORTHFIELD LABORATORIES INC.
ADD 1
The current market for blood in the United States is estimated to be in the
multiple billions of dollars. There were 12.4 million units of blood transfused
into approximately 4 million recipients in 1999, according to the latest figures
available from the National Blood Data Resource Center. Of that amount, about
2.5 million units are used in urgent, acute blood loss situations - Northfield's
primary focus.
ANNUAL BUSINESS UPDATE
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 was founded in 1985. The company is headquartered in
Evanston, Illinois, and its stock is traded on the Nasdaq National Market System
under the symbol NFLD.
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: WWW.NORTHFIELDLABS.COM
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