Cites Important Advances in Clinical Development and Regulatory Affairs
EVANSTON, Ill., Oct. 12 /PRNewswire/ -- Northfield Laboratories Inc.
(Nasdaq: NFLD), at its annual business update webcast earlier today, told
shareholders that it was enthusiastic about the company's future prospects
based on significant results from its clinical trials and important progress
made toward a regulatory filing of its oxygen-carrying blood substitute,
PolyHeme(TM).
In the treatment of urgent blood loss, where Northfield focuses its
attention and clinical trials, and where management believes the greatest
market opportunity is, Dr. Steven Gould, president of Northfield, said, "We
continue to accumulate and expand our impressive clinical experience and have
already demonstrated a remarkable survival benefit using PolyHeme in massive
blood-loss situations -- situations where we have transfused up to 20 units or
more of PolyHeme in a 20-minute period. This dose is equal to twice the
normal total human blood volume. According to published reports in the
scientific literature, on average, survival in this critical state is less
than 20 percent. Northfield, on the other hand, has observed patient survival
of 75 percent in its clinical studies using PolyHeme."
The company believes these results present clear evidence of PolyHeme's
ability to provide an enhanced survival rate for bleeding patients in
situations where blood might not be available, and to thereby fulfill a
critical unmet need.
In discussing its regulatory status, Gould cited an FDA workshop last year
that considered criteria for evaluating the safety and efficacy of blood
substitutes. At that meeting, the discussions suggested that testing should
occur in both trauma and elective surgery that would include both stressed and
stable patients. It was also felt that products should be given in high
dosages at rapid infusion rates. These criteria were determined based on how
a blood substitute will likely be used. Gould mentioned that the panel at the
workshop also felt strongly that survival was the appropriate endpoint that
should be evaluated in trauma.
In his discussion of the workshop considerations, Gould reminded
shareholders that Northfield was the only sponsor testing in both trauma and
elective surgery; the only sponsor that has been able to safely and rapidly
infuse massive quantities of a blood substitute; and the only sponsor
assessing survival in a formal protocol for trauma. "We, therefore, believe
we are adequately and appropriately addressing all of the FDA issues," he
said.
The company stated that the FDA approval process is an ongoing progression
of data analysis, dialogue with the FDA and preparation of a Biologic License
Application (BLA). "As you refine and fine-tune each, you increase the
likelihood of gaining approval once the application is filed. The goal is not
simply to submit or file the BLA, it is to get it approved," said Gould. "We
remain confident that we are proceeding properly and as rapidly as we can. I
believe we are on the right track, and I'm confident that we will gain
approval for PolyHeme."
Proxy Voting
Prior to the start of the business update, shareholders voted to re-elect
Northfield's six directors to the board for a term of one year and ratified
KPMG LLP as its independent auditors for the fiscal year ending May 31, 2001.
Online Format
This was the first time Northfield presented its business update online.
Richard DeWoskin, chairman and chief executive officer, said his goal was to
provide information on the company's activities to as many shareholders as
possible, not only those who could afford the time and expense of attending
the annual presentation in person. Management is considering hosting a
webcast presentation from time-to-time as corporate developments warrant.
Although there were technical difficulties this morning with the webcast
vendor's server, it is now functioning properly and the replay is available at
http://www.vcall.com for 30 days. Interested parties may also access the conference
call replay of today's business update by dialing 888/266-2086 and entering
the access code 4553327.
Upcoming Presentations
Northfield will be making presentations at a number of scientific and
business conferences in late October and early November: the American College
of Surgeons Annual Clinical Congress, the Midwest BioMarketplace presented by
the Chicago Biotech Network, the Illinois Society of Anesthesiologists Fall
Meeting, the NATO Civil-Military Blood Conference, and the Prudential-Vector
Securities Health Care Conference.
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. 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 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.
For more information on Northfield Laboratories Inc. via facsimile at no
cost, simply dial 1-800-PRO-INFO and enter the company code NFLD.
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, 847-864-3500; or General, Leslie
Hunziker of The Financial Relations Board, 312-266-7800
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