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SCHEDULE 14A INFORMATION
PROXY STATEMENT PURSUANT TO SECTION 14(a)
OF THE SECURITIES EXCHANGE ACT OF 1934
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[ ] Preliminary Proxy Statement
[ ] Confidential, for Use of the Commission only (as permitted by
Rule 14a-6(e)(2))
[ ] Definitive Proxy Statement
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[X] Soliciting Material Under Rule 14a-12
NORTHFIELD LABORATORIES INC.
(Name of Registrant as Specified in its Charter)
C. ROBERT COATES
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(Name of Person(s) Filing Proxy Statement if other than the Registrant)
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3) Filing Party: C. Robert Coates
4) Date Filed: August 19, 2002
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Press Release
SOURCE: C. Robert Coates
'COMPASIONATE USE' OF POLYHEME SAVES LIVES, SAY COATES AND WILLIAMS
LAKE FOREST, Ill., Aug. 19 - Even though PolyHeme, Northfield Laboratories
Inc.'s (Nasdaq: NFLD) oxygen-carrying blood substitute, has yet to clear Food
and Drug Administration hurdles for commercial use, Dr. Michael Rie knows the
product works and believes in its potential.
An anesthesiologist who works at the State Trauma Center at the University of
Kentucky, Dr. Rie had first-hand experience with PolyHeme.
The case goes back to 1998, and PolyHeme was in clinical trials at the time. "We
got a 'compassionate use' authorization from the company to treat a Jehovah's
Witness who had refused blood transfusions," Dr. Rie said.
"Our patient wasn't a trauma victim, but a young woman in her 30s with a colon
problem. Before her operation she suffered from chronic kidney impairment but
did not require dialysis. She bled after surgery and became anemic to the point
where she was quite likely to die. Going into kidney failure, she had to be put
on dialysis," Rie continued. The patient received PolyHeme, survived and was
able to become independent of dialysis.
The experience, Dr. Rie said, convinced him that PolyHeme was a product "that
could deliver." The doctor draws this analogy: "PolyHeme is to the year 2002
what the medical evacuation helicopter was to Vietnam. That is, it gives you an
extra moment up-front to bring in the severely injured to give them a chance at
surgery."
Besides having no known serious or unexpected adverse side effects, PolyHeme
offers four key advantages:
- It requires no special storage
- It has an extended shelf life (i.e., about 12 months under refrigerated
conditions, compared to 28 to 42 days permitted for blood)
- It is universally compatible and requires no cross-matching
- It exits the body quickly
"The problem is the FDA does not know how to evaluate a product like this," said
Dr. Rie. "One of the issues involves making an exception to the rules calling
for randomized double-blind placebo controlled trials. In other words, in a
cancer test, one patient gets a cancer-fighting drug and the other salt water.
But you can't do that in this type of research. If the government were to
torpedo the product because there was no randomized study, we would have a
situation where the FDA had proposed ethically inappropriate research."
Dr. Rie contended, "If the product is safe and has efficacy and no serious side
effects that we know of, why would the FDA not want to pass the product?"
In light of homeland security issues, Dr. Rie said he sees a place for PolyHeme
as part of the military arsenal. It also belongs in ambulances and emergency
rooms.
The military has a stockpile of frozen blood. But Dr. Rie said there are
problems with frozen blood: mainly, about 20 percent of the red cells become
broken during the thawing process. Adding to the pressure is the nation's
shrinking blood supply. As concerns escalate over mad cow disease and other
contamination, new restrictions have come into play about who can donate blood.
Such rules are expected to diminish by five to nine percent the pool of
potential donors.
"Northfield, with its blood substitute PolyHeme, is still the frontrunner. It
should set the standards for how these products are tested by the FDA," Dr. Rie
concluded.
Raising the profile of PolyHeme is part of the action plan of C. Robert Coates
and Bert Williams III, candidates for Northfield's board. They would like to
hear from shareholders about other cases in which PolyHeme was used to save
lives.
In addition, the candidates vow to:
- Find a major pharmaceutical partner for Northfield to provide cash and
experienced management to get PolyHeme approved by the FDA;
- Ask Northfield to partner with companies to extend possible applications
of PolyHeme as a transport delivery mechanism for other drugs;
- Work with the Department of Defense and the Homeland Security Agency to
explore the possibility of stockpiling PolyHeme as a safe, effective
blood substitute for emergencies;
- Gain representation on Northfield's board as independent directors; and
- Keep investors informed of Northfield news.
PolyHeme as a Possible Solution for Jehovah's Witnesses
PolyHeme, Northfield Laboratories' hemoglobin-based oxygen-carrying blood
substitute, holds promise for Jehovah's Witnesses who do not accept blood
transfusions based on religious convictions.
The denomination, which has about 6.1 million followers worldwide and nearly one
million members in the United States alone, bans whole blood transfusions for
its members, citing biblical passages, but allows non-blood replacement fluids.
"We wouldn't give an endorsement on a specific product (such as PolyHeme), but
we're watching developments carefully," said Mark Sanderson in a telephone
interview from the Watchtower Bible and Tract Society, at its Brooklyn, N.Y.
headquarters, where he is with hospital information services. Sanderson said his
group tries to keep abreast of relevant developments.
He said that the Watchtower Society, the governing body of the Jehovah's
Witnesses, has ruled that the use of substances that contain a product
fractionated from red cells, white cells, platelets or plasma was permissible.
"Using blood substitutes remains a matter of conscience," Sanderson added.
Although some patients have embraced this type of product, many will take a more
guarded view based on risk, benefit and religious considerations.
Sanderson said it was difficult to estimate the number of people who died
because of refusing a whole blood transfusion and because an acceptable
substitute was unavailable. He also noted, "Our patients have been undergoing
major surgeries from liver transplants to open-heart surgery without blood
transfusions for many years before these products were ever conceived."
PolyHeme does not contain any of the banned substances. In fact, the human-
derived hemoglobin oxygen-carrying component is even purified before being added
to the blood substitute solution.
Contact Information
If you are a shareholder with comments, suggestions or questions about receiving
a Coates-Williams proxy, please call Simon Goldberg of the Robert Coates Group
at 1-800-295-0841, extension 240 or e-mail us at sgoldberg@rcoates.com.
SOURCE: C. Robert Coates