-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, QNKUBlOdxeKdWuRJu2nQx8Ou8RVCSfItg0SzsTNk99rltKjbgjLmsSa5ZKJ5ys20 z+pma2oeLJ+6vTbO4aSVcA== 0001091818-02-000412.txt : 20020819 0001091818-02-000412.hdr.sgml : 20020819 20020819134945 ACCESSION NUMBER: 0001091818-02-000412 CONFORMED SUBMISSION TYPE: DFAN14A PUBLIC DOCUMENT COUNT: 1 FILED AS OF DATE: 20020819 FILED BY: COMPANY DATA: COMPANY CONFORMED NAME: COATES C ROBERT CENTRAL INDEX KEY: 0001168232 FILING VALUES: FORM TYPE: DFAN14A BUSINESS ADDRESS: STREET 1: 100 FIELD DRIVE STREET 2: SUITE 130 CITY: LAKE FOREST STATE: IL ZIP: 60045 BUSINESS PHONE: 8002950841 (X220) SUBJECT COMPANY: COMPANY DATA: COMPANY CONFORMED NAME: NORTHFIELD LABORATORIES INC /DE/ CENTRAL INDEX KEY: 0000920947 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 363378733 STATE OF INCORPORATION: DE FISCAL YEAR END: 0531 FILING VALUES: FORM TYPE: DFAN14A SEC ACT: 1934 Act SEC FILE NUMBER: 000-24050 FILM NUMBER: 02742267 BUSINESS ADDRESS: STREET 1: 1560 SHERMAN AVE STREET 2: SUITE 1000 CITY: EVANSTON STATE: IL ZIP: 60201-4800 BUSINESS PHONE: 8478643500 MAIL ADDRESS: STREET 1: 1560 SHERMAN AVE STE 1000 STREET 2: 37TH FLOOR CITY: EVANSTON STATE: IL ZIP: 60201-4800 DFAN14A 1 north020819_dfan14a.txt PRESS RELEASE ================================================================================ SCHEDULE 14A INFORMATION PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 Filed by the Registrant [ ] Filed by a Party other than the Registrant [X] Check the appropriate box: [ ] Preliminary Proxy Statement [ ] Confidential, for Use of the Commission only (as permitted by Rule 14a-6(e)(2)) [ ] Definitive Proxy Statement [ ] Definitive Additional Materials [X] Soliciting Material Under Rule 14a-12 NORTHFIELD LABORATORIES INC. (Name of Registrant as Specified in its Charter) C. ROBERT COATES ---------------- (Name of Person(s) Filing Proxy Statement if other than the Registrant) Payment of Filing Fee (Check the appropriate box): [X] No fee required. [ ] $125 per Exchange Act Rules 0-11(c)(1)(ii), 14a-6(i)(1), 14a-6(i)(2) or Item 22(a)(2) of Schedule 14A. [ ] Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. 1) Title of each class of securities to which transaction applies: 2) Aggregate number of securities to which transaction applies: 3) Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (Set forth the amount on which the filing fee is calculated and state how it was determined): 4) Proposed maximum aggregate value of transaction: 5) Total fee paid: [ ] Fee paid previously with preliminary materials. [ ] Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the Form or Schedule and the date of its filing. 1) Amount Previously Paid: 2) Form, Schedule or Registration Statement No.: 3) Filing Party: C. Robert Coates 4) Date Filed: August 19, 2002 ================================================================================ 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. 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