-----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, JrKaSBkDnrrHr25wf9FDfIRRyUqM4FU3dwMel0sm9CBl0EnfF4lv194DMgSIoIRf +QVySfAcCBT2geI3k03AVg== 0000950137-99-003474.txt : 19990927 0000950137-99-003474.hdr.sgml : 19990927 ACCESSION NUMBER: 0000950137-99-003474 CONFORMED SUBMISSION TYPE: DEFA14A PUBLIC DOCUMENT COUNT: 1 FILED AS OF DATE: 19990924 FILER: 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: DEFA14A SEC ACT: SEC FILE NUMBER: 000-24050 FILM NUMBER: 99716996 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 DEFA14A 1 DEFINITIVE ADDITIONAL MATERIALS 1 SCHEDULE 14A (RULE 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES EXCHANGE ACT OF 1934 (AMENDMENT NO. ) Filed by the Registrant [x] Filed by a Party other than the Registrant [ ] 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 [x] Definitive Additional Materials [ ] Soliciting Material Pursuant to Rule 14a-11(c) or Rule 14a-12 NORTHFIELD LABORATORIES INC. - -------------------------------------------------------------------------------- (Name of Registrant as Specified in Its Charter) - -------------------------------------------------------------------------------- (Name of Person(s) Filing Proxy Statement if other than the Registrant) Payment of Filing Fee (Check the appropriate box): [x] No fee required. [ ] 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: - -------------------------------------------------------------------------------- (4) Date filed: - -------------------------------------------------------------------------------- 2 CLINICAL DEVELOPMENT This was another exciting year for Northfield Laboratories. We continue to believe we are in the leadership position in the field of blood substitutes based on the experience of our clinical trials with PolyHeme(TM) in both trauma and elective surgery. We are presently reviewing all of our clinical trial data in detail. Although we anticipate the clinical trials continuing until license approval and perhaps beyond, we believe the cumulative clinical experience with PolyHeme is approaching a level that may be sufficient to consider submission of a license application to the FDA. We look forward with enthusiasm to the approval of PolyHeme as the first blood substitute to be available for human use in this country. Our trials in elective surgery are progressing well. We are conducting these trials at approximately 15 major medical centers throughout the United States. Although we remain shielded from the data regarding efficacy, we are informed of any adverse safety events. We are delighted that there have been no substantive safety concerns. We are gratified by the number of unsolicited favorable comments received from the physician investigators. We are confident 1 3 the trial is producing results which will be of great value in the application for licensure of PolyHeme. However, the most impressive results have occurred in our ongoing trials in trauma and urgent surgery. The maximum allowable dose of PolyHeme in these trials is now 20 units (1000 grams or 10 liters). We have infused this dose in a number of critically injured patients. Twenty units are the equivalent of two times the total blood volume of the average adult. This is an extraordinary achievement! PolyHeme is the only blood substitute in clinical trials that is being tested at large enough doses to truly be considered for use in treating acute blood loss in trauma and surgical settings. We believe these data will be both prominent and compelling in the process of gaining approval for PolyHeme. Our experience to date has demonstrated an increase in survival in patients suffering from massive hemorrhage. In April, we presented our data to the U.S. Department of Health and Human Services (HHS) Advisory Committee on Blood Safety and Availability in Bethesda, Maryland. The Committee was addressing the potential reduction in the nation's blood supply 2 4 that might occur due to concerns about new disease threats, and the possible benefits that approval of a blood substitute might provide. We were pleased to have the opportunity to address this group. During the presentation we reported results from 53 patients who received between 6 and 20 units of PolyHeme. None of the patients described in the testimony received banked blood during the study period. Of the 53 patients, 27 had less than 25% of their own blood after infusion with PolyHeme. Furthermore, 20 of these 27 individuals had less than 12% of their own blood remaining, and 5 had less than 6% of their blood left after the PolyHeme infusion. Based on historical results in the published scientific literature, these 27 patients had an expected survival rate of less than 20% if blood had not been available. However, even in the absence of blood, 85% of these patients survived after infusions of PolyHeme, essentially the same results that would have been predicted if blood had been used. These are remarkable results. The data demonstrate that PolyHeme can increase survival in life-threatening hemorrhage when blood may be 3 5 unavailable. Unavailability of blood usually occurs in rural hospitals or pre-hospital settings. However, it is not uncommon even in large urban hospitals, where hectic surgical schedules and the occurrence of multiple bleeding patients can lead to delays in compatibility testing, and cause the available supply of blood to be temporarily inadequate. In these situations, PolyHeme should be particularly useful in providing convenient and rapid replacement for blood lost during urgent hemorrhage. Our presentation received a favorable response at the HHS meeting, and stimulated much excitement and discussion. We were gratified to be able to share our results at this important public scientific forum. In addition to publication in peer-reviewed scientific journals, we believe such presentations represent the most appropriate and effective manner to disseminate information concerning our progress. COMMERCIAL DEVELOPMENT Along with the FDA's product approval, the successful commercial introduction of PolyHeme will also depend on the approval of our manufacturing process. During the past year we have completed the engineering changes and process validation that are necessary in anticipation of filing for approval of our 4 6 product. Additionally, we are in the process of increasing the production capacity of our existing manufacturing facility from 4,000 units per year to 10,000. While discussions regarding collaborative relationships that could involve the large scale manufacture of PolyHeme continue, the remaining time required to successfully complete the arrangements and construct and validate such a facility would carry us beyond our current target date for product approval. Therefore, we are planning an additional expansion of the manufacturing capacity at our present site. We believe this approach is financially prudent yet sufficient for commercial viability. Our relationships with the major blood collection agencies continue to evolve. In addition to our current agreements, we are addressing other potential sources of hemoglobin to be used as our starting material. These include both human and non-human sources of hemoglobin. We remain confident that the necessary quantities of starting material will be available for the commercial manufacture of PolyHeme. As always, we remain vigilant with regard to managing our expenses. We believe our existing capital resources will be sufficient for operating capital 5 7 requirements for the next 24 to 36 months, so that we can accomplish our objective of bringing PolyHeme to market. FUTURE Northfield Laboratories management has high expectations for this next year. Despite many major changes in the field of blood substitutes in this past year, we have remained focused on our goal. We appreciate your ongoing support and interest, and as we stated last year, look forward to achieving our mutual goal of becoming the first sponsor to successfully obtain approval for human use of a blood substitute. Sincerely, /s/ Richard DeWoskin - ---------------------------------- Richard DeWoskin Chairman & Chief Executive Officer /s/ Steven A. Gould, M.D. - ----------------------------------- Steven A. Gould, M.D. President & Chief Operating Officer 6 -----END PRIVACY-ENHANCED MESSAGE-----