<PAGE> 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:
--------------------------------------------------------------------------------
<PAGE> 2
TO OUR SHAREHOLDERS
During the past year Northfield Laboratories continued its efforts to
complete the successful development of PolyHeme(TM) as the first blood
substitute to be commercially available for human use in this country. We remain
optimistic that we will achieve this goal. The year included important advances
in the areas of clinical development, regulatory affairs and manufacturing and
supply. We are pleased to provide you with this summary of Northfield's
accomplishments.
CLINICAL DEVELOPMENT
The most crucial area remains the clinical development of PolyHeme. We
continue to believe that the greatest value of a blood substitute will be in the
clinical setting of urgent, life-threatening blood loss in trauma and surgery.
The number of recipients treated with PolyHeme in this setting continues to
grow. More impressive than the number of patients, however, is the accumulated
experience in the subset of patients receiving rapid, large volume infusions of
PolyHeme. The normal volume of blood in an average adult is 10 units. Nearly 40
patients have received between 10 and 20 units of PolyHeme, representing
replacement of the total volume of blood at least once, and on 13 occasions,
twice. We are not aware of any other clinical trials that involve such rapid,
massive infusion of a blood substitute.
Our clinical trials have allowed us to assess the ability of PolyHeme to
support life during massive hemorrhage in patients not receiving red cells.
After infusion of PolyHeme, we are able to distinguish the level of hemoglobin
provided by both the red cells and by PolyHeme. We can therefore observe the
contribution of PolyHeme to maintaining an adequate total hemoglobin level in a
bleeding patient. To date, nearly 40 patients in our clinical trials have had
red cell hemoglobin values fall below critical levels during hemorrhage. The
published data in the scientific literature report that the survival rate for
surgical patients at very low red cell hemoglobin levels can be less than 20%.
In contrast, the survival rate in our trial for patients with life-threatening
red cell hemoglobin levels who received PolyHeme in lieu of red cells was
increased to 75%, a dramatic improvement. The mortality rate in our trial
reflects the severity of the underlying trauma, and is comparable to the outcome
in trauma patients with similar injuries who receive blood. These important
observations demonstrate that rapid, massive infusion of PolyHeme during
hemorrhage provides life-sustaining benefit by maintaining an adequate total
concentration of hemoglobin.
As we have reported previously, our clinical trial in elective surgery is
producing important results. However, patient accrual is progressing slower than
anticipated due to the complex protocol. We continue to consider additional
elective surgery trials with different protocols to more broadly and rapidly
confirm PolyHeme's capability as an alternative to blood in critical care
situations.
REGULATORY ISSUES
There has been considerable activity on the regulatory front. The FDA has
recently been faced with a number of difficult issues dealing with the current
use of blood and blood products. There continues to be evidence of a shortage of
donated blood that occurs at predictable times due to vacations, holidays and
other recurring events. Increasing concern about the safety of donated blood has
led to further restrictions on the eligibility of blood donors. In particular,
the concern about "mad cow disease" has resulted in the elimination of the
category of volunteer blood donors who have spent extended time in Great
Britain. In addition, the FDA has been faced with a number of highly publicized
safety issues in certain drugs that only surfaced once these drugs were approved
and on the market. The inevitable result of these events has been a heightened
scrutiny of safety data for investigational products. We are sensitive to these
issues and are working diligently to provide appropriate assurances to the FDA
about the safety of PolyHeme. A number of sponsors of other blood substitute
programs have described their experiences with their products in elective
surgery, but to date none have publicly disclosed data demonstrating they have
achieved the necessary milestones to complete their trials.
In September of last year, the FDA sponsored a workshop in conjunction with
the National Institutes of Health to consider and develop guidelines for the
development of blood substitutes. The full proceedings have been available to
the public on the Internet. There were many important issues considered during
the workshop. Some of the discussions suggested that testing of a blood
substitute should occur in both trauma
<PAGE> 3
and elective surgery, including both stable and stressed patients. Furthermore,
evaluations of safety should include rapid infusions at high doses. With regard
to efficacy, although reduction in allogeneic transfusion was considered a
suitable endpoint in elective surgery, the most compelling endpoint would be a
reduction in mortality in trauma and urgent care. We believe that only
Northfield's approach to clinical development will satisfy these
recommendations.
MANUFACTURING SUPPLY
During the past year we expanded our manufacturing capacity of PolyHeme
from 4,000 to 10,000 units annually. We continue to explore a possible expansion
into additional facilities adjacent to our current manufacturing facility. Our
preliminary engineering studies indicate that an additional capacity of
50-60,000 units could be successfully developed in that space. We remain in
discussion with several potential manufacturing, marketing/distribution, and
source supply partners, and have not ruled out entering into an alliance in one
or more of these areas in the future.
SCIENTIFIC AND INVESTOR PRESENTATIONS
During the past year we have made formal, public presentations at the FDA
workshop on blood substitutes described above, at the annual meeting of the
American Association of Blood Banks in November of 1999, and at a number of
invited lectureships at academic programs throughout the country. We have also
participated at healthcare investment conferences sponsored by Prudential Vector
Securities in November of 1999, and Deutsche Bank - Alex Brown in May of this
year. In the coming months, we will be presenting at a Post-Graduate course on
Pre-and Postoperative Care at the annual meeting of the American College of
Surgeons in October, and at a NATO conference on blood use in November. We will
also be presenting again in November at this year's Prudential Vector Healthcare
Conference. In conjunction with our press releases that frequently accompany
these presentations, we believe we have adopted the most appropriate, thoughtful
and effective approach to disseminate information concerning our progress.
NEW ANNUAL MEETING FORMAT
We are pleased to announce that we will be using a new format this year to
provide information simultaneously to all of our shareholders in connection with
our upcoming annual meeting. After the official business of the meeting has
concluded, the annual update and the question and answer session we have
traditionally presented to shareholders attending the annual meeting will
instead be broadcast exclusively over the Internet. Shareholders can access the
presentation through www.vcall.com or www.Northfieldlabs.com. Shareholders
without Internet access will be able to listen to the report by calling a toll
free number. The call-in number will be made available approximately 1 week
before the presentation. The report will be repeated following the annual
meeting for the convenience of shareholders. The replay will be available for 30
days on the Internet, and for 7 days by telephone.
Questions from shareholders for the question and answer session should be
submitted in writing or via electronic mail during the period leading up to the
annual meeting. Please submit your questions by regular mail to our corporate
office at Northfield Laboratories Inc., 1560 Sherman Ave., Suite 1000, Evanston,
IL 60201, or via E-mail to [email protected]. All questions should be
submitted at least 7 days prior to the annual meeting.
Northfield Laboratories management appreciates the support of its
shareholders. We continue to focus on our goal. The past year has included a
number of important developments and changes in the field of blood substitutes.
We remain optimistic with high expectations for the next year.
Sincerely,
[Richard DeWoskin]
Richard DeWoskin
Chairman & Chief Executive Officer
[Steven A. Gould]
Steven A. Gould, M.D.
President & Chief Operating Officer
