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NORTHFIELD LABORATORIES INC.
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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
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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
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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
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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
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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
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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
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Richard DeWoskin
Chairman & Chief Executive Officer
/s/ Steven A. Gould, M.D.
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Steven A. Gould, M.D.
President & Chief Operating Officer
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