BALTIMORE, May 6 /PRNewswire/ -- Addressing institutional investors at a
conference sponsored by Alex Brown & Co. Northfield Laboratories Inc.
(Nasdaq: NFLD) will indicate today that the development of its blood
substitute product, PolyHeme(TM) is in the home stretch with market
introduction planned for sometime during 1999.
    Northfield recently announced clearance from the Food and Drug
Administration to begin Phase III trials of its blood substitute, PolyHeme at
the 6 unit (3,000 milliliters) level.  The advanced trial, the first Phase III
study by any company to include direct replacement of blood in large volumes,
is the only one of its kind and marks a milestone for both a blood substitute
and Northfield.  Phase III trials follow very successful and unprecedented
results from the company's Phase II trials, which included infusion of up to
ten units (5,000 milliliters) of PolyHeme in place of blood in trauma and
urgent need settings.  Ten units represents 100 percent of an average person's
blood volume.
    "Clearly we see ourselves alone in the home stretch of an almost 25-year
odyssey to bring a blood substitute to market," said Richard DeWoskin,
Northfield's chairman and chief executive officer.  "We expect this study to
demonstrate complete avoidance of donated blood use in a significant number of
patients undergoing high-volume-blood-loss surgical procedures.  This seems to
be the most compelling endpoint in elective surgery."
    The randomized, controlled study will include about 250 elective surgery
patients and is expected to take approximately 12 months to complete once
under way, beginning late in the second quarter.  The development stage
company has completed testing with more than 100 individuals to date.
    "We have advanced to the point that the question of science is now being
replaced with the question of size and scope of the commercial market for our
product," said DeWoskin.  "Having shown success in Phase II trials, we fully
expect that our Phase III trials will demonstrate the adaptability of PolyHeme
to replace the need for blood in an elective surgery setting in addition to
trauma."
    Northfield Laboratories is the only company to report achievement of this
high dose level in any phase of clinical testing.  The company maintains that
in order for a blood substitute product to be commercially viable,
manufacturing costs need to be competitive with the cost of blood and the
blood substitute needs to demonstrate efficacy and safety at high dosage
levels.  The company indicated that no other company working on a replacement
for blood in these critical settings has disclosed sufficient information to
indicate any level of success in this area.
    Dr. Steven A. Gould, Northfield's president, said, "Demand for PolyHeme
will be driven by physician behavior.  A major thrust of current transfusion
therapy continues to be the avoidance of using donated blood.  In addition to
the potential for the transmission of disease or the possibility for mistakes
in blood typing, particularly in emergency situations, the transfusion of
donated blood can have significant negative repercussions at a later date
because of immunization issues brought on by this form of tissue transplant.
However, the blood sparing alternatives currently being used are costly,
cumbersome and not user friendly to either the patient or attending
physicians."
    Early response by physicians across the country, including emergency room
physicians, anesthesiologists, and surgeons, indicate that there will be a
strong demand for a safe and effective oxygen carrying blood substitute like
PolyHeme.  More than 8.5 million units of blood are transfused in these
settings annually.  At an average price per unit of well over $300, this
equates to a $3 billion market for either blood or an oxygen carrying
substitute product used in transfusions.
    DeWoskin also stated, "Now that we are in the Phase III study, our efforts
will be largely focused on the business side of delivering PolyHeme to market
within a 24-month time frame.  A first step is to begin construction of a
manufacturing facility with a capacity of 300,000 units and which can be
easily expanded to 600,000 units.  We have selected a site, design work is
progressing and we would expect to break ground in the fall of 1997."
    The company has previously announced an agreement with hemerica, Inc., a
blood collection agency, for a supply of blood, which is the raw material for
the manufacture of PolyHeme.  The company is negotiating additional supply
agreements with other blood collection groups.  Without competition for this
product, Northfield is confident of the availability of raw material at
economic prices.
    "With an intended product launch in 1999, we also anticipate entering into
a marketing and distribution arrangement with a strategic partner," said
DeWoskin.  "We would like to have such a partner in place at least a year
prior to product launch.  Over the next 12 months, we expect to finalize such
an agreement with one or possibly more of the parties with whom we have had
ongoing discussions for  worldwide distribution of PolyHeme, he added.  "Until
then, we are well positioned financially to accomplish all of our objectives
without the need for additional capital prior to a product launch."
Meanwhile, Northfield intends to continue trials of its product in areas other
than elective surgery and trauma situations.
    Northfield Laboratories was founded in 1985.  The Company is headquartered
in Evanston, Illinois, and its stock is traded on the Nasdaq National Market
under the symbol NFLD.

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