Outlines Initial Manufacturing and Marketing Plans
EVANSTON, Ill., Sept. 4 /PRNewswire/ --
Northfield Laboratories Inc. (Nasdaq: NFLD), at its annual business update
webcast late last week, told shareholders that is was extremely proud to be
the first in its field to have submitted a Biologics License Application (BLA)
to the Food and Drug Administration (FDA) for a blood substitute for human
use.
Through its BLA, Northfield is seeking approval to manufacture and market
its patented blood substitute product, PolyHeme(TM), as an ideal
oxygen-carrying resuscitative fluid for use in the treatment of urgent,
life-threatening blood loss. Management said that based on the strength of
its data, it believes that PolyHeme addresses a critical, unmet medical need
and provides life-saving therapy. As such, the company has requested priority
review and fast-track designation, which it hopes will lead to accelerated
approval as described in the FDA regulations.
"It's been an exciting and challenging year for us," said Richard
DeWoskin, chairman and chief executive officer. "We are gratified that our
work has been so favorably received by the scientific and medical community.
Our trial results document a very compelling clinical benefit that we believe
provides the substantial evidence of safety and efficacy required by the FDA.
In addition to the BLA submission, which was truly a seminal event in our
history and the history of the field of blood substitutes, there were also a
number of other important developments in our latest fiscal year. Our patent
portfolio was strengthened, and we made important progress in our ongoing
efforts to increase our manufacturing capacity."
Management also noted that while it was a difficult year on Wall Street
and for the Nasdaq in particular, it was notified recently of the company's
selection for inclusion in the Russell 3000 Index for 2002.
After discussing the company's technology, a process that starts with
human red blood cells, Dr. Steven A. Gould, president, summarized the benefits
of PolyHeme. "PolyHeme can be given to any individual without the need for
compatibility testing. It has a shelf life in excess of 12 months versus the
42-day maximum shelf life of stored blood. And, manufacturing modifications
allow us to eliminate viruses that might transmit disease. Our data show that
PolyHeme supports life in humans following massive hemorrhage and the virtual
absence of red cells, and is safe during rapid and massive infusion. We,
therefore, believe that PolyHeme represents an ideal resuscitative fluid."
Gould mentioned that it takes approximately 1.7 units of starting human
red cells to manufacture one unit of PolyHeme -- a highly efficient yield --
and that when prepared, one unit of PolyHeme is equivalent to blood in that it
contains 50 grams of hemoglobin.
Clinical Trials Unique
Northfield's clinical trials have been conducted in three areas. Its
major focus has been in urgent use in massive hemorrhage, primarily trauma, at
a dose of up to 20 units, as necessary, with the focus being on survival. The
normal blood volume of an adult is about 10 units. So by giving 20 units,
twice the standard total blood volume is being replaced. In certain massive
blood-loss situations, the company has infused patients with up to 20 units of
PolyHeme in as brief a period as 20 minutes -- a remarkable event. The
historical survival for such patients, reported in published scientific
literature, is less than 20 percent. According to management, the observed
survival in its seriously injured trauma patients is better than 75 percent, a
dramatic improvement that the company believes provides unequivocal evidence
of the life-sustaining capability of PolyHeme. Northfield is the only sponsor
assessing survival in a formal protocol. In the question and answer period of
the presentation, management was asked if there were any serious adverse
events documented that were considered directly related to PolyHeme. Gould
said, "The answer to that is a strong -- no."
Its trials in elective surgery have been at a dose of up to six units with
the focus being on the elimination of the use of donated blood. And its
compassionate-use trials are life saving therapy on a case-by-case basis when
no alternative treatment is available. "We continue to make remarkable
observations in these ongoing trials for compassionate use, and believe we are
the only sponsor actually enrolling patients in this type of protocol," said
Gould.
In his remarks regarding the company's future plans for clinical
development, he said, "We are considering other protocols in elective surgery,
but at this time have not finalized our plans. We will continue to explore
additional indications that may lead to subsequent applications for other
areas. And we intend to continue our life-saving use of the product, which we
think is very important. Finally, we will pursue non-U.S. submissions of our
current data for urgent life-threatening blood loss."
Management noted that it would be presenting its trial data in urgent
blood loss at the annual meeting of the American College of Surgeons in New
Orleans in October. The ACS is the largest surgical meeting in the United
States, and a very important forum for the presentation of Northfield's work.
The company hopes to have the full details of this presentation published in
the coming year.
Initial Manufacturing & Marketing Plans in Place
Management told shareholders that its manufacturing capacity has been
successfully scaled up to 10,000 units per year. And it has leased another
manufacturing facility that would provide 75,000 additional units annually.
It will take anywhere from 16 to 20 months at a cost of $26 to $30 million to
build out that space, but it will be large enough to support commercial
production, once completed. The company continues to explore potential
manufacturing partnerships as it proceeds to larger, commercial-scale capacity
in the future.
In commenting on the source and availability of raw material, Gould said,
"We presently have relationships and short-term purchasing contracts with both
the American Red Cross and the Blood Centers of America (BCA), which together
account for close to 70 percent of the blood collected in the U.S. each year.
We have a longer-term, three-year contract with the BCA that will actually go
into effect when we're ready for commercial manufacture. Further, we are
confident that an adequate supply is obtainable both now and over the long
term. We have no concerns about the shortage of blood affecting the
availability of starting material for PolyHeme in the future."
Northfield plans to use a specialty sales force with an educational focus
to reach its target market, who are likely to be trauma surgeons and critical
care specialists. It also will continue to explore potential marketing
partnerships.
With $28.7 million of cash on hand, the company said it estimates needing
an additional $40 million for manufacturing expansion, further clinical
developments, and initial marketing efforts, and noted that there are a
variety of financing options available. Management said it would pursue the
one that provides the best value for shareholders.
In its closing remarks, management said, "We think our regulatory position
is unique. The pending FDA guidance on blood substitutes will include
conclusions from a workshop that occurred at the FDA and the National
Institutes of Health in the fall of 1999. What we perceive as the important
conclusions from that workshop, and the issues the FDA will be looking for
blood substitute applicants to address, are: clinical experience in both
trauma and elective surgery in stable and stressed patients; rapid and
substantial volume infusions of the product, and; survival as an end point in
trauma and urgent blood loss. We are addressing and have addressed all of
those issues, and therefore believe we had sufficient documentation to submit
our BLA.
"A sponsor always anticipates many questions throughout the entire review
process, as a result we expect an interesting and challenging dialogue with
the FDA in the period to follow. This is the first application for an
entirely new product, so there's no precedent for the FDA. We're embarking on
an entirely new adventure -- with confidence and optimism."
Proxy Voting
Prior to the start of the business update presentation, shareholders voted
to re-elect Northfield's six directors to the board for a term of one year,
and ratified KPMG LLP as its independent auditors for the fiscal year ending
May 31, 2002.
Replay of Business Update Available
A replay of the webcast presentation will be available until September 30,
2001, by logging on to http://www.northfieldlabs.com or http://www.videonewswire.com . A
telephonic replay will be available through September 7, 2001, by dialing
888-266-2086 and providing the passcode, 5458560.
About the Company
Northfield Laboratories, founded in 1985, is a leading developer of an
oxygen-carrying blood substitute. The company is headquartered in Evanston,
Illinois, and its stock is traded on the Nasdaq National Market System under
the symbol NFLD.
Statements in this release that are not strictly historical are
"forward-looking" statements that are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements involve known and unknown risks, which may cause
the company's actual results in the future to differ materially from expected
results. Northfield cautions that the FDA approval process for PolyHeme
continues to be subject to significant risks and uncertainties. The FDA could
refuse to accept Northfield's BLA in its current form. If Northfield's BLA is
accepted, the FDA could deny its approval for the commercial sale of PolyHeme
or could require additional clinical tests as a condition to its approval. If
FDA approval for the commercial sale of PolyHeme is granted, the indication
uses for which PolyHeme may be marketed could be significantly limited by the
FDA. Other risks may include: competition from other blood substitute
products; the company's ability to obtain regulatory approval to market
PolyHeme commercially; the company's and/or its representative's ability to
successfully market and sell PolyHeme; the company's ability to manufacture
PolyHeme in sufficient quantities; the company's ability to obtain an adequate
supply of raw materials; the company's ability to maintain intellectual
property protection for its proprietary product and to defend its existing
intellectual property rights from challenges by third parties; the
availability of capital to finance planned growth; and the extent to which the
hospitals and physicians using PolyHeme are able to obtain third-party
reimbursement, as described in the company's filing with the Securities and
Exchange Commission.
Visit the Northfield website at: http://www.northfieldlabs.com
SOURCE Northfield Laboratories Inc.
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Related links:
http://www.frbinc.com
http://www.northfieldlabs.com
CONTACT:
Richard DeWoskin, Chief Executive Officer of
Northfield Laboratories, +1-847-864-3500; or Leslie Hunziker,
General Information, of The Financial Relations Board,
+1-312-640-6760
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