Clinical Trial Patient Enrollment Nears Completion; Patient Count Reaches 700
EVANSTON, Ill., Jun 16, 2006 (BUSINESS WIRE) -- Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that
it signed an agreement with First Industrial, L.P., to purchase the
building Northfield currently occupies as lessee in Mt. Prospect, IL
for $6.7 million. The transaction is scheduled to close in late June,
subject to customary terms and conditions.
This 106,000 square foot property will be used for Northfield's
first planned commercial facility for the manufacture of PolyHeme(R),
the Company's human hemoglobin-based oxygen carrier, as well as to
house laboratory, quality, and administrative personnel. Engineering
and size optimization activities for the space are already underway,
as previously announced. It is expected that the facility will be
capable of producing approximately 100,000 units or more of
PolyHeme(R) annually. The Company has indicated that the major capital
expenditure associated with this expansion will not occur until
topline data from the current trauma trial has been analyzed and
reported, sometime in the Fall.
"Purchasing the building where we will manufacture PolyHeme(R) is
a major step toward realizing our commercialization plans," said
Steven A. Gould, M.D., Chairman and Chief Executive Officer. "Owning
the space allows us the autonomy and flexibility we need to meet the
anticipated market demand for a product that has the potential to
sustain lives that otherwise might be lost."
Clinical Trial Update
The Company also announced that enrollment is nearing completion
in its pivotal Phase III trauma study. Approximately 700 patients of
the planned total of 720 have been enrolled at Level I trauma centers
across the United States.
"Reaching the 700 patient mark is a tribute to the dedication and
commitment of the investigators, their institutions and the EMS
providers participating in this complex and groundbreaking study,"
said Gould. "We look forward to completion and to reporting on the
trial results," he added.
Analyst and Institutional Investor Meeting
Northfield will be hosting an analyst and institutional investor
event in New York on August 8, 2006. This year's event is entitled
Delivering Trauma Care Today and Tomorrow. Several distinguished
experts will speak on issues including access to trauma care and EMS
systems, recently the subject of a series of reports prepared by the
National Academy of Sciences' Institute of Medicine. As with last
year's event, this forum will be available to all shareholders via
live webcast. Details will be available approximately one week prior
to the date.
About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an
oxygen-carrying resuscitative fluid for the treatment of urgent, large
volume blood loss in trauma and resultant surgical settings.
PolyHeme(R) is a solution of chemically modified human hemoglobin that
requires no cross matching and is therefore compatible with all blood
types. It has a shelf life in excess of 12 months. Enrollment is
currently underway in a pivotal Phase III trial of PolyHeme(R)
beginning in the pre-hospital setting. For further information, visit
This press release may contain forward-looking statements
concerning, among other things, Northfield's future business plans and
strategies and clinical and regulatory developments affecting our
PolyHeme(R) red blood cell substitute product. These forward-looking
statements are identified by the use of such terms as "intends,"
"expects," "plans," "estimates," "anticipates," "should," "believes"
and similar terms. These forward-looking statements involve inherent
risks and uncertainties. Our actual results may therefore differ
materially from those predicted by the forward-looking statements
because of various factors and possible events, including our ability
to obtain FDA approval to market PolyHeme commercially, the
availability of capital to finance our clinical trials and ongoing
business operations, our ability to obtain adequate supplies of raw
materials and to manufacture PolyHeme in commercial quantities, our
ability to market PolyHeme successfully, the possibility that
competitors will develop products that will render PolyHeme obsolete
or non-competitive, our ability to protect our intellectual property
rights, the outcome of certain governmental inquires and purported
class action lawsuits as described in our most recently filed
quarterly report on Form 10-Q, the possibility that we may be subject
to product liability claims and other legal actions, our dependency on
a limited number of key personnel, the uncertainty of third party
reimbursement for our product and other risks and uncertainties
described from time to time in our periodic reports filed with the
Securities and Exchange Commission, including our most recently filed
quarterly report on Form 10-Q and annual report on Form 10-K. These
forward-looking statements speak only as of the date of this press
release. We do not undertake any obligation to update or publicly
release any revisions to forward-looking statements to reflect events,
circumstances or changes in expectations after the time such statement
is made. All subsequent written and oral forward-looking statements
attributable to Northfield or any person acting on our behalf are
qualified by this cautionary statement.
SOURCE: Northfield Laboratories Inc.
Northfield Laboratories Inc.
Sophia H. Twaddell, 847-864-3500
Paula Waters, 312-751-3735