11.06.2007 21:00:00
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Northfield Laboratories Announces New Regulatory Leadership
Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that Richard
D. Newman, Ph.D., D.A.B.T., will assume a leadership role for the
Company in Regulatory Affairs. Dr. Newman has served as a consultant to
Northfield on all aspects of regulatory matters since 2003. Eva Essig,
Ph.D., who previously served in this role, has accepted a regulatory
position in the pharmaceutical industry.
"We have worked closely with Ric on regulatory
affairs over the past four years and value the expertise he brings
Northfield as we move forward in the regulatory process,”
said Steven A. Gould, M.D., Chairman and Chief Executive Officer.
Dr. Newman has substantial senior level management experience in
regulatory and clinical affairs. He spent more than 25 years at Procter
and Gamble, G.D. Searle, and Baxter Healthcare Corporation working on
biologics, drugs and medical devices. At Baxter, Dr. Newman served in
the Renal Division as Vice President from 1992-2002, beginning with
Regulatory Affairs, and assuming increasing levels of responsibility for
Clinical Affairs, and then Research and Development where he directed
Global Product Development.
About Northfield Laboratories
Northfield Laboratories Inc. is a leader in developing an
oxygen-carrying red blood cell substitute for the treatment of
life-threatening blood loss, when an oxygen-carrying fluid is required
and red blood cells are not available. PolyHeme®
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. For further information, visit www.northfieldlabs.com. Forward Looking Statement 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 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 the
possibility that since the data from our Phase III clinical trial have
not been submitted to, or reviewed by, FDA, they may not be
sufficient to demonstrate the safety or effectiveness of PolyHeme, our
ability to obtain FDA approval to market PolyHeme commercially, our
ability to obtain priority review, 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
inquiries and purported class action lawsuit as described in our most
recently filed annual report on Form 10-K and 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 annual report on Form 10-K
and quarterly report on Form 10-Q. 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.
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