SCHEDULE 14A
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INFORMATION REQUIRED IN PROXY STATEMENT
SCHEDULE 14A INFORMATION
SCHEDULE 14A INFORMATION
PROXY STATEMENT PURSUANT TO SECTION 14(a) OF THE SECURITIES
EXCHANGE ACT OF 1934 (AMENDMENT NO. )
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Preliminary proxy statement. | |
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NORTHFIELD LABORATORIES INC.
(Name of Registrant as Specified in Its Charter)
(Name of Person(s) Filing Proxy Statement if Other Than the Registrant)
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To My Fellow Shareholders:
Fiscal 2008 presented many challenges and opportunities for
Northfield as we worked to complete our Biologics License
Application (BLA) for
PolyHeme®.
The focus of fiscal 2009, perhaps the most important year in
Northfield’s history, will be the successful submission and
filing of the BLA with a designation of priority review, with
the potential to culminate with a marketing approval for the
sale of PolyHeme. We believe strongly in PolyHeme’s
potential to save lives, and are dedicated to making our product
available for patients with life threatening hemoglobin levels
when blood is not available.
The year began with a pre-BLA meeting with FDA last summer. The
meeting was informative and constructive. Although the challenge
of preparing the BLA has required considerably more time than
anticipated, we believe that the resulting application will make
a strong case for the approval of PolyHeme, which is our
ultimate goal.
The BLA consists of three sections: clinical, preclinical, and
chemistry, manufacturing and controls (CMC). While the key
clinical data are the results of our multicenter Phase III
trial, the clinical section includes information from all
studies in humans, starting with our Phase I volunteer
experience. As we have reviewed and reanalyzed the results of
our clinical studies, we have expanded the number of data sets
we believe should be included. This has required the generation
of multiple additional tables, listings, figures, and graphs,
and the subsequent additional analyses of this information in
order to provide the most comprehensive summary and
interpretation of the totality of our clinical data. That
process continues as we finalize the portions of the BLA that
address the important integrated summaries of efficacy and
safety, the risk-benefit analysis, and the product labeling.
We have also reviewed and reanalyzed all of the preclinical
reports that have been previously submitted in order to provide
the most meaningful interpretation of those data. Completing the
CMC section continues to be one of the most time consuming parts
of the process. The current Good Manufacturing Practices (cGMP)
requirements for commercial manufacturing have evolved
considerably over the past two decades since our pilot facility
was first opened. Since our plan is to seek FDA approval using
this site as our first commercial facility, we have made
multiple improvements and updates, all of which required
subsequent validation, in order to confirm cGMP compliance.
Based on these activities, we now anticipate the final BLA will
be submitted in the fourth calendar quarter of 2008. The
submission triggers a number of important events. FDA has a
60 day period to conduct its initial review and make a
decision on the filing of the BLA and the designation of
priority review. We continue to believe that PolyHeme satisfies
the stated criteria for priority review based on its potential
to address an unmet medical need. The stated time for priority
review under the Prescription Drug User Fee Act is six months.
It is likely that our BLA would be considered at a meeting of
the Blood Products Advisory Committee (BPAC). The Committee is
comprised of independent experts who would review
Northfield’s data and raise questions for the Company at a
public meeting. At the end of that meeting, BPAC members would
have the opportunity to vote on the safety and efficacy of
PolyHeme for the proposed indication. While the decisions of the
Advisory Committee are not binding, FDA carefully considers the
recommendations of these expert committees. These are all
milestone events for Northfield in fiscal 2009.
We had many opportunities to disseminate the results of the
Phase III trial. In October the data were presented at the
American College of Surgeons, and the presentation formed the
basis for a paper which has been submitted to a peer-reviewed
journal for publication. The study results were also presented
at a plenary session at the XI International Symposium on Blood
Substitutes in Beijing. We have also continued to work with our
investigators as they complete the process of final public
disclosure at their individual sites.
There has been considerable interest in the field of
hemoglobin-based oxygen carriers, or HBOCs, this year. In April,
FDA and NIH jointly sponsored a
two-day
public workshop entitled Hemoglobin-Based Oxygen Carriers:
Current Status and Future Directions. The program included
presentations of clinical data by all sponsors developing HBOCs,
including Northfield, as well as discussions of the basic
science of hemoglobin, and the interactions of hemoglobin with
nitric oxide. At this meeting we also had the opportunity to
present new data on cardiac events in the Phase III trial
as classified in a blinded analysis by the Cardiac Subcommittee
of the Independent Data Monitoring Committee that monitored our
Phase III trial. The results, based on uniformly applied
objective criteria, indicated that more than half of the
patients in both the PolyHeme and the control groups had some
evidence of myocardial infarction, or MI, confirming the
difficulty of diagnosing MI in trauma patients.
A number of key scientific papers were published during the year
addressing the safety of blood as well as HBOCs. Several of
these studies reported that many of the cardiovascular adverse
events experienced in HBOC trials also occur in patients who
receive blood transfusions. In fact, the role of nitric oxide
for both blood and HBOCs, and the significance of the age of
stored blood in relation to safety, are now of great interest to
the transfusion medicine community. Northfield has begun to
collaborate with investigators in the field of nitric oxide
biology to explore some of these issues and how their findings
might relate to PolyHeme
We participated in a number of important meetings related to the
advancement of trauma care, including the Endpoint Initiative
Meeting in Dallas in February hosted by the National Trauma
Institute, and the Decision Gate in Progress Review at
Fort Detrick in March. The latter is held each year to
brief the Commander of the U.S. Army Medical Research and
Materiel Command on the progress of the many different research
programs designed to bring forward products that will be useful
to the military, and to begin considering the designation of
funding for acquisition purposes. We were invited to attend and
to discuss the progress we have made with the development of
PolyHeme. This is an exciting opportunity for Northfield.
Based on our funds available as of May 31, 2008, we believe
we have sufficient financial resources to support the BLA
submission and review process, including a pre-approval
inspection of our manufacturing facility, for approximately the
next year. We are hopeful a successful submission and filing of
the BLA with priority review will lead to opportunities to
secure the additional funding needed to move PolyHeme into
commercialization. Our annual report includes additional
information regarding our financial position and our plans
relating to Northfield’s future.
Our proxy statement this year includes two important proposals
that are part of our plan to secure additional funding and to
continue to retain and attract the talented employees critical
to achieving our objectives. These proposals are unanimously
supported by our Board of Directors and I strongly urge you to
review the information in our proxy statement and vote
“for” each of these proposals at our upcoming annual
meeting of stockholders.
As I stated at the outset, our focus for fiscal 2009 is the
successful submission and filing of the BLA with a designation
of priority review. I hope you now have a better understanding
of the enormity of the task. We believe our clinical data
demonstrate PolyHeme has the potential to provide
life-sustaining capability to bleeding patients when blood is
not immediately available, and to thereby address a critical
unmet medical need. We believe PolyHeme has a favorable
benefit-to-risk
profile for this indication. In addition, there are multiple
logistic benefits of PolyHeme that add to the compelling basis
for the use of PolyHeme in those clinical settings. This is our
case to FDA.
Once more I wish to take this opportunity to thank you, our
shareholders, for your loyal support of our efforts to bring
PolyHeme to commercial reality. I look forward to reporting our
progress as the year proceeds.
Sincerely,
Steven A. Gould, M.D.
Chairman and Chief Executive Officer
Chairman and Chief Executive Officer