PolyHemeTreatment for Bleeding
PolyHeme BLA Accepted for Filing and Granted Priority Review
BLA for PolyHeme Accepted for Filing and Granted Priority Review
EVANSTON, Ill.--(BUSINESS WIRE)--Dec 30, 2008 - Northfield Laboratories Inc. (Nasdaq: NFLD) announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its Biologics License Application (BLA) for PolyHeme, the Company's investigative human hemoglobin-based red cell substitute for the treatment of life-threatening red blood cell loss when an oxygen-carrying fluid is required and red blood cells are not available. In addition, FDA has designated the submission for Priority Review, with a review goal date of April 30, 2009.
"Filing of our BLA for PolyHeme with Priority Review is a key milestone for Northfield," said Steven A. Gould, M.D., Chairman and Chief Executive Officer. "We are now one step closer to delivering a potential life-saving therapy to patients who need transfusion in situations when blood is not available."
Northfield announced that it had submitted the BLA for PolyHeme on October 29, 2008, based on its comprehensive development program, including data from its Multicenter Phase III randomized, double-blind trial involving 720 trauma patients. Findings from this study were presented at the American College of Surgeons, appeared online in the Journal of the American College of Surgeons in November, and are scheduled for publication in the print edition in January 2009.
About Northfield Laboratories
Northfield Laboratories is a leader in developing a hemoglobin-based oxygen-carrying red blood cell substitute. The initial indication we are seeking for our investigational product PolyHeme is the treatment of life-threatening red blood cell 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 an extended shelf life in excess of 12 months. For further information, visit http://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 FDA may not meet the required time periods for the review of our BLA under applicable laws, regulations and guidances, our potential inability to obtain FDA approval to market PolyHeme commercially based on our BLA, our potential inability to regain compliance with applicable Nasdaq listing standards, our need to obtain additional capital to finance our ongoing business operations and the construction of an expanded commercial-scale manufacturing facility, our potential inability to obtain adequate supplies of raw materials and to manufacture PolyHeme in commercial quantities, our potential inability to market PolyHeme successfully, the possibility that competitors will develop products that will render PolyHeme obsolete or non-competitive, our potential inability to protect our intellectual property rights, the outcome of a purported class action lawsuit 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 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.
Posted: December 2008
- Northfield Receives Complete Response Letter for PolyHeme BLA - May 1, 2009
- Northfield Laboratories Inc. Announces Submission of BLA for PolyHeme - October 29, 2008