Northfield Labs Pulls Plug on Blood Substitute Operations in Illinois

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Reported by Annette Kreuger, Industrial Info Resources (Sugar Land, Texas)--In a virtual bloodbath, Northfield Laboratories (NASDAQ:NFLD) (Evanston, Illinois) issued a statement on May 8, announcing "that it has terminated the employment of substantially all of its operational and staff employees at its manufacturing facility in Mount Prospect, Illinois and headquarters in Evanston, Illinois." The action follows the Food and Drug Administration's (FDA) recent rejection of the company's Biologics License Application for PolyHeme, a human hemoglobin-based, oxygen-carrying red blood cell substitute.

Friday's announcement is just the latest in a long line of bad news for Northfield and its attempts to bring PolyHeme to market. The product appeared to hold great promise for seriously injured patients. Traditionally, patients sustaining severe blood loss receive a saline solution at the scene of the injury before being transported to the hospital where blood would then be available. Universally compatible, there is no need to cross-type for PolyHeme, making it immediately available for use as an initial resuscitative fluid. The potential benefits of the product increased substantially when considering battlefield applications.

Northfield has released excerpts of the FDA's April 2009 rejection letter, which stated that the PolyHeme pivotal trial, "... did not meet the pre-specified primary efficacy endpoint" and that "based on the totality of the data in the application, FDA has determined that the data submitted do not support the proposed indication." The FDA also noted that "the safety data of all controlled studies reveal that the administration of PolyHeme places the patients at a higher risk of significant adverse events." Some reports placed the death rate for trauma patients treated with PolyHeme at more than 13% compared with a death rate of just less than 10% for patients treated with saline and blood.

In 2002, while confidently anticipating FDA approval of the product, the company began making serious plans to build a commercial-scale plant (Source: Industrial Info Resources' (Pharmaceutical Tracker - Online Database). The project, which would have had a capacity of 100,000 units of PolyHeme, went through a series of delays over the years, but appeared closer to fruition when the company contracted with Jacobs Engineering (NYSE:JEC) (Pasadena, California) in 2006. A scheduled construction start of summer 2007 was delayed following discrepancies in Phase III clinical trial data regarding PolyHeme. For more information, see January 8, 2007, news article - Phase III Trial Data Discrepancies Put Brakes on Northfield Labs' Plan to Build Commercial-Scale Plant in Illinois.

Northfield had already received considerable heat over its trial methods, which ended in December 2006. Hoping to reach a minimum of 720 patients nationwide, the company had a total of 18 test sites scattered among 32 Level 1 Trauma facilities throughout the country. The controversy arose over whether proper measures were being taken to assure patient consent before receiving the product. The program Northfield used, which was FDA-approved, allowed waiving the test subjects' informed consent in life-threatening situations. Others could choose to opt out of the program following response to public notices, most often published in local newspapers. For more information, see January 4, 2005, news article - Houston Participates in Controversial Phase III Clinical Trials for Blood Substitute PolyHeme.

While Northfield considers its next step, the company's stock has tumbled to $0.20. This is down from a 52-week high of $1.72.

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