To: Biomaven who wrote (4567 ) 8/29/2001 11:12:12 AM From: Ian@SI Respond to of 52153 and another shoe drops.... +++++++++ August 29, 2001 Northfield Applies for FDA Approval Of Human Blood-Substitute Product By THOMAS M. BURTON Staff Reporter of THE WALL STREET JOURNAL Northfield Laboratories Inc. said it submitted an application to the Food and Drug Administration for possible approval of its oxygen-carrying blood-substitute product, called PolyHeme, for use in human patients. The move by Northfield, Evanston, Ill., makes it the first company to file with the U.S. government in the race to market an artificial blood product that could be used in place of donated blood in human trauma and surgical patients. The announcement by Northfield follows by a day the statement by a competitor, Biopure Corp. of Cambridge, Mass., that it has met safety and efficacy standards set by the FDA for its product, Hemopure, and that it plans to file this year for possible approval by the federal agency. Tuesday, Northfield shares were up 22 cents to $17.30 in 4 p.m. trading on the Nasdaq Stock Market. The company hasn't publicy released data from its Phase III clinical trial, the last stage of clinical study. Northfield's blood substitute is intended to reduce the need for donated blood and -- especially in the case of trauma surgery -- would in theory do away with the time-consuming need to cross-match blood types between donated blood and the patient's blood. The artificial product could also have a far longer shelf life than does donated blood. The market for blood is in the billions of dollars, but questions surrounding the blood-substitute industry include whether the product can be offered at a comparable price to that of donated blood. Also, fears of HIV or hepatitis infection with donated blood have waned in recent years as the technological ability to screen out infected blood has improved. Wall Street has long believed that the artificial-blood market could be a substantial one, but it has taken years longer for a product to come to fruition than had once been expected. In 1998, another competitor, Baxter International Inc., suspended clinical trials on its product, and it subsequently switched its emphasis to a later-generation product. Northfield's product is engineered from outdated human donated blood, while Biopure's is derived from purified cow's blood; some other products are totally artificial.