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Biopure Seeks Regulatory Approval To Market Hemopure In South Africa
CAMBRIDGE, Mass., July 20 /PRNewswire/ Biopure(R) Corporation has filed an application with South Africa's Medicines Control Council to market Hemopure(R) [hemoglobin glutamer -- 250 (bovine)], the company's investigational oxygen-carrying solution or "oxygen therapeutic. " The proposed product indication is to eliminate or reduce red blood cell transfusions in elective surgeries.
Biopure recently completed a multi-center, non-U.S. Phase III clinical trial evaluating the perioperative use of Hemopure in non-cardiac surgery, which included several sites in South Africa. The study results from this clinical trial form the basis for Biopure's marketing application in South Africa.
Biopure Corporation, headquartered in Cambridge, Mass., is a leading developer, manufacturer and marketer of oxygen therapeutics. These pharmaceuticals are intravenously administered into the circulatory system to deliver oxygen to the body's tissues. Biopure has developed and manufactures two hemoglobin-based oxygen therapeutic solutions. Hemopure(R), for human use, is being further evaluated in a pivotal Phase III clinical trial in the United States. Oxyglobin(R) [hemoglobin glutamer -- 200 (bovine)], the only hemoglobin-based oxygen therapeutic approved by the U.S. Food and Drug Administration, is a veterinary product that has been commercially available since March 1998 for the treatment of anemia in dogs, regardless of the cause. |