Biopure

Biopure Corporation was a biopharmaceutical company that specialized in oxygen therapeutics (blood substitutes) for both human and veterinary use. The company developed, manufactured, and marketed oxygen therapeutics, designed to transport oxygen to the body's tissues. The oxygen technology uses hemoglobin-based oxygen carrying molecules in solution (HBOCs) to increase oxygen transfer to the tissues. The competing companies with Biopure were Allied Pharmaceutical, Northfield Laboratories, Baxter International and Hemosol of Toronto. The company developed two products: Hemopure (HBOC-1) [hemoglobin glutamer-250 (bovine)] for human use, and Oxyglobin (HBOC-301) [hemoglobin glutamer-200 (bovine)] for veterinary use.^[1][2] In April 2001, Hemopure was approved for commercial sale in South Africa for treatment of acute anemia in general surgery.^[3] It is currently approved there and in Russia.^[4] However, Hemopure has not been able to gain approval in the U.K. or the U.S. because of safety and reliability concerns of the European Commission and the U.S. Food and Drug Administration (FDA) respectively.^[5] The company formed an agreement with the U.S. Navy to aid in preclinical testing of Hemopure for out-of-hospital treatment of trauma patients in hemorrhagic shock. Oxyglobin is the only oxygen therapeutic approved for treatment of canine anemia in both Europe and the U.S. and has been used in treatment for thousands of cases.^[6] Unable to obtain FDA approval for Hemopure to date, Biopure ceased operations in 2009 and its assets were purchased by OPK Biotech LLC in September 2009.^[7] On July 16, 2009 Biopure announced it had filed for bankruptcy protection under Chapter 11, Title 11, United States Code and entered into an agreement with OPK Biotech LLC for the sale of substantially all of its assets.^[8] It in turn went bankrupt and "Hemoglobin Oxygen Therapeutics LLC was organized in February 2014 in connection with the acquisition of OPK Biotech."^[9] Through it, Hemopure is still available under FDA’s Expanded access Program (EAP).^[4]

The company held nearly 30 patents relating to its oxygen therapeutics. Their patented and proprietary oxygen technology utilizes blood from cattle to develop the "hemoglobin-based" oxygen carrier rather than blood from humans. Most importantly, the issue of blood type matching is eliminated due to the "universal" nature of this oxygen therapeutic. The products are administered intravenously to deliver oxygen to the body's tissue through the formulated composition of purified hemoglobin from cattle blood and a balanced salt solution.^[1]

In Hemopure, the average oxygen content is maximized due to the reduced size of the stabilized HBOC molecules in comparison to red blood cells (RBCs). Oxyglobin primarily differs from Hemopure in molecule size of the stabilized HBOC. Oxyglobin is approved for oxygen fluid therapy and an alternative to RBC transfusion in dogs, and is administered intravenously as well. The stabilized HBOC then flows through the blood plasma in the body, where oxygen transport takes place. Due to the reduced size of the HBOC in Hemopure, oxygen can be transported to restricted areas where normal RBCs fail to reach. Another advantage of this patented oxygen technology is the increased shelf life of 36 months through storage conditions at room temperature, while RBCs must be refrigerated and discarded if not used after six weeks. However, these products are only indicated for temporary oxygen replenishment through the oxygen bridge, with an average half-life of 19 hours (specifically Hemopure), therefore long term oxygen support requires RBC blood transfusion.^[1]