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Biopure
Biopure Corporation was a biopharmaceutical company that specialized in oxygen therapeutics 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) (glutamer-250 (bovine) ) for human use, and Oxyglobin (HBOC-301) (glutamer-200 (bovine) ) for veterinary use.〔(Biopure Corporation Homepage. ) ''www.biopure.com''. Last accessed 2008-10-10.〕〔John T. Gourville (May 29, 1998) (Cases: Biopure Corporation Case Study. ) Harvard Business School〕 As of April 2001, Hemopure was approved for commercial sale in South Africa for treatment of acute anemia in general surgery.〔Feder, B. (2001-04-10) (Technology; South Africa expected to approve use of blood substitute ) New York Times. Last accessed 2008-10-10.〕 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.〔(2008-04-07) (Biopure’s blood product runs into regulatory obstacle ) — Boston Business Journal (from Biopure press release). Last accessed 2008-10-10.〕 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 treated thousands of cases.〔(Biopure Oxyglobin Product Homepage ) Biopure ''oxyglobin.com'' Last accessed 2008-10-10.〕 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 of 2009.〔(Biopure - Form 10-Q Quarterly Report ) U.S. Securities and Exchange Commission (SEC) 2009-06-22.〕 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 .〔(Biopure - Form D8K - Completion of Acquisition or Disposition of Assets ) SEC 2009-08-24.〕
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.〔
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 must be discarded 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.〔
== Side effects ==
According to clinical trials with Hemopure, the following adverse events occurred at greater than or equal to 5%: transient yellow skin discoloration, nausea, mild to moderate increase in blood pressure (10 to 20 mm/Hg), vomiting, low urine output, difficulty swallowing, flatulence, and low red blood cell count. The use of Oxyglobin has shown the following common side effects: discoloration of the skin, mucous membranes and urine. Adverse events such as vomiting and melena (dark color feces) can also occur. Dogs with impaired cardiac function and other conditions that are prediposed to circulatory overload can have adverse events after Oxyglobin administration. Repeat administration requires careful monitoring.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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