Company Profile

In September 2009, OPK Biotech acquired the assets of BioPure after the firm went into Chapter 11 being unable to satisfy FDA safety concerrns re.the firm's blood substitute HemaPure. Biopure has been developing a technology that used applied separations and purifications to produce biologically active products such as hemoglobin-based oxygen-carrying solution. Offering pharmaceuticals called oxygen therapeutics, intravenously administered to deliver oxygen to the body's tissues. one was Hemopure® [hemoglobin glutamer – 250 (bovine) - an investigational product being evaluated for human use in a pivotal, multinational Phase III clinical trial as a perioperative alternative to red blood cell transfusion in orthopedic surgery. Other studies are evaluating the product's use in trauma, in ischemic conditions such as heart attack and stroke, and in hypoxic tumors. Oxyglobin® [hemoglobin glutamer – 200 (bovine)], the only oxygen therapeutic of its kind approved by the U.S. FDA and the European Commission, is commercially available in the United States for the treatment of anemia in dogs. Biopure's U.S. and foreign patents cover the manufacture of ultra-pure and room temperature stable hemoglobin solutions and their use as oxygen therapeutics. The mission of Biopure Corporation (Nasdaq: BPUR) is to introduce revolutionary new drugs that deliver lifesaving oxygen. The company has pioneered the development and manufacture of oxygen therapeutics, a new class of pharmaceuticals that are intravenously administered to deliver oxygen to the body's tissues. Biopure's products represent a new Oxygen Bridge™ treatment approach for managing patients' oxygen requirements in a broad range of potential medical applications. Hemopure® [hemoglobin glutamer - 250 (bovine)], or HBOC-201, Biopure's first-in-class product for human use, is approved in South Africa for treating adult surgical patients who are acutely anemic and for eliminating, reducing or delaying the need for allogenic red blood cell transfusion in these patients. As a prerequisite to further company-sponsored clinical trials in the United States, Biopure is currently addressing the U.S. Food and Drug Administration’s questions regarding the product’s safety and efficacy and questions arising out of the company’s biologics license application to market Hemopure in the United States for a similar indication in orthopedic surgery patients. As part of this process, the company is conducting FDA-requested animal studies. Biopure is also developing Hemopure for other potential medical applications in trauma and as a cardioprotective agent in ischemic conditions. Oxyglobin® [hemoglobin glutamer - 200 (bovine)], or HBOC-301, the only hemoglobin-based oxygen therapeutic approved by the U.S. FDA and the European Commission, is a veterinary product indicated for the treatment of