Biopure Corporation (NASDAQ:BPUR)
Industry: Healthcare

Listed 20 Consecutive Market Days. On List as of 09/26/2006 Through 10/24/2006

Biopure Corporation, incorporated in 1984, develops and manufactures oxygen therapeutics, a class of pharmaceuticals that are administered intravenously to transport oxygen to the body's tissues. Using the Company's technology, it has developed and manufactures two products: Hemopure (HBOC-201) for human use, and Oxyglobin (HBOC-301) for veterinary use. Hemopure is approved in South Africa for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, reducing or delaying the need for donated red blood cell transfusions in these patients. Oxyglobin is approved by the United States Food and Drug Administration (FDA) and by the European Commission for the treatment of anemia in dogs. The Company markets its products under the trade name Biopure, Hemopure and Oxyglobin. The Company's clinical development strategy for ischemia is to conduct parallel pilot trials of Hemopure to assess the potential of several ischemia indications (wound healing, acute coronary ischemia and cardiac surgery) before committing funding for advanced trials. It is pursuing its ischemia development program in Europe and South Africa. Biopure Corporation completed the first pilot trial in coronary ischemia during the fiscal year ended September 30, 2005 (fiscal 2005). The regulatory authorities in the United Kingdom and Greece have authorized the Company to conduct a multi-center Phase 2 clinical trial in patients undergoing multi-vessel coronary artery bypass graft (CABG) surgery. This pilot trial is designed to assess the safety and feasibility of Hemopure in reducing heart damage and enhancing tissue preservation during cardiopulmonary bypass. In fiscal 2005, Biopure Corporation completed a 45-patient pilot trial in Europe that was designed to assess the safety and feasibility of Hemopure in patients with single-vessel coronary artery disease who were undergoing angioplasty and stent procedures or percutaneous coronary intervention (PCI). Biopure Corporation's two products, Hemopure and Oxyglobin, are oxygen carrying biological drugs called oxygen therapeutics. South Africa's Medicines Control Council granted marketing approval for Hemopure for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, delaying or reducing the need for red blood cell transfusions in these patients. Since this approval, over 350 patients in South Africa have received Hemopure the Company provided without charge, as part of its medical education program. The Company submitted an application to the FDA seeking regulatory approval to market Hemopure in the United States for a similar indication in adult patients undergoing orthopedic surgery. It has conducted 23 clinical trials of Hemopure involving 1,512 humans, of whom 835 were administered Hemopure. Biopure Corporation is in the process of initiating three clinical trials that are designed to enroll a total of 180 human subjects, approximately 100 of whom are expected to receive Hemopure. Hemopure has been administered on an emergency compassionate use basis to 33 human patients in the United States with life threatening anemia when compatible red blood cells were unavailable or unacceptable. The Company's veterinary product, Oxyglobin, is similar to Hemopure except for its molecular size. The FDA Center for Veterinary Medicine and the European Commission approved Oxyglobin in both cases for the treatment of canine anemia, regardless of the cause of the anemia. Hemopure and Oxyglobin have been tested in over 200 completed animal studies. The Company competes with Northfield Laboratories Inc.

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As Of: 10/07 00:00 ET
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