Hemopure
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Hemopure, developed by Biopure (BPUR), is an oxygen-therapeutic based on chemically stabilized bovine hemoglobin. It has been developed for potential use in humans as a substitute for blood, which can be in short supply, carries a risk of being used improperly, may cause reactions, or may carry infection. Hemopure has been approved for human use and commercial sale in South Africa since April 10, 2001, a first and only for this product class. But despite this, BPUR has only managed to sell a total of $8,000 worth of Hemopure in South Africa in the intervening five years through July 31, 2006- according to corporate documents. Demand for Hemopure is negligible and the few very limited sales are heavily subsidized by BPUR investors.
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[edit] Clinical trials
In the most recently completed human trial of Hemopure in the United States, Hemopure was not found to be inferior to blood. However safety concerns did arise which caused the FDA to impose a ban on further clinical testing of the product on human test subjects in the United States. The FDA and Biopure reached an agreement to conduct a series of animal tests designed to study those safety concerns and determine whether a new round of human testing could safely be initiated. Most, if not all, of these tests have been completed and their findings submitted and studied by the FDA. Outside the United States, human testing of Hemopure is allowed in South Africa and in Europe.
The U.S. Naval Medical Research Center, which is collaborating with Biopure in the study of Hemopure, was recently granted $4 million in additional Congressional funding for the U.S. Navy to continue research and development of Hemopure. This was through the FY 2006 Defense Appropriations Bill signed by President Bush on December 30, 2005. And while the FDA has suggested that Hemopure be reformulated to improve its safety profile, discussions are reportedly ongoing between the FDA, Biopure, and Naval and academic researchers over ways of addressing the FDA safety concerns without changing the current product formulation.
[edit] Attributes
- It is stable for 36 months (three years) at room temperature
- It does not require refrigeration, warming or reconstitution
- It is compatible with all blood types
- It does not require blood typing, testing or cross-matching
- It is ultra-purified through a patented pharmaceutical manufacturing process that has been demonstrated to remove or inactivate potential contaminants, including infectious agents (e.g. viruses, bacteria and TSE agents).
[edit] Studies
Hemopure and its producing company Biopure, are subjects in a Harvard Business School marketing strategy case.
