BioPure Corporation, which was founded in 1984 by entrepreneurs Carl Rausch and David Judelson, is a privately owned biopharmaceutical firm specializing in the ultra purification of proteins for human and veterinary use. In 1998 Biopure pioneered the development of oxygen therapeutics using "Hemoglobin", a new class of pharmaceuticals that are intravenously administered to deliver oxygen to the body's tissues. Biopure's two products, Hemopure for human use, and Oxyglobin for animal veterinary use, both represented a new Oxygen based treatment approach for managing patients' oxygen requirements in a broad range of potential medical applications. The factor distinguishing Biopure's two products from other blood substitute products being developed by two possible rivals, Baxter International and Northfeild Laboratories, is that its hemoglobin based source is bovine rather than human and was derived from the blood cells of cattle. Both of Biopure's blood substitute products were in the final stages of the approval process of the Food and Drug Administration (FDA) in 1998. Oxyglobin had just received the FDA's approval for commercial release declaring it safe and effective for medical use. Hemopure was entering final Phase 3 clinical trials and was optimistically expected to see final FDA approval for release in 1999. The FDA approval of Oxyglobin and its possible subsequent release into the veterinary market caused concern over whether the early release of Hemoglobin would impinge BioPure's ability to price Hemopure when the product finally received approval. Given that the two products were almost identical in properties and function, it was thought that the early release of Oxyglobin would create an unrealistic price expectation for Hemopure if released first.
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