Biopure gets first approval for Hemopure in SA

9 April 2001

Biopure's blood substitute Hemopure (hemoglobin glutamer - 250 [bovine])has been approved in South Africa for the treatment of acute anemia and avoidance of red blood cells in adult surgery patients. This is the first-ever approval of an oxygen therapeutic for human use, notes Biopure, which says it plans to file for registration of Hemopure in the USA later this year, with submissions in Europe and other countries following thereafter.

Hemopure will be marketed in South Africa by local companies Network Healthcare Holdings and Community Healthcare Holdings, via their joint subsidiary Tshepo Pharmaceuticals. Tshepo will launch the product in the first half of next year, once Biopure ramps up its production capacity for the drug. In the meantime, Biopure is making the drug available at no cost to select Netcare hospitals in South Africa.

Hemopure, which is based on purified hemoglobin derived from bovine red cells, is intended for use as an "oxygen bridge" to help stabilize anemic surgery patients until they manufacture their own red blood cells or compatible cells can be administered.

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