Biopure launches Hemopure anemia therapeutic in South Africa

By Angela McDaniels

Seattle, Jan. 30 - Biopure Corp. said it has made the first sale of its room-temperature-stable oxygen therapeutic Hemopure (hemoglobin glutamer - 250 (bovine)) in South Africa.

The product is approved in South Africa for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, delaying or reducing the need for allogenic red blood cell transfusions in these patients.

"This first ever commercial sale of a hemoglobin-based oxygen therapeutic for human use is a milestone in the field of oxygen therapeutics and represents decades of research and development by the company," chairman and chief executive officer Zafiris G. Zafirelis said in a company news release.

"It is also an important step in understanding how doctors perceive and use the product outside of clinical trials."

In April 2001, South Africa's Medicines Control Council granted marketing clearance for the product. However, issues between Biopure and the original product registration holder and distributor delayed marketing and sales activities, the company said. Biopure acquired control of the product registration in 2005.

Biopure said it plans to submit an application to the European regulatory authorities in mid 2006 for Hemopure for the treatment of acute anemia in orthopedic surgery patients.

The company's veterinary product, Oxyglobin (hemoglobin glutamer - 200 (bovine)), is indicated for the treatment of anemia in dogs. It is the only oxygen therapeutic approved by the Food and Drug Administration and the European Commission, according to the release, and Biopure has sold about 173,000 units of the product.

Biopure is based in Cambridge, Mass., and develops, manufactures and markets pharmaceuticals intravenous therapeutics that deliver oxygen to the body's tissues.

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