A Medical Device Daily

Biopure (Cambridge, Massachusetts) yesterday reported that it has made the first commercial sale of its oxygen therapeutic Hemopure (hemoglobin glutamer — 250 (bovine)), with that sale coming 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,“ said Zafiris Zafirelis, Biopure CEO and chairman. “It is also an important step in understanding how doctors perceive and use the product outside of clinical trials.“

Biopure said its initial sales targets are providers that have used or been trained to use Hemopure as part of a post-approval medical education program. In April 2001, South Africa's Medicines Control Council granted marketing clearance for the product (Medical Device Daily, April 2001). However, it said that issues between Biopure and the original product registration holder and distributor delayed marketing and sales.

In 2005, Biopure acquired control of the product registration, selected a warehousing and shipping agent and appointed a sales agent. And in early January, the company reported that it had complied with new import regulations and shipped product to South Africa to support the initiation of sales and marketing activities.

The company said it plans to apply in Europe, in mid-2006, for approval of an acute anemia indication in orthopedic surgery patients.

Hemopure has not been approved for sale in other jurisdictions, including the U.S. or the European Union.