Innovative developer of oxygen therapeutics selects clinivation’s quality systems infrastructure and process solutions.
Framingham, MA, May 8, 2006 – clinivation, Inc. announced today that Biopure Corporation (NASDAQ: BPUR) has selected clinivation’s quality systems infrastructure and process solutions.
“Biopure is the revolutionary leader in oxygen therapeutics – new drugs that deliver lifesaving oxygen – for important medical applications associated with ischemia or acute anemia,” said Joseph Kozikowski, M.D., clinivation’s Chief Executive Officer.
“We are delighted that Biopure Corporation’s management has selected clinivation to help extend their quality systems and position their manufacturing and development operations for continued growth and expansion,” he continued.
Clinivation’s rapidly-implementable quality systems infrastructure solutions are pre-configured, matched to specific client needs, and designed to scale with product history and organization growth.
About Biopure Corporation
Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body’s tissues. Hemopure® [hemoglobin glutamer – 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic.
The product has not been approved for sale in other countries. Biopure plans to apply in Europe, in mid 2006, for approval of an acute anemia indication in orthopedic surgery patients. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to supporting the U.S. Naval Medical Research Center’s government-funded development of a potential out-of-hospital trauma indication. To date, Hemopure has been administered to over 350 patients post approval in South Africa and to over 800 human subjects in clinical trials, including two ongoing trials in Europe and South Africa. The company’s veterinary product Oxyglobin® [hemoglobin glutamer – 200 (bovine)], or HBOC-301, the only oxygen therapeutic approved by the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. To date, Biopure has sold approximately 173,000 units of Oxyglobin, which have been used to treat an estimated 90,000 animals.