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According to John Tomera, Director of Regulatory Affairs at Biopure, "Weare pleased with the MHRA's inspection result, which attests to our effortstoward consistently maintaining quality standards. We anticipate being ablereadily to address all of the issues that were cited by the MHRA."
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As previously announced, Biopure has pending with the MHRA a marketingauthorization application to market Hemopure in the United Kingdom for acuteanemia during elective orthopedic surgery where red blood cell transfusion isnot available. The inspection is a routine part of the application procedure.
No inspection of the company's manufacturing facility in Massachusetts isscheduled at this time or expected to occur before the MHRA next communicatesabout the pending application.
Biopure Corporation
Biopure Corporation develops, manufactures and markets pharmaceuticals,called oxygen therapeutics, that are intravenously administered to deliveroxygen to the body's tissues. Hemopure(R) [hemoglobin glutamer -- 250(bovine)], or HBOC-201, is approved for sale in South Africa for the treatmentof surgical patients who are acutely anemic. The company is developingHemopure for other indications and is supporting the U.S. Navy's government-funded efforts to develop a potential out-of-hospital trauma indication.Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer -- 200(bovine)], or HBOC-301, the only oxygen therapeutic approved for marketing byboth the U.S. Food and Drug Administration and the European Commission, isindicated for the treatment of anemia in dogs. Biopure has sold approximately200,000 units of Oxyglobin since 1998.Contact: Tiana Gorham Biopure Corporation (617) 234-6826 [email protected]
SOURCE Biopure Corporation
