CAMBRIDGE, Mass., March 19 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has completed its inspection of the company’s Pennsylvania manufacturing facility. The inspection report contained no “Critical” and no “Major” deficiencies in compliance with good manufacturing practices. The MHRA report identified shortcomings characterized as “Other,” with a request for a response detailing the company’s corrective actions within 35 working days.
According to John Tomera, Director of Regulatory Affairs at Biopure, “We are pleased with the MHRA’s inspection result, which attests to our efforts toward consistently maintaining quality standards. We anticipate being able readily to address all of the issues that were cited by the MHRA.”
As previously announced, Biopure has pending with the MHRA a marketing authorization application to market Hemopure in the United Kingdom for acute anemia during elective orthopedic surgery where red blood cell transfusion is not available. The inspection is a routine part of the application procedure.
No inspection of the company’s manufacturing facility in Massachusetts is scheduled at this time or expected to occur before the MHRA next communicates about the pending application.
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(R) [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 company is developing Hemopure 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 by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 200,000 units of Oxyglobin since 1998.
IR@biopure.com
CONTACT: Tiana Gorham of Biopure Corporation, +1-617-234-6826,
IR@biopure.com
Web site: http://www.biopure.com/
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