CAMBRIDGE, Mass., March 19 /PRNewswire-FirstCall/ -- Biopure
Corporation (Nasdaq: BPUR) 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.
Contact: Tiana Gorham
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html/
CONTACT:
Tiana Gorham of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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