Biopure Operations Compliant With U.K. Manufacturing ... ( CAMBRIDGE Mass. April 11 /- Biopu...)

Biopure Operations Compliant With U.K. Manufacturing Guidelines

Date:4/11/2008

CAMBRIDGE, Mass., April 11 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has found the company's Pennsylvania manufacturing facility to be in general compliance with the principles and guidelines of good manufacturing practices as identified in the Commission Directives. The company received confirmation that it has responded successfully to the issues classified as "Other" in the MHRA's original inspection letter. The original inspection report contained no "Critical" or "Major" deficiencies.

As previously announced, Biopure has been invited by the MHRA to meet with the MHRA team of reviewers to discuss issues still outstanding from the application for registration of Hemopure for use in the treatment of acute anemia following orthopedic surgery blood loss when blood is not readily available or not an option. The company intends to announce the date of this meeting when it is set, as well as the outcome of the meeting and an anticipated timeline for the resolution of issues.

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 oxy
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Biopure Operations Compliant With U.K. Manufacturing ...( CAMBRIDGE Mass. April 11 /- Biopu...)