CAMBRIDGE, Mass., April 11 Biopure Corporation(Nasdaq: BPUR) announced today that the United Kingdom's Medicines andHealthcare products Regulatory Agency (MHRA) has found the company'sPennsylvania manufacturing facility to be in general compliance with theprinciples and guidelines of good manufacturing practices as identified in theCommission Directives. The company received confirmation that it hasresponded successfully to the issues classified as "Other" in the MHRA'soriginal inspection letter. The original inspection report contained no"Critical" or "Major" deficiencies.
As previously announced, Biopure has been invited by the MHRA to meet withthe MHRA team of reviewers to discuss issues still outstanding from theapplication for registration of Hemopure for use in the treatment of acuteanemia following orthopedic surgery blood loss when blood is not readilyavailable or not an option. The company intends to announce the date of thismeeting when it is set, as well as the outcome of the meeting and ananticipated timeline for the resolution of issues.
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 by both theU.S. Food and Drug Administration and the European Commission, is indicatedfor the treatment of anemia in dogs. Biopure has sold approximately 200,000units of Oxyglobin since 1998.
Statements in this release that are not strictly historical are forward-looking statements, including any statements implying that the company will beable to respond to the MHRA questions or that Hemopure will attain marketingauthorization in the United Kingdom and including statements implying that anyclinical trial will be initiated and/or carried out to completion or thatstudy results will be as desired, and any statements that might imply thatHemopure may receive marketing approval in the UK or any other jurisdictionsor for additional indications in South Africa. Actual results and theirtiming may differ materially from those projected in these forward-lookingstatements due to risks and uncertainties. These risks include, withoutlimitation, uncertainties regarding the company's financial position,including its limited cash resources and need to raise additional capital topursue its business, the company's ability to satisfactorily address theissues raised in the MHRA correspondence or additional issues raised at alater date, unexpected costs and expenses, delays and adverse determinationsby regulatory authorities, unanticipated problems with the product'scommercial use, whether or not product related, and with product distributors,sales agents or other third parties, delays in clinical trials, and the otherfactors identified under the heading "Risk Factors" in the Company's quarterlyreport on Form 10-Q filed on March 17, 2008, which can be accessed in theEDGAR database at the U.S. Securities and Exchange Commission's (SEC) website,http://www.sec.gov. The company undertakes no obligation to release publiclythe results of any revisions to these forward-looking statements to reflectevents or circumstances arising after the date hereof. A full discussion ofthe company's operations and financial condition can be found in the company'sfilings with the SEC.Contact: Tiana Gorham Biopure Corporation (617) 234-682