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 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.
Statements in this release that are not strictly historical are
forward- looking statements, including any statements implying that the
company will be able to respond to the MHRA questions or that Hemopure will
attain marketing authorization in the United Kingdom and including
statements implying that any clinical trial will be initiated and/or
carried out to completion or that study results will be as desired, and any
statements that might imply that Hemopure may receive marketing approval in
the UK or any other jurisdictions or for additional indications in South
Africa. Actual results and their timing may differ materially from those
projected in these forward-looking statements due to risks and
uncertainties. These risks include, without limitation, uncertainties
regarding the company's financial position, including its limited cash
resources and need to raise additional capital to pursue its business, the
company's ability to satisfactorily address the issues raised in the MHRA
correspondence or additional issues raised at a later date, unexpected
costs and expenses, delays and adverse determinations by regulatory
authorities, unanticipated problems with the product's commercial use,
whether or not product related, and with product distributors, sales agents
or other third parties, delays in clinical trials, and the other factors
identified under the heading "Risk Factors" in the Company's quarterly
report on Form 10-Q filed on March 17, 2008, which can be accessed in the
EDGAR database at the U.S. Securities and Exchange Commission's (SEC)
website, http://www.sec.gov. The company undertakes no obligation to
release publicly the results of any revisions to these forward-looking
statements to reflect events or circumstances arising after the date
hereof. A full discussion of the company's operations and financial
condition can be found in the company's filings with the SEC.
Contact: Tiana Gorham
|SOURCE Biopure Corporation|
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