CAMBRIDGE, Mass., May 2 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that a meeting with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) is scheduled for May 29, 2008 in the UK.
The purpose of the meeting is to clarify the issues outlined in a letter Biopure received in April 2008 from the United Kingdom's Commission on Human Medicines regarding the company's application for marketing authorization for Hemopure(R). The issues relate to quality, clinical efficacy, safety and the reliability of data monitoring and auditing of clinical trials. The letter stated that the Commission was "reassured" on a number of the questions raised in its initial comment letter, but indicated that both "major" and "other" pharmacological and clinical issues either were not yet resolved by the Company's submission made in November 2007 or were only resolved in part.
As Biopure previously announced on April 11, 2008, the MHRA 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.
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 its launch in 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.
The content of this press release does not necessarily reflect the
position or the policy of the U.S. Government or the Department of Defense,
and no official endorsement should be inferred.
Contact: Tiana Gorham
|SOURCE Biopure Corporation|
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