CAMBRIDGE, Mass., June 5 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today an update regarding a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) addressing the Company's pending application for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250 (bovine)].
The meeting, held on May 29, was attended by Biopure scientific representatives and the pharmaceutical and clinical assessors from the MHRA. The subject of the meeting was manufacturing and quality. The pharmaceutical assessor accepted Biopure's proposed strategies for answering pending questions and provided clarification. The company is confident that it can resolve all of these issues satisfactorily. No new issues were raised.
As previously reported, the Commission has not advised the company to withdraw its application. The Company has been advised that such a request would be the customary means of indicating futility or rejection of an application. Biopure submitted its application for the treatment of acutely anemic adult orthopedic surgery patients less than 80 years of age in July 2006, and the MHRA accepted it for review in September 2006. The MHRA issued its preliminary opinion, part of the normal review process, in December 2006. In Biopure's response to the preliminary opinion letter, submitted in November 2007, Biopure changed the indication to the treatment of acute anemia following orthopedic surgery blood loss when blood is not readily available or not an option. An issue in resolving the Commission's clinical comments could be that Biopure has not completed a clinical trial for anemia in patients where blood was not available or an option. Its relevant trials, on which the marketing application is based, compared Hemopure with red blood cell transfusions. The clinical issues are to be discussed at a separate meeting to be scheduled for later in June.
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.
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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