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
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
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html/
CONTACT:
Tiana Gorham of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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