Biopure Corporation
(Nasdaq: BPUR) announced today that the Food and Drug Administration’s
(FDA) Blood Products Advisory Committee will meet in open session on
December 14, 2006 to discuss the Navy’s proposed RESUS clinical trial of
Biopure’s investigational oxygen therapeutic Hemopure(R) [hemoglobin
glutamer – 250 (bovine)] for out-of-hospital treatment of hemorrhagic shock
resulting from traumatic injury. FDA has invited the Naval Medical Research
Center (NMRC) and Biopure to present at the meeting.
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. Biopure has applied
in the United Kingdom for regulatory approval of a proposed orthopedic
surgical anemia indication. The company is developing Hemopure for a
potential indication in cardiovascular ischemia, in addition to 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 by the U.S. Food and Drug Administration and
the European Commission, is indicated for the treatment of anemia in dogs.
Statements in this press release that are not strictly historical are
forward-looking statements, including any that might imply that the
proposed RESUS trauma trial will receive authorization to proceed. 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, unexpected costs and expenses, delays and
determinations by regulatory authorities, and delays in or unpredictable
outcomes of clinical trials. 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 U.S. Securities
and Exchange Commission, including under the heading “Risk Factors” in the
Form 10-Q filed on September 11, 2006, which can be accessed in the EDGAR
database at the SEC Web site, 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.
Biopure Corporation
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