CAMBRIDGE, Mass., July 14 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today issued the following statement regarding the Food and
Drug Administration's cancellation of the Blood Products Advisory Committee
meeting scheduled for July 14, 2006 to discuss the Navy's proposed RESUS
clinical trial of Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] for the
out-of-hospital treatment of trauma patients with acute blood loss:
Biopure is disappointed that the meeting was delayed. The company intends
to continue supporting the Navy as the sponsor of the proposed trial. Biopure
agrees with and supports the Navy's statement on this matter, which is
accessible via the Navy Medicine home page at
http://navymedicine.med.navy.mil/ or directly at
http://navymedicine.med.navy.mil/default.cfm?selmod=12482A4C-2A5E-780B-
4FB1E40698282CDE&issueid=272&articleid=01.
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. 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. The company'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.
The content of this announcement 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.
Statements in this announcement that are not strictly historical are
forward-looking statements, including those that might imply that the
proposed RESUS trauma trial will be allowed to proceed or that the
marketing application for Hemopure in the United Kingdom will be accepted
for review, will receive marketing authorization or will result in
substantial sales. 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, unanticipated problems
with the product's commercial use, whether or not product related, and with
product distributors, sales agents or other third parties, 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 June 9, 2006, which can be accessed in
the EDGAR database at the SEC Web site, http://www.sec.gov.
Contact: Douglas Sayles Herb Lanzet (Investors)
Biopure Corporation H.L. Lanzet Inc.
(617) 234-6826 (212) 888-4570
IR@biopure.com lanzet@aol.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://navymedicine.med.navy.mil
http://www.prnewswire.com/comp/131224.html /
CONTACT:
Douglas Sayles of Biopure Corporation,
+1-617-234-6826, IR@biopure.com; or Herb Lanzet (Investors) of
H.L. Lanzet Inc., +1-212-888- 4570, lanzet@aol.com
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