Biopure Corporation
(Nasdaq: BPUR) announced today that it has been notified by the Food and
Drug Administration (FDA) that the FDA’s Blood Products Advisory Committee
will meet on July 14, 2006 to discuss the Navy’s proposed RESUS clinical
trial of the company’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.
As previously announced, NMRC’s investigational new drug application (IND)
for RESUS is on clinical hold at FDA.
“We believe that the product holds promise as an emergency pre-hospital
treatment until patients can receive blood or other standard treatment at a
hospital, and we look forward to presenting our data,” said Biopure
Chairman and CEO Zafiris G. Zafirelis.
The Blood Products Advisory Committee reviews and evaluates available
data concerning the safety, effectiveness, and appropriate use of blood
products derived from blood and serum or biotechnology which are intended
for use in the diagnosis, prevention, or treatment of human diseases, and,
as required, any other product for which FDA has regulatory responsibility,
and advises the Commissioner of Food and Drugs of its findings regarding
the safety, effectiveness, and labeling of the products, on clinical and
laboratory studies involving such products, on the affirmation or
revocation of biological product licenses, and on the quality and relevance
of FDA’s research program which provides the scientific support for
regulating these agents.
In order for the proposed RESUS trial to proceed, FDA must lift the
clinical hold and the Department of Defense and the institutional review
boards of participating hospitals in the communities where the study would
take place must provide final authorization.
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 product has not
been approved for sale in other countries. Biopure plans to apply in
Europe, in mid 2006, for approval of an acute anemia indication in
orthopedic surgery patients. The company is developing Hemopure for a
potential indication in cardiovascular ischemia, in addition to supporting
the U.S. Naval Medical Research Center’s government-funded development of 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.
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 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 March
13, 2006, which can be accessed in the EDGAR database at the SEC Web site
sec.
Biopure Corporation
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