CAMBRIDGE, Mass., Jan. 30 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that it has made the first sale of its
room-temperature-stable oxygen therapeutic Hemopure(R) (hemoglobin glutamer --
250 (bovine)) in South Africa. The product is approved in South Africa for
the treatment of adult surgical patients who are acutely anemic and for the
purpose of eliminating, delaying or reducing the need for allogenic red blood
cell transfusions in these patients.*
"This first ever commercial sale of a hemoglobin-based oxygen therapeutic
for human use is a milestone in the field of oxygen therapeutics and
represents decades of research and development by the company," said Biopure
Chairman and CEO Zafiris G. Zafirelis. "It is also an important step in
understanding how doctors perceive and use the product outside of clinical
trials."
Biopure's initial sales targets are medical providers that have used or
been trained to use Hemopure as part of a post-approval medical education
program. In April 2001, South Africa's Medicines Control Council granted
marketing clearance for the product; however, issues between Biopure and the
original product registration holder and distributor delayed marketing and
sales activities. In 2005, Biopure acquired control of the product
registration, selected a warehousing and shipping agent and appointed a sales
agent. In early January 2006, Biopure announced that it had complied with new
import regulations and shipped product to South Africa to support the
initiation of sales and marketing activities.
About 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 jurisdictions, including the U.S. or the European
Union. Biopure plans to apply in Europe, in mid 2006, for approval of an
acute anemia indication in orthopedic surgery patients. 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. To date, Biopure has sold approximately 173,000 units of
Oxyglobin, which have been used to treat an estimated 90,000 animals.
Statements in this press release that are not strictly historical are
forward-looking statements, including any that might imply that Biopure may
realize significant sales revenues for Hemopure. 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-K filed on January 17, 2006, which can be accessed in the EDGAR database at
the SEC Web site, http://www.sec.gov. 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.
* The South Africa package insert for Hemopure is available online at
http://www.biopure.com/Hemopure/SAfricaPI. Hemopure has not been
approved for sale in other jurisdictions, including the U.S. or the
European Union.
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://www.biopure.com/Hemopure/SAfricaPI
Company News On-Call:
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. for Biopure, +1-212-888-4570, lanzet@aol.com
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