CAMBRIDGE, Mass., Jan. 4 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that it has complied with new import
regulations and shipped product to South Africa to support the initiation of
marketing and sales activities for its room-temperature-stable oxygen
therapeutic Hemopure(R) [hemoglobin glutamer - 250 (bovine)]. 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.(*)
"We've implemented a new support structure in South Africa and resolved
the issues that previously prevented us from offering the product for sale,"
said Biopure President and CEO Zafiris G. Zafirelis. "The information we gain
about how doctors perceive and use the product should facilitate our planning
for larger markets and our development of other potential indications."
In 2005, Biopure acquired control of the registration for Hemopure in
South Africa, selected a warehousing and shipping agent, and appointed as its
sales agent Abazali Bio Ventures (Pty) Ltd., a new company formed to sell
biotechnology products in the region. The chief executive of Abazali Bio
Ventures is the former general manager of a large, multi-national American
pharmaceutical company in South Africa. Sales representatives are being
trained to start calling on medical providers.
"Since approval, over 350 patients in South Africa have received Hemopure
we previously provided without charge as part of our medical education
program," said Zafirelis. "We plan to initially target the medical providers
who've used or been trained to use the product as part of that program."
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. The company is developing Hemopure(R)
[hemoglobin glutamer - 250 (bovine)], or HBOC-201, for a potential indication
in cardiovascular ischemia and, in collaboration with the U.S. Naval Medical
Research Center, for a potential out-of-hospital trauma indication. The
product is approved in South Africa for the treatment of surgery patients who
are acutely anemic and for eliminating, delaying or reducing allogenic red
blood cell transfusions in these patients. Hemopure has not been approved for
sale in other jurisdictions, including the U.S. or the European Union.
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 those that imply that Biopure may
realize 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,
determinations by U.S. or South African 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 September 9, 2005, 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, Biopure Corporation,
+1-617-234-6826, IR@biopure.com; Investors: Herb Lanzet, H.L.
Lanzet Inc., +1-212-888-4570, lanzet@aol.com
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