CAMBRIDGE, Mass., Jan. 4 /PRNewswire-FirstCall/ -- Biopure Corporation 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.comlanzet@aol.com
Biopure Corporation
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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