CAMBRIDGE, Mass., Jan. 30 /PRNewswire-FirstCall/ -- Biopure Corporation 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.comlanzet@aol.com
Biopure CorporationCONTACT: 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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