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Agency Takes Adverse Decision to Biopure's Product Registration in South Africa
Date:10/28/2008

e been no serious adverse events required to be reported to the MCC from clinical use of the product in approximately 500 patients. Consequently, an appeal should establish that there is not a basis for this action. Biopure expects that local experts will strongly support its appeal.

Upon learning that the negative communication had been sent to the Minister of Health of South Africa and to each other country where Biopure had ongoing trials, Biopure demanded a retraction and sent an objection to the National Institutes of Health (NIH) regarding Charles Natanson of the NIH signing the Public Citizen letters using his NIH title. Earlier this month, Biopure brought an action against Natanson alleging various torts, including defamation, trade libel and intentional interference with prospective business advantage, seeking injunctive relief and damages. Biopure is announcing the filing of that litigation separately.

The MCC also ordered the halt of clinical trials in South Africa, but Biopure had already stopped patient enrollment in its trials there earlier this year, for reasons of slow enrollment and cost containment.

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 Company is developing Hemopure for other indications and is supporting the U.S. Navy's government-funded efforts to develop a potential out-of-hospital trauma indication. Biopure's veterinary product Oxyglobin(R) [hemoglobin glutamer - 200 (bovine)], or HBOC-301, the only oxygen therapeutic approved for marketing by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 20
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SOURCE Biopure Corporation
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