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

CAMBRIDGE, Mass., Oct. 28 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that it had received a notice from the Medicines Control Council (MCC) of South Africa indicating its decision to discontinue the registration of Hemopure [hemoglobin glutamer-250 (bovine)], Biopure's oxygen therapeutic for human use. The decision is subject to appeal. Biopure intends to appeal the decision promptly and expects to continue to market the product while the appeal is pending. The appeal is estimated to take a year to resolve.

The MCC decision comes after a letter sent to the South Africa Minister of Health on May 22, 2008, asking that the then ongoing clinical trials of Hemopure in South Africa be brought to a halt because of the "evidence against blood substitutes." The letter was sent by Public Citizen and signed by three of the authors of a so-called meta-analysis of hemoglobin-based blood substitutes published online April 28, 2008, by the Journal of the American Medical Association. The letter to the Minister of Health characterized the results of, and enclosed a copy of, the article.

Biopure expects that an appeal before a hearing body, to be chosen by the Minister of Health, but subject to challenge by Biopure, will succeed. Biopure has done all required reporting on Hemopure's usage since its approval for marketing in South Africa in 2001, including monitoring and reporting to the MCC on use of the product in the first 80 patients treated. Thereafter, a South African doctor consulting for Biopure collected patient data on more than 200 patients, published an article on that clinical experience and submitted the information to the MCC. Since Hemopure was approved for marketing in South Africa, there hav
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SOURCE Biopure Corporation
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