SOUTH AFRICA APPROVAL South Africa’s Medicines Control Council granted the world’s first regulatory approval of Hemopure for the treatment of adult surgery patients who are acutely anemic and for the purpose of eliminating, delaying or reducing the need for allogeneic red blood cell transfusions in these patients. Biopure has contracted South Africa-based Tshepo Pharmaceuticals Limited to market and distribute Hemopure in Sub-Saharan Africa, and the companies plan to commercially launch Hemopure nationally in South Africa in 2002. Tshepo is a joint subsidiary of South Africa-based healthcare provider Network Healthcare Holdings Limited (Netcare) and Community Healthcare Holdings Limited.

U.S. PHASE III CLINICAL TRIAL ENDPOINTS MET The primary study endpoints were met in a U.S. Phase III orthopedic surgery trial of Hemopure. The primary efficacy endpoint was the elimination of red blood cell transfusions, at 42 days post surgery, in at least 35 percent of patients receiving Hemopure. The primary safety endpoint was that patients treated with Hemopure have outcomes no worse than patients treated with red blood cells. This assessment was based on an independent safety endpoint evaluation committee's (SEEC) blinded review of each patient's case report form and medical records to determine the overall medical risk to patients receiving Hemopure versus donated blood.

SOUTH CAROLINA MANUFACTURING FACILITY To prepare for worldwide commercialization of Hemopure, Biopure and Sumter Realty Group, LLC signed a letter of intent for the construction and financing of a $120 million biopharmaceutical manufacturing facility in Sumter, S.C. Groundbreaking is planned for Spring 2002 and is expected to result in a validated, FDA approved plant in late 2004. This facility is engineered to have an initial production capacity of 500,000 Hemopure units per year.