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"This unique oxygen carrier could profoundly impact public health issues in Africa as the product's purity, compatibility with all blood types and two-year room temperature stability address many of the medical and logistical problems surrounding the treatment of anemia with red blood cells."
Richard Friedland, M.D.In April 2001, South Africa's Medicines Control Council (MCC) granted the world's first regulatory approval of a hemoglobin-based oxygen therapeutic product for human use when it approved Hemopure for the treatment of adult surgery patients who are acutely anemic and for the purpose of eliminating, reducing or delaying 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. Tshepo (which means “Hope” in Tswana) will launch the product nationally in South Africa in the second half of 2002 after Biopure completes the expansion of its Cambridge, Mass. manufacturing facility’s production capacity.
Tshepo is a joint subsidiary of South Africa-based healthcare provider Network Healthcare Holdings Limited or “Netcare” and Community Healthcare Holdings Limited. Netcare is an investment holding company whose subsidiaries include the largest private doctor and hospital chain in Africa, pre-hospital and emergency services, pharmaceutical procurement, medical education and training, patient referrals from other African countries, healthcare insurance and e-commerce. Community Healthcare Holdings Limited is a black-owned investment holding company that owns several healthcare-related investments.
Biopure is initially supplying product to South Africa at no cost for introduction on a limited basis at select hospitals. Biopure expects to sell approximately 10,000 units of Hemopure in 2002 and 30,000 or more units in 2003. The company also plans to collect patient outcomes data to demonstrate the pharmacoeconomic implications and cost effectiveness of this new treatment. Market expansion in Sub-Saharan Africa will depend on demand, Biopure’s production, the product’s clinical development in other potential applications and its regulatory status in other countries.
The South Africa package insert for Hemopure is available online at http://www.biopure.com/hemopurepi/rsa or per request by calling (617) 234-6863.
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