CAMBRIDGE, Mass., Feb. 1 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that it has signed an agreement formalizing the termination of its contract with Tshepo Pharmaceuticals Ltd., the former registration holder and marketing and distribution agent in South Africa for Biopure's oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)], thereby effecting the transfer of the registration and resolving a long delay in the company's ability to market the product in that country. Biopure has appointed an interim registration holder and has selected a warehousing and shipping agent to physically distribute the product in South Africa. Biopure is also seeking to register itself as a pharmaceutical marketing company in South Africa so it can directly hold the product registration.
"One of our goals when I joined Biopure was to gain control of marketing and distribution for Hemopure in South Africa," said Zafiris G. Zafirelis, Biopure's president and CEO since June 2004. "Having met this goal, we're now preparing to submit a pricing proposal to the government's Medicines Pricing Committee and are considering marketing the product to hospitals through our South Africa office on a limited basis as our resources allow. We'll assess the timing and extent of these activities during the next several weeks."
South Africa's Medicines Control Council approved Hemopure in 2001 for the treatment of adult surgical patients who are acutely anemic and for the purpose of eliminating, delaying or reducing the need for allogeneic red blood cells. The product has not yet been offered for sale due to the former contractual dispute with Tshepo Pharmaceuticals. However, post approval more than 300 patients in South Africa have been treated with Hemopure units that Biopure previously provided without charge.
Hemopure is an oxygen therapeutic, or oxygen-carrying biologic drug, consisting of stabilized bovine hemoglobin formulated in a balanced salt solution. These polymerized (chemically cross-linked) hemoglobin molecules circulate in the plasma (the fluid part of blood) when infused and are smaller, less viscous and more readily release oxygen to tissues than red blood cells. Unlike stored blood, Hemopure is ultrapurified, compatible with all blood types, and stable for three years without refrigeration.
About Biopure Corporation
Biopure Corporation develops and manufactures intravenously administered pharmaceuticals, called oxygen therapeutics, that deliver oxygen to the body's tissues. The company is developing Hemopure(R) [hemoglobin glutamer -- 250 (bovine)], or HBOC-201, for a potential indication in cardiovascular ischemia and, in collaboration with the U.S. Naval Medical Research Center, for an out- of-hospital trauma indication. The product is approved in South Africa for treating adult surgical patients who are acutely anemic and for eliminating, delaying or reducing the need for allogeneic red blood cell transfusions in these patients. Hemopure has not been approved for sale in any other jurisdictions, including the United States or the European Union. Biopure'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.
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. Statements in this press release that are not strictly historical may be forward-looking statements. Actual results may differ materially from those projected in these forward- looking statements due to risks and uncertainties regarding the company's operations and business environment. These risks include, without limitation, uncertainties regarding the company's ability to generate revenues, cash requirements, unexpected costs and expenses, insurance coverage, and possible delays and unforeseen costs related to clinical trials, regulatory approvals and marketing and distribution of the company's products. 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, and specific factors that could cause the company's actual performance to differ from current expectations, can be found in the company's filings with the U.S. Securities and Exchange Commission, including the Form 10-K filed on January 14, 2005, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov/, or through the Investor Relations section of Biopure's website, http://www.biopure.com/ .
Contact: Douglas Sayles