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Biotech / Medical : Biopure Corp (BPUR) -- Ignore unavailable to you. Want to Upgrade?

To: LLCF who wrote (193)	1/26/2001 8:04:50 AM
From: sim1	Respond to of 544

Biopure Corporation Signs European Distributors for Oxyglobin(R) Company to Introduce Veterinary Oxygen Therapeutic(TM) In European Union Within 90 Days CAMBRIDGE, Mass., Jan. 25 /PRNewswire/ -- Biopure Corporation (Nasdaq: BPUR - news) today announced that it has contracted three established veterinary distributors to support European sales of the company's intravenous Oxygen Therapeutic(TM) solution, Oxyglobin® (hemoglobin glutamer - 200 (bovine)), for the treatment of canine anemia, a potentially life-threatening condition that affects millions of dogs each year. This distribution network will provide veterinarians in the European Union access to a treatment option previously available only in the United States. Oxyglobin received marketing clearance from the U.S. Food and Drug Administration in January 1998 and from the European Commission in November 1999. Biopure plans to introduce Oxyglobin in selected European countries within the next three months. The European distributors are Arnolds Veterinary Products Ltd. in the United Kingdom, A. Albrecht GmbH + Co. in Germany and Centravet in France. England-based Dales Pharmaceuticals Ltd. will import, store and release the product to the European market. Dales and Arnolds are sister companies owned by Dechra Pharmaceuticals PLC. Biopure has established an advisory board of leading European veterinary academicians and arranged for publications and lectures, including scientific presentations at upcoming European veterinary conferences. ``In the coming months we'll expand awareness and understanding of this new Oxygen Therapeutic treatment paradigm through key veterinary markets in Europe. However, we'll continue to follow a controlled-growth marketing strategy that's consistent with our manufacturing capability and need to produce our advanced-stage product Hemopure® for human use,'' said Carl Rausch, Biopure's chairman and chief executive officer. Hemopure is similar to Oxyglobin and is produced in the same manufacturing facility. The E.U. marketing authorization was granted by the European Commission based on the favorable opinion and assessment report adopted by the European Agency for the Evaluation of Medicinal Products (EMEA) Committee for Veterinary Medicinal Products (CVMP). According to this report, Biopure's manufacturing process complies with EMEA guidelines regarding the risk of animal transmissable spongiform encephalopathy (TSE) agents and clearance studies have addressed the risk of bovine spongiform encephalopathy (BSE). ``We see the introduction of our bovine-derived, veterinary Oxygen Therapeutic in Europe as further confirmation of the company's proprietary manufacturing process,'' said Mr. Rausch. ``This patented process yields a purified oxygen-carrying solution that meets the rigorous regulatory standards for this product's efficacy and safety, including the removal of potential infectious agents.'' Canine Anemia Anemia is a deficiency of red blood cells or hemoglobin (the protein in red blood cells that carries oxygen) caused by blood loss, insufficient red blood cell production or disease. This condition compromises the oxygen-carrying capacity of blood and creates an oxygen deficiency in tissues, which in severe cases can cause organ damage or death. Blood transfusion is traditionally the only treatment that immediately relieves the clinical signs of anemia in dogs. However, blood transfusions are limited in Europe because of the lack of commercial blood banks and the unavailability of donor blood. Research shows that veterinary practices in France, Germany and the United Kingdom see a combined 2.2 million cases of canine anemia each year, which represents approximately 13 percent of the 16.4 million dogs in these three countries. Biopure Corporation Biopure Corporation, headquartered in Cambridge, Mass., is a leading developer, manufacturer and marketer of a new class of pharmaceuticals, called Oxygen Therapeutic(TM) solutions, which are intravenously administered to deliver oxygen to the body's tissues. Hemopure® (HBOC-201) is an investigational Oxygen Therapeutic solution being evaluated for human use in a recently completed pivotal Phase III clinical trial as a perioperative alternative to red blood cell transfusion in orthopedic surgery. The company expects to file a marketing application in the United States and Europe in 2001. Oxyglobin® (hemoglobin glutamer - 200 (bovine)), the only Oxygen Therapeutic solution of its kind approved by the U.S. FDA and the European Commission, is commercially available in the United States for the treatment of anemia in dogs. Biopure Netherlands B.V. is the marketing authorization holder for Oxyglobin in the European Union. Statements in this press release that are not strictly historical may be forward-looking statements. There can be no assurance that Biopure Corporation will be able to commercially develop its oxygen therapeutic products and that necessary regulatory approvals will be obtained or that any clinical trials will be successful. Actual results may differ from those projected in forward-looking statements due to risks and uncertainties that exist in the company's operations and business environment. These risks include, without limitation, the company's stage of product development, history of operating losses and accumulated deficits, and uncertainties related to clinical trials, regulatory approval, manufacturing and market acceptance. 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 Biopure'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, which can be accessed in the EDGAR database at the SEC Web site, www.sec.gov, or through the Investor section of Biopure's Web site, www.biopure.com . Contact: Douglas Sayles Brad Miles (media) Associate Director BMC Communications Corporate Communications (212) 477-9007 x17 Biopure Corporation Jonathan Fassberg (investors) (617) 234-6826 The Trout Group PR@biopure.com (212) 477-9007 x16 SOURCE: Biopure Corporation