Biopure's oxygen therapeutic, oxyglobin, receives first European Union approval for treating anemia in dogs

BIOPURE'S OXYGEN THERAPEUTIC, OXYGLOBIN, RECEIVES FIRST EUROPEAN UNION APPROVAL FOR TREATING ANEMIA IN DOGS Cambridge, Mass., December 2 - Biopure(R) Corporation (Nasdaq: BPUR) today announced that the European Commission has issued a marketing authorization for Oxyglobin(R) (hemoglobin glutamer - 200 (bovine)) that is valid in all 15 European Union countries for the treatment of canine anemia, a potentially life- threatening condition that affects millions of dogs each year. Oxyglobin, the only commercially available oxygen therapeutic of its kind in the world, was first approved for this indication by the U.S. Food and Drug Administration in January 1998. "With the issues surrounding bovine products in Europe, we see the E.U. approval of our bovine-derived oxygen therapeutic as further confirmation of the company's proprietary manufacturing process," said Carl W. Rausch, Biopure's chairman and chief executive officer. "This patented process meets the rigorous standards for Good Manufacturing Practices and yields a purified oxygen-carrying solution that addresses many of the availability and safety issues surrounding blood transfusions." The E.U. marketing authorization is based on the favorable opinion and assessment report adopted in July 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 for minimizing the risk of transmitting animal spongiform encephalopathy agents and clearance studies have addressed the risk of bovine spongiform encephalopathy. Biopure uses a similar process to manufacture Hemopure(R) [hemoglobin glutamer - 250 (bovine)], an investigational oxygen therapeutic for human use being evaluated in a pivotal U.S. Phase III clinical trial as a perioperative alternative to red blood cell transfusion. Hemopure has been administered to more than 600 human patients in 21 completed or ongoing clinical trials. Both Hemopure and Oxyglobin are compatible with all blood types, can be stored at room temperature for two years, and are purified through a patented, validated process that removes infectious agents and other potential contaminants. Biopure holds 11 patents in E.U. countries and 17 U.S. patents relating to the collection, ultrapurification, manufacture, packaging and use of its oxygen therapeutics technology. 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. A New Treatment Option Oxyglobin is a sterile, intravenously administered oxygen-carrying solution consisting of bovine hemoglobin that has been purified and chemically cross-linked (several smaller molecules bound together) for stability. Each unit of Oxyglobin contains 16 grams of cross-linked hemoglobin in 125 milliliters of a balanced salt solution. These linked hemoglobin molecules circulate in the plasma (the fluid part of blood) when infused and transport oxygen even in the absence of red blood cells. "Oxyglobin is a readily available therapeutic that allows veterinarians to treat anemic dogs effectively and safely by providing immediate oxygen-carrying support," said Urs Giger, Dr. med. vet., Diplomate, ACVIM and ECVIM, Charlotte Newton Sheppard Professor of Medicine at the University of Pennsylvania School of Veterinary Medicine, and Professor of Medicine at the University of Zurich. "Essentially, the product acts as an immediate oxygen bridge to stabilize the anemic animal until the underlying condition can be controlled and the animal's body can produce its own new red blood cells." Biopure has sold more than 35,000 units of Oxyglobin in the United States for use in a broad range of anemia-related conditions. In addition to its commercial use, the product has been studied in more than 2000 animals and in 10 different species. Results from a pivotal multi-center clinical trial of 64 anemic dogs showed a 95 percent efficacy rate in those treated with Oxyglobin compared with 32 percent in the untreated control group. Oxyglobin-treated dogs had significantly increased plasma hemoglobin concentrations and improved physical conditions as measured by heart rate, attitude and physical activity compared to pre-treatment. In safety trials, the most commonly reported adverse reactions in dogs were a transient discoloration of sclera and urine, vomiting, and over- expanded vascular volume when administered at a higher than recommended rate. Less frequent adverse events that may or may not have been related to the administration of Oxyglobin included diarrhea, fever, arrhythmia and tachypnea. Biopure Corporation Biopure Corporation, headquartered in Cambridge, Mass., is a leading developer, manufacturer and marketer of oxygen therapeutics for use in veterinary and human medicine. These pharmaceuticals are intravenously administered into the circulatory system to deliver oxygen to the body's tissues. Oxyglobin(R) is approved in the United States and European Union for veterinary use, and Hemopure(R) is an investigational product being evaluated in advanced clinical trials for human use. Biopure Netherlands B.V. is the marketing authorization holder for Oxyglobin in the European Union. Biopure has manufacturing facilities in Cambridge, Mass., Souderton, Pa., and Dover, N.H. 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, safety, efficacy, regulatory approval, patent protection 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. Contact: Douglas Sayles, Associate Director, Corporate Communications of Biopure Corporation, tel USA +1 617-234-6826, PR@biopure.com; or Investors - Jonathan M. Nugent, or Media - Lisa Fern, both of Burns McClellan, Inc., tel New York +1 212-213-0006; or European media - Mike Sinclair, tel UK +44 171 665 6643, all for Biopure Company News On-Call: http://www.prnewswire.com/comp/131224.html or fax, +1800 758-5804, ext. 131224 Web site: http://www.biopure.com (BPUR) ------------------------------------------------------------ Please visit http://www.bit.se for further information The following files are available for download: http://www.bit.se/bitonline/1999/12/02/19991202BIT00040/bit0001.doc http://www.bit.se/bitonline/1999/12/02/19991202BIT00040/bit0002.pdf