Biopure CEO Presents Hemopure(R) Phase III Clinical Trial Update At Chase H&Q Healthcare Conference
Company Preparing to File Biologic License Application in 2001 for Product Indication to Eliminate or Reduce Allogeneic Red Blood Cell Transfusion in Elective Surgery Patients
CAMBRIDGE, Mass., Jan. 8 /PRNewswire/ -- Biopure Corporation (Nasdaq: BPUR - news) has held an ``end of Phase III'' meeting with the U.S. Food and Drug Administration (FDA), expects to sign a letter of intent in January for asset-based debt financing of a large-scale manufacturing facility, and is proceeding with preparations to file a Biologic License Application (BLA) in 2001 for its investigational product Hemopure® (HBOC-201), company Chairman and Chief Executive Officer Carl W. Rausch will report today at the Chase H&Q 19th Annual Healthcare Conference in San Francisco.
On August 31, 2000, Biopure completed enrollment of 693 patients in a pivotal, multinational Phase III clinical trial evaluating Hemopure as a perioperative alternative to red blood cell transfusion in orthopedic surgery patients. In December, Biopure met with the FDA to discuss this recently completed trial and the company's plan to file a BLA for perioperative use of Hemopure to eliminate or reduce red blood cell transfusions in elective surgery patients. Following this meeting, the company is continuing with its preparations to file a BLA for this indication.
Biopure is currently working to lock the database from the pivotal Phase III trial. A preliminary look at the data was very supportive and encouraged the company to move ahead on both the BLA and a new manufacturing plant. Biopure has been advised that premature disclosure of the trial data could bias the independent analysis required by the study protocol and impede the company's filing plans. Therefore, trial results will be reported during the first half of 2001 after the final database has been locked and the study report has been prepared for inclusion in the BLA.
Biopure expects to sign a letter of intent during January for asset-based debt financing of an $85 million manufacturing facility capable of producing 500,000 units of Hemopure annually. The company will announce the location of this new facility and other details when they are finalized. Biopure's existing manufacturing facility, in Cambridge, Mass., is currently being expanded to accommodate an approximate production capacity of 100,000 Hemopure units per year.
Red Blood Cell Controlled Clinical Trials
To date more than 1300 patients have been enrolled and more than 800 patients have been administered Hemopure in 22 clinical trials, including four red blood cell controlled trials in cardiac, vascular, general and orthopedic surgeries. To ensure that only patients in need of a transfusion were entered into these red blood cell controlled trials, each patient was randomly assigned to receive either Hemopure or allogeneic red blood cells at the first transfusion decision. In this respect, Biopure's trials are unique compared to other clinical trials completed to date for investigational oxygen-carrying solutions.
Hemopure® (HBOC-201)
Hemopure is a sterile, intravenously administered Oxygen Therapeutic(TM) solution that delivers oxygen to tissues and enhances the offloading of oxygen from circulating red blood cells. It consists of ultra-pure, chemically cross-linked bovine hemoglobin (the protein that carries oxygen) formulated in a balanced salt solution. This stabilized, acellular hemoglobin circulates directly in plasma (the fluid part of blood) when infused and has lower viscosity and releases oxygen to tissues more efficiently than red blood cells. Hemopure is compatible with all blood types, stable at room temperature (2 degrees to 30 degrees C) for three years, and purified through patented and proprietary techniques that are validated to remove potential contaminants, including infectious agents such as bacteria, viruses and the agents thought to cause transmissible spongiform encephalopathies.
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.
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, Associate Director, Corporate Communications, Biopure Corporation, 617-234-6826, or PR@biopure.com; or media, Brad Miles of BMC Communications, 212-477-9007, ext. 17, for Biopure Corporation; or investors, Jonathan Fassberg of The Trout Group, 212-477-9007, ext. 16, for Biopure Corporation.
SOURCE: Biopure Corporation |
