CAMBRIDGE, Mass., July 11 /PRNewswire-FirstCall/ -- Biopure Corporation today announced that it has submitted a marketing authorization application (MAA) to the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) for Hemopure(R) [hemoglobin glutamer - 250 (bovine), or HBOC-201], the company’s universally compatible, room-temperature-stable oxygen therapeutic. Biopure is seeking MHRA authorization to market this new biologic medicine in the U.K. for the treatment of acutely anemic adult orthopedic surgery patients less than 80 years of age.
The MAA contains reports of preclinical studies and clinical trials of Hemopure, including new analyses of existing data from a 688-patient Phase III orthopedic surgery trial conducted in the United States, South Africa, Europe and Canada and from a 160-patient Phase 3 general non-cardiac surgery trial conducted in South Africa and Europe. The application also contains an integrated database of all completed trials, including data for approximately 1500 total subjects, of which more than 800 were administered Hemopure. In addition, the MAA describes the post-approval clinical experience with Hemopure in South Africa, where the product is indicated for the treatment of adult surgical patients who are acutely anemic.
In preparing to file this application, the company provided data to and consulted with leading academic medical experts, regulatory advisors and regulatory authorities in Europe. Biopure submitted its application through the U.K. National Procedure. The MHRA usually determines the acceptability of an MAA for review within a few weeks. Once the MAA is accepted, the complete review period can vary but generally takes more than a year. If marketing authorization is granted, the company may seek registration of the product in other member states in the European Economic Area through the Mutual Recognition Procedure.
Acute Anemia
Anemia is a deficiency of red blood cells in the bloodstream caused by blood loss (e.g., from surgery or injury) or other disorders, which can compromise the body’s oxygen-carrying capacity and in severe cases lead to cell damage, organ dysfunction or death. Hemoglobin is a protein normally contained within red blood cells that carries and releases oxygen to the body’s tissues.
Hemopure is an intravenously administered pharmaceutical 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. Hemopure is ultra-purified, compatible with all blood types, and stable for three years without refrigeration (2 to 30 degrees Celsius).
Biopure Corporation
Biopure Corporation develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, that are intravenously administered to deliver oxygen to the body’s tissues. Hemopure(R) [hemoglobin glutamer - 250 (bovine)], or HBOC-201, is approved for sale in South Africa for the treatment of surgical patients who are acutely anemic. Biopure has applied in the United Kingdom for regulatory approval of a proposed orthopedic surgical anemia indication. The company is developing Hemopure for a potential indication in cardiovascular ischemia, in addition to supporting the U.S. Navy’s government-funded efforts to develop a potential out-of-hospital trauma indication. The company’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. Biopure has sold approximately 177,000 units of Oxyglobin, which have been used to treat an estimated 90,000 animals.
Statements in this announcement that are not strictly historical are forward-looking statements, including those that might imply that the marketing application for Hemopure in the United Kingdom will be accepted for review, will receive marketing authorization or will result in substantial sales. Actual results and their timing may differ materially from those projected in these forward-looking statements due to risks and uncertainties. These risks include, without limitation, uncertainties regarding the company’s financial position, unexpected costs and expenses, delays and determinations by regulatory authorities, unanticipated problems with the product’s commercial use, whether or not product related, and with product distributors, sales agents or other third parties, and delays in or unpredictable outcomes of clinical trials. 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 can be found in the company’s filings with the U.S. Securities and Exchange Commission, including under the heading “Risk Factors” in the Form 10-Q filed on June 9, 2006, which can be accessed in the EDGAR database at the SEC Web site, http://www.sec.gov.
The content of this announcement 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.
Contact: Douglas Sayles Herb Lanzet (Investors) Biopure Corporation H.L. Lanzet Inc. (617) 234-6826 (212) 888-4570 IR@biopure.comlanzet@aol.com
Biopure Corporation
CONTACT: Douglas Sayles, Biopure Corporation, +1-617-234-6826,IR@biopure.com; Investors, Herb Lanzet, H.L. Lanzet Inc. for BiopureCorporation, +1-212-888-4570, lanzet@aol.com
Web site: http://www.biopure.com/
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