CAMBRIDGE, Mass., July 14 /PRNewswire-FirstCall/ -- Biopure Corporation today issued the following statement regarding the Food and Drug Administration’s cancellation of the Blood Products Advisory Committee meeting scheduled for July 14, 2006 to discuss the Navy’s proposed RESUS clinical trial of Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] for the out-of-hospital treatment of trauma patients with acute blood loss:
Biopure is disappointed that the meeting was delayed. The company intends to continue supporting the Navy as the sponsor of the proposed trial. Biopure agrees with and supports the Navy’s statement on this matter, which is accessible via the Navy Medicine home page at http://navymedicine.med.navy.mil/ or directly at http://navymedicine.med.navy.mil/default.cfm?selmod=12482A4C-2A5E-780B- 4FB1E40698282CDE&issueid=272&articleid=01.
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.
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.
Statements in this announcement that are not strictly historical are forward-looking statements, including those that might imply that the proposed RESUS trauma trial will be allowed to proceed or 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.
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 of Biopure Corporation, +1-617-234-6826,IR@biopure.com; or Herb Lanzet (Investors) of H.L. Lanzet Inc., +1-212-888-4570, lanzet@aol.com
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