CAMBRIDGE, Mass., Nov. 8 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that it has submitted a complete response to the provisional opinion letter issued by the United Kingdom Commission on Human Medicines (CHM) arising out of CHM’s review of Biopure’s application for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250 (bovine)]. The indication requested in the response is for the treatment of acutely anemic adult orthopedic surgery patients under 80 years of age when blood is not readily available or not an option.
As stated in prior releases, the Company submitted its application to the U.K. authorities in July 2006. The company received a provisional opinion letter in December 2006, which contained the CHM’s questions and requests for additional analyses. Biopure met with the Medicines and Healthcare products Regulatory Agency (MHRA), the decision making body, in September 2007 to review its proposed responses to key questions and subsequently finalized the responses. Once an applicant responds to the Commission’s questions it generally takes four to six months for the agency to make a final determination. If marketing authorization is granted, the company could seek registration of the product in other member states in the European Economic Area through the Mutual Recognition Procedure.
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. In addition to its application in the U.K., the company is developing Hemopure for other indications and is supporting the U.S. Navy’s government-funded efforts to develop a potential out-of-hospital trauma indication. Biopure’s veterinary product Oxyglobin(R) [hemoglobin glutamer - 200 bovine)], or HBOC-301, the only oxygen therapeutic approved by both the U.S. Food and Drug Administration and the European Commission, is indicated for the treatment of anemia in dogs. Biopure has sold approximately 186,000 units of Oxyglobin, which have been used to treat an estimated 100,000 animals.
Statements in this release that are not strictly historical are forward- looking statements, including those statements implying that any planned clinical trial will be carried out or that study results will be as desired, statements related to the timing and response of the review of the marketing application in the U.K. and any statements that might imply that Hemopure may receive marketing authorization in the U.K. or in additional jurisdictions or for additional indications. 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, including its limited cash resources and need to raise additional capital to pursue these initiatives, unexpected costs and expenses, delays and adverse 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, delays in or unpredictable outcomes of clinical trials, and the other factors identified under the heading “Risk Factors” in the company’s quarterly report on Form 10-Q filed on June 14, 2007, which can be accessed in the EDGAR database at the U.S. Securities and Exchange Commission’s (SEC) website, http://www.sec.gov. 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 SEC.
IR@biopure.com lanzet@aol.com
CONTACT: Tiana Gorham 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
Web site: http://www.biopure.com/
Company News On-Call: http://www.prnewswire.com/comp/131224.html /
