CAMBRIDGE, Mass., Dec. 30 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that the Food and Drug Administration has advised the U.S. Naval Medical Research Center ("NMRC") by letter that it may not initiate a clinical trial of Biopure's product Hemopure [hemoglobin glutamer - 250 (bovine)], under a proposed protocol submitted to the FDA on November 21, 2008. As previously announced, the Navy had filed a protocol for a proposed trial for the resuscitation of operational casualties with severe hemorrhagic shock without availability of blood transfusions ("Op RESUS").
While the FDA letter acknowledges that the proposed trial addresses some of FDA's concerns previously communicated, it gives three regulatory bases for the hold: safety of subjects, protocol design deficient to meet its stated objectives; and the content of the investigator brochure (a summary of information for those carrying out the trial) and related items. Concerning safety, the FDA hold letter refers to the risk of exacerbation of bleeding resulting from product infusion and the "adverse event profile of [Hemopure]." However, the letter refers in particular to the results of three previous trauma trials with adverse mortality rates, none of which was a Hemopure trial and one of which, according to the FDA, did not involve a hemoglobin based oxygen carrier. According to the FDA, based on these trials with other products, it cannot presently approve IND protocols with agents that may raise blood pressure in acute hemorrhagic shock.
The letter requests a "Clinical Hold Complete Response." The Company does not know how the NMRC will proceed.
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. On November 21, 2008, the Company announced that it had terminated most of its work force for financial reasons. Using its limited resources, the Company is developing Hemopure 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 for marketing 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 more than 200,000 units of Oxyglobin since its launch.
Statements in this release that are not strictly historical are forward-looking statements, including any statements implying that the Company or the U.S. Navy will be able to proceed with any clinical trial of Hemopure. 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 its business, delays and adverse determinations by the FDA and other regulatory authorities, unanticipated problems with the product's commercial use, whether or not product related, delays in clinical trials, and the other factors identified under the heading "Risk Factors" in the Company's quarterly report on Form 10-Q filed on September 15, 2008, 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.
CONTACT: Rob Skiba of Biopure Corporation, +1-617-234-6500, IR@biopure.com