CAMBRIDGE, Mass., Oct. 28 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that it had received a notice from the Medicines Control Council (MCC) of South Africa indicating its decision to discontinue the registration of Hemopure [hemoglobin glutamer-250 (bovine)], Biopure's oxygen therapeutic for human use. The decision is subject to appeal. Biopure intends to appeal the decision promptly and expects to continue to market the product while the appeal is pending. The appeal is estimated to take a year to resolve.
The MCC decision comes after a letter sent to the South Africa Minister of Health on May 22, 2008, asking that the then ongoing clinical trials of Hemopure in South Africa be brought to a halt because of the "evidence against blood substitutes." The letter was sent by Public Citizen and signed by three of the authors of a so-called meta-analysis of hemoglobin-based blood substitutes published online April 28, 2008, by the Journal of the American Medical Association. The letter to the Minister of Health characterized the results of, and enclosed a copy of, the article.
Biopure expects that an appeal before a hearing body, to be chosen by the Minister of Health, but subject to challenge by Biopure, will succeed. Biopure has done all required reporting on Hemopure's usage since its approval for marketing in South Africa in 2001, including monitoring and reporting to the MCC on use of the product in the first 80 patients treated. Thereafter, a South African doctor consulting for Biopure collected patient data on more than 200 patients, published an article on that clinical experience and submitted the information to the MCC. Since Hemopure was approved for marketing in South Africa, there have been no serious adverse events required to be reported to the MCC from clinical use of the product in approximately 500 patients. Consequently, an appeal should establish that there is not a basis for this action. Biopure expects that local experts will strongly support its appeal.
Upon learning that the negative communication had been sent to the Minister of Health of South Africa and to each other country where Biopure had ongoing trials, Biopure demanded a retraction and sent an objection to the National Institutes of Health (NIH) regarding Charles Natanson of the NIH signing the Public Citizen letters using his NIH title. Earlier this month, Biopure brought an action against Natanson alleging various torts, including defamation, trade libel and intentional interference with prospective business advantage, seeking injunctive relief and damages. Biopure is announcing the filing of that litigation separately.
The MCC also ordered the halt of clinical trials in South Africa, but Biopure had already stopped patient enrollment in its trials there earlier this year, for reasons of slow enrollment and cost containment.
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. 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 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 approximately 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 any
appeal will be successful. 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, 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 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: Tiana Gorham
|SOURCE Biopure Corporation|
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