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Biopure's Marketing Application for Hemopure(R) Accepted for Review In United Kingdom

Posted on: Tuesday, 12 September 2006, 09:01 CDT

CAMBRIDGE, Mass., Sept. 12 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has validated the marketing authorization application (MAA) the company submitted on July 10, 2006 for Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for the treatment of acutely anemic adult orthopedic surgery patients under 80 years of age. Validation signifies that the application is complete and has been accepted for review.

As previously announced, Biopure submitted its application to the MHRA through the U.K. National Procedure. The time period for the agency's decision on the MAA can vary but generally takes a year or more following validation. During this review period, the company anticipates receiving questions from the MHRA. If marketing authorization is granted, the company would have the option to seek registration of the product in other member states in the European Economic Area through the Mutual Recognition Procedure.

Anemia is a deficiency of red blood cells in the bloodstream caused by blood loss 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 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 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 September 11, 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.com lanzet@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., for BiopureCorporation, +1-212-888-4570, lanzet@aol.com

Web site: http://www.biopure.com/

Company News On-Call: http://www.prnewswire.com/comp/131224.html

Source: PRNewswire-FirstCall

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