CAMBRIDGE, Mass., Jan. 10 /PRNewswire-FirstCall/ -- Biopure Corporation announced today that, as expected, it has received a provisional opinion letter from the United Kingdom Commission on Human Medicines containing comments and questions based on its review of the company's marketing authorization application (MAA) for Hemopure(R) [hemoglobin glutamer - 250 (bovine)] for the treatment of acutely anemic adult orthopedic surgery patients under 80 years of age. The letter provides Biopure the opportunity to respond to these issues before the Commission gives its final advice to the Medicines and Healthcare products Regulatory Agency (MHRA), the licensing authority in the U.K.
The letter identifies and captions as "Major" issues relating to toxicology, quality, clinical efficacy and safety, including the product's benefit-risk balance in the proposed indication when blood is readily available. It captions as "Other" several dozen issues primarily relating to chemistry, manufacturing and controls. Unless these issues are satisfactorily addressed, the Commission may be unable to recommend marketing authorization.
"Based on our initial review of the letter, we believe the issues are addressable," said Biopure Chairman and CEO Zafiris G. Zafirelis. "During the next several weeks, we expect to continue evaluating the issues and the time and resources required to fully respond to the Commission's questions."
Biopure submitted its application to the MHRA through the U.K. National Procedure in July 2006, and the MHRA accepted it for review in September 2006. The issuance of a provisional opinion letter with questions from the Commission on Human Medicines, which is an advisory body to the MHRA, is a standard, interim step in the review process. Under U.K. regulations, the company has up to six months to respond to the Commission's questions, and can request an extension. The time period for the agency's final decision on the MAA can vary. 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.
Anemia
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(R)
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). Other than red blood cell transfusion, there is no approved therapeutic for human use in Europe or the U.S. that can transport oxygen to tissues.
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. Biopure'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 180,000 units of Oxyglobin, which have been used to treat an estimated 98,000 animals.
Statements in this press release that are not strictly historical are forward-looking statements, including statements regarding Biopure's ability to satisfactorily address the issues raised by the U.K. Commission on Human Medicines, the timing for preparing any such response, and the timing for any subsequent regulatory actions. Actual results 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, delays in or unpredictable outcomes of clinical trials, and the factors identified under the heading "Risk Factors" in the company's Form 10-Q filed on September 11, 2006, 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.
The content of this press release 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.comlanzet@aol.com
Biopure CorporationCONTACT: Douglas Sayles of Biopure Corporation, +1-617-234-6826,IR@biopure.com; or Investors, Herb Lanzet of H.L. Lanzet Inc.,+1-212-888-4570, lanzet@aol.com, for Biopure Corporation
Web site: http://www.biopure.com//
Company News On-Call: http://www.prnewswire.com/comp/131224.html/
