Biopure Provides Further Comment on U.K. Regulatory Body Letter Regarding Marketing Application for Hemopure
CAMBRIDGE, Mass., January 10, 2007 /PRNewswire-FirstCall/ -- Biopure Corporation has issued further comment regarding the provisional opinion letter that the company received from the United Kingdom Commission on Human Medicines. As announced earlier today, the letter contains comments and questions based on the Commission's 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 issuance of such a letter is a standard, interim step in the U.K. review process that was expected by Biopure.
"We believe that we can address the Commission's questions and that we have a reasonable chance of receiving marketing authorization based on the advice of our European regulatory consultant and our own initial assessment of the letter," said Biopure Chairman and CEO Zafiris G. Zafirelis. "We are still assessing the letter and the time and resources required to respond. As part of this process, we intend to consult with our medical advisory board in the U.K. We also intend to communicate with the regulatory assessors who evaluated our application to discuss our responses, including new analyses of existing clinical data and potential changes to the application to improve the benefit-risk balance to patients in the U.K."
The comments in the Commission's letter are in two categories. "Major objections" is the Commission's term for questions that must be fully and satisfactorily answered. The "other" issues are of lesser importance. Under U.K. regulations, the company has up to six months to respond to the Commission's questions, and can request an extension, before the Commission gives its final advice to the Medicines and Healthcare products Regulatory Agency (MHRA), the licensing authority in the U.K.
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, the timing for any subsequent regulatory actions, and the likelihood of receiving marketing authorization. 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) 888-4570IR@biopure.com email@example.com
Web site: http://www.biopure.com//
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Posted: January 2007