CAMBRIDGE, Mass., Nov. 8 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that it has submitted a complete response to
the provisional opinion letter issued by the United Kingdom Commission on
Human Medicines (CHM) arising out of CHM's review of Biopure's application
for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250
(bovine)]. The indication requested in the response is for the treatment of
acutely anemic adult orthopedic surgery patients under 80 years of age when
blood is not readily available or not an option.
As stated in prior releases, the Company submitted its application to
the U.K. authorities in July 2006. The company received a provisional
opinion letter in December 2006, which contained the CHM's questions and
requests for additional analyses. Biopure met with the Medicines and
Healthcare products Regulatory Agency (MHRA), the decision making body, in
September 2007 to review its proposed responses to key questions and
subsequently finalized the responses. 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.
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. In addition to its
application in the U.K., 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 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 186,000 units of
Oxyglobin, which have been used to treat an estimated 100,000 animals.
Statements in this release that are not strictly historical are
forward- looking statements, including those statements implying that any
planned clinical trial will be carried out or that study results will be as
desired, statements related to the timing and response of the review of the
marketing application in the U.K. and any statements that might imply that
Hemopure may receive marketing authorization in the U.K. or in additional
jurisdictions or for additional indications. 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 these initiatives, 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 or
unpredictable outcomes of clinical trials, and the other factors identified
under the heading "Risk Factors" in the company's quarterly report on Form
10-Q filed on June 14, 2007, 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 Herb Lanzet (Investors)
Biopure Corporation H.L. Lanzet Inc.
(617) 234-6826 (212) 888-4570
IR@biopure.com lanzet@aol.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html /
CONTACT:
Tiana Gorham of Biopure Corporation,
+1-617-234-6826, IR@biopure.com; or Herb Lanzet (Investors) of
H.L. Lanzet Inc., +1-212-888-4570, lanzet@aol.com
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