CAMBRIDGE, Mass., July 11 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today announced that it has submitted a marketing
authorization application (MAA) to the United Kingdom's Medicines and
Healthcare products Regulatory Agency (MHRA) for Hemopure(R) [hemoglobin
glutamer - 250 (bovine), or HBOC-201], the company's universally
compatible, room-temperature-stable oxygen therapeutic. Biopure is seeking
MHRA authorization to market this new biologic medicine in the U.K. for the
treatment of acutely anemic adult orthopedic surgery patients less than 80
years of age.
The MAA contains reports of preclinical studies and clinical trials of
Hemopure, including new analyses of existing data from a 688-patient Phase
III orthopedic surgery trial conducted in the United States, South Africa,
Europe and Canada and from a 160-patient Phase 3 general non-cardiac
surgery trial conducted in South Africa and Europe. The application also
contains an integrated database of all completed trials, including data for
approximately 1500 total subjects, of which more than 800 were administered
Hemopure. In addition, the MAA describes the post-approval clinical
experience with Hemopure in South Africa, where the product is indicated
for the treatment of adult surgical patients who are acutely anemic.
In preparing to file this application, the company provided data to and
consulted with leading academic medical experts, regulatory advisors and
regulatory authorities in Europe. Biopure submitted its application through
the U.K. National Procedure. The MHRA usually determines the acceptability
of an MAA for review within a few weeks. Once the MAA is accepted, the
complete review period can vary but generally takes more than a year. If
marketing authorization is granted, the company may seek registration of
the product in other member states in the European Economic Area through
the Mutual Recognition Procedure.
Acute Anemia
Anemia is a deficiency of red blood cells in the bloodstream caused by
blood loss (e.g., from surgery or injury) 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
polymerized (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 be accepted
for review, 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 June 9, 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
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html /
CONTACT:
Douglas Sayles, Biopure Corporation,
+1-617-234-6826, IR@biopure.com; Investors, Herb Lanzet, H.L.
Lanzet Inc. for Biopure Corporation, +1-212-888-4570,
lanzet@aol.com
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