CAMBRIDGE, Mass., Sept. 12 /PRNewswire-FirstCall/ -- Biopure
Corporation (Nasdaq: BPUR) 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
SOURCE Biopure Corporation
 back to top
Related links:
http://www.biopure.com
http://www.prnewswire.com/comp/131224.html /
CONTACT:
Douglas Sayles, of Biopure Corporation,
+1-617-234-6826, IR@biopure.com ; or Herb Lanzet, Investors, of
H.L. Lanzet Inc., for Biopure Corporation, +1-212-888-4570,
lanzet@aol.com
|
