Biopure Corporation
(Nasdaq: BPUR) announced that it had recently met with the FDA to
discuss the compassionate use protocol submitted by the company in July. At
the FDA’s suggestion, the company intends to submit a protocol for a Phase
2 randomized trial for the treatment of autoimmune hemolytic anemia and
other forms of hemolytic anemia, including alloantibody anemia but
excluding sickle cell anemia. Hemopure has been used previously, on a
compassionate use basis, to treat patients with these conditions.
The proposed patient group was included in the compassionate use
protocol previously proposed to the FDA. A study protocol for the treatment
of autoimmune hemolytic anemia and other forms of hemolytic anemia would be
in place of that compassionate use protocol. Biopure may continue to work
with the FDA on compassionate use cases through single patient INDs that
are requested from treating physicians.
Autoimmune hemolytic anemia is a group of disorders characterized by a
malfunction of the immune system that produces antibodies to the patient’s
red blood cells attacking them as if they were substances foreign to the
body. This group of disorders is uncommon, can occur at any age and affects
women more often than men.
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 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 the
FDA will approve any study protocol for the use of Hemopure in the U.S.,
the patients eligible for such a study, and any statements that might imply
that Hemopure may receive marketing approval 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, 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, and delays in or unpredictable outcomes of clinical trials, and
the 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, sec. 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 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.
Biopure Corporation
biopure