CAMBRIDGE, Mass., April 7, 2008 /PRNewswire-FirstCall/ -- Biopure
Corporation (Nasdaq: BPUR) announced today that it has received a comment
letter from the United Kingdom's Commission on Human Medicines addressing
the company's application for marketing authorization for Hemopure(R)
[hemoglobin glutamer - 250 (bovine)] pending with the Medicines and
Healthcare products Regulatory Agency (MHRA).
The comment letter states that the Commission was "reassured" on a
number of the questions raised in its initial comment letter, but indicated
that both "major" and "other" pharmacological and clinical issues either
were not yet resolved by the Company's submission made in November 2007 or
were only resolved in part. In addition, the comment letter poses several
new questions. The comment letter invites Biopure to discuss the issues
with the MHRA team of three medical, statistical and pharmaceutical
reviewers.
The Commission has not advised the company to withdraw its application.
The company has been advised that such a request would be the customary
means of indicating futility or rejection of an application.
"We intend to proceed by meeting and consulting with the UK regulatory
review team, as suggested, as soon as possible, for clarification of their
requirements," said Biopure Chairman and CEO Zafiris G. Zafirelis. "Based
on preliminary advice, we are encouraged to proceed with the application."
Biopure intends to announce the date of its meeting with the MHRA
reviewers when it is set, as well as the outcome of the meeting and an
anticipated timeline.
According to the Commission, there are no major preclinical issues. The
major remaining issues relate to quality, clinical efficacy, safety and the
reliability of data monitoring and auditing of clinical trials. The
Commission also noted the lack of data in trauma patients as a concern
related to the potential for off-label use of Hemopure. Unless the company
resolves the Commission's issues, the Commission may be unable to recommend
marketing authorization to the MHRA.
Biopure submitted its application for the treatment of acutely anemic
adult orthopedic surgery patients under 80 years of age in July 2006, and
the MHRA accepted it for review in September 2006. The MHRA issued its
preliminary opinion, part of the normal review process, in December 2006.
In Biopure's response to the preliminary opinion letter, submitted in
November 2007, Biopure changed the indication to the treatment of acute
anemia following orthopedic surgery blood loss when blood is not readily
available or not an option. A complexity in resolving the Commission's
issues could be that Biopure has not completed a clinical trial for anemia
in patients where blood was not available or an option.
Anemia
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(R)
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). Other than red blood cell
transfusion, there is no approved therapeutic for human use in Europe or
the U.S. that can transport oxygen to tissues.
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. 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 for
marketing 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 200,000 units of Oxyglobin since its launch in 1998.
Statements in this release that are not strictly historical are
forward- looking statements, including any statements implying that the
company will be able to respond to the MHRA questions or that Hemopure will
attain marketing authorization in the United Kingdom and including
statements implying that any clinical trial will be initiated and/or
carried out to completion or that study results will be as desired, and any
statements that might imply that Hemopure may receive marketing approval in
the UK or any other jurisdictions or for additional indications in South
Africa. 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 its business, the
company's ability to satisfactorily address the issues raised in the MHRA
correspondence or additional issues raised at a later date, 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 clinical trials, and the other factors
identified under the heading "Risk Factors" in the Company's quarterly
report on Form 10- Q filed on March 17, 2008, 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: Tiana Gorham
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
 back to top
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
|
