CAMBRIDGE, Mass., Sept. 14 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) announced today that the U.S. Securities and Exchange
Commission (SEC) today filed a civil injunctive proceeding against the
company, two former officers and one current officer.
"The company intends to seek dismissal of the SEC's claims or judgment in
its favor and expects to prevail," said Robert A. Buhlman of Bingham McCutchen
LLP, counsel to the company. "Biopure intends to establish that its
disclosures were accurate based on governing law, testimony provided by the
FDA to the SEC, the FDA's review procedures and practices, and what was
communicated by FDA at the relevant times."
A principal claim by the SEC is based on a contention by the SEC that
confuses the safety of the product with the safety of a proposed clinical
trial design. The claim is that the company should have disclosed in April
2003 that FDA put on hold a proposed clinical trial of the company's
investigational oxygen therapeutic Hemopure(R) in trauma patients in the
hospital setting. Under FDA regulations, a proposed trial is either placed on
hold within 30 days or it may proceed as submitted. When FDA communicated the
hold, it asked data questions described as "safety concerns."
The company disagrees that it was required to disclose the hold status of
the proposed trial in a new indication. The company did not disclose the
filing of the proposed protocol. It is not uncommon for there to be a
dialogue with the FDA over a proposed trial. The company does not and did not
view the data questions or the proposed trial itself to be material to an
investment decision, as opposed to normal back-and-forth between the FDA and
clinical trial sponsors. In addition, in-hospital trauma was not planned as
an indication for commercial development and the company spent an
insignificant amount on the proposed trial.
FDA had designated the in-hospital trauma trial as a separate
investigational new drug application (IND) from the company's then-pending
biologics license application (BLA) for a proposed orthopedic surgery
indication. The FDA questions about data were asked in the context of the in-
hospital trauma IND and referred to data that had also been submitted in the
BLA. The company intends to prove that the FDA questions were specific to the
in-hospital trauma IND, and FDA was not addressing the status of the
orthopedic surgery BLA in its communications about the IND.
The in-hospital trauma IND at issue in the SEC action was withdrawn by the
company in November 2003. That withdrawn in-hospital trauma IND is not to be
confused with the currently proposed IND for treatment of trauma patients in
the out-of-hospital setting. That out-of-hospital trauma IND is currently on
hold after FDA asked different questions than were asked in April 2003.
A second contention in the SEC suit concerns a separate communication by
FDA with the company about the orthopedic surgery BLA. The SEC staff has
claimed that the company's disclosures concerning a July 30, 2003 FDA letter
about the BLA was too positive in tone, in the staff's view. The August 1,
2003 press release about the letter said that FDA had completed its review of
the BLA and that the letter asked for additional information, which it did.
The July 30 BLA letter did not ask for additional clinical trials and the
August 1 press release reported that. The July 30 BLA letter did not mention
"safety concerns" and neither did the press release.
Biopure Corporation develops and manufactures intravenously administered
pharmaceuticals, called oxygen therapeutics, that deliver oxygen to the body's
tissues. The company is developing Hemopure(R) [hemoglobin glutamer - 250
(bovine)], or HBOC-201, for a potential indication in cardiovascular ischemia
and, in collaboration with the U.S. Naval Medical Research Center, for an out-
of-hospital trauma indication. The product is approved in South Africa for
treating surgery patients who are acutely anemic and for eliminating, delaying
or reducing allogeneic red blood cell transfusions in these patients. Hemopure
has not been approved for sale in any other jurisdictions, including the
United States or the European Union. 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.
Statements in this press release that are not strictly historical may be
forward-looking statements. Actual results may differ materially from those
projected in these forward- looking statements due to risks and uncertainties
regarding the company's operations and business environment. These risks
include uncertainties regarding the company's SEC lawsuit and related private
claims. 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, and specific factors that could
cause the company's actual performance to differ from current expectations,
can be found in the company's filings with the U.S. Securities and Exchange
Commission, including the Form 10-Q filed on September 9, 2005, which can be
accessed in the EDGAR database at the SEC Web site, http://www.sec.gov, or
through the Investor Relations section of Biopure's website,
http://www.biopure.com.
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:
Douglas Sayles
Biopure Corporation
(617) 234-6826
IR@biopure.com
SOURCE Biopure Corporation
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Related links:
http://www.biopure.com
Company News On-Call:
http://www.prnewswire.com/comp/131224.html
CONTACT:
Douglas Sayles of Biopure Corporation,
+1-617-234-6826, IR@biopure.com
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