CAMBRIDGE, Mass., July 12 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today commented on articles published in the Wall Street
Journal on July 6, 11, and 12, 2006. The articles reference adverse events
in prior surgery trials of Biopure's investigational oxygen therapeutic
Hemopure(R) [hemoglobin glutamer - 250 (bovine)] and their potential
significance in relation to two key events: the marketing application
Biopure filed in the United Kingdom for the treatment of acutely anemic
orthopedic surgery patients under age 80, and the Food and Drug
Administration's upcoming Blood Products Advisory Committee (BPAC) meeting
to discuss the Navy's proposed RESUS clinical trial of Hemopure for
out-of-hospital treatment of trauma patients with acute blood loss. The
company's comments also correct misperceptions about why the BPAC meeting
is being held in closed session.
To avoid pre-empting discussion of issues that may arise at the BPAC
meeting, Biopure has generally avoided responding on the record to recent
media inquiries. However, in response to what Biopure perceived to be an
imbalanced perspective, the company recently provided contextual
information on the record. Because this information was not addressed in
recent articles, the company is issuing the following comments:
Clinical trials are conducted to identify the circumstances under which
the benefit of an investigational product (in this case, a potential
first-in- class product) exceeds the risks, so that appropriate guidelines
such as patient population, dosage, etc. can be applied to a product label
and/or future study protocols. In such trials, safety is evaluated by
counting adverse events, but not all adverse events are test-agent related.
Orthopedic Surgery
In a previously completed Phase III trial of Hemopure versus red blood
cell transfusion in the treatment of acutely anemic orthopedic surgery
patients, 40 percent of the patients in the Hemopure arm were "crossover"
patients who received both Hemopure and allogenic red blood cells. In this
trial and in the integrated safety database of all Hemopure trials, the
difference in the incidence of serious adverse events between patient
groups largely disappears when sub-group stratification is done, such as
eliminating patients over age 80 or removing the "crossover" patients.
There were also differences in fluid volume management between patient
groups, which led to more fluid overload in the Hemopure group, hence more
cardiac/respiratory events, particularly in patients over age 80.
The marketing authorization application Biopure recently submitted in
the United Kingdom is the company's first such application in Europe and
incorporates the considerable work that has been done to address questions
arising from the Phase III orthopedic surgery trial. In preparing this
submission, the company included new analyses of existing data and also
provided data to and consulted with leading academic medical experts,
regulatory advisors and regulatory authorities in Europe.
Biopure anticipates that a report on the Phase III orthopedic surgery
trial, data from which were previously presented at medical meetings, will
be submitted in a few weeks to a peer-reviewed journal for publication.
Out-of-Hospital Trauma
With regard to the Navy's proposed RESUS trauma trial, the treatment of
hemorrhagic shock outside the hospital is a very different clinical setting
than elective orthopedic surgery in the hospital. RESUS is designed to
investigate whether "life can be saved" in the out-of-hospital setting,
where donor blood is not available, while the orthopedic surgery trial was
designed to see if blood transfusion could be avoided. The risk-benefit
equation is very different in the out-of-hospital trauma setting. Moreover,
the proposed RESUS protocol includes measures to maximize this risk-benefit
equation, including the following:
* RESUS targets patients who are in an acutely critical physiologic
state -- e.g, they are generally hypotensive (critically low blood
pressure) indicating hypovolemia (low blood volume);
* In RESUS, Hemopure would be used only during transport to the
emergency room, where standard care would then be administered (including
blood if indicated);
* RESUS currently targets a high-risk patient population with a much
higher historical mortality than the orthopedic surgery population;
* RESUS contains well-defined inclusion/exclusion criteria, treatment
guidelines and paramedic training regimens;
* RESUS has been defined and modified under the direction of a panel of
military and academic experts from various disciplines such as trauma,
emergency medicine, critical care, etc.
Importantly, there is also a strong preclinical basis for proceeding
with RESUS, based on published and unpublished studies in various animal
models of hemorrhagic shock conducted at various institutions by various
investigators. These studies strongly support the hypothesis that, in an
out-of-hospital trauma situation, Hemopure may be a superior resuscitative
fluid than current non-oxygen carrying solutions. Biopure believes the
opportunity to explore this premise in a well-designed clinical trial is
valid when there are patients at risk who, data suggest, may benefit from
Hemopure.
Because patients would be unconscious or traumatized, the trial design
provides an exception from informed consent and a community consultation
and disclosure process, as defined in FDA regulation 21 CFR 50.24.
FDA Blood Products Advisory Committee Meeting
Regarding the upcoming BPAC meeting being held in closed session, the
company is completing and correcting the record as follows:
* Biopure knows of no precedent where an advisory committee meeting to
discuss an investigational clinical trial proposal was held in open
session. Open meetings are typically held to discuss new drug or biologic
applications under review for marketing approval.
* Neither the FDA, Biopure nor the Navy insisted on a closed meeting.
The FDA provided Biopure and the Navy with the agency's requirements for
conducting either an open or closed meeting. For an open meeting, both
Biopure and the Navy would be required to sign waivers permitting the FDA
to publicly disclose confidential information.
* The preparation time and submission deadlines differ for open and
closed advisory committee meetings. For open meetings, longer lead times
are required for preparing and editing materials to preserve
confidentiality where necessary.
* Biopure considered signing such a waiver for clinical and preclinical
data, excluding manufacturing and other proprietary information, but did
not complete a waiver. There was concern that the prerequisites for an open
meeting could have significantly delayed the meeting. Therefore, in order
to
focus on substantive preparations, Biopure and the Navy agreed that the
meeting would be held in closed session.
* In order for the proposed RESUS trial to proceed, FDA must lift the
clinical hold and the Department of Defense (DoD) and the institutional
review boards of participating hospitals in the communities where the study
would take place must provide final authorization.
* If the clinical hold is lifted and DoD approval obtained, the details
of the proposed trial and the product's potential risks and benefits for
the out- of-hospital treatment of trauma patients with acute blood loss
would be made publicly available through a clinical trial website and
extensive community notification activities.
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.
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.
Statements in this announcement that are not strictly historical are
forward-looking statements, including those that might imply that the
proposed RESUS trauma trial will be allowed to proceed or 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.
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 of Biopure Corporation,
+1-617-234-6826, or IR@biopure.com; Herb Lanzet (Investors), H.L.
Lanzet Inc., +1-212-888-4570, or lanzet@aol.com
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