CAMBRIDGE, Mass., July 25 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) today announced through a letter to stockholders its most
recent progress in the clinical development of its lead oxygen therapeutic,
Hemopure(R). The letter to stockholders was filed on Form 8-K with the
Securities and Exchange Commission today. A summary of the progress
reported on includes the following:
Biopure has submitted a final study report to the FDA for the first
trial in its cardiovascular ischemia program (COR-001). COR-001 was a phase
2 safety and feasibility study trial that evaluated 45 patients with
coronary artery disease who were undergoing percutaneous coronary
intervention, or PCI. Investigators have started a COR-002 trial, also a
phase 2 trial, which is currently enrolling patients in the Netherlands.
This study is intended to enroll up to 10 patients and could be completed
in the near future.
In addition to re-starting a compassionate use program in January, the
company has submitted a study protocol to the FDA for the use of Hemopure
in the United States in certain life-threatening situations where red blood
cell transfusion is not an option. This is the first step towards
formalizing the compassionate use of Hemopure without requiring an IND for
each new case. To date, the FDA has approved all requests and granted
single-patient INDs to Biopure for the treatment of individual patients
with life-threatening anemia when red blood cell transfusion was not an
option. The company continues to receive requests for Hemopure use in
life-threatening situations on a weekly basis.
The U.S Navy Medical Research Center (NMRC) submitted a revised study
protocol for RESUS, a proposed clinical trial to study the use of Hemopure
to "Restore Effective SUrvival in Shock" that the FDA has on clinical hold.
The revised protocol is based on commentary in an FDA Blood Products
Advisory Committee meeting held in December 2006 and subsequent
communications with the FDA. The general objective of this Phase 2 study is
to test the NMRC hypothesis that HBOC-201 could be safe and tolerable and
decrease morbidity and mortality in trauma patients before they arrive at
the hospital.
Biopure has met with the Medicines and Healthcare products Regulatory
Agency (MHRA) in the United Kingdom to discuss comments received from the
MHRA in a December 2006 letter relating to an application for market
authorization. The company expects to submit its response to the MHRA
letter by the end of this summer.
Biopure's Cambridge manufacturing facility was recently inspected by
representatives of the MHRA who undertook an inspection on behalf of the
EMEA (European Agency for the Evaluation of Medicinal Products) relating to
the veterinary product, Oxyglobin. As a result of the inspection, Biopure
has received a GMP ("good manufacturing practices") certificate for its
plant.
With respect to business development activities, the company is
considering a possible licensing opportunity to manufacture and sell
Hemopure in certain Asian countries yet to be finalized. In this regard,
the company is in discussions with individuals from the Malaysia Technology
Development Corporation (the venture capital arm of the Malaysian Ministry
of Science, Technology and Innovation) and private investors. A proposed
transaction would likely involve an investment in Biopure class A common
stock at a premium and the establishment of a production facility for
Hemopure in Malaysia to supply the selected Asian territories. Biopure
cannot give assurance that a transaction will occur, as any license remains
subject to negotiation and required approvals.
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 182,000 units of Oxyglobin, which have been
used to treat an estimated 100,000 animals.
Statements in this letter that are not strictly historical are forward-
looking statements, including those that might imply that the Navy's
proposed RESUS clinical trial will be allowed to proceed or that Hemopure
may receive marketing approval in additional jurisdictions or for
additional indications, and those that might imply the timing of regulatory
submissions and regulatory actions. 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, 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 letter 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: Todd Wood
Biopure Corporation
(617) 234-6576
IR@biopure.com
Herb Lanzet (Investors)
H.L. Lanzet Inc.
(212) 888-4570
lanzet@aol.com
SOURCE Biopure Corporation
 back to top
Related links:
http://www.biopure.com/
http://www.prnewswire.com/comp/131224.html/
CONTACT:
Todd Wood of Biopure Corporation,
+1-617-234-6576, IR@biopure.com; or Investors, Herb Lanzet of
H.L. Lanzet Inc., +1-212-888-4570, lanzet@aol.com
|
