Biopure Receives FDA Response to Hemopure(R) Marketing Application
CAMBRIDGE, Mass., Aug. 1 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq:
BPUR) announced today that the U.S. Food and Drug Administration (FDA) has
completed its review of the company's biologic license application (BLA) for
Hemopure(R) [hemoglobin glutamer - 250 (bovine)] and issued a letter requesting
additional information. The letter focuses primarily on clarification of clinical and
preclinical data and includes some comments on labeling. It does not request additional
clinical trials. Biopure has applied to market Hemopure in the United States for the
treatment of acutely anemic adult patients undergoing orthopedic surgery and for the
elimination or reduction of red blood cell transfusions in these patients.
With 30 days remaining in the original BLA review cycle, the issuance of the letter has
suspended the FDA review clock until Biopure submits a complete response.
"We're encouraged that the FDA has finished its review and provided comprehensive
feedback in advance of the formal action due date. By maintaining thirty days on the
review clock, the FDA is encouraging us to work with them to complete the approval
process as quickly as possible," said Biopure President and CEO Thomas A. Moore.
"We'll work with the Agency to address the remaining questions and will provide our
answers as expeditiously as possible."
Anemia is a shortage of RBCs in the body that can create an oxygen deficit and lead to
cell damage, organ dysfunction or, in severe cases, death. Acute anemia, usually
caused by blood loss, is the primary indication for a RBC transfusion. In 1999,
approximately 1.4 million RBC units were transfused in 500,000 high blood loss
orthopedic surgical procedures.* These statistics are expected to increase as the
population ages.
Hemopure is an oxygen therapeutic, or drug, consisting of chemically stabilized bovine
hemoglobin formulated in a balanced salt solution. This stabilized, acellular hemoglobin
circulates directly in plasma (the fluid part of blood) when administered intravenously,
increasing oxygen delivery and diffusion. The product is compatible with all blood types,
is stable for three years at room temperature (2 degrees to 30 degrees Celsius), and is
purified through patented and proprietary techniques that are validated to remove
potential contaminants.
Biopure Corporation
Biopure Corporation, headquartered in Cambridge, Mass., is the leading manufacturer
and marketer of oxygen therapeutics, a new class of drugs that are intravenously
administered to deliver oxygen to the body's tissues for the treatment of acute surgical
anemia and other potential medical applications. Hemopure(R) [hemoglobin glutamer -
200 (bovine)] is approved in South Africa for the treatment of acutely anemic surgical
patients and for eliminating, delaying or reducing the need for red blood cell
transfusion in these patients. The company's veterinary product, Oxyglobin(R)
[hemoglobin glutamer - (200 bovine)], is a similar oxygen therapeutic approved in the
United States and European Union for the treatment of anemia in dogs.
Statements in this press release that are not strictly historical may be forward-looking
statements. There can be no assurance that Biopure Corporation will be able to
commercially develop its oxygen therapeutic products, that necessary regulatory
approvals will be obtained, that anticipated milestones will be met in the expected
timetable, that any clinical trials will be successful, or that any approved product will
find market acceptance and be sold in the quantities anticipated. Actual results may
differ from those projected in forward-looking statements due to risks and
uncertainties that exist in the company's operations and business environment. These
risks include, without limitation, the company's stage of product development, history
of operating losses and accumulated deficits, and uncertainties and possible delays
related to clinical trials, regulatory approvals, possible healthcare reform,
manufacturing capacity, marketing, market acceptance, competition and the availability
of sufficient financing to support operations. 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
Biopure's operations and financial condition, and specific factors that could cause the
company's actual performance to differ from current expectations, can be found on the
company's Web site at www.biopure.com/corporate/legal/home_legal.htm and in the
company's filings with the U.S. Securities and Exchange Commission, which can be
accessed in the EDGAR database at the SEC Web site, www.sec.gov, or through the
Investor section of Biopure's Web site, www.biopure.com.
* Theta Reports study entitled "Synthetic Blood Products Worldwide" and the National
Center for Health Statistics' 1999 National Hospital Discharge Survey.
Contact:
Douglas Sayles Biopure Corporation
(617) 234-6826
[email protected] Lee Stern (investors)
The Trout Group
(212) 477-9007 x22
[email protected]
SOURCE Biopure Corporation