CAMBRIDGE, Mass., Jan. 10 /PRNewswire-FirstCall/ -- Biopure Corporation
(Nasdaq: BPUR) has issued further comment regarding the provisional opinion
letter that the company received from the United Kingdom Commission on
Human Medicines. As announced earlier today, the letter contains comments
and questions based on the Commission's review of the company's marketing
authorization application (MAA) for Hemopure(R) [hemoglobin glutamer - 250
(bovine)] for the treatment of acutely anemic adult orthopedic surgery
patients under 80 years of age. The issuance of such a letter is a
standard, interim step in the U.K. review process that was expected by
Biopure.
"We believe that we can address the Commission's questions and that we
have a reasonable chance of receiving marketing authorization based on the
advice of our European regulatory consultant and our own initial assessment
of the letter," said Biopure Chairman and CEO Zafiris G. Zafirelis. "We are
still assessing the letter and the time and resources required to respond.
As part of this process, we intend to consult with our medical advisory
board in the U.K. We also intend to communicate with the regulatory
assessors who evaluated our application to discuss our responses, including
new analyses of existing clinical data and potential changes to the
application to improve the benefit-risk balance to patients in the U.K."
The comments in the Commission's letter are in two categories. "Major
objections" is the Commission's term for questions that must be fully and
satisfactorily answered. The "other" issues are of lesser importance. Under
U.K. regulations, the company has up to six months to respond to the
Commission's questions, and can request an extension, before the Commission
gives its final advice to the Medicines and Healthcare products Regulatory
Agency (MHRA), the licensing authority in the U.K.
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 180,000 units of Oxyglobin, which have been
used to treat an estimated 98,000 animals.
Statements in this press release that are not strictly historical are
forward-looking statements, including statements regarding Biopure's
ability to satisfactorily address the issues raised by the U.K. Commission
on Human Medicines, the timing for preparing any such response, the timing
for any subsequent regulatory actions, and the likelihood of receiving
marketing authorization. Actual results 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, delays in or
unpredictable outcomes of clinical trials, and the factors identified under
the heading "Risk Factors" in the company's Form 10-Q filed on September
11, 2006, 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: 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; or Investors, Herb Lanzet of
H.L. Lanzet Inc., +1-212-888-4570, or lanzet@aol.com
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