CAMBRIDGE, Mass., June 5 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today an update regarding a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA) addressing the Company's pending application for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250 (bovine)].
The meeting, held on May 29, was attended by Biopure scientific representatives and the pharmaceutical and clinical assessors from the MHRA. The subject of the meeting was manufacturing and quality. The pharmaceutical assessor accepted Biopure's proposed strategies for answering pending questions and provided clarification. The company is confident that it can resolve all of these issues satisfactorily. No new issues were raised.
As previously reported, the Commission has not advised the company to
withdraw its application. The Company has been advised that such a request
would be the customary means of indicating futility or rejection of an
application. Biopure submitted its application for the treatment of acutely
anemic adult orthopedic surgery patients less than 80 years of age in July
2006, and the MHRA accepted it for review in September 2006. The MHRA
issued its preliminary opinion, part of the normal review process, in
December 2006. In Biopure's response to the preliminary opinion letter,
submitted in November 2007, Biopure changed the indication to the treatment
of acute anemia following orthopedic surgery blood loss when blood is not
readily available or not an option. An issue in resolving the Commission's
clinical comments could be that Biopure has not completed a clinical trial
for anemia in patients where blood was not available or an option. Its
relevant trials, on which the marketing app
|SOURCE Biopure Corporation|
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