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Biopure Receives Comment Letter From U.K. Regulatory Body on Marketing Application for Hemopure(R)
Date:4/7/2008

CAMBRIDGE, Mass., April 7, 2008 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) announced today that it has received a comment letter from the United Kingdom's Commission on Human Medicines addressing the company's application for marketing authorization for Hemopure(R) [hemoglobin glutamer - 250 (bovine)] pending with the Medicines and Healthcare products Regulatory Agency (MHRA).

The comment letter states that the Commission was "reassured" on a number of the questions raised in its initial comment letter, but indicated that both "major" and "other" pharmacological and clinical issues either were not yet resolved by the Company's submission made in November 2007 or were only resolved in part. In addition, the comment letter poses several new questions. The comment letter invites Biopure to discuss the issues with the MHRA team of three medical, statistical and pharmaceutical reviewers.

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.

"We intend to proceed by meeting and consulting with the UK regulatory review team, as suggested, as soon as possible, for clarification of their requirements," said Biopure Chairman and CEO Zafiris G. Zafirelis. "Based on preliminary advice, we are encouraged to proceed with the application."

Biopure intends to announce the date of its meeting with the MHRA reviewers when it is set, as well as the outcome of the meeting and an anticipated timeline.

According to the Commission, there are no major preclinical issues. The major remaining issues relate to quality, clinical efficacy, safety and the reliability
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SOURCE Biopure Corporation
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