CAMBRIDGE, Mass., May 2 /PRNewswire-FirstCall/ -- Biopure Corporation (Nasdaq: BPUR) today announced that a meeting with the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) is scheduled for May 29, 2008 in the UK.
The purpose of the meeting is to clarify the issues outlined in a letter Biopure received in April 2008 from the United Kingdom's Commission on Human Medicines regarding the company's application for marketing authorization for Hemopure(R). The issues relate to quality, clinical efficacy, safety and the reliability of data monitoring and auditing of clinical trials. The letter stated 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.
As Biopure previously announced on April 11, 2008, the MHRA found the Company's Pennsylvania manufacturing facility to be in general compliance with the principles and guidelines of good manufacturing practices as identified in the Commission Directives.
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. The company is
developing Hemopure for other indications and is supporting the U.S. Navy's
government-funded efforts to develop a potential out-of-hospital trauma
indication. Biopure's veterinary product
|SOURCE Biopure Corporation|
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