This morning, Biopure Corporation (Nasdaq: BPUR) announced 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 commission was reassured on a number of questions raised in the initial comment letter. The comment letter invites Biopure to discuss the issues with the MHRA team.
Biopure has not been advised to withdraw its 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 is expected to announce the date of its meeting with MHRA.
Biopure develops, manufactures and markets pharmaceuticals, called oxygen therapeutics, which are administered intravenously. Hemopure® is approved for sale in South Africa for the treatment of patients that are acutely anemic. Biopure’s veterinary product Oxyglobin®, or HBOC-301, the only oxygen therapeutic approved for marketing by both the U.S. Food and Drug Administration and the European Commission, is used for the treatment of anemia in dogs.
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