Biopure Announces 2008 Third Quarter Financi...(ESUS) to be conducted in the U.S. with c...)

Date:8/21/2008

ESUS) to be conducted in the U.S. with community notification and the right to opt out rather than individual patient consent. The NMRC has proposed subsequently a similar protocol for military casualties in the field called Op RESUS with subjects who would sign an informed consent prospectively.

The Company postponed the meeting we had planned to request for July 2008 with the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom on the Company's pending application for marketing authorization for Hemopure. The Company decided to apply its limited resources to the submission of the AML protocol and working with the FDA. As previously noted, FDA and the MHRA have communicated about Hemopure.

BPAC Meeting

On September 11, 2008, Biopure is scheduled to deliver a brief presentation on Hemopure and its safety and efficacy at the Blood Products Advisory Committee meeting at the FDA. The meeting agenda includes a review of the workshop on hemoglobin based oxygen carriers held at the National Institutes of Health in Bethesda, Maryland on April 29 and 30, 2008.

Publications

The journal Expert Opinion Biological Therapeutics has published a Drug Evaluation focused on HBOC-201, authored by Jonathan S. Jahr, M.D., et al, of the David Geffen School of Medicine at UCLA, Department of Anesthesia. The article, appearing in the September 2008 issue of the journal, is entitled, "HBOC-201, hemoglobin glutamer-250 (bovine), Hemopure (Biopure Corporation)." Dr. Jahr was a principal investigator in Biopure's pivotal trial in orthopedic surgery patients and co-author of a June 2008 Journal of Trauma article that presented the data from that trial. The Expert Opinion article concludes that; "While HBOC-201 may not replace allogenic blood transfusions, it may serve to allow critically ill patients to be resuscitated in the field or hospital setting until either regeneration of red cell occurs or a transfusion is available." Addi
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SOURCE Biopure Corporation Copyright©2008 PR Newswire. All rights reserved

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