Biopure Receives Comment Letter From U.K. Regulatory Body on Marketing Application for H...(of data monitoring and auditing of clini...),Health

Date:4/7/2008

of data monitoring and auditing of clinical trials. The Commission also noted the lack of data in trauma patients as a concern related to the potential for off-label use of Hemopure. Unless the company resolves the Commission's issues, the Commission may be unable to recommend marketing authorization to the MHRA.

Biopure submitted its application for the treatment of acutely anemic adult orthopedic surgery patients under 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. A complexity in resolving the Commission's issues could be that Biopure has not completed a clinical trial for anemia in patients where blood was not available or an option.

Anemia

Anemia is a deficiency of red blood cells in the bloodstream caused by blood loss or other disorders, which can compromise the body's oxygen-carrying capacity and in severe cases lead to cell damage, organ dysfunction or death. Hemoglobin is a protein normally contained within red blood cells that carries and releases oxygen to the body's tissues.

Hemopure(R)

Hemopure is an intravenously administered pharmaceutical consisting of stabilized bovine hemoglobin formulated in a balanced salt solution. These chemically cross-linked hemoglobin molecules circulate in the plasma (the fluid part of blood) when infused and are smaller, less viscous and more readily release oxygen to tissues than red blood cells. Hemopure is ultra-purified, compatible with all blood types, and stable for three years without refrigeration (2 to 30 degrees Celsius). Other than red blood cell transfusion, there is no approved therapeutic for human use in
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