Biopure Corporation announced that its Biologic License Application (BLA) for Hemopure [hemoglobin glutamer - 250 (bovine)] has been accepted for review by the U.S. Food and Drug Administration (FDA). The acceptance is based on the agency''s determination that the BLA is adequate to permit a substantive and meaningful review.
On July 31, 2002, Biopure submitted an electronic BLA to the FDA seeking regulatory clearance to market Hemopure in the United States for the treatment of acute anemia in adult patients undergoing orthopedic surgery, and for eliminating or reducing the need for red blood cells in these patients. The application was based on two Phase III clinical trials and an integrated database of all 22 Hemopure clinical trials, including data for more than 1400 total subjects of which more than 800 received Hemopure.
"This is the fourth regulatory milestone for our technology we''ve passed that no competitor has achieved," said Biopure''s President and CEO Thomas A. Moore. "Approvals for our veterinary product in the United States and European Union, the approval of Hemopure in South Africa for human use and now FDA acceptance of our BLA for review in the United States."
"While the FDA will decide whether our application is approvable, this acceptance is further affirmation of the substantive clinical data we''ve amassed. This latest ''first'' for Biopure should help support our efforts to establish new business relationships and product indications. We will continue to work closely with the FDA on this review while also preparing other international filings," added Moore.
Hemopure is an intravenously administered pharmaceutical consisting of chemically stabilized bovine hemoglobin (the protein that carries oxygen) formulated in a balanced salt solution. This stabilized, acellular hemoglobin circulates directly in plasma (the fluid part of blood) when infused and has lower viscosity and releases oxygen to tissues more efficiently than red blood cells. Hemopure is compatible with all blood types, stable both refrigerated and at room temperature (2 degrees to 30 degrees C) for up to three years, and is purified through patented and proprietary techniques that are validated to remove potential contaminants, including infectious agents such as bacteria, viruses and transmissible spongiform encephalopathy (TSE) agents.