Why this document matters
From surgical development to trauma and prehospital oxygen delivery.
The 2002 Annual Report is especially important because it documents the moment when Biopure explicitly identified trauma, emergency-room care and the prehospital or ambulance setting as the next clinical development priority for Hemopure. It also records military-supported research planning, a U.S. FDA biologic license application under review, continued South African human-use experience and a mature veterinary Oxyglobin program.
FDA review · Hemopure BLABiopure reported that its biologic license application for Hemopure was filed in July 2002 and accepted for FDA review in October 2002 for acute anemia in elective orthopedic surgery patients.
Prehospital and ambulance trauma priorityThe report states that Biopure's first clinical priority beyond surgical anemia was to evaluate Hemopure for stabilizing trauma patients in emergency-room and prehospital or ambulance settings.
U.S. military collaborationBiopure reported a U.S. Army grant for a Phase II trauma trial and work with the Army, Navy and Air Force on a broader civilian and military trauma program. It also described proposed collaboration with the Naval Medical Research Center.
Clinical evidence baseThe report describes 22 Hemopure clinical trials, more than 1,400 total subjects in the integrated trial database, and more than 800 subjects who received Hemopure. These are historical company-reported figures.
Preclinical programBiopure reported more than 180 preclinical animal and laboratory studies, including hemorrhagic shock, trauma and tissue-oxygenation models.
Oxyglobin veterinary experienceThe report states that more than 115,000 Oxyglobin units had been sold following U.S. FDA approval in 1998 and European approval in 1999 for canine anemia.
Manufacturing scaleBiopure described expanded facilities designed for approximately 75,000 Hemopure units, with installed equipment aimed at 100,000-unit capacity and longer-term plans for a 500,000-unit facility.