ANNUAL REPORT 2002

 
BIOPURE CORPORATION

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Milestones



1984
Company founded and began business at Tufts New England Enzyme Center in Boston, Mass. 1984 to 1989: $14.4M raised (net)
 		 
1987
Manufacturing support facility established in Dover, N.H.
 		 
1990
1990-1991: Pilot manufacturing facility constructed in Cambridge, Mass.

1990-1999: $242 million raised (net) prior to Biopure's initial public offering
 		 
1992
Two U.S. patents issued
 		 
1994
1994-1996: Front-end manufacturing facility constructed in Souderton, Pa.

Two U.S. patents issued

Hemopure: 1994-1998: 12 Phase I/II and 2 Phase II clinical trials (11 surgical, 3 non-surgical) conducted in the United States and Europe
 		 






1986
Oxyglobin: investigational new animal drug (INAD) application filed with U.S. Food and Drug Administration (FDA)
 		 

1988
Hemopure: Original investigational new drug (IND) application filed with U.S. FDA
 		 

1991
Boston manufacturing operations transferred to Cambridge, Mass. facility

Hemopure: First Phase I clinical trial initiated (frozen formulation)
 		 

1993
Hemopure: 1993-1994: Four Phase I clinical trials of Hemopure (room temperature formulation)

Oxyglobin: Pivotal clinical trial
 		 





1995
Corporate offices relocated to Cambridge, Mass.

Oxyglobin: 1995-1996: Phased submission of new animal drug application (NADA) filed with U.S. FDA
 		 
1998
Five U.S. patents issued

Hemopure: Phase II double-blind cardiac surgery trial presented at American Heart Association annual meeting

Oxyglobin: U.S. FDA approval of Oxyglobin for the treatment of anemia in dogs; Veterinary marketing application filed with the European Medicines Evaluation Agency (EMEA)
 		 
2000
1990-1991: Pilot manufacturing facility constructed in Cambridge, Mass.

Follow-On Public Offering (Net $83.7 million)

One U.S. patent issued

Hemopure: Phase II vascular surgery trial published in Journal of Vascular Surgery

Oxyglobin: Flexible dose range approved by U.S. FDA; U.S. expiration date extended to three years
 		 
2002
$35.5 million raised (net)

Hemopure: Biologic license application (BLA) filed with and accepted for review by U.S. FDA; U.S. Army trauma research grant awarded

Manufacturing facilities in Mass. and Pa. expanded

Biopure South Africa Ltd. established
 		 






1997
Four U.S. patents issued

Hemopure: 1997-1999: Phase III general non-cardiac surgery trial in South Africa and Europe

Oxyglobin: U.S. FDA inspection of manufacturing facilities
 		 

1999
Initial Public Offering (Net $37.7 million)

Four U.S. patents issued

Hemopure: marketing application filed with South Africa's Medicines Control Council (MCC); U.S. Phase III orthopedic surgery trial initiated

Oxyglobin: European Commission (EC) approval of Oxyglobin for the treatment of anemia in dogs
 		 

2001
Engineering begun for new manufacturing facility in Sumter, S.C.

Two U.S. patents issued

Hemopure: Approved by South Africa's MCC for the treatment of acute anemia in adult surgery patients; Primary study endpoints met in U.S. Phase III orthopedic surgery trial

Oxyglobin: European launch of Oxyglobin; Flexible dose range approved by EC; European expiration date extended to three years
 		 




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