FOR IMMEDIATE RELEASE
Contact: Shari Beagelman
Phone: (212) 614-4673
Email: [email protected]
Contact: Tracy Condon
Phone: (212) 614-4219
Email: [email protected]
WORLD'S FIRST "BLOOD SUBSTITUTE" RECEIVES FDA APPROVAL FOR TREATMENT OF CANINE ANEMIA
First in a New Category called "Oxygen Therapeutics"
Product for Use in Humans in Advanced Clinical Trials
Cambridge, MA., January 30, 1998 -- The US Food and Drug Administration (FDA) has given BIOPURE"š Corporation approval to market Oxyglobin"š solution, the first-ever oxygen therapeutic -- sometimes described as a blood substitute -- for the treatment of canine anemia. Oxyglobin was developed by BIOPURE, which also has a similar oxygen therapeutic for humans in advanced clinical trials in the US and Europe for the treatment of surgical blood loss anemia, and a variety of other critical-care uses.
"When the history of 20th-century medicine is written, the development of oxygen therapeutics will be listed among the top ten advances in medicine," said C. Everett Koop, MD, former US Surgeon General and a BIOPURE Director. "Because of its purity, efficacy and convenience, this product class has the potential to revolutionize the practice of medicine, especially in critical-care situations."
Oxyglobin, [hemoglobin glutamer - 200 (bovine)], is a sterile, ready-to-use, room temperature stable, intravenous solution consisting of ultrapurified, chemically modified hemoglobin. Although often described as a "substitute" for blood because it delivers oxygen throughout the body, research indicates oxygen therapeutics, like plasma, profuse further, more rapidly and more efficiently in the body than red blood cells. Because of this increased efficiency, there is the potential for far more clinical applications than possible with blood transfusions alone.
Oxygen therapeutics developed by BIOPURE offer key advantages over donated human or canine blood: they do not require blood-typing or cross-matching for use; they can be stored at room temperature (2∞ to 30∞ C) for up to two years; they can be produced in ample supply; they are derived from controlled donor sources; and the BIOPURE patented production process eliminates potential bacterial, viral and other infectious agents.
"Although donated blood will continue to be an important element in broad-based medical care, BIOPURE's unique oxygen therapeutics provide many clinical advantages to blood in critical-care situations," said Carl Rausch, chief executive officer, BIOPURE. "Oxyglobin can be administered immediately to stabilize dogs that otherwise would die. It is safe and effective -- without the challenges associated with obtaining, storing, typing, cross-matching and warming stored donated blood."
"Because of their high manufacturing costs and limited availability of raw materials, we do not believe that any of our competitors in the human product market can compete with us in the veterinary market," said Rausch. "The FDA's Center for Veterinary Medicine has granted BIOPURE a five-year marketing exclusivity for Oxyglobin because no active ingredient has been approved in any other application." The company estimates worldwide veterinary market potential to be significant, and conservatively estimates growth to over $100 million in the next five years."
"Oxyglobin is a breakthrough in the decades-long struggle by medical science to address an unmet medical need for a safe, convenient therapy to immediately supply oxygen to tissues that would remain oxygen-deprived for minutes to hours due to loss of blood while waiting for the effects of any of the current therapies, including a blood transfusion," said Edward E. Jacobs, Jr., MD, senior vice president, Medical Affairs, BIOPURE.
The Search for a Blood Substitute
Research scientists in the government and private sectors have been working to develop a blood substitute for use in humans for more than 50 years. Efforts intensified in the early 1980s with the advent of acquired immune deficiency syndrome (AIDS) and the risk of transmitting HIV and other infections, such as hepatitis, via donated blood. Although initial efforts were largely unsuccessful, dramatic improvements in purification techniques have resolved safety and efficacy issues. BIOPURE's successes in animal testing combined with the veterinarian's difficulty in obtaining compatible blood for animals, led BIOPURE to pursue products for both the veterinary and human markets. Patented Product and Production Process
Oxyglobin is a natural product created by using purified hemoglobin molecules derived from a managed bovine source. The oxygen therapeutics developed and produced by BIOPURE are patented and have been chemically modified for storage at room temperature, to deliver oxygen efficiently and to increase vascular persistence. Canine Anemia
The role of hemoglobin in red blood cells is to deliver sufficient oxygen throughout the body. Anemia is a reduction in the number of red blood cells which undermines the ability to carry oxygen from the lungs to body tissue. It is a potentially life-threatening condition that often goes untreated in dogs. (Each year, of the four million anemic dogs that could benefit from an oxygen therapeutic, only one in 16 historically has received a blood transfusion.)
"Anemia is a common condition in dogs that often is not treated because donated blood is not available or is too labor-intensive to administer," said Robert Murtaugh, DVM, Tufts University School of Veterinary Medicine. "Because Oxyglobin is easily accessible, it will give every veterinarian the ability to treat anemic dogs effectively, and will be especially useful in critical situations where an animal must be stabilized immediately."
Research Results
The company's products have been studied in more than 2,000 animals and 11 species. The product for human use has been administered to more than 350 individuals and has been well-tolerated.
The Oxyglobin data was collected from multiple studies which included more than 250 dogs. Results from a pivotal multicenter clinical trial of 64 anemic dogs showed a 95 percent efficacy rate in those treated with Oxyglobin compared with 32 percent in the control group, which received cage rest. Oxyglobin-treated dogs also had significantly increased total plasma hemoglobin concentrations (more oxygen in the plasma), and a significantly improved physical condition as measured by heart rate, attitude and physical activity compared to pre-treatment. Canine Safety Trial Results
The most commonly reported adverse reactions in some dogs were a transient discoloration of mucous membranes, sclera and urine; vomiting; and overexpanded vascular volume when administered at a higher than recommended rate. Less frequent adverse events that may or may not have been related to the administration of Oxyglobin included tachypnea, diarrhea, fever and arrhythmia.
Oxyglobin will be shipped to customers at emergency and critical-care veterinary centers in approximately four weeks and subsequently will be available to the nation's approximately 20,000 veterinary practices. The Corporation
BIOPURE" Corporation is a private company headquartered in Cambridge, Massachusetts, focusing on the identification, ultrapurification, application and manufacture of room temperature-stable therapeutic proteins for human and veterinary use. With more than 150 employees, BIOPURE has been defining and creating alternative solutions for delivering oxygen since 1984. BIOPURE has FDA-approved, state-of-the-art manufacturing facilities totaling 80,000 square-feet located in Cambridge, MA, Dover, NH and Souderton, PA. BIOPURE can be found on the World Wide Web at http://www.biopure.com.
Editor Note: Full product information for Oxyglobin is available upon request by calling Shari Beagelman or Tracy Condon at (212) 614-4673/4219.
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