Baxter’s recombinant antihaemophilic Factor VIII protein-free method (rAHF/PFM), an investigational therapy currently in phase III clinical trials, is a new category of recombinant Factor VIII prepared entirely without the addition of any human or animal raw materials in the cell culture process, purification or final formulation.
Results from a randomized double-blind, cross-over study comparing rAHF/PFM and the control, Recombinate (recombinant antihaemophilic factor), indicate that rAHF/PFM and Recombinate rAHF are bioequivalent and should exhibit comparable hemostatic efficacy in the management of Haemophilia A.
FURTHER REDUCING THEORETICAL RISK
rAHF/PFM is being developed in response to concerns about the theoretical transmission of currently unknown viruses or diseases through the continued use of human- or animal-derived components during the production process and final formulation.
All currently available recombinant Factor VIII therapies use human or animal-derived proteins at some point in their production processes or final product formulations. To date, more than 5 billion units of Recombinate rAHF have been supplied to the haemophilia community since the first clinical study infusion was administered in 1987, and there have been no confirmed cases of disease transmission associated with its use.
However, according to a recommendation from the Medical Advisory and Scientific Council (MASAC) of the National Hemophilia Federation, "all efforts should be made to remove human albumin from recombinant Factor VIII products. Moreover, increased efforts should be made to eliminate human and bovine proteins from the manufacturing process of recombinant Factor VIII products. "
Baxter’s next generation recombinant Factor VIII, rAHF/PFM, was developed in response to this recommendation. “For the haemophilia community, having a Factor VIII concentrate produced without adding human or animal raw materials confers a greater comfort level about treatment,” said Gordon Bray, MD, global medical director, Baxter BioScience. “The preparation of rAHF/PFM virtually eliminates the theoretical risk of disease transmission that may be associated with the use of human- or animal- derived raw materials or stabilizers.”
rAHF/PFM was developed using a cell line derived from the one used for Recombinate production.
ABOUT HAEMOPHILIA
Haemophilia is caused by the absence or severe deficiency of Factor VIII, a protein in human blood critical for proper blood coagulation. More than approximately 350,000 people are living with haemophilia worldwide. Patients can experience spontaneous, uncontrolled internal bleeding that often is associated with pain, chronic joint destruction and, if left untreated, death.
People with haemophilia infuse themselves with clotting factors on average three times a month, unless they are on a preventative regimen, in which case they could infuse multiple times per week. Barring other complications or disorders, clinicians today expect a near normal life expectancy for patients, provided they receive proper treatment.
ABOUT BAXTER
Baxter International Inc (NYSE: BAX) is a global health care company that, through its subsidiaries, provides critical therapies for people with life-threatening conditions. Baxter's bioscience, medication delivery and renal products and services are used to treat patients with some of the most challenging medical conditions including cancer, hemophilia, immune deficiencies, infectious diseases, kidney disease and trauma.
(Baxter and Recombinate are trademarks of Baxter International Inc. Baxter is registered in the U.S. Patent and Trademark Office.)
This news release contains forward-looking statements that involve risks and uncertainties, including technological advances in the medical field, product demand and market acceptance, actions of regulatory bodies, the impact of competitive products and pricing, and other risks detailed in the company's filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements.
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