First clinical data presented on latest technological advance in haemophilia a therapy

Seville, Spain, May 21, 2002 The first recombinant Factor VIII therapy for Haemophilia A prepared entirely without the use of human- or animal-derived additives was found to be bioequivalent to the current gold-standard recombinant therapy according to data presented today at the XXV International Congress of the World Federation of Hemophilia.

Baxters 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.

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 eli

Contact: Deborah Spak
Porter Novelli

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