Arecor in conjunction with the National Institute for Biological Standards and Control (NIBSC) are developing several stable aqueous formulations of recombinant clotting factors one of which is Factor VIII. This development is funded by TSB (Technology Strategy Board).

The prophylactic use of recombinant Factor VIII (rFVIII) has been recognized to reduce the number of bleeding episodes suffered by hemophiliacs and prevent joint damage. However, this mode of administration is limited because presently all marketed versions of rFVIII are only available as powders for reconstitution. The reconstituted powders are self-administered by infusion through an intravenous device and therefore the patients would benefit from ready-to-us use stable aqueous formulation which could be administered in the home via a miniaturized pump.

By the application of Arestat-T™, Arecor have overcome the instability commonly observed in formulations of rFVIII post reconstitution creating for the first time a real possibility of having a stable liquid formulation of rFVIII.

• The Arestat-T™ formulation of aqueous rFVIII (100 IU/ml) is stable at ambient temperature.
• The stability of the formulation has been independently confirmed in a controlled storage trial conducted by NIBSC where stability data for periods greater than 20 weeks are available
• The activity of stable aqueous Arestat-T™ formulation of rFVIII is determined by a qualified clotting assay
• The stability profile of Arestat-T™ formulation of rFVIII is significantly better than the marketed comparator in its aqueous form.