Pharmaceutical composition comprising factor VIII and...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Peptide containing doai

Reexamination Certificate

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C514S802000, C514S834000, C424S450000, C530S350000, C530S380000, C530S383000

Reexamination Certificate

active

06930087

ABSTRACT:
A pharmaceutical composition for parenteral administration comprising a therapeutically effective amount of a protein or polypeptide and substantially neutral colloidal particles. The particles comprise approximately 1-20 mole percent of an amphipathic lipid derivatized with a biocompatible hydrophilic polymer which carriers substantially no net charge. The protein or polypeptide is capable of externally binding the colloidal particles, or is capable of binding polyethylene glycol, and is not encapsulated in the colloidal particles. A preferred protein is factor VIII, whose half-life is extended and which is protected from serum inhibitor antibodies by injecting it as a component of the composition.

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Barrowcliffe et al., “Binding to phospholipid protects factor VIII from inactivation by human antibodies” 1983, J. Lab. Clin. Med. 101:34-43.
Kemball-Cook, Interaction of Factor VIII with Phospholipids: Role of Composition and Negative Charge, 1992, Thromb. Res. 67:57-71.
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