LongAte; NecLip-pdFVIII; liposome-formulated plasma-derived Factor VIII

Status - MAA filed in 2011

Organizations involved:

Recoly NV – Manuf.; R&D; Tech.

Bayer Healthcare AG – World mar k.

Description: LongAte is a pegylated non-encapsulating liposomal formulation of plasma-derived Factor VIII. NecLip liposome technology increases the hemostatic efficacy of high-purity, plasma-derived FVIII (pdFVIII). [Note, a recombinant-based counterpart (BAY-79-4980) is in clinical trials].

NecLip (non-encapsulating liposomes) technology is based on the phenomenon whereby certain proteins and peptides that contain a specific sequence of amino acids spontaneously bind to the surface of certain PEGylated liposomes. The combination of a NecLip liposome and a bound protein enhance the therapeutic efficacy of certain proteins. PEGylated liposomes are microscopic fluid-filled spheres with synthetic non-toxic polyethylene glycol molecules attached to their surface. Traditional technologies either encapsulate a drug within a PEGylated liposome or directly PEGylate the drug itself. NecLip differs from these traditional approaches in that the protein or peptide attaches to the surface of our PEGylated liposome, thus enhancing the therapeutic efficacy of the protein without requiring any change in the manufacturing or extracting methods of the protein or its mode of administration to patients.

Companies: LongAte was developed and is manufactured by Rocoly NV. Bayer has marketing rights in most territories.

Status: MAA was reported as filed in 2011.