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Kogenate - Liposomal

Bayer AG

Drug Names(s): Kogenate FS - Pegylated Liposome Diluent, BAY 79-4980

Description: Kogenate-Liposomal is a combination of Bayer's Kogenate FS (recombinant factor VIII [rFVIII] antihemophilic factor) with Zilip Pharma’s synthetic polyethylene glycol (PEG)-coated liposomes, in order to make the product longer-acting. The PEG coating is to prevent an immune reaction against the liposomes. The formulation has shown to result in specific, high affinity, non-covalent binding of rFVIII to exterior surfaces of liposomes, and does not interfere with activity of the molecule.

Kogenate provides a means of temporarily replacing the missing clotting factor FVIII in order to correct or prevent bleeding episodes, allowing the body’s blood-clotting process to function properly.

Deal Structure: In November 2004, Bayer HealthCare, Biological Products (BP) division, announced it had signed an exclusive, global technology licensewith Zilip-Pharma for the development andcommercialization of a longer-acting Kogenate product. The deal between Bayer and Zilip-Pharma involves the application of patented liposome technology developed by Zilip-Pharma and its affiliated companies over several years.

Upon achievement of key milestones, including successful clinical development andregulatory approvals in key regions, upfront and milestone payments from Bayer toZilip-Pharma would total 100 million US-Dollar plus royalties from sales of the newproduct. The agreement covers applications of the liposome technology to the currentKogenate recombinant factor VIII molecule, as well as other factor VIII molecules,which could be developed by Bayer in the future. Zilips liposomal technology utilizes PEGylated liposomes free of biologicals.

Zilip-Pharma is a wholly owned subsidiary of Recoly...See full deal structure in Biomedtracker

Partners: Recoly N.V.

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