Bayer signs development deal for longer-acting Kogenate

Bayer HealthCare, Biological Products (BP) division, has signed an exclusive, global technology licence with Zilip-Pharma for the development and commercialisation of a new, longer-acting Kogenate product.

The deal involves the application of patented liposome technology developed by Zilip-Pharma and its affiliated companies over several years. Clinical results obtained by Zilip-Pharma suggest that a prolonged interval between bleeding episodes - one week or more - occurs when factor VIII attached to liposomes is administered to individuals with hemophilia A.

Upon achievement of key milestones, including successful clinical development and regulatory approvals in key regions, upfront and milestone payments from Bayer to Zilip-Pharma would total US$100m plus royalties from sales of the new product. The agreement covers applications of the liposome technology to the current Kogenate recombinant factor VIII molecule, as well as other factor VIII molecules, which could be developed by Bayer in the future.

Bayer BP recognised that a factor VIII product requiring less frequent infusions would represent a true breakthrough for people living with hemophilia. 'The results from early studies by the Zilip-Pharma group of companies, which included pilot clinical studies, demonstrated great promise for this cutting-edge technology leading to our partnership with them,' said David Naveh, Bayer Biological Products' project champion for the partnership.

Zilip-Pharma's liposomal technology utilises PEGylated liposomes free of biologicals, which have a longer half-life and have been used successfully with other approved products. The polyethylene glycol (PEG) coating helps avoid detection by the immune system. The pilot clinical studies by the Zilip-Pharma group suggest that Kogenate molecules attached to the surface of these liposomes can extend the interval between bleeding episodes requiring fewer treatments especially in prophylactic regimens.

  'The results clearly show the potential for this treatment and we are very pleased that Bayer will undertake the development of the use of our technology within this area,' said Robert Taub, founder of Zilip-Pharma.

Bayer and Zilip-Pharma hope that the next-generation Kogenate could be launched in five years, pending continued positive clinical results, required regulatory reviews, and necessary licence approvals.