Medgenics, Inc., the company that has developed a novel technology for the manufacture and delivery of therapeutic proteins continuously in patients using their own tissue, announces that, on 10 February 2011, it signed an exclusive worldwide license with the Regents of the University of Michigan of patent rights relating to certain uses of variants of clotting Factor VIII developed by Professor Randall Kaufman of the University of Michigan, a leading authority on Factor VIII.
The variants of Factor VIII being licensed have been reported by various researchers to have greater production and delivery performance to the blood circulation compared with standard forms of Factor VIII.
Medgenics is actively developing a unique technology called HEMADURE - a Biopump producing Factor VIII intended for use in hemophilic patients.
As previously announced the Company has developed Biopumps that produce active Factor VIII and is continuing to collaborate with Baxter Healthcare to improve the Biopump performance to reach Factor VIII levels projected to be clinically useful.
Medgenics intends to use the variants of Factor VIII licensed from the Regents of the University of Michigan to determine whether it can increase Factor VIII production from the HEMADURE Biopump.
In ongoing laboratory studies, the Company has demonstrated significantly greater Factor VIII production from Biopumps utilizing one of these licensed variants. These studies are continuing.
The market for injected Factor VIII was approximately US $4.0 billion in 2009 (La Merie Business Intelligence, R&D Pipeline, Top 20 Biologics 2009 (March 10, 2010)).
The License Agreement covers a portfolio of 2 issued and 3 pending patents and requires the Company to pay an initial license fee of $25,000 to the Regents of the University of Michigan, as well as continuing annual license fees, milestone payments of US $750,000 (in aggregate) related to the progress of research and development, of which US $400,000 will be recoupable against royalties, patent maintenance costs, royalties ranging between 2% and 5% and sublicense fees ranging between 4% and 6%.
The exclusive worldwide license will expire upon the expiration of the last to expire of the patent rights licensed in 2026.