Strategic Partnership for PKU
In May 2005, BioMarin entered into a strategic partnership with Merck Serono SA for the development and commercialization of Kuvan® (sapropterin dihydrochloride) Tablets for the treatment of phenylketonuria (PKU), PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase), currently in Phase 2 development for the treatment of PKU.
Pursuant to the terms of this agreement, Merck Serono will equally share Phase 3 development costs associated with the development of these product candidates in exchange for exclusive rights to market them outside of the United States and Japan, pending regulatory approval. BioMarin retains all rights within the United States and Canada. Both companies are individually responsible for the costs of commercializing the products within their respective territories. Merck Serono will pay BioMarin royalties on its net sales of these products and milestone payments for the successful completion of certain development and approval milestones. These milestone payments total up to $232 million, of which $45 million are directly associated with Kuvan for PKU.