Merck has opted to return its Phenylketonuria (PKU) candidates Kuvan and Peg-Pal back to BioMarin from January 2016. Merck will instead focus on other R&D areas, and will receive €340M in compensation (5 times the annual sales of Kuvan) with €180M for future Peg-Pal milestones. This appears to support the back-peddling trend of major Biotechs invested in rare diseases.
Kuvan was originally developed for the autosomal recessive disease Phenylketonuria (PKU) in a joint effort by Merck-Serono and California’s BioMarin. Licensed and marketed by Merck, Kuvan went on to receive world-wide approval for use as an oral treatment for PKU by both the EU EMA and US FDA since 2007. Now Merck has decided to relinquish its licensing rights of Kuvan and Phase II PKU drug Peg-Pal. BioMarin will also compensate Merck with €180M in milestone payment Peg-Pal’s development.
Phenylketonuria is a rare genetically conferred metabolic disease, where the amino acid phenylanaline (PHE) is not broken down properly.