BioMarin grants exclusive data on Kuvan to Asubio

California, USA-based BioMarin Pharmaceutical has licensed to Asubio Pharma, a subsidiary of Daiichi Sankyo, exclusive rights to data and intellectual property contained in the Kuvan (sapropterin dihydrochloride) New Drug Application. Asubio will use this data to supplement its current filing with the Japanese Ministry of Health, Labor and Welfare for approval of its BH4 product, the active ingredient in Kuvan, for the treatment of phenylketonuria in Japan. The application is for a label extension for its current BH4 product marketed in Japan for primary BH4 deficiency. Kuvan is an investigational, oral small-molecule drug for the treatment of PKU being developed in partnership with Merck Serono, a division of Merck KGaA of Germany.

"We have had a long-standing relationship with Asubio regarding BH4 as their early work on BH4 was important to our success in Kuvan development. We are pleased to finalize this new agreement to facilitate approval in Japan. While Asubio already holds the exclusive rights to its own data to commercialize BH4 for all indications in Japan, this new data greatly expands the clinical data set on treatment of PKU and is expected to accelerate the timing for the label extension of Asubio's current BH4 product," said Jean-Jacques Bienaime, chief executive of BioMarin.

The US firm will receive a milestone payment for approval as well as double-digit royalties on net sales of BH4 for PKU in Japan, further details of which were not disclosed.