Asubio Granted Japanese Approval for Label Extension of Biopten

BioMarin Pharmaceutical has announced that Asubio Pharma, a subsidiary of Daiichi Sankyo, has received marketing approval from the Japanese Ministry of Health, Labour and Welfare for a label extension of Biopten, which contains the same active ingredient as Kuvan in the US, for the treatment of patients with phenylketonuria.

BioMarin will receive a milestone payment of $1.5 million for this marketing approval along with double-digit royalties on net sales of Biopten for phenylketonuria (PKU) in Japan under an exclusive license of data and intellectual property contained in the Kuvan new drug application.

Jean-Jacques Bienaime, CEO of BioMarin, said: “We are proud to work with Asubio to further expand our geographic reach and help to bring the first drug treatment option to PKU patients in Japan. We are also looking forward to the pending Kuvan approval by the European Medicines Agency, which we expect by the end of 2008.”