BioMarin Pharmaceutical Inc. announced today that Asubio Pharma Co., Ltd. (a subsidiary of Daiichi Sankyo), has received marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for a label extension of Biopten(R) (sapropterin dihydrochloride), which contains the same active ingredient as Kuvan(R) in the U.S., for the treatment of patients with phenylketonuria (PKU). 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 PKU in Japan under an exclusive license of data and intellectual property contained in the Kuvan new drug application.
The details can be read here.
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