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Kuvan

BioMarin Pharmaceutical Inc.

Drug Names(s): Phenoptin, sapropterin dihydrochloride, 6R-BH4, BH4, SUN-0588, Biopten [Japan], Sapropterin [EU]

Description: Kuvan (6R-BH4) is an enzyme cofactor that is a second generation, proprietary oral form of naturally occurring tetrahydrobiopterin (BH4). BH4 is the cofactor for the enzyme phenylalanine hydroxylase, which breaks down phenylalanine.

In phenylketonuria patients, phenylalanine hydroxylase activity is absent or deficient.

Deal Structure: Revenue splits for this drug are BioMedTracker estimates.

U.S. historical revenue excludes the EU royalty revenue included in BioMarin's reported sales for Kuvan. WW historical revenue comprises U.S. sales, EU sales and estimates of Japan sales based on the 15% royalty earned from Daiichi.

Daiichi Suntory and BioMarin
Kuvan was discovered by Daiichi Suntory Pharma and is sold in Japan by Maruho Co., Ltd. as Biopten. In Japan, BioMarin will receive milestone payments as well as double-digit royalties on net sales of BH4 for PKU from Asubio Pharma (a subsidiary of Daiichi Sankyo).

BioMarin and Merck KGaA
BioMarin and Merck Eprova (a subsidiary of Merck KGaA) entered into an agreement for equal sharing of costs for clinical development and manufacturing of Kuvan. BioMarin has the worldwide intellectual property right and will pay royalties on sale of phenoptic products to Merck Eprova. Biomarin also has right of first refusal to...See full deal structure in Biomedtracker

Partners: Merck KGaA Daiichi Sankyo Co., Ltd.


Kuvan News


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