Merck Serono to market Kuvan in EU
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
BioMarin's synthetic enzyme cofactor Kuvan (sapropterin) is approved in the EU and will be marketed by partner Merck Serono to treat patients with the orphan conditions hyperphenylalaninemia in phenylketonuria or BH4 deficiency. This is the first approved therapeutic to manage PKU in the European market BioMarin said Dec. 9. BioMarin receives a $30 million milestone for the EU marketing approval plus royalties on net sales of Kuvan in the EU. The drug was approved in 2007 for that indication in the U.S. (1Pharmaceutical Approvals Monthly January 2008, p. 3)