BioMarin Pharmaceutical Inc. has acquired global rights to Kuvan (sapropterin dihydrochloride) and pegvaliase from Merck Serono. BioMarin will provide Merck with an upfront payment of €340 million. An additional €60 million in milestones will be paid to Merck if combined sales of Kuvan and pegvaliase reach undisclosed cumulative sales thresholds. In addition, €125 million will be paid to Merck for regulatory milestones related to pegvaliase. Previously, BioMarin had exclusive rights to Kuvan in the U.S. and Canada and to pegvaliase in the U.S. and Japan. BioMarin will now have exclusive worldwide rights toKuvan and pegvaliase with the exception of Kuvan in Japan. Approved in 2007 in the U.S., Kuvan is a commercialized product for the treatment of patients with phenylketonuria (PKU). Pegvaliase is currently in registration-enabling pivotal studies as a potential therapeutic option for adult patients with phenylketonuria. With the potential approval of pegvaliase, the two products combined will expand and globalize BioMarin’s position by offering a wider range of treatment options to patients worldwide with PKU.

In 2005, Merck acquired from BioMarin the exclusive rights to Kuvan and the option to develop pegvaliase in markets outside of the U.S. and Japan. By regaining these rights to both products, BioMarin has the opportunity to expand its commercial efforts across the company’s global territories. Kuvan is currently sold by Merck in many countries where BioMarin has a commercial presence for both Naglazyme (galsulfase) and Vimizim (elosulfase alfa). Kuvan has orphan drug exclusivity in Europe until 2020. Upon closing of the transaction in January 2016, BioMarin will record all sales and profits of Kuvan.

“This is an excellent transaction for BioMarin as it provides numerous operational and strategic synergies for the Company,” said Jean-Jacques Bienaime, chairman and chief executive officer, BioMarin. “We will leverage our established worldwide infrastructure and strong relationships within the PKU community to ensure that patients globally have access to Kuvan, and potentially pegvaliase upon approval. We look forward to expanding our PKU franchise beyond the U.S. and Canadian markets and into our existing commercial footprint of about 60 countries where Kuvan is currently sold.”