BioMarin buys global rights to phenylketonuria franchise from Merck

Merck Serono has agreed to sell the global rights of Kuvan (sapropterin dihydrochloride) and pegvaliase to BioMarin Pharmaceutical Inc, California (USA), as Merck focuses its healthcare business on core areas.
 
Under the terms of the agreement, BioMarin will provide Merck with an upfront payment of Euro 340 million. An additional Euro 60 million in milestones will be paid to Merck if combined sales of Kuvan and pegvaliase reach undisclosed cumulative sales thresholds. In addition, Euro 125 million will be paid to Merck for regulatory milestones related to pegvaliase. Previously, BioMarin had exclusive rights to Kuvan in the US and Canada and to pegvaliase in the US and Japan.
   
Under the terms of the transaction, BioMarin will now have exclusive worldwide rights to Kuvan and pegvaliase with the exception of Kuvan in Japan. Approved in 2007 in the US, Kuvan is a commercialised product for the treatment of patients with phenylketonuria (PKU), a rare metabolism disorder. 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 globalise BioMarin's leadership 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 US 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).