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Strategic Partnership for PKU and Cardiovascular Program
In May 2005, BioMarin entered
into a strategic partnership with Merck Serono SA
(virt-x: SEO and NYSE: SRA) for the development
and commercialization of Kuvan™ (sapropterin dihydrochloride)
for the treatment of phenylketonuria (PKU), PEG-PAL
(PEGylated recombinant phenylalanine ammonia lyase),
currently in Phase 1 development for the treatment
of PKU, and 6R-BH4 for the treatment of cardiovascular
indications, currently in Phase 2 development.
Pursuant to the terms of this agreement, Merck Serono
will equally share Phase 3 development costs associated
with the development of these product candidates
in exchange for exclusive rights to market them
outside of the United States and Japan, pending
regulatory approval. BioMarin retains all rights
within the United States and Canada. Both companies
are individually responsible for the costs of commercializing
the products within their respective territories.
Merck Serono will pay BioMarin royalties on its
net sales of these products and milestone payments
for the successful completion of certain development
and approval milestones. These milestone payments
total up to $232 million, of which $45 million are
directly associated with Kuvan for PKU. In 2007,
BioMarin realized $28.3 million in collaborative
revenues from Merck Serono. |
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