Merck Agrees to Return Kuvan® Rights to BioMarin Pharmaceutical to Strengthen Focus on Core Business

Darmstadt, Germany (ots/PRNewswire) -


- Agreement with BioMarin, a leading company in the treatment of genetic and rare
diseases, also includes returning option to develop and commercialize Peg-Pal 
- Merck to receive upfront payment of EUR 340 million, plus up to EUR 185 million in
additional milestones 


Merck, a leading company for innovative and top-quality high-tech
products in healthcare, life science and performance materials, today
announced that it has reached an agreement with BioMarin
Pharmaceutical, Inc., San Rafael, California, U.S., to return the
rights to Kuvan(R), used to treat phenylketonuria (PKU), a rare
metabolism disorder, as the company focuses its healthcare business
on core areas.

In addition to Kuvan(R), the two companies agreed that Merck will
return its option to develop and commercialize Peg-Pal, an
investigational drug that is also designed for the treatment of PKU,
an autosomal recessive genetic disorder caused by either a defect or
a deficiency of the enzyme phenylalanine hydroxylase or its co-factor
tetrahydrobiopterin. Merck will receive an upfront payment of EUR 340
million, equal to five times its annual sales, for Kuvan(R), plus up
to EUR 185 million in additional milestones for both products. The
agreement is expected to become effective Jan. 1, 2016.

"Returning the rights of Kuvan(R) and Peg-Pal to BioMarin will
allow Merck to fully focus on its core businesses, as well as further
align R&D investment behind key strategic areas," said Belén Garijo,
Member of the Executive Board of Merck and CEO Healthcare. "Patients
suffering from PKU will continue to benefit from these therapeutic
options, as well as from BioMarin's long-term expertise in rare
diseases."

Merck remains highly committed to the patients in the field of
endocrinology, and in particular to advancing the treatment of growth
hormone deficient patients with Saizen(R).

Over the past years, Merck has re-aligned its healthcare business
with a special focus on developing novel therapies in the areas of
neurology, oncology, immuno-oncology and immunology, in addition to
maximizing its existing portfolio of drugs in developed countries as
well as expanding its footprint in Emerging Markets.

Merck had acquired the rights for Kuvan(R) and the option to
Peg-Pal in markets outside of the U.S. and Japan from BioMarin in
2005.* Since launching Kuvan(R) as a treatment alternative to diet
alone, which constituted a paradigm shift at the time, Merck has
significantly contributed to improving PKU management. More recently,