Merck Agrees to Return Kuvan® Rights to BioMarin Pharmaceutical to Strengthen Focus on Core Business - Seite 3

co-factor that works in conjunction with the enzyme phenylalanine
hydroxylase (PAH) to metabolize phenylalanine into tyrosine. Clinical
data show that Kuvan(R) produces significant reductions in blood
phenylalanine concentration in a large subset of patients.

Most common adverse reactions reported with the use of Kuvan(R)
include headache, rhinorrhea, pharyngolaryngeal pain, nasal
congestion, cough, diarrhea, vomiting, abdominal pain, and low levels
of phenylalanine in the blood.

Kuvan(R) is approved in 51 countries worldwide, including member
states of the European Union and the USA. Under the terms of the
former agreement with BioMarin, Merck Serono had received exclusive
rights to market Kuvan(R) in all territories outside the USA, Canada
and Japan, all these rights have now been returned to BioMarin.

About Peg-Pal  

PEG-PAL (PEGylated recombinant phenylalanine ammonia lyase or
'PAL', pegvaliase) is an investigational drug that substitutes for
the PAH enzyme in phenylketonuria (PKU). PEG-PAL is being developed
as a potential treatment for patients whose blood phenylalanine
levels are not adequately controlled by Kuvan(R) or who have trouble
controlling and maintaining their phenylalanine levels).

About BioMarin  

BioMarin is a global biotechnology company that develops and
commercializes innovative therapies for patients with serious and
life-threatening rare and ultra-rare genetic diseases. The company's
portfolio consists of five commercialized products and multiple
clinical and pre-clinical product candidates.

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Merck is a leading company for innovative and top-quality
high-tech products in healthcare, life science and performance
materials. The company has six businesses - Merck Serono, Consumer
Health, Allergopharma, Biosimilars, Merck Millipore and Performance
Materials - and generated sales of EUR 11.3 billion in 2014. Around
39,000 employees work for Merck in 66 countries to improve the
quality of life for patients, to foster the success of customers, and
to help meet global challenges. Merck is the world's oldest
pharmaceutical and chemical company - since 1668, the company has
stood for innovation, business success and responsible
entrepreneurship. Holding an approximately 70% interest, the founding
family remains the majority owner of the company to this day. Merck,
Darmstadt, Germany holds the global rights to the Merck name and
brand. The only exceptions are Canada and the United States, where
the company operates as EMD Serono, EMD Millipore and EMD Performance
Materials.

ots Originaltext: Merck KGaA
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