Merck agrees to return Kuvan rights to BioMarin Pharmaceutical to strengthen focus on core business

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 will receive an upfront payment of €340 million, equal to five times its annual sales, for Kuvan, plus up to €185 million in additional milestones for both products. The agreement is expected to become effective 1 January 2016. “Returning the rights of Kuvan 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. 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 Mmarkets. Merck had acquired the rights for Kuvan and the option to Peg-Pal in markets outside of the US and Japan from BioMarin in 2005. Since launching Kuvan 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, Merck’s SPARK study helped pave the way for the treatment of infants with PKU below 4 years of age with Kuvan. By returning the rights to BioMarin, Merck is confident that the product will continue to serve the best interest of the medical community and patients. A leading company in the treatment of genetic and rare diseases, BioMarin is dedicated to improving the treatment options and to providing all resources needed to continue to make Kuvan available, as well as to explore potential future therapies in this area, such as Peg-Pal. Merck will work closely with BioMarin during the transition to ensure continuous access to Kuvan for patients, physicians and health authorities. Kuvan is indicated for the treatment of hyperphenylalaninemia due to PKU in patients of all ages who have shown to be responsive to Kuvan, or due to tetrahydrobiopterin (BH4) deficiency.