American biotechnology company BioMarin has entered into binding terms with Denmark-based Ascendis Pharma, resolving all patent and ancillary disputes pending globally, including before the US International Trade Commission (ITC) concerning Ascendis’s Yuviwel.
Developed by Ascendis Pharma, Yuviwel (navepegritide) is a once-weekly prescription medicine approved by the US Food and Drug Administration (FDA) in February 2026 to increase height and linear growth in paediatric patients aged 2 years and older with achondroplasia and open growth plates (epiphyses).
Achondroplasia is a rare genetic condition that causes the most common form of disproportionate dwarfism and is associated with an increased risk of muscular, neurological and cardiorespiratory complications. The condition is estimated to affect more than 250,000 people worldwide.
Under the agreement, Ascendis will pay BioMarin a royalty equivalent to 20% of net US sales of Yuviwel, retroactive to the date of its first commercial sale and 18% of net sales in the European Union, Brazil and South Korea until May 2030.
“This outcome incentivises companies like BioMarin to keep investing in the kind of long-term innovation that is critical to bringing breakthrough treatments to the people who need them,” said Alexander Hardy, President and CEO of BioMarin.
The settlement includes a license for BioMarin’s patents related to Yuviwel for all current and potential indications, including achondroplasia and hypochondroplasia. It also covers the use of Yuviwel in combination with other medicines.
Under the terms of the agreement, BioMarin will dismiss its pending Section 337 investigation before the ITC and the parties will resolve all claims relating to the asserted intellectual property, including litigation pending in Brazil, Denmark, Germany, South Korea and the Northern District of California.
BioMarin said that the agreement recognises the value of its pioneering innovations in C-type natriuretic peptide (CNP) technology, including the development of VOXZOGO(vosoritide), while providing a framework that enables continued access to medicine for children with achondroplasia around the world.
VOXZOGO is approved in the US, Japan and Australia to increase linear growth in children of all ages with achondroplasia with open epiphyses. In the EU, VOXZOGO is indicated for the treatment of achondroplasia in children 4 months of age and older whose epiphyses are not closed, as confirmed by appropriate genetic testing.
The US FDA accepted BioMarin’s supplemental New Drug Application (sNDA) for VOXZOGOfor full approval in children with achondroplasia. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2027.
