BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), based in the United States, and Denmark’s Ascendis Pharma A/S have entered into binding terms that resolve all pending patent and ancillary disputes over Yuviwel, including proceedings before the U.S. International Trade Commission (ITC).
Under the agreement, Ascendis will pay BioMarin royalties on net sales of Yuviwel in several markets through May 2030.
- 20% of net sales in the U.S., retroactive to the first commercial sale
- 18% of net sales in the European Union, Brazil and South Korea
“This outcome incentivizes 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 Chief Executive Officer of BioMarin. “We have spent decades focused on understanding the underlying biology of rare genetic conditions, building the deep scientific expertise that led to our development of six first-in-disease medicines for patients. We look forward to continuing to innovate, bringing forward the next generation of medicines for people with serious genetic conditions, and building on our ongoing momentum for children with achondroplasia.”
Settlement scope#
The license covers BioMarin patents related to Yuviwel for all current and potential indications, including achondroplasia and hypochondroplasia, as well as use of Yuviwel in combination with other medicines.
BioMarin will dismiss the pending Section 337 investigation before the ITC. The parties will also resolve all claims relating to the asserted intellectual property, including litigation pending in Brazil, Denmark, Germany, South Korea and the Northern District of California.
Company background#
The agreement recognizes the value of BioMarin’s innovations in C-type natriuretic peptide (CNP) technology, including the development of VOXZOGO (vosoritide), while providing a framework for continued access to medicine for children with achondroplasia worldwide.
BioMarin, founded in 1997 and based in San Rafael, California, is a biotechnology company with nine commercial therapies and a clinical and preclinical pipeline focused on genetically defined conditions.
