On Sunday, BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) reached a binding settlement with Ascendis Pharma A/S (NASDAQ:ASND)to resolve all global patent disputes regarding the medication Yuviwel.
Ascendis Pharma’s Yuviwel (navepegritide, developed as TransCon CNP) is a once-weekly prescription injection approved by the FDA to increase linear height growth in children aged 2 years and older with achondroplasia who have open growth plates.
In March, the FDA approved Yuviwel, the first and only once-weekly treatment for children with achondroplasia.
Ends Global Legal Disputes
The sweeping agreement ends ongoing legal conflicts and intellectual property challenges between the two pharmaceutical companies, including a U.S. International Trade Commission (ITC) investigation.
Under the newly established financial terms, Ascendis will pay BioMarin a 20% royalty on all net sales of Yuviwel within the U.S.
The companies agreed to apply this royalty rate retroactively, covering all transactions dating back to the drug’s initial commercial sale.
Additionally, BioMarin will collect an 18% royalty on net sales generated across the European Union, Brazil, and South Korea. These international royalty payments will remain active and continue through May 2030.
Ascendis Receives License For BioMarin Patents
The settlement grants Ascendis a full license to utilize BioMarin’s patents associated with Yuviwel. This comprehensive license covers all current and potential medical indications, specifically including hypochondroplasia and achondroplasia.
Furthermore, the agreement permits the use of Yuviwel in combination treatments involving other medicines.
Both parties will also dismiss all related intellectual property claims and lawsuits currently active in the Northern District of California, Germany, Denmark, South Korea, and Brazil.
Ascendis Targets 500 Million Euros In 2026 Operating Cash Flow
As previously communicated, Ascendis expects to generate more than 500 million euros in operating cash flow in 2026 and believes that it can achieve 5 billion euros in revenue in 2030.
Yuviwel revenue for the second quarter of 2026 totaled 8 million euros.
More than 220 unique Yuviwel patient enrollments by more than 100 prescribing healthcare providers, with more than 65% of enrollments approved for reimbursement in the U.S. through July 31, 2026.
Yuviwel European Review Remains Underway
Marketing Authorization Application remains under review by the European Medicines Agency, with a decision anticipated in the fourth quarter of 2026.
Ascendis Pharma expects to initiate enrollment in a Phase 3 trial in the second half of the year to investigate TransCon CNP monotherapy for hypochondroplasia.
Price Action: Ascendis Pharma shares were down 0.21% at $247.40 and BioMarin Pharmaceutical shares were up 3.33% at $66.81 during premarket trading on Monday, according to Benzinga Pro data.
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