After manufacturing setback at FDA, Ascendis strikes $150M royalty deal on its first commercial drug

06 Sep 2023
www.fiercepharma.com
Drug Approval
As Ascendis launches Skytrofa, it's also trying to win approval for a second product. Now, it has secured some cash in exchange for royalties.
RoyAscendisrma, a comSkytrofawn for ponying up chunks of cash in exchange for long-term drug royalties, has hopped on board with Ascendis Pharma's long-acting growth hormone Skytrofa.
Royalty Pharmar the $150 million in funding, Ascendis will grant Royalty a 9.15% royalty on its U.S. Skytrofa revenues starting JAscendis PharmaSkytrofa
With the cash, Ascendis aims to reduce its coAscendispital and brRoyalty products to patients “as fast as possible,” CEO Jan Mikkelsen said in a statement.
Skytrofa, whichAscendis known as TransCon hGH, won approval in 2021 for children ages 1 and older with growth hormone deficiency who weigh at least 25.4 pounds. It's the first approved pediatric therapy for the condition that can be taken once weekly as opposed to the standard-of-care daily somatropin.
Skytrofa generated 36 million eurTransCon hGHion) in 2022, and Ascendis recently raised its full-year 2growth hormone deficiencyfor the drug to between 165 million euros and 170 million euros.somatropin
Meanwhile, Ascendis' application for TransCon PTH was due for aAscendisproval decision in April, but those efforts hit a setback.
In a compleAscendisnse letter, the FDTransCon PTHe issue with anyFDAinical data nor did it request more studies. Instead, the agency flagged manufacturing concerns. Specifically, the agency cited issues with Ascendis’ manufacturing control strategy for the variability of delivered doses.
Ascendis recently submitted additioFDA information about its updated manufacturing control strategy and held a “constructive” meeting with the agency, the company said in its second-quarter earnings report. The company aims to resubmit its TransCon PTH application by October.
Ascendisved, the med would be Ascendis’ second approved product.
As for Skytrofa, that drug has a new rival in Pfizer and OPKO Health’s Ngenla, which recently gained an FDA nod to treat kids 3 and older with stunted growth. The rival drug was hot on Ascendis’ heels until the FDA requested longer-term data and hit the partners' application with a complete response letter.
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