Royalty Pharma, renowned for its investments in exchange for long-term drug royalties, has entered into a collaboration with Ascendis Pharma regarding the long-acting growth hormone known as Skytrofa.
In this partnership, Royalty Pharma is providing $150 million in funding to Ascendis. In return, Ascendis will grant Royalty Pharma a 9.15% royalty on its U.S. Skytrofa revenues, starting from January 1, 2025.
Ascendis aims to utilize this funding to reduce its cost of capital and expedite the delivery of its products to patients. CEO Jan Mikkelsen emphasized the importance of bringing their products to market as quickly as possible.
Skytrofa, also referred to as TransCon hGH, obtained approval in 2021 for the treatment of children aged 1 and older with growth hormone deficiency (GHD) who weigh at least 25.4 pounds. It is the first approved pediatric therapy for GHD that can be administered once weekly, offering an alternative to the standard daily somatropin treatment.
“This transaction reflects the significant value of Skytrofa. We are pleased to partner with Royalty Pharma, a leading funder of innovation across the biopharma industry, and look forward to partnering with them in the coming years. With this funding, we continue to reduce our cost of capital and provide added flexibility to support our global commercial capabilities to bring our TransCon products to patients as fast as possible.”
– Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer
The drug generated 36 million euros ($39 million) in revenue in 2022, and Ascendis has raised its revenue expectations for the full year 2023 for Skytrofa, projecting earnings between 165 million euros and 170 million euros.
On another front, Ascendis submitted an application for TransCon PTH, which was due for an FDA approval decision in April. However, this effort faced a setback when the FDA issued a complete response letter. The FDA’s concerns were related to manufacturing rather than clinical data, specifically focusing on Ascendis’ manufacturing control strategy for dose variability. Ascendis has since submitted additional information and held productive discussions with the FDA. The company intends to resubmit its TransCon PTH application by October.
“We are excited to partner with Ascendis, a global, integrated biopharmaceutical company focused on endocrine rare disease and oncology. Skytrofa, as the first US approved weekly growth hormone therapy for pediatrics, addresses significant unmet patient need, which is underscored by its strong launch. We look forward to Ascendis’ continued success in reaching as many patients as possible with this important therapy as well as the potential for label expansion in additional indications.”
– Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma
If approved, TransCon PTH would mark Ascendis’ second approved product. Skytrofa faces competition from Pfizer and OPKO Health’s Ngenla, which recently received FDA approval for the treatment of children aged three and older with growth issues. However, the FDA requested longer-term data and issued a complete response letter to the application for Ngenla, delaying its market entry.