Privately-held Swiss company Ferring Pharmaceuticals announced that Royalty Pharma has acquired a synthetic royalty on US net sales of Ferring’s Adstiladrin (nadofaragene firadenovec-vncg) for up to USD 500 million, of which USD 300 million is upfront and a further USD 200 million in milestone payment.

In December 2022, the US Food and Drug Administration approved Adstiladrin, an adenoviral vector-based gene therapy indicated for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.

The milestone payment is contingent on certain manufacturing goals that are expected to be achieved in 2025 for the FDA-approved intravesical gene therapy that Ferring will make available next month through an early experience program.

Under the terms of the accord, Royalty Pharma is acquiring a 5.1 percent royalty on net sales of Adstiladrin in the USA, which will increase to 8.0 percent upon payment of the manufacturing-related milestone. The royalty is expected to end in the early to mid-2030s.

“This major investment by Royalty Pharma, the largest buyer of biopharmaceutical royalties and a leading funder of innovation, is yet another demonstration of the value and confidence in our gene therapy Adstiladrin to address significant unmet medical needs for patients. It also highlights its significant potential as a key growth driver for Ferring, and our commitment to Uro-Oncology,” said Jean-Frédéric Paulsen, executive chairman of Ferring Pharmaceuticals.

The US FDA approval of Adstiladrin was based on results of the Phase III clinical trial, which met its primary endpoint with more than half (51 percent, n=50 of 98; 95 percent CI 41 to 61) of patients with carcinoma in situ with or without concomitant high-grade Ta or T1 disease (CIS ± Ta/T1) achieving a complete response (CR) by three months. Of the patients who achieved an initial CR, 46 percent (n=23 of 50) continued to remain free of high-grade recurrence at 12 months.