Ferring sells some Adstiladrin royalties to Royalty Pharma ahead of US rollout
24 Aug 2023
Gene TherapyLicense out/in
Ferring Pharmaceuticals agreed to sell royalties on US net sales of the gene therapy Adstiladrin (nadofaragene firadenovec-vncg) to Royalty Pharma for up to $500 million, including $300 million upfront, the companies announced Thursday. The therapy was cleared by the FDA late last year for patients with high-grade, Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), regardless of the presence of papillary tumours.
Adstiladrin - a replication-deficient recombinant adenovirus that delivers human interferon alfa-2b cDNA into the bladder epithelium - is administered every three months into the bladder via a urinary catheter. Ferring noted that under the deal with Royalty Pharma, a $200-million milestone payment is linked to manufacturing goals that are expected to be achieved in 2025.
Earlier this year, the FDA cleared a prior-approval supplement (PAS) to the biologics license application for Adstiladrin, which enabled the scale-up of drug substance manufacturing process at FinVector's facility in Finland. Ferring expects to make the therapy available in the US next month through an early experience programme, with supplies increasing into 2024.
As part of the agreement, Royalty Pharma will acquire a 5.1% percentage royalty on net sales of Adstiladrin in the US, which will increase to 8% 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…is yet another demonstration of the value and confidence in our gene therapy Adstiladrin to address significant unmet medical needs for patients," remarked said Jean-Frédéric Paulsen, Ferring's executive chairman.
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