Ferring Pharmaceuticals announced today the U.S. Food and Drug Administration (FDA) approved a state-of-the-art drug product manufacturing hub in Parsippany, NJ, for its intravesical non-replicating gene therapy ADSTILADRIN® (nadofaragene firadenovec-vncg). The approval expands Ferring's manufacturing capabilities to three cutting-edge sites dedicated to bringing ADSTILADRIN to patients and secures a final $200 million payment from Royalty Pharma (NASDAQ:RPRX) as part of a royalty-based financing agreement announced in 2023.
ADSTILADRIN is the first and only intravesical non-replicating gene therapy approved by the FDA for patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors (±Ta/T1). Bladder cancer is the sixth most diagnosed cancer in the United States, and the majority of patients are diagnosed with non-muscle invasive disease.