The U.S. Food and Drug Administration (FDA) has approved Ferring Pharmaceuticals’ 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 sites dedicated to bringing ADSTILADRIN to patients and secures a final $200 million payment from Royalty Pharma 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).

Located on Ferring’s U.S. campus in Parsippany, NJ, the new manufacturing site features a cutting-edge manufacturing suite, fully integrated with specialized modern technology and equipment to produce another source of supply for ADSTILADRIN. The 12,000 square foot facility features renewable energy solutions such as waste heat recovery with heat pumps and solar energy, complementing Ferring’s commitment to protect the environment by reducing its impact on the planet.

“The FDA approval of our new manufacturing facility for ADSTILADRIN represents our unwavering dedication to delivering high-quality, innovative therapies at scale,” said Armin Metzger, Executive Vice President, Chief Technical Operations Officer, Ferring Pharmaceuticals. “This expansion and diversification of our manufacturing footprint will further ensure stable and sustainable supply of ADSTILADRIN to meet the anticipated growth in global demand.”