Ferring expands gene therapy production to U.S. site

The U.S. FDA has approved Ferring Pharmaceuticals’ drug product manufacturing hub in Parsippany, New Jersey, for its intravesical non-replicating gene therapy, Adstiladrin.

Located on Ferring’s U.S. campus in Parsippany, 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 uses renewable energy solutions such as waste heat recovery with heat pumps and solar energy.

The new facility joins two existing manufacturing sites in Kuopio, Finland dedicated to bringing Adstiladrin to patients. It also triggers a final $200 million payment from Royalty Pharma, as part of a royalty-based financing agreement announced in 2023.

First approved in 2022, 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 with carcinoma in situ with or without papillary tumors.