Ferring Pharmaceuticals has received FDA approval for a new drug product manufacturing hub in Parsippany, New Jersey. The factory will produce its intravesical non-replicating gene therapy ADSTILADRIN.
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 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.
“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.”
Located on Ferring’s U.S. campus in Parsippany, NJ, the new manufacturing site is fully integrated with specialized 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.
“ADSTILADRIN has transformed the treatment landscape for BCG-unresponsive bladder cancer patients and drives Ferring’s continued growth in uro-oncology,” said Bipin Dalmia, Global Head of Uro-Oncology and Urology Franchise, Ferring Pharmaceuticals. “The growing body of clinical evidence for ADSTILADRIN — including the recently announced independent real-world data2 and data from our Japan Phase 3 trial3 — underscores the impact of this therapy. The FDA’s approval of this additional manufacturing site is a testament to our commitment to make ADSTILADRIN globally available to every bladder cancer patient who needs it.”
