Parsippany, N.J. — Ferring Pharmaceuticals has received approval from the U.S. Food and Drug Administration (FDA) for a new manufacturing facility in Parsippany, New Jersey, dedicated to producing ADSTILADRIN® (nadofaragene firadenovec-vncg), the company’s intravesical non-replicating gene therapy for bladder cancer. The approval marks a significant expansion of Ferring’s production capacity and secures a final $200 million payment from Royalty Pharma under a previously announced royalty-based financing agreement.
ADSTILADRIN is the first and only FDA-approved intravesical non-replicating gene therapy for patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. Bladder cancer is the sixth most diagnosed cancer in the United States, with the majority of cases classified as non-muscle invasive.
The newly approved 12,000-square-foot manufacturing hub in Parsippany complements Ferring’s existing production sites in Kuopio, Finland. The expanded manufacturing footprint is designed to ensure a stable and sustainable global supply of ADSTILADRIN as demand for the therapy continues to grow. The facility features advanced manufacturing suites equipped with specialized technology and incorporates renewable energy solutions, including waste heat recovery systems and solar power, reflecting Ferring’s commitment to environmental sustainability.
“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 and Chief Technical Operations Officer at Ferring Pharmaceuticals. “This expansion and diversification of our manufacturing footprint will further ensure a reliable supply of ADSTILADRIN to meet anticipated global demand.”
ADSTILADRIN has emerged as a transformative therapy for patients with BCG-unresponsive bladder cancer, a population with limited treatment options. The therapy has been supported by a growing body of clinical evidence, including independent real-world data and results from Ferring’s Japan Phase 3 trial.
“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 at Ferring Pharmaceuticals. “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.”
