The U.S. Food and Drug Administration has approved a second drug product manufacturing facility for Ferring Pharmaceuticals’ Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating gene therapy for bladder cancer.
The approved site is located in Parsippany, New Jersey, and joins Ferring’s existing facilities in Kuopio, Finland. The expansion is aimed at strengthening production capacity and diversifying the company’s manufacturing footprint as it prepares to meet growing global demand for the therapy.
Adstiladrin is approved for the treatment of adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.
Ferring now operates three facilities dedicated to the production of Adstiladrin. The company says the new site is equipped with state-of-the-art manufacturing technologies to ensure a stable and sustainable supply of the gene therapy. The 12,000-square-foot facility features renewable energy solutions such as waste heat recovery with heat pumps and solar energy.
The FDA approval has triggered a final milestone payment of $200 million to Ferring from Royalty Pharma, in accordance with a prior financing agreement tied to the commercialization of Adstiladrin.
“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,” Armin Metzger, executive vice president and chief technical operations officer at Ferring, said in a statement.
Ferring Pharmaceuticals, founded in 1950 and headquartered in Switzerland, is a privately-owned biopharmaceutical company specializing in reproductive medicine, gastroenterology, orthopaedics, microbiome-based therapeutics, and uro-oncology gene therapy. The company has over 7,000 employees globally, with its U.S. operations based in Parsippany.