Ferring Pharmaceuticals has opened a state-of-the-art global manufacturing hub in Finland for the drug substance of its intravesical non-replicating gene therapy Adstiladrin (nadofaragene firadenovec-vncg). This represents a significant milestone in Ferring’s capabilities and capacity to meet the current and expected growth in demand for this gene therapy for people with non-muscle invasive bladder cancer (NMIBC).
Adstiladrin (nadofaragene firadenovec-vncg) is approved in the U.S. for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumours.
“In January this year, we announced full commercial availability of Adstiladrin® in the U.S. We have now embarked on a broad programme of clinical research to enlarge the body of evidence for Adstiladrin® and plan for regulatory submissions in other global markets. Today’s announcement marks an important milestone in ensuring stable and sustainable global supply of Adstiladrin® to meet the anticipated growth in demand,” said Bipin Dalmia, Global Head, Uro-Oncology and Urology Franchise, Ferring Pharmaceuticals.
Armin Metzger, Executive Vice President and Chief Technical Operations Officer, Ferring Pharmaceuticals, added: “The continued investment and expansion of our gene therapy manufacturing infrastructure reflects Ferring’s strong commitment to deliver end-to-end solutions for even the most highly complex manufacturing challenges as part of our mission to fulfil the unmet clinical needs for people with bladder cancer.”
According to the International Agency for Research on Cancer, bladder cancer is now the ninth most diagnosed cancer worldwide, previously ranked tenth. This rising global incidence underscores the necessity to expand the supply of innovative treatments for this disease.
In addition to this European investment in drug substance, Ferring has further strengthened and diversified its nadofaragene firadenovec-vncg supply chain and is also nearing completion of a new manufacturing facility for drug product at Ferring’s U.S. campus in Parsippany, New Jersey.
Located in Kuopio, Finland, the new European manufacturing site features a cutting-edge manufacturing suite, fully integrated with modern technology to produce adenovirus vector-based gene therapy drug substance in large quantities. The 25,000 square metre facility features renewable energy solutions such as waste heat recovery with heat pumps and solar energy.
