After unlocking commercial supply and enlisting a manufacturing partner earlier this year, Ferring Pharmaceuticals has reached a new turning point on its quest to satisfy current and future demand for its groundbreaking gene therapy Adstiladrin.
Ferring on Thursday opened a new global manufacturing hub in Kuopio, Finland, to help produce drug substance for Adstiladrin, which was approved by the FDA in late 2022 as the first gene therapy to target high-risk and non-muscle invasive bladder cancer (NMIBC) in patients who no longer respond to therapy.
The gene therapy’s green light specifically covers patients with high-risk Bacillus Calmette-Guérin-unresponsive NMIBC with carcinoma in situ with or without papillary tumors. The advanced medicine offers patients an alternative to the typical treatment option of bladder removal.
The new 25,000-square-meter facility houses a manufacturing suite equipped with modern technology to produce adenovirus vector-based gene therapy drug substance in “large quantities,” Ferring said in a release.
The plant has also been designed with the company’s carbon footprint in mind, featuring renewable energy measures like waste heat recovery and solar energy, Ferring added.
And Ferring isn’t stopping there. In its release, the company noted that it’s “nearing completion” of another new manufacturing facility for drug product at Ferring’s existing campus in Parsippany, New Jersey.
Ferring has previously said it expects the Kuopio and Parsippany sites to reach full capacity by 2025. Once that capacity is unlocked, the company is in line to receive $200 million in milestone payments from Royalty Pharma under a 2023 royalty deal worth upward of $500 million.
“Today’s announcement marks an important milestone in ensuring stable and sustainable global supply of Adstiladrin to meet the anticipated growth in demand,” Bipin Dalmia, the global head of Ferring’s uro-oncology and urology franchise, said in a statement.
The ribbon cutting in Finland follows several other Adstiladrin supply moves this year.
In January, Ferring announced that its gene therapy was “fully available” across the U.S. Prior to that, the company had been providing Adstiladrin through an “Early Experience Program” designed to “treat as many patients as possible in the short term while ensuring every patient who started on Adstiladrin had the ability to continue therapy.”
Then, in April, Ferring tapped SK pharmteco to help produce, test and release the gene therapy following regulatory sign-offs and a tech transfer. As with this week’s announcement, Ferring touted the SK team-up as a means to meet projected commercial growth of Adstiladrin.
With regards to demand projections, Ferring on Thursday highlighted findings from the International Agency for Research on Cancer, which now ranks bladder cancer as the ninth most-diagnosed malignancy worldwide.