After Adstiladrin's FDA approval in late 2022, Ferring Pharmaceuticals finally established unfettered supply of the bladder cancer gene therapy earlier this year. Now, the company has locked down a long-term supplier in SK pharmteco.
With the agreement, SK will be on tap to manufacture, test and release the med following regulatory clearances and the completion of a technology transfer process.
The move to boost and diversify Ferring’s manufacturing base for Adstiladrin is one of many meant to help meet the “projected commercial growth” of the non-replicating gene therapy, according to a company release.
Other than SK's contributions, the drug's long-term supply base will come from capacity expansions currently underway at Ferring’s facilities in Finland and Parsippany, New Jersey. The drugmaker said it will disclose updates on those projects later this year.
Production at those sites is expected to reach full capacity by 2025, when Ferring expects to receive $200 million in milestone payments from Royalty Pharma through a royalty deal worth up to $500 million.
Ferring attributes its growth and demand projections for the med to a recent trend of increased bladder cancer incidence worldwide. According to a February report from the World Bladder Cancer Patient Coalition, the disease has risen to the ninth most common cancer globally.
“Stable and sustainable supply is a vital part of our mission to fill this unmet clinical need for the patients we serve,” Ferring’s global head of uro-oncology Bipin Dalmia, Ph.D., said in a statement.
Adstiladrin is approved to treat patients with high-risk Bacillus Calmette-Guérin-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.
It’s the first gene therapy that can target high-risk and non-muscle invasive bladder cancer in patients who no longer respond to standard therapy, offering an alternative to the typical treatment option of bladder removal.
As of January, the drug is fully available to patients across the U.S. after Ferring achieved full product supply “ahead of schedule,” the company said at the time.