Ferring Pharmaceuticals and SK pharmteco have agreed to scale up commercial manufacturing capacity for the drug substance of Ferring’s intravesical non-replicating gene therapy ADSTILADRIN (nadofaragene firadenovec-vncg) for ensuring long-term future supply.
 
Following technology transfer, SK pharmteco, a contract development manufacturing organization (CDMO), will be qualified as another source for manufacturing, testing, and release of the medicine, subject to regulatory approval by the U.S. Food and Drug Administration (FDA).
 
ADSTILADRIN was approved by the FDA in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors.
 
This additional scale up and diversification of drug substance capacity demonstrates Ferring’s commitment to securing future long-term supply of ADSTILADRIN to meet the projected commercial growth of its non-replicating gene therapy. In addition to this contract manufacturing agreement, dedicated capacity expansion of ADSTILADRIN is well underway at facilities in Ferring’s existing site in Finland and its U.S. campus in Parsippany, New Jersey.
 
“Ferring takes its responsibilities to patients with high-risk BCG-unresponsive NMIBC very seriously – especially when pioneering in the emerging field of gene therapy commercial manufacturing,” said Bipin Dalmia, Global Head, Uro-Oncology Franchise, Ferring Pharmaceuticals. “Following our January announcement of full availability of ADSTILADRIN across the U.S. and expansion of our clinical trials program, this agreement with SK pharmteco comes alongside major investments in our own manufacturing capabilities to assure the breadth of our long-term supply base. Stable and sustainable supply is a vital part of our mission to fill this unmet clinical need for the patients we serve.”
 
“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy ADSTILADRIN,” added Joerg Ahlgrimm, CEO for SK pharmteco. “Our integrated approach, incorporating customizable clinical and commercial GMP manufacturing solutions with comprehensive in-process testing, quality control, and lot release programs, provides unparalleled support to our partners throughout their product lifecycle and is in perfect alignment with our mission of expediting the delivery of potentially life-saving therapies to patients across the globe.”