Ferring Pharmaceuticals and SK pharmteco today announced an agreement to scale up commercial manufacturing capacity for the drug substance of Ferring’s intravesical gene therapy Adstiladrin® (nadofaragene firadenovec-vncg) for ensuring long-term future supply. Following technology transfer, SK pharmteco, a contract development manufacturing organisation (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 state-of-the-art facilities in Ferring’s existing site in Finland and its U.S. campus in Parsippany, New Jersey. Ferring will provide updates on the progress of these near-term projects later in 2024.
“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.”
The need to scale up supply of strategically important medicines for bladder cancer across geographies is demonstrated by the trend of increased disease prevalence worldwide. The World Bladder Cancer Patient Coalition has reported that bladder cancer became the ninth most common cancer in the world (a rise from tenth) according to new data published in February 2024 (IARC GLOBOCAN 2022).1 In the United States, it is the seventh most common cancer, fourth among men, 2-3 and 75% of bladder cancer presents as NMIBC.4
“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy Adstiladrin®,” said Joerg Ahlgrimm, Chief Executive Officer 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.”
SK pharmteco was selected based on their competencies and alignment on core values across the two companies following a thorough assessment of potential CDMOs with gene therapy development and GMP manufacturing capabilities.
