Ferring Pharmaceuticals and SK pharmteco today announced an agreement to scale up commercial manufacturing capacity for Ferring’s drug substance intravesical non-replicating gene therapy, Adstiladrin.
The deal will help ensure the long-term future supply of gene therapy. Following the technology transfer, SK pharmteco will be qualified as another source for manufacturing, testing and release of the medicine, subject to FDA approval.
Ferring’s Adstiladrin was FDA-approved in December 2022 for adult patients with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors.
“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy Adstiladrin,” CEO Joerg Ahlgrimm said. “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.”
In conjunction with the contract manufacturing agreement, Ferring’s existing site in Finland and its U.S. site in New Jersey will have a dedicated capacity expansion of Adstiladrin.
“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,” Bipin Dalmis, global head of the uro-oncology franchise at Ferring Pharmaceuticals, said in a news release. “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.”
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