The treatment 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.
According to both companies, this scale up secures future long-term supply of Adstiladrin to meet its projected commercial growth.
“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy Adstiladrin,” said Joerg Ahlgrimm, CEO of 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.”
The World Bladder Cancer Patient Coalition has reported that bladder cancer is now the ninth most common cancer in the world, with more treatments desperately needed.
In the United States, it is the seventh most common cancer and the fourth most common among men.
In addition to the contract manufacturing agreement, Ferring is building two additional manufacturing facilities at its 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 fanchise at 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 will be qualified to manufacture Adstiladrin following a technology transfer and subject to regulatory approval by the U.S. Food and Drug Administration (FDA).
