USA — Ferring Pharmaceuticals, a Swiss pharmaceutical company, has announced that it has received clearance from the Food and Drug Administration (FDA) to scale up the manufacturing of its new gene therapy for bladder cancer.
This regulatory approval will allow Ferring to commence the expansion of its drug substance manufacturing process in collaboration with its sister company, FinVector Oy, located in Kuopio, Finland, as they prepare for the upcoming product launch.
FinVector Oy, a Finnish biopharmaceutical firm specializing in current Good Manufacturing Practice (cGMP) manufacturing, initiated the construction of a new viral vector manufacturing site using the iCELLis manufacturing platform from Pall Corporation in May 2022.
This site will be dedicated to the production of Adstiladrin, the gene therapy for bladder cancer. To support the increased manufacturing capacity, the company anticipates hiring an additional 500 employees in the coming years.
Ferring’s Adstiladrin underwent development starting in 2011, and with the approval received last year, the gene therapy is now on track for its initial marketing phase.
Adstiladrin is designed to treat non-muscle invasive bladder cancer (NIMBC), a high-risk form of the most common type of bladder cancer.
This particular condition is unresponsive to Bacillus Calmette-Guérin therapy. The gene therapy utilizes an adenovirus vector to deliver a gene encoding the immune-stimulating protein interferon alfa-2b.
It is administered via a catheter to the bladder once every three months.
This groundbreaking treatment marks the first and only FDA-approved intravesical gene therapy for patients with this specific condition.
Ferring Pharmaceuticals boasts a clinical development pipeline comprising therapies for reproductive medicine, maternal health, urology, uro-oncology, and more.
Currently, the company has five approved therapies in the latter therapy areas, including Firmagon (degarelix), Minirin (desmopressin), and Testim (testosterone).
Ferring had previously stated the need to expand its manufacturing capacity before the planned product launch in the second half of 2023.
The clearance of a “prior-approval supplement” enables Ferring to adhere to its timeline and enhance production capabilities at the newly constructed facility in Finland, which is expected to become one of the largest viral vector manufacturing sites worldwide.
Additionally, another manufacturing plant currently under construction in New Jersey will contribute to the company’s near-term production capacity.
Nevertheless, gene therapies often face manufacturing challenges and viral vector bottlenecks, even after overcoming the demanding development process.
Ferring’s gene therapy faced FDA rejection two years prior to its approval due to manufacturing-related issues.
Ferring anticipates an increase in the supply of Adstiladrin in 2024 following its planned rollout in the second half of this year.
Non-muscle invasive bladder cancer is characterized by cancer cells remaining only in the lining of the bladder.
Common treatment options for this condition include bladder removal surgery, chemotherapy, and/or administration of the BCG vaccine into the bladder.
Bladder cancer ranks as the sixth most common cancer in the United States, and the American Society of Clinical Oncology predicts that 82,290 adults will receive a bladder cancer diagnosis in 2023.
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