Ferring Pharmaceuticals and SK pharmteco Form Gene Therapy Manufacturing Pact

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Ferring Pharmaceuticals and SK pharmteco, a contract development manufacturing organization, have formed an agreement to scale up manufacturing capacity for the drug substance of Adstiladrin (nadofaragene firadenovec-vncg), Ferring’s intravesical gene therapy for treating a form of bladder cancer. The companies will scale up capacity to commercial levels to ensure long-term future supply, they stated in an April 18, 2024 press release.

Once technology transfer in complete, SK pharmteco, will be qualified as another source for the manufacture, testing, and release of the therapy, dependent on regulatory approval by FDA. FDA approved Adstiladrin in December 2022 (1) for treating adult patients with high-risk bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS). The therapy is applicable for patients with or without papillary tumors.

“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, in the press release. “Following our January announcement (2) of full availability of Adstiladrin across the US [United States] 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.”

In addition to this contract manufacturing agreement, Ferring Pharmaceuticals indicated in the press release that it is well underway with expanding dedicated capacity for the therapy at its facilities in Finland and in the US, where the company has a campus in Parsippany, NJ. The company expects to have updates on these capacity expansion projects later in 2024.

The increased prevalence of bladder cancer across geographies drives the need to scale up supply of strategically important bladder cancer treatments. The companies stated in the press release that, “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) [3].”

“SK pharmteco is proud to partner with Ferring Pharmaceuticals as a manufacturer of the breakthrough gene therapy Adstiladrin,” said Joerg Ahlgrimm, chief executive officer, SK pharmteco, in the release. “Our integrated approach, incorporating customizable clinical and commercial GMP [good manufacturing practice] 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.”

References

1. FDA. FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer. Press Release, Dec. 16, 2022.
2. Ferring Pharmaceuticals. Ferring announces full availability of ADSTILADRIN (nadofaragene firadenovec-vncg) in the US. Press Release, Jan. 16, 2023.
3. World Bladder Cancer Patient Coalition GLOBOCAN. GLOBOCAN 2022: Bladder Cancer 9th Most Common Worldwide. Press Release, Feb. 14, 2024.

Source: SK pharmteco