Ferring Pharmaceuticals lands $300M in 5.1% royalty sale to Royalty Pharma

Ferring Pharmaceuticals is pulling in $300 million and a potential $200 million milestone from Royalty Pharma in exchange for a 5.1% percentage royalty on net sales of its gene therapy Adstiladrin, just as it gears up to roll out the treatment commercially.

The $200 million milestone payment depends on hitting manufacturing goals in 2025, while the royalty payments are expected to end in the early- to mid-2030s. According to Ferring, the money from Royalty Pharma will be used to scale up manufacturing, commercialization and clinical development for the drug.

The royalty percentage will go up to 8% if the manufacturing milestone payment is reached.

The FDA approved Adstiladrin in 2022 for the treatment of adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. At the time, Ferring said it expects to commercially launch the drug in the second half of 2023.

Around 75% to 80% of newly diagnosed bladder cancers are classified as NMIBC, which is a type of cancer that has grown through the lining of the bladder but hasn’t yet invaded the muscle layer. It’s also a cancer with a high rate of recurrence.

The therapy consists of a non-replicating adenovirus vector containing the gene interferon alfa-2b, which is administered by catheter into the bladder once every three months.

Adstiladrin will be available next month through an early experience program for the treatment of adult patients with the cancer. Earlier this spring, the FDA approved a Prior-Approval Supplement to the BLA for the therapy, which enabled a scale-up of the drug substance manufacturing process. A facility is also under construction at Ferring’s manufacturing site in Parsippany, NJ.

Bipin Dalmia

“After several decades of little progress in the field, Adstiladrin brings a major innovation to patients with high-risk NMIBC who no longer respond to current first-line treatment and have few other good options,” Bipin Dalmia, Ferring’s global head of the uro-oncology franchise, said in a statement. “This agreement positions us well for continued significant and sustained investment to further advance Adstiladrin as the foundation of our leadership drive in Uro-Oncology.”

Adstiladrin’s approval was based on a single-arm trial of 157 patients with high-grade non-muscle invasive bladder cancer, where investigators zeroed in on a subgroup — 103 patients with bladder cancer that is confined to the superficial layer, with or without concomitant high-grade Ta or T1 papillary disease — for the primary endpoint.

After receiving one intravesical injection of nadofaragene firadenovec, 51% of those patients achieved a complete response, the FDA said, and the median duration of response was 9.7 months. In addition, 46% of responding patients remained in complete response for at least one year, the FDA added.

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