Royalty Pharma plc and Ferring Pharmaceuticals announced that Royalty Pharma has acquired a synthetic royalty on US net sales of Ferring’s Adstiladrin® (nadofaragene firadenovec-vncg) for up to US $500 million comprised of an upfront payment of US $300 million and a US $200 million milestone payment. The milestone payment is contingent on certain manufacturing goals that are expected to be achieved in 2025 for the FDA-approved intravesical gene therapy that Ferring will make available next month through an early experience program for the treatment of 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.
Under the terms of the agreement, Royalty Pharma is acquiring a 5.1% percentage royalty on net sales of Adstiladrin in the United States, which will increase to 8.0% upon payment of the manufacturing-related milestone. The royalty is expected to end in the early to mid-2030s.
“This major investment by Royalty Pharma, the largest buyer of biopharmaceutical royalties and a leading funder of innovation, is yet another demonstration of the value and confidence in our gene therapy Adstiladrin to address significant unmet medical needs for patients. It also highlights its significant potential as a key growth driver for Ferring, and our commitment to Uro-Oncology,” said Jean-Frédéric Paulsen, Executive Chairman of Ferring Pharmaceuticals.
Bladder cancer is the sixth most common cancer in the United States, with NMIBC representing approximately 75% of all new bladder cancer cases. Adstiladrin is a non-replicating adenovirus vector-based gene therapy for the treatment of adult patients with high-risk BCG-unresponsive NMIBC. Although BCG remains the first-line standard of care for people living with high-grade NMIBC, more than 50% of patients who receive initial treatment with BCG will experience disease recurrence and progression within one year, with many developing BCG-unresponsive disease. In April 2023, the FDA approved a Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the therapy which enabled the scale-up of drug substance manufacturing process.
“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. Our ambition is for Adstiladrin to become the new standard of care and the backbone therapy for these patients and to drive research in other urothelial cancers. 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,” said Bipin Dalmia, Global Head, Uro-Oncology Franchise of Ferring Pharmaceuticals.
“We are delighted to partner with Ferring, a research-driven, global specialty biopharmaceutical company. This investment is consistent with our strategy of acquiring royalties on innovative therapies in areas of high unmet patient need,” said Pablo Legorreta, founder and Chief Executive Officer of Royalty Pharma. “Adstiladrin is the first gene therapy in our diversified royalty portfolio. We believe it has blockbuster potential and we are pleased to provide funding to support the launch of Adstiladrin and help Ferring reach as many patients as possible with this important therapy in the United States.”
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