Gilead exits J&J royalty deal for liver drug ahead of potential FDA nod

Gilead (NASDAQ:GILD) has paid $320M to buy out the liver disease therapy seladelpar ahead of a potential FDA approval next week, the company’s CFO Andrew Dickinson said during the company’s recent earnings call.

The payment ends the company’s requirement to pay up to an 8% royalty on seladelpar net sales to J&J (NYSE:JNJ), from which its then-developer CymaBay Therapeutics acquired its licensing rights in 2006.

Seladelpar, which belongs to a drug class known as PPARδ (selective peroxisome proliferator-activated receptor delta) agonists, is currently under FDA priority review for primary biliary cholangitis (PBC), an autoimmune disease affecting bile ducts in the liver.

Early this year, the FDA accepted its new drug application for PBC, issuing August 14, 2024, as the target action date. Gilead (GILD) acquired CymaBay for $4.3B a few weeks later.

The payment is expected to increase a category of asset acquisition expenses called acquired in-process research and development (IPR&D) costs to $4.7B in 2024, up from $4.4B in the previous projection, Dickinson said.

Other developers of PBC drugs include Genfit (GNFT) (OTCPK:GNFTF) and Ipsen (OTCPK:IPSEY) (OTCPK:IPSEF), which won FDA accelerated approval for their product Iqirvo in June. Intercept Pharmaceuticals, which marketed the PBC therapy Ocaliva, was acquired by the Italian pharmaceutical company Alfasigma in November.