With Gilead Sciences on the verge of an FDA decision for its liver disease drug seladelpar, the company has paid Johnson & Johnson $320 million to exit an 18-year-old licensing agreement on the compound.
The buyout removes Gilead’s obligation to pay an 8% royalty on sales of seladelpar, Gilead Chief Financial Officer Andrew Dickinson said Thursday on a quarterly conference call. The licensing deal was struck in 2006, with J&J agreeing to handle the patenting of seladelpar for CymaBay Therapeutics.
In February of this year, Gilead paid $4.3 billion to acquire the California biotech, which had positioned seladelpar for approval to treat primary biliary cholangitis (PBC). An approval is expected to come by the FDA target date of Wednesday, Aug. 14, with Gilead standing “ready to launch,” according to Chief Commercial Officer Johanna Mercier.
“We are able to leverage our existing commercial footprint in liver diseases and continue building upon these relationships to quickly bring seladelpar to many of the 130,000 people impacted by PBC in the U.S. who progressed after initial treatment,” Mercier said.
PBC is an autoimmune condition characterized by impaired bile flow and the accumulation of bile acids in the liver, leading to inflammation and fibrosis.
Over time, patients become increasingly fatigued and develop a debilitating itch (pruritus). In the absence of treatment, the condition can require a liver transplant or lead to premature death. It primarily affects women between the ages of 30 and 60.
An analyst consensus compiled by Bloomberg early this year pegged seladelpar’s peak sales potential at $1 billion.
If approved, Gilead's drug will compete with Intercept Pharmaceuticals’ Ocaliva, which was approved for the disorder in 2016. Before Intercept was acquired by Italian private company Alfasigma last year, it expected sales of Ocaliva in 2023 to reach between $320 million and $340 million.
Additionally, two months ago, French companies Genfit and Ipsen scored approval for their PBC drug Iqirvo.