Gilead Buys Out Janssen’s Royalty Rights to Seladelpar for Primary Biliary Cholangitis Treatment

Gilead (NASDAQ: GILD)’s financial report for the second quarter of 2024, followed by an earnings call, has disclosed a significant transaction: the company has paid Johnson & Johnson’s Janssen division USD 320 million to acquire full royalty rights to the PPAR-delta agonist, seladelpar, a drug for which Gilead obtained global sales rights through its USD 4.3 billion acquisition of CymaBay Therapeutics Inc. (Nasdaq: CBAY) earlier this year. This strategic move by Gilead’s CFO, Andrew Dickinson, comes as the FDA’s PDUFA date for seladelpar’s approval decision approaches.

Seladelpar, filed for the treatment of primary biliary cholangitis (PBC), is supported by robust Phase III data from the ASSURE trial. The payment to Janssen effectively cancels an 8% royalty agreement that was initially part of the deal Janssen had with CymaBay. PBC, while considered a rare disease, affects an estimated 130,000 individuals in the U.S., predominantly women over 40, and can significantly impair liver function and quality of life, with potential liver-related mortality risks.

In their Q2’24 report, Gilead showcased a 5% year-on-year increase in global sales, propelled by its HIV, liver disease, and oncology segments. HIV products accounted for USD 4.7 billion of Gilead’s total sales, with a 3% year-on-year growth. Biktarvy (bictegravir /emtricitabine /tenofovir alafenamide) emerged as the company’s top-selling brand, with Q2’24 sales reaching USD 3.2 billion, marking an 8% year-on-year increase.- Flcube.com

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