Women’s-health-focused pharma Organon is grabbing exclusive global licensing rights to Sebela Pharmaceuticals’ newly approved hormone-free copper intrauterine device in a deal potentially worth more than $532 million.
Under an agreement announced Monday, Feb. 23, Organon will pay $27.5 million upfront for the right to market Sebela’s Miudella, billed as the first FDA-approved device of its kind in 40 years.
Organon also agreed to shell out up to $505 million for potential sales-based milestones as well as tiered double-digit royalties based on net sales, the company said in a release.
The agreement is subject to regulatory review and FDA approval of Miudella’s alternate supply chain entities, Organon said.
Sebela won FDA approval for Miudella in February 2025 for the prevention of pregnancy for up to three years, but the device is not yet commercially available.
Once on the market, it will compete in the U.S. with CooperSurgical’s hormone-free copper IUD ParaGard, which received FDA approval in 1984 for pregnancy prevention for up to 10 years.
Both devices work by releasing copper ions into the uterus, impairing sperm’s motility and ability to fertilize an egg. But Miudella contains a smaller, flexible frame and a fully preloaded inserter within a small, tapered insertion tube and uses less than half the dose of copper, Sebela said when the device was approved last year.
For New Jersey-based Organon, Miudella will bolster its portfolio of women’s reproductive health products, including birth control options such as its long-acting Nexplanon implant and NuvaRing vaginal contraceptive ring.
The deal comes after a bumpy 2025 for the Merck spinout, which included layoffs and the exit of its longtime CEO following an internal investigation that uncovered questionable Nexplanon sales practices. The company also faced generic competition that decimated NuvaRing sales.
Back in July, Organon ended clinical development of a drug candidate for endometriosis—which it had hailed as perhaps its “biggest potential opportunity”—after it failed a phase 2 trial.
The company also announced plans to sell its Jada postpartum uterine bleeding or hemorrhage system to Laborie Medical Technologies in November in a move to reduce debt and continue its “deleveraging efforts.”
