Organon (NYSE:OGN) has entered into an exclusive global licensing agreement with Sebela Pharmaceuticals for Miudella, a hormone-free copper intrauterine device (IUD), as the healthcare company moves to bolster its reproductive health portfolio.
The Jersey City-based company will pay $27.5 million at closing, according to a statement Monday.
The deal includes potential milestone payments of up to $505 million based on sales targets, along with tiered double-digit royalties on net sales.
The acquisition targets a gap in the U.S. contraceptive market.
Miudella, which received U.S. Food and Drug Administration approval on Feb. 24, 2025, is the first hormone-free copper IUD cleared for the American market in 40 years.
While the device is approved for pregnancy prevention for up to three years, it is not yet commercially available.
The transaction remains subject to regulatory review under the Hart-Scott-Rodino Antitrust Improvements Act and requires FDA approval of Miudella’s alternate supply chain entities.
The move aligns with Organon’s strategy to diversify its women’s health offerings.
Miudella features a flexible nitinol frame and a 3.7mm insertion tube, designed to offer a long-acting, reversible option for women seeking non-hormonal alternatives.