Organon (OGN) announced that it has entered into an agreement to exclusively license global rights to Miudella, Sebela Pharmaceuticals’ hormone-free copper intrauterine device contraceptive. The effectiveness of this transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and to FDA approval of Miudella’s alternate supply chain entities and certain other conditions. Miudella was approved by the FDA on February 24, 2025, for the prevention of pregnancy in females of reproductive potential for up to three years and is not yet commercially available. Under the terms of the agreement, Organon will pay $27.5M at closing, with potential sales-based milestone payments of up to $505M, as well as tiered double-digit royalties based on net sales.
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