JERSEY CITY, N.J. -- Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, announced today that it has entered into an agreement to exclusively license global rights to MIUDELLA, Sebela Pharmaceuticals’ hormone-free copper intrauterine device (IUD) contraceptive. The effectiveness of this transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and to U.S. Food and Drug Administration (FDA) approval of MIUDELLA's alternate supply chain entities and certain other conditions.

MIUDELLA, the first hormone-free copper IUD approved in the U.S. in the last 40 years, is complementary to Organon’s commercial capabilities and would further Organon’s commitment to building a portfolio of products that meet women’s diverse reproductive health needs. 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. MIUDELLA offers an additional option for women seeking long-acting, reversible, hormone-free contraception. MIUDELLA contains a unique flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm.[1]

Under the terms of the agreement, Organon will pay $27.5 million at closing, with potential sales-based milestone payments of up to $505 million, as well as tiered double-digit royalties based on net sales.

INDICATION FOR MIUDELLA®
MIUDELLA® is a copper-containing intrauterine system (IUS) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.

IMPORTANT SAFETY INFORMATION

·WARNING: Improper insertion of intrauterine systems, including MIUDELLA®, increases the risk of complications.
·Proper training prior to first use of MIUDELLA® can minimize the risk of improper insertion.
·MIUDELLA® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MIUDELLA® REMS program to ensure healthcare providers are trained on the proper insertion of MIUDELLA® prior to first use. Further information is available at miudellarems.com and 1-855-337-0772.