This transaction strengthens Organon\u2019s contraception portfolio and expands long-acting reversible options for women<\/i><\/p>\n
JERSEY CITY, N.J.–(BUSINESS WIRE<\/a>)– \nApproved by the US Food and Drug Administration (FDA) on February 24, 2025, MIUDELLA is the first hormone-free copper IUD to be introduced in the US in over 40 years. Indicated for the prevention of pregnancy for up to three years in females of reproductive potential, MIUDELLA is 99% effective. It features a proprietary SLIMSERTTM <\/sup>technology, which consists of a highly flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm.1<\/sup><\/p>\n \nMIUDELLA is anticipated to be commercially available in late 2026. The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS). A REMS is a strategy used by the FDA to manage known or potential risks associated with a product. To mitigate complications due to potential improper insertion, MIUDELLA will only be available in the US through the MIUDELLA REMS program. See additional safety information below.<\/b><\/p>\n \n\u201cMIUDELLA represents an important hormone-free option in contraception, expanding choices for women seeking long\u2011acting reversible birth control,\u201d said Joe Morrissey, Chief Executive Officer of Organon. \u201cBy building on our long history in contraception and leveraging our deep expertise and capabilities, this agreement strengthens Organon\u2019s ability to deliver contraceptive options that meet the needs of women.\u201d<\/p>\n \n\u201cDeveloped by Sebela Women\u2019s Health, MIUDELLA represents an effective option for pregnancy prevention,\u201d said Alan Cooke, Chief Executive Officer and President of Sebela Pharmaceuticals. \u201cWe are delighted to complete this global license agreement with Organon. Organon offers the scale, launch readiness and access capabilities needed to bring this valuable product efficiently into clinical practice and help ensure MIUDELLA reaches more women who are looking for hormone-free contraception options.\u201d<\/p>\n \nTruist Securities, Inc. acted as financial advisor to Sebela Pharmaceuticals.<\/p>\n About MIUDELLA<\/b><\/p>\n \nMIUDELLA was investigated in three clinical trials in the US in 1,904 women aged 17 to 45 years. The Phase 3 prospective, multicenter, single-arm, open-label study was conducted in 42 centers in the US with a primary endpoint of contraceptive efficacy through 3 years of use as assessed by the Pearl Index (defined as the number of pregnancies per 100 women over one year).1<\/sup> In the efficacy cohort of women aged 17 to 35 years from the Phase 3 study (n=1397), the first-year Pearl Index was 0.94 (95% CI, 0.43-1.78) and the cumulative 3-year Pearl Index was 1.05 (95% CI, 0.66-1.60)\u2014in other words, 99% effective, with an overall placement success rate of 98.8%. The most common adverse reactions (\u22655%) observed in clinical trials were heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia. In the first year, 8.5% of participants across all three studies discontinued treatment due to bleeding or pain adverse events, which decreased to 3.2% by year 3. Expulsion rates ranged from 1.9% in year 1 to 0.9% in year 3.<\/p>\n Indication<\/b><\/p>\n Selected Safety Information<\/b><\/p>\n WARNING: RISK OF COMPLICATIONS DUE TO IMPROPER INSERTION<\/b><\/p>\n CONTRAINDICATIONS<\/b><\/p>\n WARNINGS AND PRECAUTIONS<\/b><\/p>\n \nFurther information is available at www.miudellarems.com<\/a> and 1-855-337-0772.<\/p>\n Subclinical PID:<\/span> PID may be asymptomatic but still result in tubal damage and its sequelae.<\/p>\n<\/li>\n ADVERSE REACTIONS<\/b><\/p>\n Before prescribing MIUDELLA, please read the full <\/b>Prescribing Information<\/b><\/a>, including Boxed Warning.<\/b><\/p>\n About Organon \nHeadquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com<\/a> and follow us on LinkedIn<\/a>, Instagram<\/a>, X<\/a>, YouTube<\/a>, TikTok<\/a> and Facebook<\/a>.<\/p>\n Cautionary Note Regarding Forward-Looking Statements About Sebela Pharmaceuticals For more information, visit <\/b>www.sebelapharma.com<\/b><\/a>.<\/b><\/p>\n Sebela Forward-Looking Statement \n\u00a0<\/p>\n
\nOrganon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced the completion of a global licensing agreement with Sebela Pharmaceuticals, granting Organon exclusive rights to MIUDELLA\u00ae<\/sup>, <\/b>a hormone-free, copper intrauterine device (IUD). Please see our prior announcement for a summary of the transaction terms<\/a>.<\/p>\n\n
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<\/b>Organon (NYSE: OGN) is a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day. With a portfolio of over 70 products across Women\u2019s Health and General Medicines, which includes biosimilars, Organon focuses on addressing health needs that uniquely, disproportionately or differently affect women, while expanding access to essential treatments in over 140 markets.<\/p>\n
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<\/b>Except for historical information, this press release includes \u201cforward-looking statements\u201d within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential benefits of Organon\u2019s exclusive license of global rights to MIUDELLA\u00ae<\/sup> and expectations regarding the timing of commercialization thereof. Forward-looking statements may be identified by words such as \u201canticipated, \u201cmay\u201d, \u201cwill\u201d, and \u201cexpected,\u201d among others. These statements are based upon the current beliefs and expectations of the company\u2019s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, weakening of economic conditions that could adversely affect the level of demand for MIUDELLA\u00ae<\/sup>; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to or affecting Medicare, Medicaid and healthcare reform, pharmaceutical pricing and reimbursement, access to the company\u2019s products, international reference pricing, including most-favored-nation drug pricing, and other pricing related initiatives and policy efforts; the impact of tariffs and other trade restrictions or domestic sourcing requirements; expanded brand and class competition in the markets in which the company operates; the failure of any supplier to provide substances, materials, or services as agreed, or otherwise meet their obligations to the company; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties, including Sebela Pharmaceuticals; the impact of higher selling and promotional costs; efficacy, safety or other quality concerns with respect to the company\u2019s marketed products, whether or not scientifically justified, leading to product recalls, withdrawals, labeling changes or declining sales; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of healthcare products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing healthcare insurance coverage; the failure by the company or its third party collaborators and\/or their suppliers to fulfill their or their regulatory or quality obligations; and volatility of commodity prices, fuel, and shipping rates that impact the costs and\/or ability to supply the company\u2019s products. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company\u2019s filings with the SEC, including the company\u2019s most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC\u2019s Internet site (www.sec.gov<\/a>). References and links to websites have been provided for convenience, and the information contained on any such website is not a part of, or incorporated by reference into, this press release. Organon is not responsible for the contents of third-party websites.<\/p>\n
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<\/b>At Sebela Pharmaceuticals, we are building a leading gastroenterology company in the US and developing innovative products in women\u2019s health. Braintree Laboratories, Inc., a part of Sebela Pharmaceuticals, has been innovating, developing, manufacturing, and commercializing gastroenterology products for over 40 years. Tegoprazan is Braintree\u2019s lead program in GERD, and in 2025 Sebela Women\u2019s Health obtained FDA approval for Miudella (copper-containing intrauterine system), the first non\u2011hormonal intra\u2011uterine device (IUD) for contraception approved in over 40 years. Sebela Pharmaceuticals has operations in Roswell, GA; Braintree, MA; and Dublin, Ireland.<\/p>\n
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<\/b>This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sebela Pharmaceuticals, Sebela Women\u2019s Health and Braintree Laboratories under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as “anticipate,” “planned,” “believe,” \u201cmay\u201d, \u201cwill\u201d, “forecast,” “estimated,” “expected,” and “intend,” among others. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the development, launch, introduction and commercial potential of Miudella; growth and opportunity, including peak sales and the potential demand for Miudella, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third-party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development and commercialization of new products. There are no guarantees that Miudella will prove to be commercially successful. While the list of factors presented here is considered representative, no such list should be considered a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and neither Sebela Pharmaceuticals, Sebela Women\u2019s Health nor Braintree Laboratories agree to undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law.<\/p>\n\n
\n ___________________________<\/td>\n<\/tr>\n \n 1<\/sup> Creinin MD, Gawron LM, Roe AH, et al. Three-year efficacy, safety, and tolerability outcomes from a phase 3 study of a low-dose copper intrauterine device. Contraception<\/i>. 2025;143:110771. doi:10.1016\/j.contraception.2024.110771<\/td>\n<\/tr>\n<\/table>\n <\/p>\n
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