Organon has completed a global licensing agreement with Sebela Pharmaceuticals, securing exclusive rights to MIUDELLA, a hormone-free copper intrauterine device (IUD). The device, approved by the US Food and Drug Administration (FDA) on February 24, 2025, is the first hormone-free copper IUD introduced in the US in over 40 years. This transaction strengthens Organon's contraception portfolio and expands long-acting reversible options for women.

MIUDELLA is indicated for the prevention of pregnancy for up to three years in females of reproductive potential and is 99% effective. The device features proprietary SLIMSERT technology, which includes a highly flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm. Commercial availability is anticipated in late 2026.

Regulatory and Safety Profile

The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS) to manage known or potential risks associated with the product. To mitigate complications due to potential improper insertion, MIUDELLA will only be available in the US through the MIUDELLA REMS program. This restricted program ensures all healthcare providers are trained on proper insertion prior to first use.

Clinical Trial Data

MIUDELLA was investigated in three clinical trials in the US involving 1,904 women aged 17 to 45 years. The Phase 3 study was conducted across 42 centers with a primary endpoint of contraceptive efficacy through 3 years of use.

The most common adverse reactions observed in clinical trials, occurring in 5% or more of participants, included heavy menstrual bleeding, dysmenorrhea, intermenstrual bleeding, pelvic discomfort, procedural pain, pelvic pain, post-procedural hemorrhage, and dyspareunia.

Strategic Implications

Joe Morrissey, Chief Executive Officer of Organon, stated that MIUDELLA represents an important hormone-free option that expands choices for women seeking long-acting reversible birth control. He noted that the agreement leverages Organon's deep expertise and capabilities to deliver contraceptive options that meet women's needs.

Alan Cooke, Chief Executive Officer and President of Sebela Pharmaceuticals, expressed that Organon offers the scale, launch readiness, and access capabilities needed to bring the product efficiently into clinical practice. Truist Securities, Inc. acted as the financial advisor to Sebela Pharmaceuticals for the transaction.

Organon and Samsung Bioepis have expanded their development and commercialization agreement to include exclusive rights for Organon to commercialize PYZCHIVA in Canada. PYZCHIVA is a biosimilar referencing STELARA (ustekinumab), developed by Samsung Bioepis, and is expected to launch in the Canadian market in 2026. The expansion deepens the collaboration between the two companies, bringing their portfolio of complementary biosimilars in Canada to six products across immunology, oncology, and dermatology.

Under the terms of the agreement, Organon will hold exclusive commercial rights to the product in Canada, while Samsung Bioepis retains responsibility for development, manufacturing, and regulatory matters. PYZCHIVA is indicated for the treatment of adult patients with chronic moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn's disease, and moderately to severely active ulcerative colitis. Specific indications for Crohn's disease include patients who have had an inadequate response, loss of response to, or were intolerant to either immunomodulators or one or more tumour necrosis factor-alpha (TNFα) antagonists, or have had an inadequate response, intolerance or demonstrated dependence on corticosteroids. For ulcerative colitis, it includes patients who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies.

The expanded portfolio now includes five other products: HADLIMA (adalimumab), BRENZYS (etanercept), RENFLEXIS (infliximab), AYBINTIO (bevacizumab), and ONTRUZANT (trastuzumab). Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets at Samsung Bioepis, stated that the partnership aims to accelerate access to biologic medicines and ensure continued supply to patients.

Dominic Bégin, President and Managing Director of Organon Canada, highlighted the company's ten-year history in delivering accessible biosimilars. He noted that leveraging Organon's capabilities provides an opportunity to expand access to treatment, supporting healthcare providers and the broader system. The collaboration reinforces a commitment to reducing spending pressures on healthcare systems and expanding patient access to medicines.

Collaboration Portfolio