Organon Enters into a Commercialization Agreement for Daiichi Sankyo’s Nilemdo® in France, Denmark, Iceland, Sweden, Finland and Norway

Key Terms

dyslipidemia medical

Dyslipidemia is a medical condition where the levels of fats in the blood—such as cholesterol and triglycerides—are outside the healthy range, increasing the risk of artery blockages and heart disease; think of it as having oily buildup in plumbing that can slow or clog flow. It matters to investors because it drives demand for drugs, medical devices and diagnostics, influences healthcare costs and insurance payouts, and can affect the commercial and regulatory prospects of companies developing treatments.

statin-intolerant medical

Statin-intolerant describes people who cannot take statin drugs—commonly prescribed to lower cholesterol—because they develop side effects such as persistent muscle pain, weakness, or abnormal liver test results that make continued use unsafe or impossible. For investors, statin intolerance matters because it creates a group of patients who need alternative therapies, shaping demand, pricing, and regulatory attention for newer cholesterol drugs much like shoppers forced to buy a substitute when a popular product doesn’t work for them.

cardiovascular disease medical

A group of conditions that affect the heart and blood vessels, such as heart attacks, strokes and clogged arteries. Think of the cardiovascular system as a body’s plumbing and engine: when pipes narrow or the pump fails, treatment, devices and long-term care become necessary. Investors watch these diseases because their prevalence drives demand for drugs, devices and services, influences healthcare costs and insurer payouts, and affects workforce productivity and regulatory risk.

ldl-c medical

LDL-C stands for low-density lipoprotein cholesterol, the portion of cholesterol carried in the blood by LDL particles that is commonly linked to buildup of plaque in arteries—think of it like sticky debris that can clog pipes. Investors care because changes in LDL-C are a key measure used by regulators and clinicians to judge the effectiveness of cardiovascular drugs and devices, shape insurance coverage, and influence market demand for treatments that lower heart attack and stroke risk.

marketing authorization holder regulatory

The marketing authorization holder is the legal entity that holds official regulatory approval to sell a medical product in a specific country or region. Think of it as the company’s license to market a drug or device—it controls sales, collects revenue, and bears regulatory obligations and risks, so investors watch this status closely because it determines who can legally commercialize the product and who is liable for compliance and post‑market responsibilities.

The agreement builds on Organon’s cardiovascular disease portfolio, leveraging expertise to expand access to new treatments for patients with dyslipidemia, especially statin-intolerant patients.

This collaboration addresses a critical gap in care that disproportionately affects women, who are at a 47% higher risk of developing statin intolerance compared to men.ⁱ

JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon today announced that it has entered into an agreement with Daiichi Sankyo Europe to commercialize Nilemdo^® (bempedoic acid) in France, Denmark, Iceland, Sweden, Finland and Norway. Nilemdo^® is a new, first-in-class drug indicated for patients with high cholesterol and cardiovascular disease risk. It provides an alternative treatment for patients that cannot be treated effectively with statins.ⁱⁱ

“This collaboration combines Organon’s commercial agility with Daiichi Sankyo’s expertise in cardiovascular innovation to bring Nilemdo^® to patients in France, Denmark, Iceland, Sweden, Finland and Norway,” says Thibault Crosnier Leconte, AVP & Managing Director at Organon Northwest Europe. “By offering a new treatment option for patients who cannot tolerate statins, we are helping to close a persistent gap in cardiovascular care—one that disproportionately affects women – whilst reinforcing our mission to deliver impactful treatments for a healthier every day.”

Cardiovascular disease is the leading cause of death in Europeⁱⁱⁱ and for women worldwide,^iv however it remains understudied, under-recognized, under-diagnosed and under-treated.^v

Nilemdo^® is the first and only treatment in its class available in these markets and provides healthcare professionals with a new therapy to reduce cardiovascular risk in patients unable to achieve adequate LDL-C reduction with statins or other lipid-lowering therapies, or in patients who are statin-intolerant or for whom statins are contraindicated.

Under the terms of the agreement, Organon will distribute and promote Nilemdo^® in France, Denmark, Iceland, Sweden, Finland and Norway. Daiichi Sankyo Europe will remain the marketing authorization holder for the product and Organon will be local representative in the territory.

About Nilemdo^®

Nilemdo^® is a lipid-lowering drug containing bempedoic acid, which inhibits ATP-citrate lyase, a key enzyme in the cholesterol biosynthesis pathway. It was approved by the European Medicines Agency (EMA) in February 2020.

Indications and use in the EU:

Hypercholesterolaemia and mixed dyslipidaemia

Nilemdo^® is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or,
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Cardiovascular disease

Nilemdo^® is indicated in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

• in patients on a maximum tolerated dose of a statin with or without ezetimibe or,
• alone or in combination with ezetimibe in patients who are statin-intolerant, or for whom a statin is contraindicated.

The recommended dose is one 180 mg tablet taken orally once daily. Nilemdo^® can be taken with or without food. If a dose is missed, the patient should take the tablet immediately and resume the usual schedule the next day.

Nilemdo^® is intended for oral use only. Complete dosage and administration instructions are provided in the medication leaflet which can be found here: Nilemdo, INN-bempedoic acid. Please consult with your healthcare professional.

Patients should be monitored regularly to assess the effectiveness and safety of the treatment, with adjustments made as needed based on individual response and tolerance.

About Organon

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’s 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.

Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare. Learn more at www.organon.com and follow us on LinkedIn, Instagram, X, YouTube, TikTok and Facebook.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, this press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s expectations about regarding its commercialization agreement for Daiichi Sankyo’s Nilemdo® in France, Denmark, Iceland, Sweden, Finland and Norway. Forward-looking statements may be identified by words such as “potential,” “mission,” “expects,” “will,” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s 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. Factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the SEC, including Organon’s most recent Annual Report on Form 10-K (as amended), Quarterly Reports on Form 10-Q (as amended), Current Reports on Form 8-K, and other SEC filings, available at the SEC’s Internet site (www.sec.gov). Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

_____________________________

i Bytyçi I, Penson PE, Mikhailidis DP, et al. Prevalence of statin intolerance: a meta-analysis. Eur Heart J. 2022;43(34):3213-3223. doi:10.1093/eurheartj/ehac015

ii European Medicines Agency, Nilemdo (bempedoic acid) Summary of product characteristics, available here: Nilemdo, INN-bempedoic acid [last accessed: January 2026]

iii WHO, Cardiovascular diseases, available here: Cardiovascular diseases EURO [last accessed: December 2025]

iv European Society of Cardiology, Cardiovascular disease in women, available here: Cardiovascular Disease in Women [last accessed: December 2025]

v Vogel B, Acevedo M, Appelman Y, et al. The Lancet women and cardiovascular disease Commission: reducing the global burden by 2030. Lancet. 2021;397(10292):2385-2438. doi:10.1016/S0140-6736(21)00684-X

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20260107056646/en/

Media:

Karissa Peer

(614) 314-8094

Felicia Bisaro

(646) 703-1807

Investor:

Jennifer Halchak

(201) 275-2711

Source: Organon & Co.