Organon Strikes European Deal for Daiichi Sankyo’s Nilemdo®

Organon Forges Strategic Alliance with Daiichi Sankyo Europe to Broaden Access to Nilemdo® in Key European Markets

Organon has announced a significant commercialization agreement with Daiichi Sankyo Europe, securing the rights to distribute and promote Nilemdo® (bempedoic acid) across France, Denmark, Iceland, Sweden, Finland, and Norway. This partnership aims to enhance patient access to Nilemdo®, a novel treatment for individuals with high cholesterol and elevated cardiovascular disease risk, particularly those who experience intolerance to statin therapy.

The collaboration underscores Organon’s commitment to expanding its cardiovascular portfolio and addressing critical unmet needs in patient care. Nilemdo® represents a significant advancement as a first-in-class therapeutic option for patients who cannot achieve adequate lipid-lowering goals with statins or for whom statins are contraindicated. This drug mechanism inhibits ATP-citrate lyase, a crucial enzyme in the cholesterol biosynthesis pathway, offering an alternative approach to managing dyslipidemia.

“This alliance brings together Organon’s commercial acumen and Daiichi Sankyo’s deep expertise in cardiovascular innovation,” stated Thibault Crosnier Leconte, AVP & Managing Director at Organon Northwest Europe. “Our objective is to deliver Nilemdo® to patients in these important European countries, providing a vital new treatment pathway for those struggling with statin intolerance. This aligns perfectly with our mission to improve health outcomes and make impactful treatments more accessible for a healthier everyday life.”

Cardiovascular disease remains a leading cause of mortality globally, particularly affecting women. However, the condition is often under-researched, under-diagnosed, and under-treated. This partnership directly addresses a gap in care, with a particular focus on women, who are known to have a significantly higher risk of statin intolerance compared to men. The strategic expansion of Nilemdo® aims to mitigate this disparity and improve cardiovascular health outcomes for a wider patient demographic.

Under the terms of the agreement, Organon will assume responsibility for the distribution and promotion of Nilemdo® in the designated territories, while Daiichi Sankyo Europe will retain the marketing authorization for the product. Organon will act as the local representative, ensuring seamless integration and market penetration.

Nilemdo®, approved by the European Medicines Agency (EMA) in February 2020, is indicated for adults with primary hypercholesterolemia or mixed dyslipidemia, and for adults with established or high-risk atherosclerotic cardiovascular disease. It can be used in conjunction with statins, other lipid-lowering therapies, or ezetimibe, depending on the patient’s specific needs and tolerance. The recommended dosage is one 180 mg tablet taken orally daily, with or without food.

About Nilemdo®:
Nilemdo® contains bempedoic acid and is indicated in the EU for adults with hypercholesterolemia and mixed dyslipidemia, and for adults with established or high risk for atherosclerotic cardiovascular disease. It works by inhibiting ATP-citrate lyase, a key enzyme in cholesterol synthesis.

About Organon:
Organon is a global healthcare company dedicated to delivering impactful medicines and solutions for a healthier every day. With a diverse portfolio spanning Women’s Health and General Medicines, including biosimilars, Organon prioritizes addressing health needs that disproportionately affect women and expands access to essential treatments in over 140 markets worldwide. Headquartered in Jersey City, New Jersey, Organon is committed to advancing access, affordability, and innovation in healthcare.

Forward-Looking Statements:
This press release contains forward-looking statements regarding Organon’s commercialization agreement for Nilemdo®. These statements are based on current beliefs and expectations and are subject to risks and uncertainties. Actual results may differ materially from those projected. Organon undertakes no obligation to update any forward-looking statements.