#Netherlands #Menarini Group #NewAmsterdam #Naarden #Ubeslo

NewAmsterdam Pharma and Menarini Group Achieve Major Milestone

In a significant development for cardiovascular health, NewAmsterdam Pharma Company N.V. and Menarini Group have received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP). This endorsement is in favor of the marketing authorization of two innovative therapies: Ubeslo® (the Obicetrapib monotherapy) and Evlarco® (a fixed-dose combination of Obicetrapib and Ezetimib). The potential approval for these treatments is aimed at patients suffering from primary hypercholesterolemia, including both heterozygous familial hypercholesterolemia (HeFH) and non-familial or mixed dyslipidemia.

Dr. Michael Davidson, CEO of NewAmsterdam, highlighted the importance of this CHMP recommendation, identifying it as a significant milestone not only for the company but also for those in need of improved therapies targeting low-density lipoprotein cholesterol (LDL-C) and other cardiovascular risk factors. He states, “With its compelling clinical profile and convenient once-daily oral administration, Obicetrapib has the potential to address a significant unmet need in patients who struggle to achieve their LDL-C goals through current treatments.”

The positive recommendation is backed by promising results from three Phase 3 clinical studies: BROADWAY, BROOKLYN, and TANDEM. These trials demonstrated statistically significant reductions in LDL-C levels of up to 40% with the monotherapy of Obicetrapib and nearly 50% when combined with Ezetimib, both compared to placebo, while maintaining a similar safety profile to placebo.

The approval process now moves to the European Commission, which is expected to make a final decision in the second half of 2026. Menarini, an established global player based in Florence, holds exclusive commercial rights for Obicetrapib in Europe and will spearhead marketing activities and regulatory collaborations in the region. Elcin Barker Ergun, CEO of Menarini, expressed excitement over reaching this key regulatory milestone, emphasizing their commitment to making Obicetrapib available across Europe.

Under the licensing agreement, Menarini will pay NewAmsterdam tiered royalties based on net sales, along with potential milestone payments that could total up to 833 million euros, contingent upon achieving various clinical, regulatory, and commercial objectives.

Insights into Obicetrapib

Obicetrapib is a novel CETP inhibitor being developed as a low-dose oral therapy that seeks to overcome the limitations associated with existing LDL-lowering treatments. Results from multiple Phase 2 studies (ROSE2, TULIP, ROSE, and OCEAN) and the previously mentioned Phase 3 trials have consistently shown significant LDL reductions while reporting an adverse effect profile akin to that of placebo. Following the initiation of the cardiovascular outcome study PREVAIL in March 2022, NewAmsterdam successfully enrolled over 9,500 patients by April 2024, furthering its investigation into the drug’s potential to reduce major adverse cardiovascular events (MACE).

Addressing Cardiovascular Disease

Cardiovascular diseases remain the leading cause of death globally, despite the availability of lipid-lowering therapies. Projections indicate that by 2050, more than 184 million adults in the U.S. could be affected by heart disease and hypertension. The alarming rise in age-adjusted mortality rates attributed to cardiovascular conditions from 2019 to 2022 highlights an urgent need for more effective treatment avenues, especially since existing therapies are insufficient for many patients. A staggering 30 million adults in the U.S. fail to meet their risk-based LDL-C targets, a situation exacerbated by lifestyle factors and comorbid conditions.

About NewAmsterdam Pharma

NewAmsterdam Pharma is dedicated to improving care for patients with metabolic diseases through innovative solutions that cater to unmet medical needs. The company's development pipeline, including Obicetrapib, represents its commitment to delivering safe, effective therapies that reduce LDL-C levels while providing comprehensive cardiovascular risk management.

About Menarini Group

Operating in 140 countries, Menarini Group is a global player in the pharmaceutical and diagnostic sectors, with a strong emphasis on R&D and high-quality manufacturing. Their extensive portfolio addresses critical areas such as cardiometabolic diseases, oncology, and beyond, aiming to elevate health standards for patients worldwide.

As the anticipation builds for the European Commission's decision, both NewAmsterdam and Menarini remain steadfast in their collaborative efforts to bring these groundbreaking cholesterol-lowering treatments to market, potentially transforming patient outcomes across Europe.