NewAmsterdam Announces Acceptance of Marketing Authorization Applications for Review by European Medicine Agency for Obicetrapib

About this update from Newamsterdam Pharma Company N.v.

-- Filings both for the obicetrapib monotherapy and obicetrapib plus ezetimibe fixed-dose combination submitted to EMA by our partner, Menarini, for treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia -- -- NewAmsterdam entitled to tiered double-digit percentage royalties ranging from the low double-digits to mid-twenties on net sales in the Menarini Territory and up to an additional €833 million upon the achievement of various clinical, regulatory and commercial milestones -- NAARDEN, The Netherlands and MIAMI , Aug. 18, 2025 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (“CVD”) with elevated low-density lipoprotein cholesterol (“LDL-C”), for whom existing therapies are not sufficiently effective or well-tolerated, today announced that the European Medicines Agency (“EMA”) has validated the Marketing Authorization Application (“MAA”) for obicetrapib 10 mg monotherapy and 10 mg obicetrapib plus 10 mg ezetimibe fixed-dose combination (“FDC”) for patients with primary hypercholesterolemia, both heterozygous familial (“HeFH”) and non-familial or mixed dyslipidemia. The MAAs were submitted by NewAmsterdam’s partner, A. Menarini International Licensing S.A. (“Menarini”), who is responsible for communications with regulatory authorities in Europe and for the commercialization and local development of obicetrapib in Europe and other collaborative activities pursuant to an exclusive License Agreement (the “Menarini License”). “The acceptance of the MAAs for obicetrapib and the obicetrapib-ezetimibe FDC by the EMA allows for review of our pivotal Phase 3 trials, including BROADWAY , BROOKLYN and TANDEM, in which we observed clinically meaningful LDL-C reductions in both the monotherapy obicetrapib group and in combination with ezetimibe, with a safety and tolerability profile comparable to placebo,” said Michael Davidson , M.D., Chief Executive Officer of NewAmsterdam. “This marks a significant step forward in our mission to deliver a novel, first in class therapeutic option to add to statin therapy to further reduce LDL-C for millions of patients not reaching their LDL-C goals. We thank our partner, Menarini, and look forward to continuing our partnership aimed at bringing a simple, oral LDL-lowering therapy to patients at risk of cardiovascular disease in Europe.” The EMA submission is based on data from BROOKLYN, TANDEM and BROADWAY Phase 3 trials, which showed 35% - 40% LDL-C lowering with obicetrapib versus placebo as a monotherapy and approximately 50% LDL-C lowering versus placebo in combination with ezetimibe. “Cardiovascular disease is the leading cause of death globally, taking an estimated 17.9 million lives each year. Despite the widespread availability of lipid lowering therapies, CVD-related deaths have risen, and patients remain above LDL-C targets, failing to achieve guidelines recommended LDL-C target goals. Patients and their doctors need additional options,” said Elcin Barker Ergun , Chief Executive Officer of the Menarini Group . “Obicetrapib, if approved, could provide an effective and safe oral option for patients with hypercholesterolemia. We look forward to working with the EMA to potentially bring this new treatment to patients in need.” In June 2022 , NewAmsterdam entered into the Menarini License to obtain and maintain regulatory approvals, commercialize and undertake local development, in each case with respect to obicetrapib 10mg either as a monotherapy or in a FDC with ezetimibe for any use, in France , Germany , Italy , Spain , UK , and 27 other European countries. Pursuant to the Menarini License, Menarini made an upfront payment to NewAmsterdam of €115.0 million. Menarini has also committed to providing €27.5 million in funding, of which €13.8 million has been paid, for research and development activities over several years, together with bearing 50% of any development costs incurred in respect of the pediatric population in the Menarini Territory (as defined in the Menarini License). NewAmsterdam is eligible to receive up to €863 million upon the achievement of various clinical, regulatory and commercial milestones, of which a total of €30 million has been received to date. If obicetrapib is approved and successfully commercialized by Menarini, NewAmsterdam will be entitled to tiered double-digit percentage royalties ranging from the low double-digits to the mid-twenties as a percentage of net sales in the Menarini Territory, with royalty step-downs in the event of generic entrance or in respect of required third-party intellectual property payments. NewAmsterdam’s Global Pivotal Phase 3 Program to Support EMA Submission NewAmsterdam previously announced positive topline results for three Phase 3 clinical trials, each with safety comparable to placebo: BROADWAY evaluated obicetrapib in 2,530 adult patients with established atherosclerotic cardiovascular disease (“ASCVD”) and/or HeFH, whose LDL-C is not adequately controlled despite being on maximally tolerated lipid-lowering therapy. In December 2024 , NewAmsterdam reported positive topline data from the BROADWAY trial. The primary endpoint was the least-squares (“LS”) mean of the percent change in LDL-C from baseline to day 84 for obicetrapib 10 mg compared to placebo. The primary endpoint was achieved with statistical significance with an LS mean LDL-C reduction of 33% (p

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