NewAmsterdam Submits Obicetrapib EMA Applications for Review.

• NewAmsterdam announces acceptance of marketing applications by European Medicine Agency. • Applications for obicetrapib monotherapy and fixed-dose combination with ezetimibe submitted. • Partner Menarini will review filings for treatment of primary hypercholesterolemia and mixed dyslipidemia. • NewAmsterdam entitled to double-digit percentage royalties on net sales in the Menarini Territory. • Additional €833 million milestone upon achievement of various clinical, regulatory, and commercial milestones.

NewAmsterdam Pharma Company N.V. (NAMS) has 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 [1].

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 [1].

Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam, stated, "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" [1].

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 [1].

Elcin Barker Ergun, Chief Executive Officer of the Menarini Group, stated, "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" [1].

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 [1].

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 [1].

References:

[1] https://www.marketscreener.com/news/newamsterdam-announces-acceptance-of-marketing-authorization-applications-for-review-by-european-med-ce7c51dfd08cf62d