Amgen Inc. / Dezima Pharma B.V.

Dyslipidemia / Hypercholesterolemia

Disease Overview

Dyslipidemia is the abnormal elevation of LDL cholesterol and/or other atherogenic lipoproteins, the principal modifiable driver of atherosclerotic cardiovascular disease (ASCVD). Despite statins, ezetimibe, and PCSK9 inhibitors, a large residual-risk population fails to reach LDL-C goals, particularly patients with familial hypercholesterolemia or statin intolerance.

Competitive Landscape

By 2015 the LDL-lowering market was anchored by generic statins (atorvastatin, rosuvastatin), Merck's Zetia/Vytorin (ezetimibe combinations), and a newly launched PCSK9 inhibitor class led by Amgen's own Repatha (evolocumab) and Sanofi/Regeneron's Praluent (alirocumab). The CETP inhibitor class had a graveyard reputation: Pfizer's torcetrapib (off-target toxicity, 2006), Roche's dalcetrapib (futility, 2012), and Lilly's evacetrapib (futility, 2015) had all failed, and Merck's anacetrapib later showed only modest CV benefit and was shelved in 2017. Against that backdrop, Amgen's $1.55B move for Dezima's TA-8995 (obicetrapib) was viewed by analysts as a contrarian bet, justified by best-in-class Phase 2b LDL-C reductions of 45-48% on top of statins (TULIP). The deal complemented Repatha by giving Amgen an oral option for statin add-on, but skepticism was immediate given class history; Amgen discontinued internal development in 2017 and out-licensed rights, ultimately selling to NewAmsterdam Pharma in 2020, which has since reported positive BROADWAY/BROOKLYN Phase 3 LDL-C data and is running PREVAIL CV outcomes.