AstraZeneca PLC / Omthera Pharmaceuticals Inc.

Severe Hypertriglyceridemia / Mixed Dyslipidemia

$533M AstraZeneca Epanova intangible asset value disclosed at 2020 STRENGTH-trial wind-down

Disease Overview

Severe hypertriglyceridemia (fasting triglycerides ≥500 mg/dL) raises the risk of acute pancreatitis and is a marker of broader cardiometabolic disease. Despite statins controlling LDL cholesterol, residual triglyceride-driven cardiovascular risk has been a persistent therapeutic gap, particularly as obesity and type-2 diabetes prevalence has risen.

Competitive Landscape

At deal signing in May 2013 the prescription omega-3 market was dominated by GlaxoSmithKline's Lovaza (omega-3-acid ethyl esters) — peaked >$1B in US sales before its 2014 patent cliff — and Amarin's Vascepa (icosapent ethyl, pure-EPA), launched January 2013. Fenofibrate franchises (Trilipix, Tricor) and niacin (Niaspan; the AIM-HIGH/HPS2-THRIVE failures had just undermined its CV positioning) were the non-omega-3 alternatives. Epanova differentiated as the first free-fatty-acid omega-3 — meant to bypass the food-effect bioavailability issue with ethyl esters — with once-daily 2g/4g dosing. AstraZeneca's strategic logic was to plug Epanova into the Crestor (rosuvastatin) cardiovascular franchise via fixed-dose combinations and use the STRENGTH cardiovascular outcomes trial to expand into the much larger mixed-dyslipidemia population. Epanova won FDA approval May 2014 for severe hypertriglyceridemia, but the STRENGTH MACE trial in mixed dyslipidemia was halted for futility in January 2020 against placebo (corn oil), prompting AstraZeneca to disclose a ~$533M intangible writedown plus inventory writedown — making this one of the highest-profile CV outcomes failures of the decade.