Merck & Co. Inc. / Schering-Plough Corporation (joint venture, ezetimibe)

Hypercholesterolemia

$5.0B Worldwide ezetimibe (Zetia + Vytorin) sales, 2006

Disease Overview

Hypercholesterolemia is elevated blood cholesterol — particularly LDL — and is the leading modifiable risk factor for atherosclerotic cardiovascular disease, driving heart attacks, strokes, and peripheral vascular disease. It is highly prevalent in US adults and historically managed with diet, exercise, and HMG-CoA reductase inhibitors (statins).

Competitive Landscape

When Merck and Schering-Plough formed their 50/50 joint venture in May 2000, the cholesterol market was a statin oligopoly: Merck's Zocor (simvastatin) and Mevacor (lovastatin), Pfizer's Lipitor (atorvastatin) — already on its way to becoming the world's best-selling drug — Bristol-Myers Squibb's Pravachol (pravastatin), and Novartis's Lescol (fluvastatin). Schering-Plough had no statin and Merck faced the looming Zocor patent cliff. Ezetimibe was a first-in-class cholesterol-absorption inhibitor (NPC1L1) discovered at Schering-Plough that worked by a complementary mechanism — blocking dietary and biliary cholesterol uptake at the brush border — meaning it could stack on top of any statin for additive LDL reduction. The JV monetized that complementarity in two steps: Zetia monotherapy launched October 2002, and the fixed-dose Vytorin (ezetimibe + simvastatin) launched 2004 immediately ahead of Zocor's 2006 patent expiry, extending Merck's franchise revenue and giving Schering-Plough a blockbuster it could not have commercialized alone. Combined ezetimibe sales reached ~$5B by 2006 and the JV ultimately set the stage for Merck's $41.1B acquisition of Schering-Plough announced in 2009.