Vytorin (Merck)
Patent Expiry: April 2017

2012 sales: $1.747 billion
2011 sales: $1.882 billion
Change: (7%)

Merck has done very well with an atherosclerosis drug whose benefits have long been in doubt. Vytorin combines Merck's ($MRK) Zetia with its statin drug Zocor to lower LDL cholesterol.

The drug has been controversial ever since the ENHANCE trial, which compared Vytorin with Zocor alone. The trial results were repeatedly delayed while Merck made an attempt to change the primary endpoint--a measure of atherosclerosis. In the end, Vytorin failed to best the statin drug at beating atherosclerosis. The trial's delays and Vytorin's failure led politicians to question the trial, cardiologists to debate Vytorin's usefulness and shareholders to sue when the drug's sales dwindled. Merck agreed in February to pay $688 million to settle the shareholders' lawsuits, which have dogged it, and Vytorin, since 2008.

Merck is hoping for better results from the more recent IMPROVE-IT trial, which also pits Vytorin against Zocor. IMPROVE-IT is testing whether Vytorin cuts the risk of heart attack, stroke, cardiovascular death and the like when compared with statin therapy alone. More than 18,000 patients are participating. An independent safety board recently signed off following a review of the data, so the study will now run its full course through September 2014. The study comes, however, as the whole LDL cholesterol strategy has come under increasing fire over efficacy and safety concerns.

For more:
Merck to pay $688M in lawsuit over failed Vytorin study
Vytorin outcomes study barrels on without a peek


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