Surprise: Merck's cholesterol combo Vytorin hits goal in long-awaited outcomes trial

Cue the celebration at Merck & Co. ($MRK) today. Its cholesterol drug Vytorin hit its goal in a long-awaited outcomes trial, beating solo statin therapy at cutting cardiovascular risk. It's a vindication for the company, which endured a storm of criticism about an earlier trial in which Vytorin fell short.

The details on the data aren't yet available; it's due for presentation at the American Heart Association meeting later today. But the mere fact that Vytorin hit its predefined endpoint--a reduction in risk of death, heart attack, stroke, angina-related hospitalization, and coronary procedures--is significant. Previously, the combo of Merck's statin Zocor and a novel therapy Zetia failed to best Zocor alone.

Both Vytorin and Zetia saw sales suffer after the previous trial defeat, and prescriptions have been sliding this year, too. That could change, with doctors more willing to experiment with it as an add-on to statins, or for patients who can't tolerate that class of meds, ISI Group analyst Mark Schoenebaum said in a note to investors. Merck isn't likely to get a big sales boost, though, and certainly not a long-term one; Zetia goes off patent in 2017.

But the Improve-It trial is not only a score for Merck. It could also have an overflow effect onto next-generation cholesterol-fighters from Amgen ($AMGN), Sanofi and Regeneron, Pfizer ($PFE), Eli Lilly ($LLY) and Merck itself, analysts say.

Some have feared that the FDA wouldn't approve these new meds without outcomes data. Even if the agency ushers the new meds onto the market, payers may demand that sort of data before agreeing to foot the bill. Pfizer plans a massive outcomes trial to prove that its PCSK9 inhibitor not only works but also delivers value to payers. Sanofi ($SNY) and Regeneron ($REGN) are spending some half-billion dollars on an outcomes test for their version, alirocumab.

- see the release from Merck

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