Vytorin Data Vexes Schering-Plough

OKLAHOMA CITY -- Merck (MRK Quote) and Schering-Plough (SGP Quote) are scrambling to salvage Vytorin, their new cholesterol-lowering drug, after a recent study raised safety concerns about the once-promising treatment.

In a special conference call held just hours ahead of their earnings reports, the two companies relied on outside medical researchers to break bad news about the recently completed Simvastatin Plus Ezetimibe in Aortic Stenosis (SEAS) study.

Terje Pedersen, a Norwegian doctor who led the SEAS trial, noted that Vytorin failed to work statistically better than placebo in reducing "major cardiovascular events" -- the study's primary endpoint -- and delivered a "disturbing finding" about the safety of the drug as well: That cancer rates among patients taking Vytorin during the SEAS study came in much higher than those among those taking placebo instead.

All told, 93 patients who took Vytorin during the SEAS trial wound up with cancer, and 39 ultimately died of the disease. Those numbers were 43% and 70% higher, respectively, than the numbers reported for patients taking placebo.

Shares of Schering-Plough finished down 11.6% to $18.95. Merck, which relies on Vytorin less for its bottom line, fell 6.2% to $35.33.

To be fair, Pedersen did offer some reason for hope. During the SEAS trial, he noted, Vytorin managed to lower so-called "bad" cholesterol by a whopping 60%. Moreover, he emphasized, the drug achieved a key secondary endpoint by statistically lowering the number of "atherosclerotic disease events" -- such as nonfatal heart attacks, coronary bypass surgeries and cardiovascular deaths -- in patients who face serious risks of such threats.