The highly anticipated results of the study that goes by the acronym "ENHANCE" are out this morning. You can see what it stands for in the companies' press release. (I wonder how many meetings and brainstorming sessions go into coming up with some of the industry's clinical trial acronyms and abbreviations.)
ENHANCE compares Merck and Schering-Plough's cholesterol fighter Vytorin (a combo of MRK's Zocor and Schering-Plough's Zetia) with Zocor alone. Zocor is also known as simvastatin and has gone generic. "The New York Times" has done a few stories in recent weeks about doctors who've been growing increasingly skeptical about the results because the companies had not released them yet. MRK and SGP officials had said they didn't know the outcome at the time.
Anyway, in the press release the companies say, "There was no statistically significant difference between (the) treatment groups on the primary endpoint."
Primary endpoint is clinical-speak for "main goal" of the study. So, in other words, Vytorin's essentially no better than Zocor alone. Some headlines are characterizing the study as a "failure." In mid-morning trading, both stocks are down but SGP is taking the brunt of the damage.
Miller Tabak healthcare analyst Les Funtleyder writes in a research note to clients this morning why that appears to be the case. "MRK has more than enough pipeline to in-line products to overcome some marketing challenges to Vytorin," he says.
Bernstein's Tim Anderson writes, "Results look benign relative to expectations." And he points out that Vytorin showed a "minor" liver-safety edge. While Goldman Sachs' Jim Kelly says, "ENHANCE trial nonevent. (And) we believe that this result does not represent a relevant difference for assessing the commercial prospects for Vytorin."
Bernstein owns at least one percent of MRK and SGP. GS has done and wants to do more investment banking for both companies and makes a market in both of their stocks.
The companies will present details of the study at the American College of Cardiology conference in March.
French say "Oui" to Merck's Gardasil
Meantime, to use a tired cliche, Merck coincidentally got a shot in the arm from France today. The business newswires report that French health officials are choosing Merck and Sanofi-Aventis' cervical cancer vaccine Gardasil over Cervarix from the European GlaxoSmithKline . As I've blogged many times before, Gardasil is a roaring success in the U.S. GSK recently announced a delay in winning FDA approval of the vaccine in the States.
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