Merck & Co., Inc. (MRK)’s Low Cholesterol

Then there’s the pipeline combo drug featuring Zetia and now off-patent Lipitor. Brian Orelli charted the drug’s bumpy regulatory course, but I’ll offer up a recap.

In 2009, the FDA turned the drug away with a refuse to file — essentially a complete response letter done before the review, rather than after. But the resubmission last year was also turned down because of lack of data. Merck turned around, collected more info, and resubmitted again. That decision should come in the first half of this year.

The glaring problem is the lack of available outcome data for this new combo. And that data won’t report until after the FDA decision. With the company’s cholesterol record, the lack of data isn’t reassuring

Foolish final thoughts
It’s not a good time to be a Merck cholesterol treatment. Vytorin continues to carry the cloud of the ENHANCE results and won’t have the chance for potential redemption until Zetia’s nearly off patent. The backup projects need backups.

Merck has enough drugs that no one drug could cripple the company. But a shaky pipeline and a few top products with issues don’t make for a healthy picture.

The article Merck’s Low Cholesterol originally appeared on Fool.com and is written by Brandy Betz.

Brandy Betz and The Motley Fool have no position in any of the stocks mentioned.

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