Merck Rolls the Dice on New Januvia Study

The drug company that got into so much trouble when it uncovered and/or disclosed a cardiovascular side-effect of a popular painkiller (Vioxx) is launching a huge study to see if an up-and-coming diabetes drug is also bad for the heart.

In a research note to clients on Friday, Deutsche Bank's Barbara Ryan unearthed this posting that went up Thursday on the government's web site for clinical trials.

I certainly don't make it a habit to comb through www.clinicaltrials.gov on a regular basis and you'd have to know what you're looking for, so a big Sarah Palin-style "shout out" to Babs (as she's affectionately referred to here in the CNBC newsroom).

The posting details a huge Duke University-run test of Merck's (MRK) Januvia that will start enrolling a hoped-for 14,000 patients beginning next month to specifically measure if long-term use of the drug affects the heart. The results won't be known until 2015. Ryan writes, "MRK appears to have taken a proactive approach for Januvia in this regard, which is a positive in our view, as it will have such data well ahead of its competitors (though not til the end of 2014), which should help it to maintain a dominant position in the...market...."

DB owns at least one percent of MRK shares, makes a market in the stock and wants to bank the company.

The study is being done after a Food and Drug Administration advisory committee voted a few months ago overwhelmingly in favor of doing heart side-effect studies on new diabetes drugs. That was prompted, in part, by the recent safety controversy over GlaxoSmithKline's (GSK) Avandia, which caused sales of that drug to take a huge hit.

Januvia is a relatively new drug for Merck and it is a growth driver. In the third quarter, sales of Januvia more than doubled over the same period last year. Merck also makes a pill combining Januvia with an older diabetes drug, metformin. That product, Janumet, saw revenue quintuple in Q3 to more than $100 million.

Coincidentally, the news of the Januvia study comes out against the backdrop of an unrelated Januvia story that's grabbing headlines. A labor union coalition is accusing CVS Caremark (CVS) of pushing Januvia over cheaper, generic diabetes treatments in a Merck-funded mailing sent by Caremark

to patients. Both of the companies say the practice is nothing out of the ordinary.