Back to top

Analyst Blog

Merck (MRK - Analyst Report) recently announced disappointing results from a long-term safety study of cholesterol management drug, Tredaptive (extended-release niacin/laropiprant). The company said that Tredaptive failed to meet its primary endpoint in the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study that compared Tredaptive plus statin therapy to statin therapy.

Results showed that adding Tredaptive to statin therapy did not lead to a significant reduction in the risk of major vascular events (a combination of coronary deaths, non-fatal heart attacks, strokes or revascularizations) compared to statin therapy. Moreover, the incidence of some types of non-fatal serious adverse events in the Tredaptive arm increased significantly.

Merck said that it will inform regulatory agencies about these results as well as health care providers in countries where the drug is approved. Tredaptive (which is also known as Cordaptive, Pelzont and Trevaclyn) is approved in about 70 countries including Europe. Merck is asking health care providers to refrain from starting new patients on Tredaptive until the newly available data is analyzed further. Additional information should be out in the first quarter of 2013.

We note that the European Medicines Agency (EMA) has initiated a review of the safety and efficacy of Tredaptive. The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) will analyze the data and provide a recommendation to the Committee on Medicinal Products for Human Use (CHMP). The CHMP, in turn, will provide an opinion regarding the regulatory status of the drug. A decision should be out next month.

The EMA has also recommended against the initiation of treatment in new patients until it has finished assessing the results.

Our Take

The failure of Tredaptive to meet the primary endpoint in the long-term study is disappointing. Tredaptive was one of the candidates in Merck’s pipeline slated for a US regulatory filing in 2013. But given the disappointing results, the company will not be seeking FDA approval for Tredaptive. Although Tredaptive sales were not significant (first nine month 2012 sales of the drug were $13 million), the study results represent a setback for Merck’s pipeline efforts.

We currently have a Neutral recommendation on Merck, which carries a Zacks #3 Rank (Hold). Large-cap pharma companies that currently look better-positioned include Novo Nordisk (NVO - Analyst Report). Novo Nordisk carries a Zacks #2 Rank (Buy).

Please login to or register to post a comment.

New to Zacks?

Start Here

Zacks Investment Research


Are you a new Zacks Member or a visitor to

Top Zacks Features

My Portfolio Tracker

Is it Time to Sell?

One of the most important steps you can take today is to set up your portfolio tracker on Once you do, you'll be notified of major events affecting your stocks and/or funds with daily email alerts.

More Zacks Resources

Zacks Rank Home - Evaluate your stocks and use the Zacks Rank to eliminate the losers and keep the winners.

Mutual Fund Rank Home - Evaluate your funds with the Mutual Fund Rank for both your personal and retirement funds.

Stock/Mutual Fund Screening - Find better stocks and mutual funds. The ones most likely to beat the market and provide a positive return.

My Portfolio - Track your Portfolio and find out where your stocks/mutual funds stack up with the Zacks Rank.

Zacks #1 Rank Top Movers for Zacks #1 Rank Top Movers

Company Symbol Price %Chg
UTD THERAPE… UTHR 117.83 +28.51%
TRIQUINT SE… TQNT 20.67 +6.52%
RF MICRO DE… RFMD 12.47 +6.04%
VASCO DATA… VDSI 14.77 +4.68%
BANCO DO BR… BDORY 15.53 +3.95%