Merck 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.
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 . Novo Nordisk carries a Zacks #2 Rank (Buy).