Merck (MRK) recently announced the presentation of results from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study that was conducted with its cholesterol management drug, Tredaptive (extended-release niacin/laropiprant).
The results were presented at the American College of Cardiology by researchers from the Clinical Trial Service Unit at Oxford University.
Preliminary results from the long term safety study had been announced in Dec 2012. Tredaptive failed to meet its primary endpoint in the 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 (13.2% versus 13.7%).
Moreover, the incidence of some types of non-fatal serious adverse events in the Tredaptive arm increased significantly. These included diabetic complications, new onset diabetes, infection, gastrointestinal, musculoskeletal, bleeding (including gastrointestinal and intracranial) and skin. A small excess in heart failure was also observed.
Earlier this year, Merck had announced its intention to take Tredaptive off the market. While Tredaptive (also known as Pelzont and Trevaclyn) is not approved in the US, it was available in 40 countries across the world and approved in 70 countries.
The failure of Tredaptive to achieve its primary endpoint in the HPS-2 THRIVE study is a disappointment especially as Tredaptive was one of the candidates in Merck’s pipeline slated for a US regulatory filing in 2013.
We currently have a Neutral recommendation on Merck, which carries a Zacks Rank #3 (Hold). Large-cap pharma companies that currently look better-positioned include Eli Lilly (LLY) and Novo Nordisk (NVO). Both are Zacks Rank #2 (Buy) stocks. Avanir Pharmaceuticals, Inc. (AVNR) also looks attractive with a Zacks Rank #2.
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