) recently announced that it is taking its cholesterol management
drug, Tredaptive (extended-release niacin/laropiprant), off the
market. While Tredaptive (also known as Pelzont and Trevaclyn) is
not approved in the US, it is available in 40 countries across
the world and approved in 70 countries.
Merck's decision was based on preliminary data from the long
term safety study, HPS2-THRIVE (
vents), and discussions with regulatory authorities.
Merck had announced disappointing results from the HPS2-THRIVE
study in Dec 2012. Tredaptive failed to meet its primary endpoint
in the study that compared Tredaptive plus statin therapy to
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
Merck's decision to take Tredaptive off the market is in line
with the recommendation of the European Medicine Agency's
Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC,
which assessed available data related to safety concerns over
Tredaptive, recommended that the marketing, supply and
authorizations of Tredaptive, Pelzont and Trevaclyn should be
suspended across the EU.
The decision to suspend Tredaptive does not come as a surprise
given the disappointing long-term safety data from the HPS-2
THRIVE study. Tredaptive sales were not significant (first nine
month 2012 sales of the drug were $13 million) and its removal
should not affect Merck's top-line.
However, Tredaptive was one of the candidates in Merck's
pipeline slated for a US regulatory filing in 2013. Therefore,
the suspension of the drug is a setback for the company's
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
Johnson & Johnson
). All three are Zacks Rank #2 (Buy) stocks.
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