Thursday, 20 December 2012
Merck's Cholesterol Drug Tredaptive Fails Primary Endpoint - Update !
12/20/2012 12:47 PM ET
Merck & Co Inc. (MRK: Quote) Thursday announced disappointing results from a study of its cholesterol drug Tredaptive and said it is abandoning plans to seek an approval for the drug from the U.S. Food and Drug Administration.
Merck said Tredaptive failed to show it could reduce heart attacks and strokes, compared with statin drugs, as per a large-scale study known as HSP2-Thrive. The drug also raised safety concerns.
Merck shares are down 2.3 percent in morning trade on the New York Stock Exchange.
Tredaptive is a single-pill combination of niacin, a B vitamin organic compound, with a Merck-developed compound called laropiprant.
Niacin is known for increasing levels of good cholesterol and lower bad cholesterol, while laropiprant is designed to inhibit a side effect of niacin related to reddening of the skin.
Merck in 2007 sought approval for Tredaptive from the FDA, which rejected the drug and asked Merck to furnish results from the HSP2-Thrive study.
HPS2-Thrive was conducted by the Clinical Trial Service Unit at Oxford University and funded by Merck. The trial enrolled about 25,670 patients at high risk of heart attack and related cardiovascular events. Patients in the study were followed for a median of 3.9 years.
The study assessed whether adding Tredaptive to a regimen including simvastatin lowers cardiovascular risk compared with the statin therapy alone.
Results showed that adding the combination of extended-release niacin and laropiprant to statin therapy did not significantly further reduce the risk of the combination of coronary deaths, non-fatal heart attacks, strokes or revascularizations compared to statin therapy.
There was a also a statistically significant increase in the incidence of some types of non-fatal serious adverse events in the group that received extended-release niacin/laropiprant.
Merck and the study investigators are informing regulatory agencies of the results. The company also is preparing communications to health-care providers in countries where the medicine is currently available.
Based on the current understanding of these new data and until further analysis can be completed, Merck is recommending that providers not start new patients on Tredaptive.
Tredaptive has been approved in about 70 countries, including in Europe, and is sold in about 40 countries. Sales through the first three quarters of 2012 were about $13 million.
Merck is trading at $42.63, down 2.35%, on a volume of 13.7 million shares on the NYSE.