MINYANVILLE ORIGINAL A heart drug being developed by Merck
in a clinical trial, dashing hopes for a new treatment option and a potentially big-selling product for the pharmaceutical giant.
The drug, Tredaptive
, is already approved in Europe and Merck hoped to reapply for US market approval assuming that a large study showed effectiveness for the therapy. (The drug was rejected by the FDA in 2008 because the agency felt the medicine needed more study.) Merck now says it does not plan to seek US approval given the study results released Thursday. Tredaptive is designed to raise good cholesterol levels to help ward off heart attacks and other cardiovascular events.
In a study of almost 26,000 people, Merck’s drug Tredaptive did not meet a study goal of significantly reducing the risk of heart attack or stroke in vulnerable patients. The drug, which includes the active ingredient niacin
, was tested in combination with statins, which are common cholesterol-lowering drugs. Niacin, a type of B vitamin, is one of the oldest treatments to control cholesterol levels.
Shares of Merck fell 3% to $42.48 in midday trading Thursday. The stock is up 15% in the past year.
In addition to the reported futility of the drug, the researchers found “a statistically significant increase in the incidence of some types of non-fatal serious adverse events.” The company wasn’t any more specific about the safety issues, but it said it was working with an independent research team at Oxford University to share the study data with regulators in the countries where the drug is approved.
“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,” Merck says in a statement.
The news Thursday also raises more questions about the use of niacin as a means to raise good cholesterol to protect against heart attacks. In early 2011, the US government stopped its own study
of Abbott Laboratories
(NYSE:ABT) drug Niaspan in combination with the statin simvastatin as a therapy to prevent heart attacks. Government researchers said the drug combo didn’t work and it may have been linked to strokes in a small group of patients in the study. Niaspan is approved in the US to treat cholesterol levels. (Simvastatin, incidentally, is the generic name for Merck’s branded cholesterol drug Zocor.)
Tredaptive (called Cordaptive when Merck sought US approval a few years ago) was considered by some Wall Street analysts to be a potentially big-selling product.
In September, Leerink Swann analyst Seamus Fernandez slashed a sales estimate for the Merck drug in half to $800 million in annual revenue by 2018. The analyst said he adjusted his estimate after consulting with leading doctors who felt that Tredaptive’s safety profile was no different than Niaspan’s. Read Niaspan’s label here
. Tredaptive includes a drug, laropiprant, designed to offset the niacin side effect of facial flushing.
Fernandez gave Merck’s study of Tredaptive a 50-50 chance of success. He said the release of the study data would be a “potential watershed event” for Merck.
Other analysts had more conservative estimates for Tredaptive. Credit Suisse analyst Catherine Arnold projected peak annual sales of $350 million by 2020.
Merck officials seemed to be at a loss for words to explain the drug’s failure.
“We are committed to working closely with the independent research team at Oxford University and with regulatory agencies to understand the results and determine next steps,” Merck’s R&D chief Peter S. Kim says in a statement.
No positions in stocks mentioned.
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