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Comparative trial of Merck & Co., Schering-Plough's
Zetia and Abbott's Niaspan halted early
  July 09, 2009
by Anna Bratulic
A comparative Phase IV study of Merck & Co. and Schering-Plough's Zetia (ezetimibe) and Abbott's Niaspan (niacin) was stopped early last month, according to a notice posted on the US National Institutes of Health's online registry of clinical trials. The posting indicated that an "independent steering committee has stopped the trial based on results of a pre-specified, blinded interim analysis," and that the decision was not due to safety concerns. Merck's shares fell as much as 5 percent on the news.
Abbott is listed as one of the trial's sponsors and collaborators, though spokespeople for the drugmaker, as well as those for the joint venture between Merck and Schering-Plough, said they did not know why the study ended and were not involved in the decision. The trial's lead investigator, Allen Taylor, declined to disclose the reason for the termination, adding that more information may be provided at a later date.
The randomised ARBITER 6 - HALTS trial began in November 2006 with a planned enrollment of 400 patients who had atherosclerotic coronary or vascular disease, or who were at high cardiovascular risk due to certain other medical conditions. The study, which was expected to conclude later this year, was designed to compare HDL- and LDL-focused dyslipidaemia treatment strategies on carotid atherosclerosis. The primary endpoint was change in carotid intima-media thickness after 14 months, according to the NIH registry.
Commenting on the development, Wells Fargo Securities analyst Larry Biegelsen speculated that "Niaspan likely performed better than Zetia in the HALTS study," estimating that positive data could eventually add as much as $400 million in sales for Abbott's product. In addition, Natixis Bleichroeder's Jon LeCroy, who said a positive or negative outcome for either drug could lead to a rise or fall in prescriptions of up to 20 percent, remarked: "We are now assuming that this trial significantly favoured Niaspan and, as a result, we are decreasing our sales estimates for both Zetia and [Merck and Schering-Plough's] Vytorin." Analyst Barbara Ryan of Deutsche Bank stated, however, that the negative impact on Merck's stock was "extremely premature and probably unwarranted."
Zetia generated revenue of $2.2 billion last year, while Niaspan garnered $786 million in sales.
Reference Articles
Merck falls after study of cholesterol drugs halted - (Bloomberg)
Merck shares fall on cholesterol study concerns - (CNBC)
Comparative study of the effect of ezetimibe versus extended-release niacin on atherosclerosis - (NIH)
Merck, Schering shares hit by early end to cholesterol trial (free preview) - (The Wall Street Journal)
Trial of cholesterol drugs terminated (free preview) - (The Wall Street Journal)
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