Merck Vytorin study to continue after panel review

Pharmaceutical company Merck & Co Inc said on Tuesday an independent monitoring board had allowed it to continue with a large trial assessing the safety and effectiveness of its Vytorin cholesterol treatment.

The panel’s decision suggests that no safety concerns have arisen for Vytorin.

The study, called IMPROVE-IT, will continue to its conclusion in September 2014, the drugmaker said. e study is looking at whether Vytorin, whose annual sales total $1.75 billion, can significantly reduce heart attacks, strokes and heart-related deaths compared with Merck’s older, generically-available Zocor.

Some analysts had hoped the panel, which has the right to look at data from the ongoing study, would rule that Vytorin’s effectiveness had already been proven and would order that the trial, which involves 18,141 patients, be halted.

Merck shares were up 4.5 percent in premarket trading.

The news may bolster hopes for a rebound in sales of Vytorin and a related Merck cholesterol fighter called Zetia. Analysts have said Merck shares are lagging as investors wait for the results of the study.

The IMPROVE-IT study involves patients with well-controlled cholesterol who had heart attacks or the kind of chest pain that can precede heart attacks.

Vytorin, approved in 2004, combines Zocor with Zetia, so the study is a measure of the clinical benefit of adding Zetia, which lowers bad LDL cholesterol by blocking the liver’s production of the blood fat.

Zetia, which is sold separately and has annual sales of almost $2.6 billion, is prescribed by doctors as a stand-alone treatment or to add to the cholesterol-lowering power of Statins such as Zocor or Lipitor.

Sales of Vytorin and Zetia have fallen since 2008 because of concerns about their effectiveness and safety.

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Reuters