FDA to review Merck, Schering-Plough trial of cholesterol drug Vytorin

SAN FRANCISCO, Jan 26, 2008 (Thomson Financial via COMTEX) -- SGP | news | PowerRating | PR Charts -- The Food and Drug Administration said Friday it plans to conduct a review of Merck & Co. and Schering-Plough Corp.'s recent trial of Vytorin, a cholesterol-lowering drug developed by the companies, once the agency receives the final study results.

The results of the trial showed no significant difference between Vytorin and Zocor in the build up of cholesterol plaque in the neck arteries, the companies said.

The FDA's early communication followed questions that were raised in the study regarding the effectiveness of Vytorin.

In a statement earlier Friday, the companies said they "strongly object to mischaracterizations about the Enhance" trial.

"While the Enhance trial was time consuming and took longer than originally anticipated to complete, our companies acted with integrity and good faith in connection with the trial. We took numerous actions to assure the quality of the reading of the ultrasound images," Thomas Koestler, president of Schering-Plough Research Institute, said in a statement.

Vytorin is a combination of Schering-Plough's Zetia and Merck's Zocor, which lost patent protection in June 2006. A generic equivalent of Zocor is available at a lower cost.

Merck shares were down $2.73, or 5.5%, at $46.83, while Schering-Plough's stock was down $1.63, or 7.8%, at $18.54. Katherine Hunt kh/vj

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