Reuters: Regulatory News: UPDATE 1-Merck says key Vytorin study cleared to continue

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UPDATE 1-Merck says key Vytorin study cleared to continue Mar 28th 2012, 12:57 Wed Mar 28, 2012 8:57am EDT * No results given for interim look at Improve-It trial * Merck says safety monitors to look at data in 9 months By Lewis Krauskopf March 28 (Reuters) - A closely watched study of Merck & Co Inc's Vytorin cholesterol treatment was cleared to continue by safety monitors, the drugmaker said on Wednesday. Wall Street has been eagerly anticipating the interim report for the 18,000-patient Improve-It study to see whether Vytorin is helping improve heart outcomes, and thereby increase sales for the franchise. However, Merck did not release any data on Wednesday, saying it has not seen the results of the interim analysis. It said only that the safety monitors overseeing the trial recommended it continue without change and that they plan to review the data again in about nine months. Vytorin is a combination of Merck's older statin cholesterol fighter Zocor and Zetia, a newer medicine which cuts bad "LDL" cholesterol through a different pathway. Vytorin and Zetia tallied sales of $4.3 billion combined last year, or about 9 percent of Merck's total, but product sales have somewhat stalled since a 2008 study called Enhance raised questions about their effectiveness. Investors have been hoping that the Improve-It trial could revive fortunes for the products, whose prospects are even more challenged now that Pfizer Inc's blockbuster Lipitor statin is available as a low-cost generic. In the Improve-It study, patients with acute coronary syndrome are being given either Vytorin or Zocor, which is now available as a generic and is also known as simvastatin. The study is examining whether Vytorin reduces risk of death, heart attacks and strokes. The safety monitors conducted the interim analysis after the trial reached 75 percent of the 5,250 clinical events called for in the design of the study. The study is projected to finish in 2013, but Merck said the timeline may change depending on the rate of clinical events. Sanford Bernstein analyst Tim Anderson said positive results would probably somewhat reignite sales of Vytorin and Zetia, and vindicate Merck, which was harshly criticized in the wake of the Enhance results. But Anderson doubted positive results would significantly boost Merck's share price given Lipitor's availability as a generic and competition from AstraZeneca's Crestor. Link this Share this Digg this Email Reprints

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