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ENHANCE Results Do Little To Enhance Merck’s Statin Product Outlook

This article was originally published in The Tan Sheet

Executive Summary

The Merck/Schering-Plough combination cholesterol therapy Vytorin has failed to demonstrate significant benefit over simvastatin alone in preventing formation of arterial plaque in the ENHANCE trial

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Sales & Earnings In Brief

Schering-Plough: Consumer health care sales advanced 2 percent in the firm's fiscal 2008 second quarter to $401 million, benefiting from the performance of laxative MiraLAX, which had sales of $28 million in the period, the Kenilworth, N.J.-based company reports July 21. MiraLAX, which was launched in February 2007 as the first Rx-to-OTC switch in the laxative category in more than 30 years, has reached the same market share as Metamucil in the powder laxative category, S-P claims ("The Tan Sheet" Dec. 11, 2006, p. 17). Consumer health sales growth was offset, however, by lower sales of OTCClaritin, which was negatively impacted by the timing of shipments, a less severe allergy season and increased competition, the company notes. Net sales in the quarter advanced 54.8 percent to $4.92 billion, including sales of Organon BioSciences, which S-P purchased in November. Net income fell 19 percent to $436 million, in part reflecting acquisition costs. The firm declined to comment on future plans for cholesterol-lowering drug Vytorin following news that it failed to benefit patients with a rare heart valve disorder. S-P markets Vytorin through a joint-venture with Merck...

Panel disputes Vytorin-cancer link

The Clinical Trials Service Unit at the University of Oxford, U.K., says data "do not provide credible evidence" that the Vytorin lipid-lowering combination product increases cancer risk. The independent oncology review panel says July 21 a previous trial suggesting the cancer link should not derail Vytorin's promise as a cardiovascular therapy. However, the panel said no significant difference appeared between patients taking Vytorin and placebo on the combined primary endpoint of major cardiovascular events caused by either atherosclerosis or aortic valve disease, or by aortic stenosis alone. This finding follows concerns raised about the general efficacy of the combination of Schering-Plough's Zetia (ezetimibe) and Merck's Zocor (simvastatin) by unfavorable results from the companies' Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial. The ENHANCE data, released in January two years after the study's conclusion, showed Vytorin had no significant edge over simvastatin alone in preventing formation of arterial plaque (1"The Tan Sheet" Jan. 21, 2008, p. 12)...

Panel disputes Vytorin-cancer link

The Clinical Trials Service Unit at the University of Oxford, U.K., says data "do not provide credible evidence" that the Vytorin lipid-lowering combination product increases cancer risk. The independent oncology review panel says July 21 a previous trial suggesting the cancer link should not derail Vytorin's promise as a cardiovascular therapy. However, the panel said no significant difference appeared between patients taking Vytorin and placebo on the combined primary endpoint of major cardiovascular events caused by either atherosclerosis or aortic valve disease, or by aortic stenosis alone. This finding follows concerns raised about the general efficacy of the combination of Schering-Plough's Zetia (ezetimibe) and Merck's Zocor (simvastatin) by unfavorable results from the companies' Ezetimibe and Simvastatin in Hypercholesterolemia Enhances Atherosclerosis Regression trial. The ENHANCE data, released in January two years after the study's conclusion, showed Vytorin had no significant edge over simvastatin alone in preventing formation of arterial plaque (1"The Tan Sheet" Jan. 21, 2008, p. 12)...

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