Merck Provides Update on IMPROVE-IT Trial


March 28, 2012 8:00 am ET

WHITEHOUSE STATION, N.J., March 28, 2012 – Merck, (NYSE:MRK), known as MSD outside the United States and Canada, today said that the Data Safety Monitoring Board (DSMB) of the IMPROVE-IT trial has completed the second pre-specified interim efficacy analysis of the study. The DSMB recommended that the study continue without change in design and stated it plans to review the data again in approximately nine months.

The DSMB conducted the planned interim efficacy analysis after the trial had reached approximately 75 percent of the 5,250 clinical endpoints called for in the study design. Merck remains blinded to the actual results of the interim analysis and to other IMPROVE-IT safety and efficacy data.

IMPROVE-IT is an 18,000 patient event-driven trial, and based on the targeted number of clinical endpoints and the current rate at which events are being reported, the projected 2013 study completion date may change. The IMPROVE-IT Executive Committee and Merck will continue to monitor the progress of the study, and Merck will update the study timeline if appropriate.

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The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.

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