Merck Statement on Clinicaltrials.gov Update Regarding the IMPROVE-IT Trial

WHITEHOUSE STATION, N.J., Jan. 7, 2010 – Merck submitted an update to clinicaltrials.gov to include a date of June 2013 as the new forecasted date for the completion of the IMPROVE-IT study. The revision is based on updated estimates reviewed by the IMPROVE-IT Executive Committee and Merck. The estimate for this event-driven trial reflects the most recent information on the pace of enrollment and the accumulation of clinical endpoints to date, and takes into account the minimum two and one-half years of follow-up called for in the study design.

It is difficult to predict specific conclusion dates for event-driven trials, particularly for large trials such as IMPROVE-IT, because of the variability in several factors, such as enrollment, discontinuation rates, and varying rates at which cardiovascular events occur. The Executive Committee and Merck will continue to monitor the progress of the study closely and update the timeline as appropriate.

There are currently approximately 16,000 patients enrolled in IMPROVE-IT; the study is planned to include up to 18,000 patients.

As previously disclosed, the Data Safety Monitoring Board will conduct an interim analysis for efficacy later this year when approximately fifty percent of the pre-specified (5,250) clinical endpoints have occurred. In addition, the IMPROVE-IT Executive Committee and Merck have developed a plan for the Data Safety Monitoring Board to conduct an additional interim efficacy analysis when approximately seventy-five percent of the pre-specified endpoints have been reached, which could result in an earlier completion of the study.

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