Merck Provides Update on IMPROVE-IT Trial
March 12, 2013 8:00 am ET
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 its planned review of study data and
recommended that the study continue.
The study design calls for the collection of 5,250 clinical endpoints.
Merck remains blinded to the actual results of this analysis and to
other IMPROVE-IT safety and efficacy data.
IMPROVE-IT is an 18,141 patient event-driven trial, and based on the
targeted number of clinical endpoints and the rate at which events are
being reported, the trial is projected to conclude in September 2014.
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. No additional interim analyses are planned.
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This news release includes “forward-looking statements” within the
meaning of the safe harbor provisions of the United States Private
Securities Litigation Reform Act of 1995. These statements are based
upon the current beliefs and expectations of Merck’s management and are
subject to significant risks and uncertainties. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
Risks and uncertainties include but are not limited to, general industry
conditions and competition; general economic factors, including interest
rate and currency exchange rate fluctuations; the impact of
pharmaceutical industry regulation and health care legislation in the
United States and internationally; global trends toward health care cost
containment; technological advances, new products and patents attained
by competitors; challenges inherent in new product development,
including obtaining regulatory approval; Merck ability to accurately
predict future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign risk;
dependence on the effectiveness of Merck patents and other protections
for innovative products; and the exposure to litigation, including
patent litigation, and/or regulatory actions.
Merck undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise. Additional factors that could cause results to differ
materially from those described in the forward-looking statements can be
found in Merck’s 2012 Annual Report on Form 10-K and the company’s other
filings with the Securities and Exchange Commission (SEC) available at
the SEC’s Internet site (www.sec.gov).
Kelley Dougherty, 908-423-4291
Skip Irvine, 267-305-5397
Carol Ferguson, 908-423-4465
Justin Holko, 908-423-5088