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.
Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.
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. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.
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.
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 2011 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).