Merck Provides Update on U.S. Regulatory Status of MK-0524A (ER niacin/laropiprant) and MK-0524B (ER niacin/laropiprant/simvastatin)
Merck recently met with the U.S. Food and Drug Administration (FDA) to discuss the Not Approvable action letter it received on April 28 in response to its New Drug Application (NDA) for MK-0524A. At the meeting, the FDA stated that additional efficacy and safety data were required and suggested that the Company wait for the results of the HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events) cardiovascular outcomes study, which is expected to be completed in January 2013.
The Company said it will continue to discuss with the FDA whether data can be provided prior to the completion of the HPS2-THRIVE study that would address the issues raised by the agency and allow for an earlier filing. In that event, the earliest Merck would file a complete response to the FDA action letter would be 2010. In addition, Merck will not seek approval for MK-0524B in the United States until it files its complete response relating to MK-0524A.
"We are disappointed, but continue to have confidence in the potential of MK-0524A to provide physicians with an important option to manage their patients' cholesterol," said Peter S. Kim, Ph.D., executive vice president and president, Merck Research Laboratories.
The clinical development program for MK-0524A continues, including the 20,000-patient HPS2-THRIVE study. That study has already enrolled 12,000 patients. It is being conducted by Oxford University and is funded through a grant from Merck.
In other countries around the world, Merck continues to pursue regulatory approvals for MK-0524A and MK-0524B.
Merck also reiterated its confidence in meeting the Company's goal of double-digit compound annual EPS growth from 2005 through 2010 excluding certain items.
Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the risk factors and cautionary statements in Item 1A of Merck's Form 10-K for the year ended Dec. 31, 2007, and in any risk factors or cautionary statements contained in the Company's periodic reports on Form 10-Q or current reports on Form 8-K, which the Company incorporates by reference.
Merck & Co., Inc.
Ron Rogers, 908-423-6449
Eva Boratto, 908-423-5185
Mike Nally, 908-423-4465
Posted: June 2008