Healthcare Industry News: MK-0524A
News Release - September 29, 2006
Merck Revises Regulatory Filing Timeline for MK-0524B, an Investigational Fixed-Dose Combination of MK-0524A and SimvastatinPhase III Studies Continue with MK-0524A Co-Administered with Simvastatin
WHITEHOUSE STATION, N.J.--(HSMN NewsFeed)--Merck & Co., Inc. today revised its filing plans for MK-0524B, its investigational fixed-dose combination of MK-0524A (a DP-1 selective inhibitor coupled with extended-release niacin) and simvastatin (ZOCORŪ(1)), confirming it will not file a worldwide marketing application in 2007. Late-stage clinical trials to support MK-0524B continue, with MK-0524A co-administered with simvastatin, as the Company continues to work on developing the fixed-dose combination formulation.
A new filing date for the fixed-dose combination of MK-0524B has not been determined.
Merck also confirmed that the clinical development program for MK-0524A continues unchanged, and the Company remains committed to filing MK-0524A in 2007. Oxford University announced in May 2006 it will conduct a 20,000-patient international study, known as HPS2-THRIVE (Treatment of HDL to Reduce the Incidence of Vascular Events), with MK-0524A plus simvastatin to investigate the benefit of the co-administration on cardiovascular disease. Preparations for patient enrollment continue as planned.
Merck announced its regulatory filing plans for MK-0524B in December 2005. The Company notified investigators in February 2006 that the MK-0524B Phase III program would continue with MK-0524A co-administered with simvastatin because of formulation issues with the fixed-dose combination. The Company's plans to bridge data from studies with MK-0524A co-administered with simvastatin to the MK-0524B fixed-dose combination remain unchanged.
MK-0524A is an investigational compound being developed for the treatment of atherosclerosis by raising HDL-C and lowering LDL-C and triglyceride levels. A combination of extended-release niacin and a selective flushing pathway inhibitor (DP-1 selective antagonist), MK-0524A will potentially reduce the risk of coronary heart disease (CHD). MK-0524B would provide the proven cardiovascular benefits of two widely recognized agents, MK-0524A and simvastatin, in a single tablet.
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 & Co., Inc. 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 cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the company incorporates by reference.
(1)ZOCORŪ (simvastatin) is a registered trademark of Merck & Co., Inc.
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