Merck & Co., Inc. Revises Regulatory Filing Timeline For MK-0524B, An Investigational Fixed-Dose Combination Of MK-0524A And Simvastatin; Kos Pharmaceuticals Shares Rise On Merck Delay
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.
About Merck
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.
Forward-Looking Statement
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(1)ZOCOR® (simvastatin) is a registered trademark of Merck & Co., Inc.
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Source: Merck & Co., Inc.