October 10, 2006
Merck delays filing for cardio combo pill
Merck said it has pushed back regulatory plans for an experimental cardiovascular pill that has been hailed by some as a possible follow-on to blockbuster cholesterol drug Zocor. The company will not file a worldwide marketing application next year for MK-524B, its investigational combination drug containing simvastatin and a novel compound said to raise good cholesterol and lower bad cholesterol and triglyceride levels. Late-stage clinical trials continue, although a new filing date has not been determined. While the fixed-dose combo pill’s schedule is delayed, Merck said it’s on track to file MK-524A, the code name for the novel half of the compound, in 2007. Merck had announced earlier this year that, due to formulation issues with the fixed-dose combination, the MK-524B Phase III program would continue with MK-524A co-administered with simvastatin. Merck’s cardiovascular pipeline has been a closely watched one, especially since last December when the company announced its regulatory filing plans for MK-524B. Merck is looking to replace Zocor, which went off patent in June. Separately, the Star-Ledger reported that Merck has been secretly testing a so-called CETP-inhibitor, a type of drug that lowers bad cholesterol and raises good cholesterol. The company registered a clinical trial for a cholesterol agent, dubbed MK-0859, on clinicaltrials.gov, the federal site that tracks drug company studies. The site notes that the agent is in Phase II testing. A Merck spokesman told The Star-Ledger it has not confirmed the agent’s mechanism of action and that it would likely do so at an upcoming business briefing in December.