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.
This material may not be published, broadcast, rewritten or redistributed in any form without prior authorization.