Merck & Co delays 2007 filing of MK-524B on formulation issue, pre-2009 launch unlikely

Merck & Co says it will delay filing an investigational triple combination cholesterol pill because of unspecified formulation difficulties. The US drug major, which had originally planned to file MK-0524B with regulators worldwide in 2007, has not set a new date for submission although it is unlikely to hit the market before 2009.

The agent, a fixed-dose combination of a DP-1 selective inhibitor coupled with extended-release niacin, called MK-0524A, and the Merck-originated cholesterol-lowering drug Zocor (simvastatin), is one of several potentially-lucrative products hoped to reverse the firm's ailing fortunes after costly litigation over withdrawn painkiller Vioxx (rofecoxib; Marketletters passim).

On the day of the news, September 29, shares in the New Jersey-based company fell $0.15 to $49.39. Gustav Ando, an analyst with Global Insights, noted the the agent is one of the biggest, most promising potential billion-dollar drugs in Merck's development pipline. "The announcement creates significant uncertainty around a company that has already been suffering from numerous problems in its research department, which was once the envy of the global pharmaceutical industry," he said. Global Insight sees the revised timeline as a big problem for the company, though it does not believe that there will be a knee-jerk reaction to go out and acquire drugs to replace MK-524B as it is a delay and not a termination of development.