FDAnews Drug Daily Bulletin


March 31, 2006

Two top executives at NitroMed have resigned amid slow sales of the heart-failure drug BiDil, the first product indicated specifically for African Americans.

NitroMed recently announced the resignations of CEO Michael Loberg and chief financial officer (CFO) Lawrence Bloch. The company has appointed Argeris Karabelas as interim CEO and Kenneth Bate as CFO.

During a recent conference call, Karabelas said NitroMed's board "felt it was time for a course correction."

Sales of BiDil (isosorbide dinitrate/hydralazine hydrochloride) have not met expectations because of problems with insurance reimbursement, sales productivity and product promotion, executives said during the conference call. BiDil sales were only $4.5 million in 2005, well below analyst estimates.

The drug was launched last July after a study found that black patients with heart failure experienced a 43 percent improvement in survival after taking BiDil, compared to those taking standard heart-failure therapy plus a placebo.

NitroMed has struggled to get insurance companies to put BiDil on their list of preferred drugs, because it is composed of two generics already available to patients.

"There is absolutely no question of the value of BiDil in the treatment of congestive heart failure in African Americans," Karabelas said. "We need to forcefully get this point across to managed care and also to be flexible in our contracts so we can achieve access, which is what we need to drive sales."