ViroPharma's stock plunged almost 50 percent on the news that its drug maribavir did not achieve the primary endpoint of a Phase III trial. In the primary analysis, there was no statistically significant difference between maribavir and placebo in reducing the rate of cytomegalovirus (CMV) disease in bone marrow transplant patients. In 681 subjects, 4.4 percent of those taking maribavir contracted the disease within six months of a transplant, compared to 4.8 percent of placebo patients. The study also failed to meet its key secondary endpoints.
The results shocked both the company and investors because earlier studies indicated the treatment was effective. ViroPharma is badly in need of a new approval due to the fact that its primary source of revenue--the antibiotic Vancocin--is facing generic competition.
"We are extremely disappointed by the outcome of this pivotal study," said Vincent J. Milano, ViroPharma's president and chief executive officer. "We just received these data and there are far more questions than answers; we still have a significant amount of work to do to fully understand this outcome and its impact on the overall program. ViroPharma, which is also testing the therapy in liver transplant patients, said it had no plans to halt that ongoing trial.
- take a look at ViroPharma's release
- see the Dow Jones report