Merck (NYSE: MRK), known as MSD outside the United States and Canada,
announced today an update on the Phase III trial assessing fracture risk
reduction with odanacatib, Merck's investigational cathepsin K (cat-K)
inhibitor. The Data Monitoring Committee (DMC) for the study recently
completed its first planned interim analysis for efficacy and
recommended that the study be closed early due to robust efficacy and a
favorable benefit-risk profile. As a result, Merck will begin taking
steps to close the trial. The DMC noted that safety issues remain in
certain selected areas and made recommendations with respect to
following up on them. Merck's previously announced plan to conduct a
blinded extension trial will allow further monitoring of the issues. The
extension trial will also continue to measure efficacy.
Merck anticipates submitting regulatory applications for approval of
odanacatib in the U.S., European Union (EU) and Japan in the first half
of 2013.
"We are encouraged by the Data Monitoring Committee's recommendation to
close the trial early," said Peter S. Kim, Ph.D., executive vice
president, Merck and president, Merck Research Laboratories, "and look
forward to reviewing the data with the scientific community to bring
forward this innovation."