Roche discontinues dalcetrapib
Roche (SIX:ROG; OTCQX:RHHBY) lost CHF5 billion ($5.4 billion) in market cap on Monday after discontinuing development of cardiovascular compound dalcetrapib. The pharma, which now has a market cap of CHF138.6 billion ($150.2 billion), said the compound showed a "lack of clinically meaningful efficacy" in a second interim analysis of the Phase III dal-OUTCOMES trial in more than 15,000 patients with stable coronary heart disease following a recent acute coronary syndrome (ACS).
According to the study's DSMB, once-daily oral dalcetrapib plus standard of care was not going to show a 15% risk reduction on the composite primary endpoint of time to first occurrence of CHD death, non-fatal acute myocardial infarction, hospitalization for unstable angina, resuscitated cardiac arrest or stroke vs. placebo plus standard of care. No safety signals were reported. Standard of care included management of LDL-C and best evidence-based medical care. All remaining studies in the dal-HEART development program for dalcetrapib have been terminated. These include the Phase III dal-OUTCOMES 2, dal-ACUTE and dal-PLAQUE 2 trials. Dalcetrapib is a small molecule inhibitor of cholesteryl ester transfer protein (CETP). ...