Shares of Amarin ($AMRN) doubled this morning after the developer announced a second round of upbeat Phase III data for its triglyceride drug, putting it on a path to a regulatory filing later this year. Investigators say that the biotech's lead drug, AMR101, met primary and secondary endpoints in the study, which follow on the heels of its promising Phase III trial late last year. And the news spurred its share price, which doubled this morning in the wake of Amarin's release.
Investigators hit their key marks in the study: A significant drop in triglycerides without a rise in LDL-C, the bad form of cholesterol. AMR101 is a clinical formulation of omega-3, a fish oil commonly recommended for regular consumption. According to Amarin, "the primary endpoint for triglyceride change was achieved at both four grams and two grams per day with median placebo-adjusted reductions in triglyceride levels of 21.5% and 10.1% for the four grams and two grams per day dose groups."
"The design and execution of the Anchor trial were robust and the trial results were very clearly positive," said Christie M. Ballantyne, M.D., the principal investigator. "I am very impressed with the performance of AMR101. In particular, whereas current triglyceride-lowering drugs may raise LDL-C and causes patient treatment concerns, AMR101 demonstrated a decrease in LDL-C beyond the decrease created by statin therapy. Furthermore, it is very encouraging for patient care that AMR101 caused reductions in significant markers of cardiovascular risk such as Apo B and non-HDL-C. The greater triglyceride reduction in patients with higher potency statin regimens is also very encouraging."
In a note this morning, Canaccord Genuity life sciences analyst Ritu Baral stated: "We think AMRN may submit the AMR101 NDA for very high triglycerides in Q3/11 and get approval in H1/12."
- here's the Amarin release