MYSTIC, Conn. (
medicinal-grade fish oil drug AMR101 significantly lowered triglyceride levels without raising "bad" LDL cholesterol, according to results of a late-stage study reported Monday.
That's the exact same lede I used last November when
Amarin reported strongly positive results from the first phase III study of AMR101
known as "Marine." Today's data from the second phase III "Anchor" study of AMR101 are equally positive and impressive -- perhaps even more so because the patients enrolled were already being treated with cholesterol-lowering statin drugs like Zocor, Crestor and Lipitor.
Amarin shares were up 65% to $14.50 in pre-market trading Monday. The stock closed Friday at $8.77.
Amarin plans to seek U.S. approval of AMR101 before the end of the third quarter. AMR101, if approved, has the potential to be a blockbuster drug generated well over $1 billion in annual sales.
AMR101 is an
ultra-purified form of the omega-3 fatty acid known as Ethyl EPA
The Anchor study enrolled patients with "mixed" trigylceride baseline levels (200-500 mg/dl) who were also on statin therapy. This is a patient population about 10 times larger than the patient population targeted in the Marine study, in which patients had very high, uncontrollable trigylceride levels.
Treatment with a 4 gram and 2 gram doses of AMR101 resulted in placebo-adjusted reductions in triglyceride levels of 21.5% and 10.1%, respectively. These results were statistically significant and met the primary endpoint of the Anchor study, Amarin said.
Just as importantly, patients treated with the 4-gram dose of AMR101 reported a 6.2% reduction in levels of LDL cholesterol, demonstrating statistically significant superiority over placebo. The lower 2-gram dose of AMR101 demonstrated a 3.6% reduction in LDL cholesterol versus placebo but this result was not statistically significant.
"I am very impressed with the performance of AMR101," said Dr. Christie Ballantyne of Houston's Methodist DeBakey Heart and Vascular Center and the principal investigator of the Anchor trial," in a statement. "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."
(GSK - Get Report)
sells a competing prescription fish oil pill known as Lovaza that generates close to $1 billion in annual sales. Lovaza, however, isn't used to treat patients with mixed triglyceride levels because the drug causes elevations of LDL or "bad" cholesterol levels.