(Updates stock price.)
MYSTIC, Conn. (
medicinal-grade fish oil drug AMR101 significantly lowered triglyceride levels without raising "bad" LDL cholesterol, according to results of late-stage study reported Monday.
Amarin said AMR101 met all the efficacy and safety endpoints in the phase III study and as a result, the company will seek U.S. approval next year instead of in 2012 as had been in expected.
Amarin shares were up about 62% to $5.75 in early Monday's trading.
AMR101 is an
The phase III study known as "MARINE" enrolled patients with very high triglyceride baseline levels above 500 mg/dl and treated them with two doses of AMR101 or a placebo for 12 weeks. Twenty-five percent of the patients were also on background cholesterol-lowering statin therapy.
Patients treated with the 4 grams/day (high dose) of AMR101 showed a median triglyceride reduction of 33% compared to placebo. Patients treated with the 2 grams/day (low dose) of AMR101 had a 20% reduction in triglycerides compared to placebo. The reductions in both groups were statistically significant.
Patients entered the AMR101 study with median baseline triglyceride levels ranging from approximately 650 mg/dl to 700 mg/dl. Doctors generally consider normal triglyceride levels to be around 150 mg/dl or lower.
markets a prescription fish oil drug known as Lovaza that demonstrated a 45% reduction in triglyceride levels, according to the drug's label. While this appears superior to AMR101, the baseline triglyceride level of patients in the pivotal Lovaza study was around 800 mg/dl -- higher than it was in Amarin's MARINE study.
Amarin says AMR101 was even more effective for a subset of patients in the MARINE study with baseline triglycerides in the 900-1,000 mg/dl range, or comparable to patients described in the Lovaza label.
For these patients, treatment with the high dose of AMR101 led to a 45% reduction in triglycerides.
Treatment with AMR101 also did not result in a statistically significant increase in levels of LDL or "bad" cholesterol compared to placebo Patients treated with the high and low doses of AMR101 reported a 2.3% drop and a 5.2% increase in LDL cholesterol, respectively, verus placebo.
Treatment with AMR101 at both doses resulted in lower overall cholesterol compared to placebo when levels of HDL or "good" cholesterol were factored in.
By comparison, Glaxo's Lovaza causes an increase in the level of LDL or "bad" cholesterol, which is one reason why the drug's use is restricted to patients with very high baseline triglyceride levels.
Amarin is conducting a second phase III study of AMR101 enrolling patients with lower or "mixed" baseline levels of triglyceride, with results expected next year.
Amarin is also expected to seek a partner for AMR101 or sell the company outright
Glaxo acquired rights to Lovaza when it purchased Reliant Pharmaceuticals in 2007 for $1.6 billion. Lovaza generates about $1 billion in annual sales.
--Written by Adam Feuerstein in Boston.
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