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12:00 AM
 | 
Dec 06, 2010
 |  BioCentury  |  Product Development

A Different Kettle of Fish

Taking on Lovaza: Amarin's AMR101 doesn't increase LDL cholesterol

Very high triglyceride levels can be controlled with purified omega-3 fatty acids and fibrates, but these therapies can also lead to significant elevation in LDL cholesterol, requiring the addition of a statin. Amarin Corp. plc believes its omega-3 product, AMR101, could be best in class based on Phase III data showing significant triglyceride reduction without an increase in LDL-C in patients with severe hypertriglyceridemia.

Next year, the company expects data from a second Phase III trial and a possible NDA submission.

Last week, Amarin reported that 2 and 4 g/day of AMR101 met the primary endpoint of significantly reducing triglycerides from baseline to week 12 vs. placebo in the Phase III MARINE trial to treat patients with severe hypertriglyceridemia (>=500 mg/dL). The 2 and 4 g doses reduced median triglyceride levels by 20% and 33% compared to placebo (p=0.0051 and p<0.0001).

The trial's SPA required a p-value of <=0.01 to...

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