Amarin, others fall on endpoint update
Amarin Corp. plc (NASDAQ:AMRN) and several companies developing lipid lowering compounds slipped on Wednesday following news that FDA no longer considers a change in serum triglyceride levels sufficient to "establish the effectiveness" of a drug for reducing cardiovascular risk in patients with triglyceride levels less than 500 mg/dL. Amarin -- which is seeking to expand the label of its hypertriglyceridemia drug Vascepa icosapent ethyl based on the endpoint -- disclosed the news in an SEC filing late Tuesday. Amarin was off $0.29 (14%) to $1.81 on Wednesday (see BioCentury Extra, Oct. 29).
Despite reporting 3Q13 earnings that beat the Street on Wednesday, Aegerion Pharmaceuticals Inc. (NASDAQ:AEGR) fell $8.07 to $85.25 on the news. The company markets Juxtapid lomitapide for homozygous familial hypercholesterolemia (hoFH), a rare genetic disease where patients typically have triglyceride levels over 500 mg/dL. Isis Pharmaceuticals Inc. (NASDAQ:ISIS) also slipped $1.72 to $34.22 on Wednesday. The company is evaluating ISIS-APOCIIIRx, an apolipoprotein C-III ( APOC3) antisense inhibitor, in a Phase II trial to treat hypertriglyceridemia in patients with triglyceride levels greater than 500 mg/dL. The primary endpoint in that trial is percent change in fasting plasma triglycerides. ...