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Amgen gains on evolocumab update

March 31, 2014 11:42 PM UTC

Amgen Inc. (NASDAQ:AMGN) gained $2.79 to $123.34 on Monday after the company for the first time provided detailed data from five Phase III trials of subcutaneous evolocumab ( AMG 145). The company previously said evolocumab once monthly or once every two weeks met the co-primary endpoints in the trials, but had not disclosed the magnitude of the reductions. This year, Amgen plans to submit global regulatory applications for the human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9).

The co-primary endpoints for four of the trials were mean percent LDL-C reductions from baseline to week 12 and percent reduction to weeks 10 and 12. The trials were MENDEL-2 to treat hyperlipidemia; GAUSS-2 trial to treat hyperlipidemia in statin-intolerant patients; LAPLACE-2 trial to treat primary hypercholesterolemia and mixed dyslipidemia; and RUTHERFORD-2 to treat heterozygous familial hypercholesterolemia (heFH). The active comparator for MENDEL-2, GAUSS-2 and LAPLACE-2 was Zetia ezetimibe from Merck & Co. Inc. (NYSE:MRK). ...