Amgen to submit evolocumab apps this year

Amgen Inc. (NASDAQ:AMGN) reported data from a fourth Phase III trial evaluating the company's evolocumab ( AMG 145) and disclosed that it plans to submit global regulatory applications this year for the human mAb against proprotein convertase subtilisin/kexin type 9 (PCSK9). Subcutaneous evolocumab given once monthly or every two weeks met the co-primary endpoints in the 1,896-patient LAPLACE-2 trial for primary hypercholesterolemia and mixed dyslipidemia. All patients in the trial also received daily statin therapy. Last week, Amgen said evolocumab met the same co-primary endpoints -- percent reduction in LDL-C from baseline to week 12 and mean percent reduction in LDL-C from baseline to weeks 10 and 12 vs. once-daily oral Zetia ezetimibe from Merck & Co. Inc. (NYSE:MRK) -- in a third trial in patients with hyperlipidemia. The trials are part of the 13-trial Phase III program for evolocumab (see BioCentury Extra, Jan. 23).

At the JPMorgan Healthcare Conference earlier this month, Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said it is planning to submit regulatory applications for its own anti-PCSK9 mAb -- alirocumab ( REGN727) -- in 2015. In October, Regeneron and partner Sanofi (Euronext:SAN; NYSE:SNY) reported the first Phase III data for alirocumab (see BioCentury Extra, Oct. 16, 2013). ...