An­a­lysts of­fer a luke­warm en­dorse­ment to Am­gen for PhI­II mi­graine da­ta; Ar­sa­nis rais­es $45.5M Se­ries D; Co­v­ance faces re­struc­tur­ing

→ An­a­lysts took a look at the da­ta on Am­gen’s lat­est Phase III for CGRP mi­graine drug erenum­ab (AMG334) and came away re­as­sured, but per­haps a bit unim­pressed. Here’s Leerink’s Ge­of­frey Porges: “The da­ta con­firm the am­ple ev­i­dence from phase 2 tri­als that sug­gest­ed that cal­ci­tonin gene-re­lat­ed pep­tide (CGRP) re­cep­tor block­ade will pro­vide the first-ever mi­graine tar­get­ed pre­ven­tion phar­ma­ceu­ti­cal treat­ment. Both tri­als demon­strat­ed the su­pe­ri­or­i­ty of AMG334 to place­bo on both the pri­ma­ry and sec­ondary end­points, as well as show­ing ex­cel­lent safe­ty and tol­er­a­bil­i­ty. While the da­ta were not over­whelm­ing­ly pos­i­tive (i.e., 60% of pa­tients with 50% re­duc­tion in mi­graine days), they were con­sis­tent and durable, which should en­sure wide­spread adop­tion by pa­tients (pro­vide pric­ing and pay­er pro­cess­ing al­low it). Am­gen’s erenum­ab ap­pears to have shown a sim­i­lar place­bo ad­just­ed ef­fect as Alder’s (OP) Eptinezum­ab in phase 2 tri­als (1 day im­prove­ment of month­ly mi­graines at week 12). The ef­fect is low­er than Lil­ly’s (OP) and Te­va’s (OP) phase 2 ef­fect sizes, which showed an im­prove­ment of 1.2 days and 2.6 days at the same time point. How­ev­er, in our opin­ion there is no doubt that erenum­ab will re­ceive reg­u­la­to­ry ap­proval de­spite da­ta that may not match ex­pec­ta­tions from ear­li­er tri­als.”

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