Am­gen $AMGN and its part­ners at No­var­tis $NVS rolled out a fresh batch of solid­ly pos­i­tive da­ta from the lat­est Phase III study of their CGRP mi­graine drug erenum­ab, back­ing up their be­lief that they can break past a line­up of ri­vals and make a block­buster score fol­low­ing a near cer­tain ap­proval now on the hori­zon.

The drug, which they plan to sell as Aimovig, will like­ly be chal­lenged by a group of com­peti­tors from Eli Lil­ly $LLY, Te­va $TE­VA and Alder $AL­DR that have all demon­strat­ed broad­ly sig­nif­i­cant da­ta in cut­ting the num­ber of mi­graine days ex­pe­ri­enced by a chron­ic suf­fer­er. So they plan to hit the mar­ket with a bat­ter­ing ram of da­ta to help clear the way with providers.

To that end, this new study demon­strat­ed a sig­nif­i­cant re­sponse in cut­ting the num­ber of mi­graine days for pa­tients who had failed two to four dif­fer­ent lines of ther­a­py by at least 50%. Com­pared with a place­bo, the drug al­so hit all the sec­on­daries on the need for res­cue meds, 75% and 100% re­spon­ders, and more.

Sean Harp­er

I talked to Am­gen R&D chief Sean Harp­er about this drug at JP­Mor­gan ear­li­er in the month, and he agreed that the drug was a near cer­tain lock at the FDA, with a like­ly ar­rival of a slate of ri­vals along­side it.

“On ef­fi­ca­cy,” he notes, “the drugs are all seem­ing to have sim­i­lar ef­fi­ca­cy. I think that’s fair.”

But that doesn’t mean that Am­gen and No­var­tis, with all their con­sid­er­able mar­ket­ing clout, can’t make their drug the stand­out.

The broad late-stage pro­gram in­cludes unique car­dio da­ta, says Harp­er, that should help make their case. And they were care­ful to come up with what they see as the best de­liv­ery op­tion, with a sim­ple once-month­ly au­toin­jec­tor that doesn’t re­quire pa­tients to take load­ing dos­es, which he says the com­pe­ti­tion will re­quire.

And it’s a mas­sive mar­ket, with some 6 to 8 mil­lion pa­tients who fit the se­vere suf­fer­er pro­file for the drug.

“These da­ta in pa­tients with mul­ti­ple treat­ment fail­ures, who are not on­ly con­sid­ered dif­fi­cult to treat but al­so have few op­tions avail­able, add to the con­sis­tent body of ev­i­dence for Aimovig,” Harp­er said in a state­ment. “We look for­ward to work­ing with reg­u­la­tors to bring the first pre­ven­tive op­tion specif­i­cal­ly de­vel­oped for mi­graine to pa­tients world­wide.”

Microcap biotech Seelos Therapeutics is halting enrollment of its study in spinocerebellar ataxia type 3 (also known as Machado-Joseph disease) because of “financial considerations,” and in order to focus on other studies, the company said today, adding that the pause would be temporary.

The study will continue with the patients who have already enrolled, and the data from them will be used to decide whether to continue enrolling others in the future.

Otonomy may be shutting down, but the lessons learned there will live on at another biotech working on new treatments for hearing loss.

San Francisco-based Spiral Therapeutics has bought certain assets related to three of Otonomy’s programs, ranging from data, patent rights, and know-how to inventory. That includes data around Otonomy’s twice-failed lead program, OTO-104 (Otividex), a sustained-exposure formulation of dexamethasone.