Evo­lus cel­e­brates green­light for Botox ri­val while Al­ler­gan coun­ter­at­tacks with a com­plaint of stolen trade se­crets

De­spite a months-long de­lay, Evo­lus has over­come man­u­fac­tur­ing faults FDA pre­vi­ous­ly found and man­aged to se­cure a nod to be­gin mar­ket­ing its Botox ri­val. And you can count on Al­ler­gan to mount a le­gal coun­ter­at­tack to block the US en­try of a bi­o­log­ic that can threat­en its $3.5 bil­lion fran­chise.

David Moataze­di

The ap­proval came just af­ter mar­ket close on Fri­day for Jeu­veau, a 900 kDa pu­ri­fied bot­u­linum tox­in type A for­mu­la­tion that re­duces frown lines — or “glabel­lar lines as­so­ci­at­ed with cor­ru­ga­tor and/or pro­cerus mus­cle ac­tiv­i­ty in adults” if you pre­fer the aca­d­e­m­ic term.

In a head-to-head Phase III tri­al in­volv­ing 540 Eu­ro­peans and Cana­di­ans, in­ves­ti­ga­tors re­port­ed re­spon­der rates of 87.2% in the group re­ceiv­ing Evo­lus’s drug, 82.8% in the Botox group, and 4.2% in the place­bo group. Oth­er Phase III tri­als con­duct­ed in the US es­tab­lished su­pe­ri­or­i­ty over place­bo, the com­pa­ny says.

Per­haps more per­ti­nent to its plan to dis­rupt a mar­ket cur­rent­ly dom­i­nat­ed by Botox, Evo­lus “an­tic­i­pates a 20-25% dis­count to mar­ket leader,” a com­pa­ny rep­re­sen­ta­tive tells End­points News in an email, with more de­tails to come.

In a trade com­plaint filed two days be­fore the ap­proval, though, Al­ler­gan claims that the ri­val wrin­kle ther­a­py pig­gy­backs on R&D se­crets stolen by a for­mer staff sci­en­tist at its part­ner Me­dy­tox.

The em­ploy­ee then al­leged­ly hand­ed the “metic­u­lous, time-con­sum­ing, and ex­pen­sive re­search” on how to con­vert the dead­ly bot­u­linum tox­in in­to a treat­ment to Dae­woong, which lat­er out-li­censed its drug, DWP-450, to Evo­lus, ac­cord­ing to a Bloomberg re­port of the fil­ing. Dae­woong al­ready mar­kets the prod­uct in South Ko­rea as Nab­o­ta.

The com­plaint, filed at the US In­ter­na­tion­al Trade Com­mis­sion in Wash­ing­ton, fol­lows 2017 com­plaints in Ko­rea that Me­dy­tox filed against Dae­woong. The cas­es are on­go­ing.

Even if Al­ler­gan gets its way this time — which is high­ly un­cer­tain — ri­val of­fer­ings from Re­vance Ther­a­peu­tics and Hugel will still be fast on its heels.

And if it doesn’t, Evo­lus be­lieves that it can move in­to the num­ber 2 share po­si­tion with­in a few years, Leerink’s Marc Good­man notes, giv­en an EU ap­proval ex­pect­ed in mid-2019 and launch in Cana­da be­fore that.

Whether achiev­ing the num­ber 2 po­si­tion hap­pens or not, we do be­lieve that in­vestors should ex­pect a no­tice­able im­pact to the Botox Cos­met­ic growth rate from new com­pe­ti­tion. We mod­el US mar­ket growth of ~9% with Botox sales growth of ~6% in 2019E and mar­ket growth of ~8% and Botox sales growth of ~5.5% in 2020E. Giv­en that Botox is the most im­por­tant as­set for Al­ler­gan, we would al­so ex­pect sig­nif­i­cant in­vestor at­ten­tion fo­cused on this share dy­nam­ic and some ex­tra volatil­i­ty in the stock, just as we saw dur­ing pre­vi­ous Botox com­peti­tor launch­es.

Hav­ing de­nied al­le­ga­tions against them, Evo­lus and Dae­woong are al­ready at work build­ing out a spe­cial­ty sales team — which Evo­lus en­vi­sioned (when it went pub­lic) to con­sist of 65 reps at launch this spring and grow to 150 over time.

Evo­lus CEO David Moataze­di — ex-aes­thet­ics chief at Al­ler­gan — has this to say in his toast to the news:

Evo­lus is the first com­pa­ny in near­ly a decade to en­ter the fast-grow­ing US aes­thet­ic neu­ro­tox­in mar­ket […] The launch of Jeu­veau will be pow­ered by our tech­nol­o­gy plat­form de­signed to elim­i­nate the fric­tion points that ex­ist for cus­tomers to­day.

Nick Leschly via Getty

UP­DAT­ED: Blue­bird shares sink as an­a­lysts puz­zle out $1.8M stick­er shock and an un­ex­pect­ed de­lay

Blue­bird bio $BLUE has un­veiled its price for the new­ly ap­proved gene ther­a­py Zyn­te­glo (Lenti­Glo­bin), which came as a big sur­prise. And it wasn’t the on­ly un­ex­pect­ed twist in to­day’s sto­ry.

With some an­a­lysts bet­ting on a $900,000 price for the β-tha­lassemia treat­ment in Eu­rope, where reg­u­la­tors pro­vid­ed a con­di­tion­al ear­ly OK, blue­bird CEO Nick Leschly said Fri­day morn­ing that the pa­tients who are suc­cess­ful­ly treat­ed with their drug over 5 years will be charged twice that — $1.8 mil­lion — on the con­ti­nent. That makes this drug the sec­ond most ex­pen­sive ther­a­py on the plan­et, just be­hind No­var­tis’ new­ly ap­proved Zol­gens­ma at $2.1 mil­lion, with an­a­lysts still wait­ing to see what kind of pre­mi­um can be had in the US.

Gene ther­a­pies seize the top of the list of the most ex­pen­sive drugs on the plan­et — and that trend has just be­gun

Anyone looking for a few simple reasons why the gene therapy field has caught fire with the pharma giants need only look at the new list of the 10 most expensive therapies from GoodRx.

Two recently approved gene therapies sit atop this list, with Novartis’ Zolgensma crowned the king of the priciest drugs at $2.1 million. Right below is Luxturna, the $850,000 pioneer from Spark, which Roche is pushing hard to acquire as it adds a gene therapy group to the global mix.

Endpoints News

Basic subscription required

Unlock this story instantly and join 52,900+ biopharma pros reading Endpoints daily — and it's free.

Ted Love. HAVERFORD COLLEGE

Glob­al Blood Ther­a­peu­tics poised to sub­mit ap­pli­ca­tion for ac­cel­er­at­ed ap­proval, with new piv­otal da­ta on its sick­le cell dis­ease drug

Global Blood Therapeutics is set to submit an application for accelerated approval in the second-half of this year, after unveiling fresh data from a late-stage trial that showed just over half the patients given the highest dose of its experimental sickle cell disease drug experienced a statistically significant improvement in oxygen-wielding hemoglobin, meeting the study's main goal.

Endpoints News

Basic subscription required

Unlock this story instantly and join 52,900+ biopharma pros reading Endpoints daily — and it's free.

J&J gains an en­thu­si­as­tic en­dorse­ment from Pres­i­dent Don­ald Trump for their big new drug Spra­va­to

Pres­i­dent Don­ald Trump has lit­tle love for Big Phar­ma, but there’s at least one new drug that just hit the mar­ket which he is en­am­ored with.

Trump, ev­i­dent­ly, has been read­ing up on J&J’s new an­ti-de­pres­sion drug, Spra­va­to. And the pres­i­dent — who of­ten likes to break out in­to a full-throat­ed at­tack on greedy drug­mak­ers — ap­par­ent­ly en­thused about the ther­a­py in a meet­ing with of­fi­cials of Vet­er­ans Af­fairs, which has long grap­pled with de­pres­sion among vet­er­ans.

News­mak­ers at #EHA19: Re­gen­eron, Ar­Qule track progress on re­sponse rates

Re­gen­eron’s close­ly-watched bis­pe­cif­ic con­tin­ues to ring up high re­sponse rates

Re­gen­eron’s high-pro­file bis­pe­cif­ic REGN1979 is back in the spot­light at the Eu­ro­pean Hema­tol­ogy As­so­ci­a­tion sci­en­tif­ic con­fab. And while the stel­lar num­bers we saw at ASH have erod­ed some­what as more blood can­cer pa­tients are eval­u­at­ed, the re­sponse rates for this CD3/CD20 drug re­main high.

A to­tal of 13 out of 14 fol­lic­u­lar lym­phomas re­spond­ed to the drug, a 93% ORR, down from 100% at the last read­out. In 10 out of 14, there was a com­plete re­sponse. In dif­fuse large B-cell lym­phoma the re­sponse rate was 57% among pa­tients treat­ed at the 80 mg to 160 mg dose range. They were all com­plete re­spons­es. And 2 of these Cars were for pa­tients who had failed CAR-T ther­a­py.

Neil Woodford, Woodford Investment Management via YouTube

Un­der siege, in­vest­ment man­ag­er Wood­ford faces an­oth­er in­vest­ment shock

Em­bat­tled UK fund man­ag­er Neil Wood­ford — who has con­tro­ver­sial­ly blocked in­vestors from pulling out from his flag­ship fund to stem the blood­let­ting, af­ter a slew of dis­ap­point­ed in­vestors fled fol­low­ing a se­ries of sour bets — is now pay­ing the price for his ac­tions via an in­vestor ex­o­dus on an­oth­er fund.

Har­g­reaves Lans­down, which has in the past sold and pro­mot­ed the Wood­ford funds via its re­tail in­vest­ment plat­form, has re­port­ed­ly with­drawn £45 mil­lion — its en­tire po­si­tion — from the in­vest­ment man­ag­er’s In­come Fo­cus Fund.

Ab­b­Vie touts new da­ta for Hu­mi­ra suc­ces­sor; Gilead inks dis­cov­ery deal

→ Ab­b­Vie is tout­ing new pos­i­tive da­ta com­par­ing their ag­ing block­buster Hu­mi­ra with their hoped-for block­buster upadac­i­tinib. Over 48 weeks a larg­er pro­por­tion of pa­tients tak­ing the ex­per­i­men­tal drug ex­pe­ri­enced clin­i­cal re­mis­sion than in the con­trol arm with Hu­mi­ra. Their drug brought in $20 bil­lion last year, top­ping the scales in the num­ber 1 slot.

→ Gilead has turned to Van­cou­ver-based Ab­Cellera for its lat­est dis­cov­ery deal. Ab­Cellera will use its know-how in “sin­gle-cell screen­ing of nat­ur­al im­mune sources” to find an­ti­body can­di­dates for Gilead to pur­sue in the in­fec­tious dis­ease field. The deal in­cludes an up­front and mile­stones.

Turns out, Rudy Tanzi did­n't see much of a sto­ry about a hid­den link be­tween En­brel and Alzheimer's ei­ther

The Wash­ing­ton Post man­aged to whip up the quick­est in­dus­try con­sen­sus I’ve ever seen that one of its re­porters was pur­vey­ing overblown non­sense with a sto­ry that Pfiz­er was sit­ting on da­ta sug­gest­ing that En­brel could be an ef­fec­tive treat­ment for Alzheimer’s. 

In cov­er­ing that bit of an­ti-Big Phar­ma fan­ta­sy — there are lots of rea­sons to go af­ter phar­ma, but this piece was lu­di­crous — I not­ed com­ments in the sto­ry from some promi­nent peo­ple in the field crit­i­ciz­ing Pfiz­er for not pub­lish­ing the da­ta. I sin­gled out Rudy Tanzi at Har­vard and then ap­plied some added crit­i­cism for the things he’s done to hype — in my opin­ion — high­ly ques­tion­able as­sump­tions. You can see it in the link. 

Adding mar­quee in­vestors, Black­Thorn bags $76M to back an AI-dri­ven strat­e­gy for pre­ci­sion neu­ro med­i­cine

As ar­ti­fi­cial in­tel­li­gence and ma­chine learn­ing loom ever larg­er in drug dis­cov­ery and de­vel­op­ment, a biotech op­er­at­ing at the “nexus” of tech­nol­o­gy and neu­ro­sciences has cashed in with $76 mil­lion in fresh fi­nanc­ing.

The big idea at Black­Thorn Ther­a­peu­tics is to do for neu­robe­hav­ioral dis­or­ders what ge­net­i­cal­ly tar­get­ed ther­a­py has done for on­col­o­gy: Re­de­fine pa­tient pop­u­la­tions by the un­der­ly­ing bi­ol­o­gy — dys­reg­u­lat­ed brain cir­cuits, or neu­rotypes — in­stead of symp­toms, there­by find­ing the pa­tients who are most like­ly to ben­e­fit at en­roll­ment phase.