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.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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Michel Vounatsos, Biogen CEO (Credit: World Economic Forum/Ciaran McCrickard)

An un­ortho­dox pro­pos­al for Bio­gen's Medicare-man­dat­ed Aduhelm tri­al

Biogen has gone full blitz since Medicare announced it would only cover its new Alzheimer’s drug when used in clinical trials, accusing the agency of discriminating against Alzheimer’s patients and trying to get physicians to change regulators’ minds.  Critics, meanwhile, cheered what they see as a necessary wall protecting payers and patients from an unproven and unsafe drug.

Far less attention, though, has gone to what a Medicare-funded clinical trial would actually look like. Biogen has operated as if it would be a standard late-stage Alzheimer’s trial, enrolling a couple thousand patients and giving half placebo.

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