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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.

The key dates for KRAS watch­ers through the end of the year — the trail is nar­row and risks are ex­treme

There’s nothing quite like a big patent win when it comes to burnishing your prospects in the pipeline. And for Amgen, which seems to have rescued Enbrel for a run to 2029, the cheering section on Wall Street is now fixed on AMG 510 and a key rival.

And it didn’t take much data to do it. 

There was the first snapshot of a handful of patients, with a 50% response rate. Then came word that Amgen researchers are also tracking responses in different cancers, at least one in colorectal cancer and appendiceal too. 

Bain's Or­ly Mis­han joins Pfiz­er's neu­ro spin­out Cerev­el; On­colyt­ic virus biotech taps Sil­la­Jen ex­ec He­le­na Chaye as CEO

→ Bain Capital is deploying one of its top investors to Cerevel Therapeutics, steering a $350 million-plus neuro play carved out of Pfizer. Orly Mishan — a co-founder and principal of Bain’s life sciences unit — was involved in the partnership that birthed the biotech spinout in the first place. As Cerevel’s first chief business officer, she is tasked with corporate development, program management as well as technical operations. 

UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.