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.

George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”

On a roll, Mer­ck blazes through a new seg­ment of the bio­mark­er trail

Merck has notched an approval for using Keytruda to treat a biomarker-based subset of first-line colorectal cancer patients with unresectable or metastatic tumors, as the pharma giant continues to find new niches for its blockbuster PD-1 star.

The OK is significant in a number of ways. Not only does it build on an accelerated approval for all tumors characterized as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); it also marks the first single treatment for colorectal cancer that doesn’t contain chemotherapy.

Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Paul Hudson, Sanofi CEO (Getty Images)

Sanofi preps an­oth­er round of lay­offs as new ex­ecs look to slim down the glob­al phar­ma in an on­go­ing re­or­ga­ni­za­tion — re­port

Sanofi is reportedly once again sharpening up the budget axe as the pharma giant prepares to chop more jobs.

Reuters reports this morning that Sanofi has its sights set on cutting 1,680 jobs in Europe, where the unions have been combating rounds of cutbacks at the Paris-based player. Sanofi itself hasn’t said anything about these cuts, as the company looks to discuss a 3-year plan with staff representatives.

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Covid-19 roundup: Vac­cines will need to beat place­bo by 50% to qual­i­fy for FDA OK; UK tri­al drops Kale­tra

The FDA will set the bar for approving a Covid-19 vaccine at 50% efficacy, the Wall Street Journal reported, meaning any successful candidate will have to reduce the risk of coronavirus disease by at least half compared to placebo.

That requirement is part of guidance that the agency is set to release later today, laying out detailed criteria for vaccine developers — some of whom are eyeing an OK by the end of the year, in line with expectations at Operation Warp Speed.

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