Mark Foley, Revance

HR vi­o­la­tion push­es Re­vance co-founder out, vault­ing for­mer Zel­tiq chief to the helm

Dan Browne Re­vance

Months af­ter Re­vance amend­ed the terms of its Botox biosim­i­lar col­lab­o­ra­tion with My­lan, the Newark, Cal­i­for­nia-based drug de­vel­op­er dis­closed its co-founder Dan Browne is step­ping down, in what ap­pears to be mys­te­ri­ous cir­cum­stances.

The com­pa­ny — which is al­so de­vel­op­ing a ri­val to Al­ler­gan’s for­mi­da­ble Botox fran­chise — on Mon­day said Browne is de­part­ing “due to mis­judg­ment in han­dling an em­ploy­ee mat­ter,” that has al­so cul­mi­nat­ed in his res­ig­na­tion from Re­vance’s board of di­rec­tors.

Board mem­ber Mark Fo­ley, for­mer chief of Zel­tiq Ther­a­peu­tics, will take over the reins as Re­vance CEO and pres­i­dent, the com­pa­ny said.

“While the change is sud­den and un­ex­pect­ed, Re­vance is still in good hands. Mark Fo­ley, who’s re­plac­ing Dan Browne, has a long track record in aes­thet­ics the for­mer Chair­man and CEO of Zel­tiq Aes­thet­ics, which was ac­quired by Al­ler­gan for ~$2.5B in 2017,” Need­ham an­a­lyst Serge Be­langer told End­points News.

End­points has con­tact­ed Re­vance for com­ment.

Browne has been in­stru­men­tal in cre­at­ing Re­vance — he helped nab its first ven­ture cap­i­tal in­jec­tion in 2006 and steered the com­pa­ny to its pub­lic de­but in 2014.

“The de­par­ture of Dan Browne was due pure­ly to an HR vi­o­la­tion and was in no re­la­tion to the DAXI prod­uct or BLA tim­ing, which is still on track for ‘the Fall.’ Al­though it is dis­ap­point­ing to learn of Dan’s de­par­ture giv­en all of his ef­forts over his 17 years with the com­pa­ny, it does not ap­pear to be at all re­lat­ed to the core as­set,” Cowen’s Ken Cac­cia­tore wrote in a note.

The com­pa­ny’s lead prod­uct, Dax­i­bot­u­linum­tox­i­nA for In­jec­tion (DAXI), is po­si­tioned as a di­rect com­peti­tor to Al­ler­gan’s Botox fran­chise — a prod­uct that is ap­proved for 13 in­di­ca­tions and gen­er­at­ed close to $3.6 bil­lion last year, de­spite the emer­gence of ri­vals: Ipsen’s Dys­port and Merz Phar­ma’s Xeomin. An­oth­er ri­val, Evo­lus scored FDA ap­proval for its prod­uct, Jeu­veau, in Feb­ru­ary this year.

Re­vance ex­pects DAXI to win US ap­proval in 2020 as a treat­ment for frown lines — the prod­uct is al­so un­der de­vel­op­ment for use in fore­head lines and crow’s feet, as well as in three ther­a­peu­tic in­di­ca­tions: cer­vi­cal dys­to­nia, adult up­per limb spas­tic­i­ty, and plan­tar fasci­itis.

Botox and its com­peti­tors typ­i­cal­ly work for 3-4 months, but DAXI has a po­ten­tial 6-month du­ra­tion claim — which could be dis­rup­tive cur­rent in­jectable bot­u­linum tox­in treat­ment par­a­digm, Cac­cia­tore said. He ex­pects DAXI could even­tu­al­ly rep­re­sent a $1 bil­lion+ prod­uct in the Unit­ed States, and even­tu­al­ly a po­ten­tial equal size in the ex-US mar­kets.

Re­vance $RVNC al­so has a col­lab­o­ra­tion with My­lan $MYL to de­vel­op a Botox biosim­i­lar, al­though Al­ler­gan $AGN — which is in the process of be­ing ac­quired by Ab­b­Vie $AB­BV in a $63 bil­lion mega-deal — has a con­tin­gency plan for its prize Botox fran­chise. Brent Saun­der’s com­pa­ny has in-li­censed a Botox fol­low-on called MT10109L — which is cur­rent­ly in late-stage de­vel­op­ment.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Stéphane Bancel, Moderna CEO

'This is not go­ing to be good': Mod­er­na CEO Ban­cel warns of a 'ma­te­r­i­al drop' in vac­cine ef­fi­ca­cy as Omi­cron spreads

Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

Since our start in 2016, Endpoints has grown fast while executing our mission to cover biopharma’s most critical developments for industry pros worldwide. As readership has grown, our advertising business has too. Endpoints advertising partners support the mission and engage their desired audiences through announcements on our email and web platforms, brand recognition in our event coverage and sponsorships of Endpoints daily and weekly reports.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.

As lead drug runs in­to a wall, De­ci­phera slims down its pipeline, puts 140 jobs on the chop­ping block

Barely a month after disappointing data shattered hopes for a major label expansion for the GI tumor drug Qinlock, Deciphera is making a major pivot — scrapping development plans for that drug and discarding another while it hunkers down and focuses on two remaining drugs in the pipeline.

As a result, 140 of its staffers will be laid off.

The restructuring, which claims the equivalent of 35% of its total workforce, will take place across all departments including commercial, R&D as well as general and administrative support functions, Deciphera said, as it looks to streamline Qinlock-related commercial operations in the US while concentrating only on a “select number of key European markets.”

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Viatris employees rang the Nasdaq bell on Nov. 16, marking the one-year anniversary of the merged Mylan and Pfizer Upjohn company

Start­ing from scratch: Vi­a­tris’ new brand, cul­ture set­tle in 1 year af­ter My­lan, Up­john merg­er

When Mylan and Pfizer’s Upjohn unit merged last year, headlines touted the $12 billion deal and newly named Viatris as the largest generic drugmaker in the world. But that’s not exactly how the company wanted to be known.

So Viatris — which rhymes with Beatrice — began working to create a new brand and culture from scratch around its distinct mix of old pharma blockbusters while layering in a massive portfolio of generic and OTC meds and building up a fresh pipeline of biosimilars.

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Jeff Dachis, founder and CEO, One Drop

Q&A: One Drop founder Jeff Dachis, from dig­i­tal agency to healthtech en­tre­pre­neur, catch­es the wave again

Jeff Dachis knows how to pick a business wave — although it may be more accurate to say he knows how to create them. The founder and CEO of digital health platform One Drop is working to transform the industry with predictive analytics and sophisticated tools. Alongside partner Bayer, which has now invested enough to own a third of the company, Dachis and One Drop are advancing data-driven personalized self-care for chronic disease management.

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Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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