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.

BY­OD Best Prac­tices: How Mo­bile De­vice Strat­e­gy Leads to More Pa­tient-Cen­tric Clin­i­cal Tri­als

Some of the most time- and cost-consuming components of clinical research center on gathering, analyzing, and reporting data. To improve efficiency, many clinical trial sponsors have shifted to electronic clinical outcome assessments (eCOA), including electronic patient-reported outcome (ePRO) tools.

In most cases, patients enter data using apps installed on provisioned devices. At a time when 81% of Americans own a smartphone, why not use the device they rely on every day?

Chris Gibson (Photo By Vaughn Ridley/Sportsfile for Web Summit via Getty Images)

Re­cur­sion founders gin for­tunes as IPO back­ers show­er $436M on one of the biggest boasts in AI -- based on some very small deals

In the AI drug development world, boasting often comes with the territory. Yet few can rival Recursion when it comes to claiming the lead role in what company execs like to call the industrialization of drug development, with promises of continued exponential growth in the number of drugs it has in the pipeline.

On Friday, the Salt Lake City-based biotech translated its unicorn-sized boasts into a killer IPO, pricing more than 24 million shares at the high end of its range and bringing in $436 million — with a large chunk of that promised by some deep-pocket backers.

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Covid-19 vac­cine halt drags on, an FDA ap­point­ment at long last, the great CRO con­sol­i­da­tion, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Conference season is upon us, and while we’d much prefer to be wandering down the hallways and presentation rooms in person, the team is ready to cover the most consequential data coming out of these scientific meetings. Get in touch early if you have news to share.

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Eli Lil­ly asks FDA to re­voke EUA for Covid-19 treat­ment

Eli Lilly on Friday requested that the FDA revoke the emergency authorization for its Covid-19 drug bamlanivimab, which is no longer as effective as a combo therapy because of a rise in coronavirus variants across the US.

“With the growing prevalence of variants in the U.S. that bamlanivimab alone may not fully neutralize, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralizing antibodies together,” Daniel Skovronsky, Lilly’s CSO, said in a statement.

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Ex­clu­sive in­ter­view: Pe­ter Marks on why full Covid-19 vac­cine ap­provals could be just months away

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, took time out of his busy schedule last Friday to discuss with Endpoints News all things related to his work regulating vaccines and the pandemic.

Marks, who quietly coined the name “Operation Warp Speed” before deciding to stick with his work regulating vaccines at the FDA rather than join the Trump-era program, has been the face of vaccine regulation for the FDA throughout the pandemic, and is usually spotted in Zoom meetings seated in front of his wife’s paintings.

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Near­ly a year af­ter Au­den­tes' gene ther­a­py deaths, the tri­al con­tin­ues. What hap­pened re­mains a mys­tery

Natalie Holles was five months into her tenure as Audentes CEO and working to smooth out a $3 billion merger when the world crashed in.

Holles and her team received word on the morning of May 5 that, hours before, a patient died in a trial for their lead gene therapy. They went into triage mode, alerting the FDA, calling trial investigators to begin to understand what happened, and, the next day, writing a letter to alert the patient community so they would be the first to know. “We wanted to be as forthright and transparent as possible,” Holles told me late last month.

The brief letter noted two other patients also suffered severe reactions after receiving a high dose of the therapy and were undergoing treatment. One died a month and a half later, at which point news of the deaths became public, jolting an emergent gene therapy field and raising questions about the safety of the high doses Audentes and others were now using. The third patient died in August.

“It was deeply saddening,” Holles said. “But I was — we were — resolute and determined to understand what happened and learn from it and get back on track.”

Eleven months have now passed since the first death and the therapy, a potential cure for a rare and fatal muscle-wasting disease called X-linked myotubular myopathy, is back on track, the FDA having cleared the company to resume dosing at a lower level. Audentes itself is no more; last month, Japanese pharma giant Astellas announced it had completed working out the kinks of the $3 billion merger and had restructured and rebranded the subsidiary as Astellas Gene Therapies. Holles, having successfully steered both efforts, departed.

Still, questions about precisely what led to the deaths of the 3 boys still linger. Trial investigators released key details about the case last August and December, pointing to a biological landmine that Audentes could not have seen coming — a moment of profound medical misfortune. In an emerging field that’s promised cures for devastating diseases but also seen its share of safety setbacks, the cases provided a cautionary tale.

Audentes “contributed in a positive way by giving a painful but important example for others to look at and learn from,” Terry Flotte, dean of the UMass School of Medicine and editor of the journal Human Gene Therapy, told me. “I can’t see anything they did wrong.”

Yet some researchers say they’re still waiting on Astellas to release more data. The company has yet to publish a full paper detailing what happened, nor have they indicated that they will. In the meantime, it remains unclear what triggered the events and how to prevent them in the future.

“Since Audentes was the first one and we don’t have additional information, we’re kind of in a holding pattern, flying around, waiting to figure out how to land our vehicles,” said Jude Samulski, professor of pharmacology at UNC’s Gene Therapy Center and CSO of the gene therapy biotech AskBio, now a subsidiary of Bayer.

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As­traZeneca-Alex­ion merg­er slides through FTC re­view af­ter sup­posed M&A crack­down pos­es no bar­ri­ers

The AstraZeneca-Alexion megamerger received a good sign Friday, despite warning signs of the tides turning against large M&A pharma deals.

US regulators at the FTC have cleared the acquisition for approval, AstraZeneca announced, all but signing off on the deal to go through once it officially closes in the third quarter. AstraZeneca originally said it was planning to buy out Alexion back in December for $39 billion.

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J&J faces CDC ad­vi­so­ry com­mit­tee again next week to weigh Covid-19 vac­cine risks

The CDC’s Advisory Committee on Immunization Practices punted earlier this week on deciding whether or not to recommend lifting a pause on the administration of J&J’s Covid-19 vaccine, but the committee will meet again in an emergency session next Friday to discuss the safety issues further.

The timing of the meeting likely means that the J&J vaccine will not return to the US market before the end of next week as the FDA looks to work hand-in-hand with the CDC to ensure the benefits of the vaccine still outweigh the risks for all age groups.

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David Stack, Pacira Biosciences CEO

In high­ly un­usu­al move, Paci­ra sues med­ical jour­nal for li­bel over its non-opi­oid painkiller

A New Jersey biotech whose only approved drug is used as a painkiller after surgeries is suing a scientific journal, its editors and a handful of authors for libel after the publication printed numerous papers and editorials that the company says discredited the drug.

Pacira Biosciences filed the complaint against the American Society of Anesthesiologists in the US District Court for New Jersey on Wednesday afternoon. A February issue of the group’s journal Anesthesiology printed three articles and other content full of “bias” that “seriously disparaged” the drug Exparel, Pacira claimed.