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.

Com­mu­ni­cat­ing the val­ue of pre­ci­sion med­i­cine

By Natasha Cowan, Content Marketing Manager at Blue Latitude Health.
Many stakeholders are confused by novel precision medicines, including patients and healthcare professionals. So, how can industry help them to navigate this complexity?

Precision medicine represents a new paradigm in healthcare. It embodies the shift from treating many patients with the same therapy, to having the tools to identify the best treatment for every patient.

Spe­cial re­port: Twen­ty ex­tra­or­di­nary women in bio­phar­ma R&D who worked their way to the top

What differentiates a woman leader in biopharma R&D from a man?

Not much, except there are fewer of them in senior posts. Data suggest women are not more risk-averse, family-oriented or less confident than their male counterparts — indeed the differences between the two sexes are negligible. But a glance at the top R&D positions in Big Pharma leaves little doubt that upward migration in the executive ranks of biopharma R&D is tough.

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The lat­est Cin­derel­la sto­ry in on­col­o­gy ends with a sud­den rout as up­dat­ed da­ta dis­play spooks in­vestors

NextCure’s turn as the Cinderella of cancer-focused biotechs was short-lived.
Just a few days after its shares $NXTC zoomed up more than 250% on some very early stage results in a SITC abstract, a more complete analysis over the weekend spiked the hype and left investors in high dudgeon as the stock price collapsed back towards earth Monday.
The focus at NextCure is centered on NC318, an antibody that is intended to shut down the immunosuppressive Siglec-15 — or S-15 — target. After adding a small group of patients to the readout, investigators circled 2 clinical responses, a complete and partial response, along with 4 stable disease cases in non-small cell lung cancer.

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Te­va spin­out rais­es $85M in IPO; No­var­tis beefs up gener­ics unit with $440M deal

→ After Teva spinout 89bio recently announced that its IPO was being held up, the company is back in the game offering 5,304,687 shares at a price of $16 per share. The company has raised $84.9 million IPO in gross proceeds and will be listed under the ticker symbol $ETNB. BofA Securities, SVB Leerink and RBC Capital Markets are the joint book-running managers for the offering. Oppenheimer & Co is the co-manager for the offering.
→ Looking to amp up its presence in Japan’s hospitals, Novartis has struck a deal to buy out Aspen’s portfolio of generics in the world’s third largest healthcare market. The pharma giant is paying $440 million for Aspen’s Japanese subsidiary.
→ Novartis said tropifexor, a non-bile acid FXR agonist, has scored on several key biomarkers of NASH in a Phase IIb trial, including reductions in hepatic fat, alanine aminotransferase and body weight compared to a placebo at 12 weeks.

Break­through sta­tus and promise of a speedy re­view ar­rives for Op­di­vo/Yer­voy com­bi­na­tion as Bris­tol-My­ers bites at Bay­er

Its frontline and single-agent aspirations have been set back, but Bristol-Myers Squibb just took a big step forward in its efforts to apply its checkpoint inhibitor Opdivo to liver cancer. The FDA has granted breakthrough status and priority review to a combination, second-line treatment.

The designation is for Opdivo (nivolumab) in combination with Yervoy (ipilimumab),  for treating advanced hepatocellular carcinoma (HCC), the most common form of liver cancer. The PD-L1 drug was already approved as a single-agent, second-line treatment for HCC. A PDUFA date was set for March 10, 2020 — just 4 months from now.

Third time un­lucky: Lipocine's lat­est quest to mar­ket their oral testos­terone drug snubbed again by FDA

Lipocine’s latest attempt at securing approval for its oral testosterone drug has fizzled yet again.

The Utah-based drug developer on Monday said the FDA has spurned its marketing application, indicating that some efficacy data on the drug, Tlando, was not up to scratch to treat male hypogonadism, a condition characterized by low production of the hormone testosterone, which is responsible for maintaining muscle bulk, bone growth, and sexual function.

UP­DAT­ED: De­cry­ing 'ar­bi­trary and capri­cious' ac­tion, Re­genxBio sues FDA over clin­i­cal holds on gene ther­a­py

When RegenxBio disclosed that the FDA had placed a partial clinical hold on one of its lead gene therapies, execs outlined several customary next steps: continuing assessment and monitoring, delaying a related IND filing, and working with the FDA to address the matter.

As it turned out, they were planning something much less mundane. Two days after announcing the hold in its Q3 update, RegenxBio filed a lawsuit seeking to set it aside, the FDA Law Blog noted.

Roche's SMA chal­lenge to Bio­gen's Spin­raza fran­chise looms larg­er with piv­otal win

Roche has just landed a crucial advance in scoring a come-from-behind win on the spinal muscular atrophy field, giving Novartis and Biogen a run for their money.

The update was brief, but Roche said risdiplam hit the primary endpoint in the placebo-controlled pivotal SUNFISH trial, meeting the threshold for change from baseline in the Motor Function Measure 32 (MFM-32) scale after one year of treatment. The results, which is the second, confirmatory portion of a two-part study, involved 180 patients with type 2 or 3 spinal muscular atrophy between 2 and 25 years old.

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Roche steers Gazy­va in­to a new PhI­II pro­gram af­ter com­bo shows promise in lu­pus nephri­tis study

Roche is working on putting together a late-stage study for its monoclonal antibody Gazyva in patients with severe kidney disease associated with lupus after a combination approach helped patients in a mid-stage study.

The 125-patient NOBILITY trial evaluated Gazyva, combined with standard-of-care treatment mycophenolate mofetil or mycophenolic acid and corticosteroids, versus standard treatment alone. The combo met the main goal of inducing a statistically superior complete renal response (CRR) of 40% at week 76, versus 18% in patients given standard treatment, Roche said.