Watch out Al­ler­gan: Re­vance’s wrin­kle-re­duc­er beats Botox in PhI­II tri­als

Re­vance Ther­a­peu­tics has re­leased late-stage da­ta for a wrin­kle-re­duc­ing drug that ri­vals Botox. If it reach­es the mar­ket, the Bay Area biotech plans to go head-to-head with the gi­ant in this field: Al­ler­gan.

Dan Browne

Re­vance $RVNC re­port­ed on two Phase III clin­i­cal tri­als of its drug, an in­jectable bot­u­linum tox­in coined RT002. The drug was test­ed against frown lines — those wrin­kles that show up be­tween your eye­brows. RT002 last­ed for six months, while Botox gen­er­al­ly on­ly lasts for three to four months. The study met its pri­ma­ry and sec­ondary end­points in the two Phase III tri­als.

RT002 could threat­en Al­ler­gan’s $AGN top-sell­ing drug, which is like­ly why the gi­ant’s stock has slipped 2 per­cent on the news this morn­ing. Botox has brought in $2.3 bil­lion in glob­al sales for the drug­mak­er dur­ing the first nine months of this year.

But crit­ics say RT002 may not be as much of a threat to Botox as Re­vance hopes. Al­ler­gan fol­lowed up the news with a state­ment kick­ing back at the small­er com­pa­ny’s da­ta.

“We do not be­lieve this da­ta will sup­port a longer du­ra­tion claim as the on­ly com­pos­ite da­ta (2-point im­prove­ment, none or mild, and both in­ves­ti­ga­tor and pa­tient) is at 30 days not at 6 months,” an Al­ler­gan spokesper­son wrote in an email.

Biotech an­a­lyst Umer Raf­fat at Ever­core ex­pressed sim­i­lar reser­va­tions in a re­search note he sent out af­ter the Re­vance news.

“It’s al­so clear that Re­vance prod­uct tracks bet­ter than Botox on du­ra­tion… by at least a month-plus,” Raf­fat wrote. “With that said, is Re­vance go­ing to get an every 6 month claim on la­bel?  I think there’s a case to be made for that, but that’s not a layup.”

Re­vance’s stock is up 36 per­cent in pre-mar­ket trad­ing Tues­day.

“These re­sults demon­strate it is sci­en­tif­i­cal­ly and clin­i­cal­ly pos­si­ble to cre­ate a sig­nif­i­cant­ly longer-act­ing neu­ro­mod­u­la­tor,” said Dan Browne, co-founder, pres­i­dent and CEO of Re­vance, in a state­ment. “We look for­ward to pro­vid­ing pa­tients and health­care pro­fes­sion­als with what we be­lieve is a new, next-gen­er­a­tion, long-act­ing neu­ro­mod­u­la­tor for the treat­ment of glabel­lar lines.”

Re­vance plans to sub­mit a Bi­o­log­ics Li­cense Ap­pli­ca­tion in the first half of 2019 and, if ap­proved, launch RT002 in the US in 2020.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

Matt Gline, Roivant Sciences CEO (Photo by John Sciulli/Getty Images for GLG)

Pfiz­er and Roivant team up again for an­oth­er 'Van­t', set­ting up an­ti-in­flam­ma­to­ry show­down with Prometheus

Pfizer and Roivant are teaming up to launch a new ‘Vant’ aimed at bringing a mid-stage anti-inflammatory drug to market, the pair announced Thursday.

There’s no name for the startup yet, nor are there any employees. Thus far, the new company and Roivant can be considered “one and the same,” Roivant CEO Matt Gline tells Endpoints News. But Pfizer is so enthusiastic about the target that it elected to keep 25% of equity in the drug rather than take upfront cash from Roivant, Gline said.

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