Af­ter abrupt­ly pulling its mar­ket­ing ap­pli­ca­tion, DBV may be left with peanuts in race against Aim­mune

They say slow and steady wins the race. In the sprint to mar­ket the first peanut al­ler­gy treat­ment, hare DBV Tech­nolo­gies $DB­VT has just fum­bled, an­nounc­ing on Wednes­day that it had re­scind­ed the mar­ket­ing ap­pli­ca­tion for its peanut al­ler­gy patch, fol­low­ing dis­cus­sions with FDA reg­u­la­tors who are seem­ing­ly un­hap­py with the state of man­u­fac­tur­ing and qual­i­ty con­trol da­ta sub­mit­ted. Mean­while, tor­toise Aim­mune $AIMT is now in pole po­si­tion to leapfrog its ri­val to se­cure first-mover ad­van­tage in the so-far un­der­served mar­ket.

To be sure, both com­pa­nies have had their share of ups and downs. In Oc­to­ber 2017, DBV re­port­ed its treat­ment — dubbed Vi­askin Peanut — was un­able to mark a sta­tis­ti­cal­ly sig­nif­i­cant sep­a­ra­tion from a place­bo in a Phase III tri­al, oblit­er­at­ing its shares, al­though the Parisian drug de­vel­op­er said it would march ahead with a mar­ket­ing ap­pli­ca­tion. Four months lat­er in 2018, arch ri­val Aim­mune came out with piv­otal da­ta on its drug, AR101, which were de­cid­ed­ly pos­i­tive, but in­vestors took is­sue with the mag­ni­tude of pa­tients that dropped out of the drug arm. In re­sponse, Nestlé Health Sci­ence-backed Aim­mune al­so so­lid­i­fied its plans to sub­mit its ap­pli­ca­tion, which is ex­pect­ed by the end of 2018.

Daniel Tassé

“Al­though the agency did not ref­er­ence any med­ical or clin­i­cal ques­tions with the sub­mis­sion of Vi­askin Peanut, the FDA did com­mu­ni­cate that the lev­el of de­tail with re­gards to da­ta on man­u­fac­tur­ing and qual­i­ty con­trols was in­suf­fi­cient in the BLA,” said DBV chief Daniel Tassé said in a state­ment on Wednes­day.

JMP an­a­lyst Li­isa Bayko was not as con­vinced.  “Man­age­ment as­sumes that there are no con­cerns around Vi­askin Peanut’s clin­i­cal mod­ule be­cause there were no ques­tions from the FDA re­gard­ing that sec­tion of the BLA. How­ev­er, the com­pa­ny nev­er di­rect­ly asked if the rest of the BLA was ac­cept­able for re­view,” she wrote in a note.

Un­sur­pris­ing­ly the two com­pa­nies’ shares were trad­ing in op­po­site di­rec­tions: DBV’s stock crashed near­ly 49% pre-mar­ket, while Aim­mune’s shares climbed about 6% be­fore the bell.

An­a­lysts keen­ly watch­ing the tri­als and tribu­la­tions of the pair of drug de­vel­op­ers in­di­cat­ed that Aim­mune is now well-poised to be­come the first FDA-ap­proved treat­ment. They al­so ex­pressed out­rage that DBV pro­vid­ed no clear time­line on when and how the ap­pli­ca­tion’s is­sues would be re­solved.

Derek Archi­la

“We are sur­prised this type of in­for­ma­tion would not have been dis­cussed with the agency pri­or to the BLA sub­mis­sion (com­pa­ny has fast track and break­through sta­tus al­low­ing them in­creased agency in­ter­ac­tion) to en­sure the re­quired da­ta was part of the pack­age…this event will on­ly in­crease in­vestors’ skep­ti­cism on man­age­ment’s abil­i­ty to ex­e­cute on its reg­u­la­to­ry ini­tia­tives, which were al­ready con­tro­ver­sial,” Stifel’s Derek Archi­la wrote.

“While DB­VT’s new CEO in­di­cat­ed he an­tic­i­pates be­ing able to pro­vide the ad­di­tion­al in­for­ma­tion need­ed to sup­port the re-fil­ing of the BLA, he of­fered no clear time­lines for a BLA re-sub­mis­sion nor tim­ing on when he ex­pects to up­date in­vestors. The CEO on­ly in­di­cat­ed on the call it would not be “un­rea­son­able” to ex­pect an up­date from the com­pa­ny dur­ing 1Q19, but ul­ti­mate­ly we don’t know when it will oc­cur.”

Bri­an Sko­r­ney

Baird’s Bri­an Sko­r­ney was even more skep­ti­cal of DBV’s for­tunes, sug­gest­ing the de­lay could spell fur­ther dis­as­ter:

(T)his dy­nam­ic like­ly low­ers the prob­a­bil­i­ty that FDA would be will­ing to over­look the Phase 3 fail­ure. Un­der a 1H19 re­view, an Ad­Com would like­ly be set up with the com­pa­ny and pa­tient ad­vo­cates mak­ing the case that “there is noth­ing else avail­able”. Un­der any like­ly re­sub­mis­sion time­line, AR101 is like­ly to have been ap­proved by a Vi­askin Ad­Com and the FDA may be less flex­i­ble when a stan­dard of care ex­ists.

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.

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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Roche HQ in Basel, Switzerland. (Image credit: Kyle LaHucik/Endpoints News)

As com­peti­tors near FDA goal­post, Roche spells out its re­peat Alzheimer's set­back

Before Roche can turn all eyes on a new version of its more-than-once-failed Alzheimer’s drug gantenerumab, the Big Pharma had to flesh out data on the November topline failure at an annual conference buzzier than in years past thanks to hotly watched rivals in the field: Eisai and Biogen’s lecanemab, and Eli Lilly’s donanemab.

There was less than a 10% difference between Roche’s drug and placebo at slowing cognitive decline across two Phase III trials, which combined enrolled nearly 2,000 Alzheimer’s patients. In its presentation at the conference Wednesday, Roche said it saw less sweeping away of toxic proteins than it had anticipated. For years, researchers and investors have put their resources behind the idea that more amyloid removal would equate to reduced cognitive decline.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lynn Baxter, Viiv Healthcare's head of North America

Vi­iV dri­ves new cor­po­rate coali­tion in­clud­ing Uber, Tin­der and Wal­mart, aimed at end­ing HIV

ViiV Healthcare is pulling together an eclectic coalition of consumer businesses in a new White House-endorsed effort to end HIV by the end of the decade.

The new US Business Action to End HIV includes pharma and health companies — Gilead Sciences, CVS Health and Walgreens — but extends to a wide range of consumer companies that includes Tinder, Uber and Walmart.

ViiV is the catalyst for the group, plunking down more than half a million dollars in seed money and taking on ringmaster duties for launch today on World AIDS Day, but co-creator Health Action Alliance will organize joint activities going forward. ViiV and the alliance want and expect more companies to not only join the effort, but also pitch in funding.

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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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SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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