Omega-backed start­up sells it­self qui­et­ly; Ab­b­Vie breaks out more Rin­voq da­ta; Re­vance gets FDA date for Botox ri­val

→ When it came in­to the lime­light with a $35 mil­lion Se­ries A fi­nanc­ing in 2018, At­ten­ua promised to re­pur­pose three oral neu­ronal nico­tinic re­cep­tor as­sets dis­card­ed by Cat­a­lyst Bio­sciences (which in turn got the drugs through a merg­er with Tar­ga­cept). But now that it’s wrapped a proof-of-con­cept tri­al of the lead drug in chron­ic cough, At­ten­ua is flip­ping the port­fo­lio to an­oth­er buy­er for yet an­oth­er use.

CO­DA Bio­ther­a­peu­tics has bought At­ten­ua and its clin­i­cal stage small mol­e­cule can­di­dates, which they say will serve to con­trol their chemo­ge­net­ic re­cep­tors de­signed to treat neu­ro­path­ic pain, fo­cal epilep­sy and oth­er neu­ro­log­ic dis­or­ders.

The South San Fran­cis­co biotech liked that At­ten­ua’s drugs come with “high-qual­i­ty drug de­vel­op­ment work al­ready com­plet­ed, one with a cur­rent­ly ac­tive IND,” CEO Michael Narachi said.

Ac­cord­ing to clin­i­cal­tri­als.gov At­ten­ua com­plet­ed its chron­ic cough study in May last year, where it com­pared bradan­i­cline to place­bo, but has not post­ed the re­sults pub­licly. “We un­der­stand that the Phase II study end­points were not met,” Narachi told End­points News via email.

Omega Funds, Abing­worth, Or­biMed and Red­mile Group in­vest­ed in At­ten­ua. The fi­nan­cial terms of the buy­out deal were not dis­closed.

Ab­b­Vie’s oral JAK in­hibitor Rin­voq, which is part­ly ex­pect­ed to fill the gi­ant Hu­mi­ra hole af­ter the megablock­buster falls off its patent cliff, has more pos­i­tive da­ta back­ing its use. The com­pa­ny on Wednes­day is­sued da­ta from a piv­otal study in pso­ri­at­ic arthri­tis pa­tients, months af­ter pub­lish­ing sim­i­lar­ly pos­i­tive re­sults from an­oth­er Phase III tri­al in the same pa­tient pop­u­la­tion. Rin­voq was ap­proved by the FDA in Au­gust for use in pa­tients with rheuma­toid arthri­tis, al­though the la­bel came with the dread­ed black box warn­ing that have plagued the class of drugs.

→  Co-founder Dan Browne may have stepped down in Oc­to­ber fol­low­ing a “mis­judg­ment in han­dling an em­ploy­ee mat­ter,” but Cal­i­for­nia-based Re­vance is go­ing full steam ahead with its Botox ri­val Dax­i­bot­u­linum­tox­i­nA for In­jec­tion (DAXI). The prod­uct has been ac­cept­ed for re­view by the FDA for use in frown lines, and the agency is ex­pect­ed to make its de­ci­sion by No­vem­ber 25. 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 in 2018, de­spite the emer­gence of ri­vals: Ipsen’s Dys­port (man­u­fac­tured by Gal­der­ma for cos­met­ic use), Merz Phar­ma’s Xeomin. An­oth­er com­peti­tor, Evo­lus, scored FDA ap­proval for its prod­uct, Jeu­veau, in Feb­ru­ary 2019.

→ Italy’s Chiesi, which has al­lied with Is­raeli biotech Pro­tal­ix to de­vel­op an en­zyme re­place­ment ther­a­py for Fab­ry dis­ease, is now carv­ing out a whole new di­vi­sion to fo­cus on rare and ul­tra-rare dis­eases. It will be head­quar­tered in Boston and con­duct R&D in lyso­so­mal stor­age dis­or­ders, as well as rare hema­tol­ogy and oph­thal­mol­o­gy dis­eases.

→ Tiny Tonix, whose ex­per­i­men­tal PTSD drug Ton­mya lost its break­through ther­a­py sta­tus, ceased en­roll­ment of a piv­otal study on Wednes­day af­ter an in­de­pen­dent mon­i­tor­ing pan­el rec­om­mend­ed stop­ping the tri­al due to fu­til­i­ty on the ba­sis that the drug like­ly does not work. Be­set with mul­ti­ple set­backs, Tonix has done every­thing in its pow­er to get Ton­mya across the fin­ish line, in­clud­ing chang­ing tri­al goal­posts and us­ing sub­set analy­ses to take the pro­gram for­ward. The drug will con­tin­ue to be test­ed in pa­tients with fi­bromyal­gia.

→ The Chi­nese tech gi­ant Ten­cent man­aged to riv­et at­ten­tion its way when the com­pa­ny tem­porar­i­ly post­ed an up­date on the coro­n­avirus epi­dem­ic that list­ed close to 25,000 deaths and more than 154,000 cas­es in Chi­na. The of­fi­cial num­ber of deaths is a bit more than 500. The con­glom­er­ate quick­ly re­vert­ed to the of­fi­cial num­bers once the re­port had been flagged by alarmed ob­servers.

Tai­wan News re­port­ed that the com­pa­ny may have in­ad­ver­tent­ly re­vealed the ac­tu­al fig­ures be­ing tracked, as op­posed to the num­bers Chi­na prefers. Ei­ther way, the re­port un­der­scores some lin­ger­ing doubts that the Chi­nese gov­ern­ment is not be­ing com­plete­ly up­front about the way it’s han­dled the brew­ing pan­dem­ic so far. The gov­ern­ment has about 60 mil­lion cit­i­zens un­der lock­down to try and help con­tain the spread of the Wuhan virus, which has se­vere­ly dis­rupt­ed the coun­try’s econ­o­my.

→ Fol­low­ing up on some promis­ing mid-stage da­ta out of ES­MO, Curis has con­vinced its part­ners at Au­ri­gene to fund and con­duct a Phase IIb/III study of CA-170 among pa­tients with non-squa­mous non-small cell lung can­cer (nsNSCLC). In ex­change Au­ri­gene, a sub­sidiary of In­dia’s Dr. Red­dy’s Labs, gets the rights to de­vel­op and com­mer­cial­ize the drug in all of Asia — adding to an ex­ist­ing agree­ment for In­dia and Rus­sia. De­signed to be used in com­bi­na­tion with chemora­di­a­tion, CA-170 is an oral drug that in­hibits both PD-L1 and VISTA.

Albert Bourla (Photo by Steven Ferdman/Getty Images)

UP­DAT­ED: Pfiz­er fields a CRL for a $295M rare dis­ease play, giv­ing ri­val a big head start

Pfizer won’t be adding a new rare disease drug to the franchise club — for now, anyway.

The pharma giant put out word that their FDA application for the growth hormone therapy somatrogon got the regulatory heave-ho, though they didn’t even hint at a reason for the CRL. Following standard operating procedure, Pfizer said in a terse missive that they would be working with regulators on a followup.

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Graphic: Alexander Lefterov for Endpoints News

Small biotechs with big drug am­bi­tions threat­en to up­end the tra­di­tion­al drug launch play­book

Of the countless decisions Vlad Coric had to make as Biohaven’s CEO over the past seven years, there was one that felt particularly nerve-wracking: Instead of selling to a Big Pharma, the company decided it would commercialize its migraine drug itself.

“I remember some investors yelling and pounding on the table like, you can’t do this. What are you thinking? You’re going to get crushed by AbbVie,” he recalled.

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Mar­ket­ingRx roundup: Pfiz­er de­buts Pre­vnar 20 TV ads; Lil­ly gets first FDA 2022 pro­mo slap down let­ter

Pfizer debuted its first TV ad for its Prevnar 20 next-generation pneumococcal pneumonia vaccine. In the 60-second spot, several people (actor portrayals) with their ages listed as 65 or older are shown walking into a clinic as they turn to say they’re getting vaccinated with Prevnar 20 because they’re at risk.

The update to Pfizer’s blockbuster Prevnar 13 vaccine was approved in June, and as its name suggests is a vaccine for 20 serotypes — the original 13 plus seven more that cause pneumococcal disease. Pfizer used to spend heavily on TV ads to promote Prevnar 13 in 2018 and 2019 but cut back its TV budgets in the past two fall and winter seasonal spending cycles. Prevnar had been Pfizer’s top-selling drug, notching sales of just under $6 billion in 2020, and was the world’s top-selling vaccine before the Covid-19 vaccines came to market last year.

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A new can­cer im­munother­a­py brings cau­tious hope for a field long await­ing the next big break­through

Bob Seibert sat silent across from his daughter at their favorite Spanish restaurant near his home in Charleston County, SC, their paella growing cold as he read through all the places in his body doctors found tumors.

He had texted his wife, a pediatric intensive care nurse, when he got the alert that his online chart was ready. Although he saw immediately it was bad, many of the terms — peritoneal, right iliac — were inscrutable. But she was five hours downstate, at a loud group dinner the night before another daughter’s cheer competition.

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Roy Baynes, Merck

FDA bats back Mer­ck’s ‘pipeline in a prod­uct,’ de­mands more ef­fi­ca­cy da­ta

Despite some heavy blowback from analysts, Merck execs maintained an upbeat attitude about the market potential of its chronic cough drug gefapixant. But the confidence may be fading somewhat today as Merck puts out news that the FDA is handing back its application with a CRL.

Dubbed by Merck’s development chief Roy Baynes as a “pipeline in a product” with a variety of potential uses, Merck had fielded positive late-stage data demonstrating the drug’s ability to combat chronic cough. The drug dramatically reduced chronic cough in Phase III, but so did placebo, leaving Merck’s research team with a marginal success on the p-value side of the equation.

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Florida Gov. Ron DeSantis (AP Photo/Wilfredo Lee, File)

Opin­ion: Flori­da is so mAb crazy, Ron De­San­tis wants to use mAbs that don't work

Florida Gov. Ron DeSantis is trying so hard to politicize the FDA and demonize the federal government that he entered into an alternate universe on Monday evening in describing a recent FDA action to restrict the use of two monoclonal antibody, or mAb, treatments for Covid-19 that don’t work against Omicron.

Without further ado, let’s break down his statement from last night, line by line, adjective by adjective.

Not cheap­er by the dozen: Bris­tol My­ers be­comes the 12th phar­ma com­pa­ny to re­strict 340B sales

Bristol Myers Squibb recently joined 11 of its peer pharma companies in limiting how many contract pharmacies can access certain drugs discounted by a federal program known as 340B.

Bristol Myers is just the latest in a series of high-profile pharma companies moving in their own direction as the Biden administration’s Health Resources and Services Administration struggles to rein in the drug discount program for the neediest Americans.

Joaquin Duato, J&J CEO (Photo by Charles Sykes/Invision/AP)

New J&J CEO Joaquin Du­a­to promis­es an ag­gres­sive M&A hunt in quest to grow phar­ma sales

Joaquin Duato stepped away from the sideline and directly into the spotlight on Tuesday, delivering his first quarterly review for J&J as its newly-tapped CEO after an 11-year run in senior posts. And he had some mixed financial news to deliver today while laying claim to a string of blockbuster drugs in the making and outlining an appetite for small and medium-sized M&A deals.

Duato also didn’t exactly shun large buyouts when asked about the future of the company’s medtech business — where they look to be in either the top or number 2 position in every segment they’re in — even though the bar for getting those deals done is so much higher.

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Amgen's Twitter campaign #DearAsthma inspired thousands of people to express struggles and frustrations with the disease

Am­gen’s #Dear­Asth­ma spon­sored tweet lands big on game day, spark­ing thou­sands to re­spond

Amgen wanted to know how people with asthma really felt about daily life with the disease. So it bought a promoted tweet on Twitter noting the not-so-simple realities of life with asthma and ended the post with a #DearAsthma hashtag, a megaphone emoji and a re-tweet button.

That was just over one week ago and the responses haven’t stopped. More than 7,000 posts so far on Twitter replied to #DearAsthma to detail struggles of daily life, expressing humor, frustration and sometimes anger. More than a few f-bombs have been typed or gif-ed in reply to communicate just how much many people “hate” the disease.