Feb 6, 2020

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. 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 and 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. Author UP­DAT­ED: Glax­o­SmithK­line's lat­est makeover in­cludes auc­tion­ing off der­ma­tol­ogy, adding new tech and lay­offs. But how many? GSK execs announced Wednesday morning that they are setting up a 2-year program to prepare the company for its split in two — consumer healthcare and the R&D-focused outfit she and research chief Hal Barron promised to revamp and reenergize 2 years ago. A key part of that effort is a new R&D reorganization in which the vaccines group — traditionally separate inside the global organization — will integrate its work with the pharma teams in order to orchestrate common research themes on both sides. And GSK is helping pay for the 2-year program with a plan to sell off non-core assets, starting with its dermatology drugs portfolio. Keep reading Endpoints with a free subscription Unlock this story instantly and join 71,400+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE Jef­frey Blue­stone ex­its Park­er and switch­es fo­cus back to au­toim­mune dis­eases in cell ther­a­py 2.0 launch Jeffrey Bluestone is returning to the scientific field where he forged his reputation as a drug hunter and top investigator. The prominent scientist has handed in his walking papers as CEO of the high profile Parker Institute for Cancer Immunotherapy, switched to the adjunct faculty at UCSF and is now launching a new company, where he plans to take a hands-on role in the development of new cell therapies for autoimmune and degenerative diseases. Keep reading Endpoints with a free subscription Unlock this story instantly and join 71,400+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE Ian Read adds a new post to his grow­ing ros­ter of post-Pfiz­er po­si­tions — and this one pays well Ian Read may have to pick up the pace a bit to meet the swelling number of jobs he’s added to his resume since recently retiring from Pfizer after a 41-year run that included 9 years at the top. Today we learned that Read is taking the chairman’s spot on the board of tech player DXC, a data management outfit that has a big focus on healthcare and the life sciences industry. Read is being well paid for his time and attention. Their SEC filing notes that the ex-Pfizer CEO and chairman will earn an annual retainer of $450,000 in stock, pro-rated to his March 16 start date. Read More Roche/PTC edge clos­er to dis­rupt­ing mar­ket for SMA ri­vals Bio­gen and No­var­tis with more pos­i­tive da­ta Roche and partner PTC Therapeutics have broken out detailed positive data backing their spinal muscular atrophy therapy, which is expected to have a good shot at eclipsing Spinraza’s market leadership. The FDA is set to make its decision on the therapy, risdiplam, by May 24. If approved — the drug is expected to generate between $2 billion and $3 billion in peak sales — and compete with Biogen’s first-to-market Spinraza and Novartis’ most-expensive-drug-in-the-world Zolgensma. Read More Par­ty on: Base edit­ing start­up, com­pu­ta­tion­al drug dis­cov­ery ex­perts and CRO bag close to $2B to­tal on their way to Nas­daq On the back of Black Diamond Therapeutics’ roaring public debut, the IPO momentum is pushing three biotech players from very different corners of the industry to shiny listings on the Nasdaq. Gene editing startup Beam Therapeutics, computational drug discovery specialist Schrödinger and contract research organization PPD have collectively bagged close to $2 billion by pricing at the top of or above the range laid out in their terms. CRISPR trailblazers raise $180M for the next big thing in gene editing Keep reading Endpoints with a free subscription Unlock this story instantly and join 71,400+ biopharma pros reading Endpoints daily — and it's free. SUBSCRIBE