No­var­tis banks on the promise of dig­i­tal ther­a­peu­tics in the man­age­ment of chron­ic dis­or­ders

Dig­i­tal ther­a­peu­tics may not have yet earned cult sta­tus with­in the health­care in­dus­try, but their promise in non-com­mu­ni­ca­ble dis­eases — that are of­ten caused or wors­ened by un­sa­vory be­hav­iors — is hard to de­ny, as Big Phar­ma makes a deep­er for­ay in­to clin­i­cal­ly-val­i­dat­ed dig­i­tal in­ter­ven­tions de­signed to en­cour­age sus­tain­able lifestyle changes to com­ple­ment tra­di­tion­al ther­a­peu­tics.

No­var­tis $NVS unit San­doz along with part­ner Pear Ther­a­peu­tics on Mon­day launched re­SET, an FDA-ap­proved dig­i­tal ther­a­peu­tic de­signed to de­liv­er cog­ni­tive be­hav­ioral ther­a­py over 12 weeks to pa­tients with sub­stance abuse dis­or­der (SUD) who are in out­pa­tient treat­ment un­der the su­per­vi­sion of a doc­tor.

Richard Fran­ci

“Adding re­SET to out­pa­tient ther­a­py en­hances be­hav­iors as­so­ci­at­ed with re­cov­ery. It lever­ages new tech­nol­o­gy to help pa­tients im­prove ab­sti­nence in sub­stances of abuse and stay in treat­ment pro­grams longer than out­pa­tient ther­a­py alone,” said San­doz chief Richard Fran­cis in a state­ment.

Poor treat­ment out­comes are the norm for SUD — a chron­ic, re­laps­ing dis­ease caused by the per­sis­tent use of al­co­hol and/or drugs — as in­con­sis­tent ac­cess and qual­i­ty of treat­ment as well as dis­par­i­ties in pay­ment and in­sur­ance for be­hav­ioral health ser­vices have cul­mi­nat­ed in low rates of ab­sti­nence and high dropout rates for a type of ther­a­py that is usu­al­ly re­source-in­ten­sive and ne­ces­si­tates face-to-face clin­i­cian in­ter­ac­tions. In 2014, about 21.5 mil­lion Amer­i­cans aged 12 and old­er (8.1%) were clas­si­fied with a sub­stance use dis­or­der in the past year, ac­cord­ing to es­ti­mates from HHS’ Sub­stance Abuse and Men­tal Health Ser­vices Ad­min­is­tra­tion.

The FDA ap­proved re­SET last year on the ba­sis of a NI­DA-spon­sored tri­al in­volv­ing 399 pa­tients with SUD. Pa­tients were ran­dom­ized to re­ceive stan­dard treat­ment — com­pris­ing in­ten­sive face-to-face coun­selling — or re­duced amount of face-to-face coun­selling plus the dig­i­tal ther­a­peu­tic. Pa­tients on the dig­i­tal ther­a­peu­tic more than dou­bled the rate of ab­sti­nence com­pared to stan­dard face-to-face coun­selling.

Dig­i­tal ther­a­peu­tics is an um­brel­la term that in­cludes tech­nol­o­gy such as wear­able de­vices, mo­bile apps and telemed­i­cine plat­forms — which is typ­i­cal­ly dri­ven by soft­ware to pre­vent, man­age, or treat dis­or­ders, in­de­pen­dent­ly or in con­cert with med­ica­tion and/or med­ical de­vices. These tools are large­ly de­signed to ad­dress chron­ic dis­eases such as di­a­betes, heart or res­pi­ra­to­ry dis­or­ders, by tar­get­ing be­hav­iors such as di­et, ex­er­cise and lifestyle that have a sig­nif­i­cant im­pact on the in­ci­dence and man­age­ment of dis­ease. Pre­scrip­tion dig­i­tal ther­a­peu­tics — such as re­SET and Abil­i­fy Mycite, the first dig­i­tal pill that car­ries an em­bed­ded sen­sor to track if pa­tients are tak­ing their med­ica­tion prop­er­ly — are val­i­dat­ed in ran­dom­ized clin­i­cal tri­als to demon­strate safe­ty and ef­fi­ca­cy.

Pear Ther­a­peu­tics is al­so de­vel­op­ing dig­i­tal ther­a­peu­tics for a host of oth­er dis­or­ders in­clud­ing schiz­o­phre­nia, PTSD and gen­er­al anx­i­ety dis­or­der. Al­though the rapid pen­e­tra­tion of smart­phones and tablets and low­er health­care costs have dri­ven the growth of the glob­al dig­i­tal ther­a­peu­tics mar­ket, pri­va­cy con­cerns could tem­per the pace of adop­tion. Still, ac­cord­ing to Al­lied Mar­ket Re­search the size of the mar­ket is set to grow to $7.83 bil­lion in 2025 from $1.75 bil­lion last year.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.