Still pon­der­ing an M&A move, Gilead­'s R&D team out­lines a Q3 line­up of set­backs on 3 pipeline drugs

Gilead CEO John Mil­li­gan

Hit on one side by slump­ing hep C rev­enue and on the oth­er side by high ex­pec­ta­tions for its pipeline ef­fort, Gilead grim­ly hung on to sim­tuzum­ab af­ter the LOXL2 en­zyme block­er flopped in two straight stud­ies. Now the Big Biotech has added sev­er­al more fail­ures to the ros­ter and put the five-time los­er on the shelf for good.

And that’s not all.

Two more drugs al­so failed a line­up of clin­i­cal tri­al tests, leav­ing Gilead $GILD look­ing weak­er on the R&D front at pre­cise­ly the time it needs to show strength. In ad­di­tion to sim­tuzum­ab, the biotech al­so wrote off the late-stage drug GS-5745 for ul­cer­a­tive col­i­tis and Crohn’s. And it’s top car­dio prospect failed a study as well, sig­nif­i­cant­ly re­duc­ing its chances of be­com­ing the big new drug that Gilead needs as hep C wanes. Mean­while, its Q3 R&D ex­pens­es spiked, large­ly due to the $200 mil­lion pay­ment it just made to Nim­bus.

Add it up and Gilead now more than ever needs to do some­thing big for the pipeline, but CEO John Mil­li­gan con­tin­ued to in­sist that the com­pa­ny will bide its time in find­ing the right deals. He not­ed:

(O)ur in­ter­est in part­ner­ships and po­ten­tial ac­qui­si­tions is not lim­it­ed to on­col­o­gy, and we are con­sid­er­ing op­por­tu­ni­ties where there is strong sci­ence and where we see the pos­si­bil­i­ty of de­vel­op­ing a tru­ly dif­fer­en­ti­at­ed prod­uct. We’ve been go­ing through an ex­ten­sive in­ter­nal re­view of pro­grams and op­por­tu­ni­ties, and an im­por­tant as­pect of our ap­proach is that we re­main open-mind­ed, but dis­ci­plined. So while we have the bal­ance sheet to ex­e­cute on mul­ti­ple op­por­tu­ni­ties, we will keep the bar high.

Gilead CSO Nor­bert Bischof­berg­er

Gilead R&D chief Nor­bert Bischof­berg­er was left to sound taps on the drug tri­als dur­ing the Q3 re­view Tues­day evening, start­ing with sim­tuzum­ab, which has now failed 5 stud­ies, in­clud­ing three re­cent 96-week at­tempts:

The da­ta in­di­cate that, while safe and well-tol­er­at­ed, there is no ev­i­dence of ef­fi­ca­cy in one study in pri­ma­ry scle­ros­ing cholan­gi­tis and in two stud­ies in NASH. One NASH study was in pa­tients with cir­rho­sis and one was in pa­tients with liv­er (20:54) fi­bro­sis. Con­se­quent­ly, we will not de­vel­op sim­tuzum­ab any fur­ther in these or any oth­er in­di­ca­tions. We will present these da­ta at fu­ture con­fer­ences.

The drug al­ready failed for pan­cre­at­ic can­cer and id­io­path­ic pul­monary fi­bro­sis.

As for GS-5745, an an­ti-MMP-9 an­ti­body, we stopped a Phase II/III study in pa­tients with ul­cer­a­tive col­i­tis be­cause of the lack of ef­fi­ca­cy. This de­ci­sion for the planned in­ter­im DSMB analy­sis af­ter the first 150 pa­tients had been en­rolled, that the study met pre-de­fined fu­til­i­ty cri­te­ria. Al­so, and not un­ex­pect­ed­ly, there was no ev­i­dence of ben­e­fit of GS-5745 in a Phase II study in pa­tients with Crohn’s dis­ease. Con­se­quent­ly, we will not fur­ther pur­sue GS-5745 for ul­cer­a­tive col­i­tis or Crohn’s.

And then came the car­dio drug ele­clazine.

Ele­clazine, or GS-6615, failed to meet its pri­ma­ry end­point in a study of pa­tients with ven­tric­u­lar tachy­car­dia, ven­tric­u­lar fib­ril­la­tion, or VT/VF, and im­plant­ed car­diovert­er-de­fib­ril­la­tors. Pa­tients were ran­dom­ized to two dos­es of ele­clazine or place­bo. The pri­ma­ry end­point was the num­ber of elec­tri­cal in­ter­ven­tions, in­clud­ing shocks and pac­ing, by the im­plant­ed de­vice. And there was no ev­i­dence of ef­fi­ca­cy of ele­clazine com­pared to place­bo. Con­se­quent­ly, we will not de­vel­op ele­clazine any fur­ther for VT/VF. Eval­u­a­tion in long QT-3 syn­drome and in hy­per­trophic car­diomy­opa­thy is con­tin­u­ing.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



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

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

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Lynn Baxter, Viiv Healthcare's head of North America

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AbCellera founder and CEO Carl Hansen (L) and Rallybio CEO Martin Mackay

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