No­var­tis’ big PhI­II for canakinum­ab scores a sur­prise win help­ing heart at­tack pa­tients

No­var­tis build­ings in Basel, Switzer­land, as seen from Dreirosen­bruecke bridge

With its new heart drug En­tresto strug­gling to find trac­tion and its top late-stage ef­fort for sere­lax­in a flop, No­var­tis to­day may have fi­nal­ly turned things around with the big Phase III win in car­dio it’s been search­ing for.

The phar­ma gi­ant’s canakinum­ab (ACZ885) sig­nif­i­cant­ly re­duced the risk of a com­pos­ite of car­dio­vas­cu­lar death, non-fa­tal my­ocar­dial in­farc­tion and non-fa­tal stroke for pa­tients with a pri­or heart at­tack and in­flam­ma­to­ry ath­er­o­scle­ro­sis. The phar­ma gi­ant is stick­ing with top line da­ta for now, but with an­a­lysts skep­ti­cal that the 6-year, 10,000-plus pa­tient study would come through, No­var­tis saw its shares jump more than 2% Thurs­day morn­ing.

This drug works by in­hibit­ing IL-1ß, a key cy­tokine, for a pro­longed pe­ri­od, tamp­ing down on in­flam­ma­tion to low­er risk to pa­tients.

In­ves­ti­ga­tors say they’ll now take the da­ta to reg­u­la­tors in search of a mar­ket­ing OK. The drug is cur­rent­ly ap­proved for rare au­toim­mune dis­eases and sold as Ilaris.

Vas­ant Narasimhan

No­var­tis’ R&D team has in­vest­ed heav­i­ly on heart fail­ure drugs in re­cent years, de­ter­mined to field block­buster meds in car­dio. But this is one of the tough­est fields in drug R&D, with reg­u­la­tors look­ing for big da­ta sets and pay­ers skep­ti­cal of see­ing val­ue in ex­pen­sive new drugs.

The dev­il now will be in the de­tails about the da­ta.

Leerink’s Sea­mus Fer­nan­dez wast­ed no time in pick­ing up on No­var­tis’ chal­lenge. He notes:

While this comes as a pos­i­tive up­side sur­prise to us, we await full da­ta from the tri­al (ex­pect­ed at an up­com­ing med­ical meet­ing) to as­sess the mag­ni­tude of ben­e­fit and the re­sults from key sec­ondary end­points be­fore in­cor­po­rat­ing this in­di­ca­tion in­to our mod­el. In the wake of the mut­ed launch­es of PC­SK9 an­ti­bod­ies and re­cent cuts to re­im­burse­ment from NICE due to a lack of ben­e­fit on CV death in Repatha’s FOURI­ER study, to­geth­er with ev­i­dence of CV ben­e­fits with two di­a­betes med­ica­tions and the mut­ed launch of En­tresto de­spite a trans­for­ma­tion­al out­come in the PAR­A­DIGM study, we be­lieve com­mer­cial suc­cess like­ly will re­quire an out­sized ben­e­fit on CV death in a sub­set of these pa­tients.

You’ll find the Re­gen­eron $REGN team on the side­lines root­ing for a block­buster suc­cess here. The biotech de­tailed its roy­al­ty agree­ment with No­var­tis on the an­ti­body this morn­ing, not­ing that the deal starts with a 4% share that ris­es to 15% once rev­enue breaks the $1.5 bil­lion mark.

De­spite the sere­lax­in set­back, No­var­tis’ R&D has been en­joy­ing sev­er­al suc­cess­es this year, in­clud­ing the re­cent head-to-head matchup with Eylea, a pos­i­tive da­ta up­date on Cosen­tyx and a lead­ing role pi­o­neer­ing CAR-T.

“De­spite cur­rent treat­ment, about 25 per­cent of heart at­tack sur­vivors will have an­oth­er car­dio­vas­cu­lar event with­in five years, mak­ing the out­come of the CAN­TOS study a promis­ing new de­vel­op­ment for pa­tients,” said Vas Narasimhan, the glob­al head of drug de­vel­op­ment and CMO at No­var­tis. “ACZ885 is the first and on­ly in­ves­ti­ga­tion­al agent which has shown that se­lec­tive­ly tar­get­ing in­flam­ma­tion re­duces car­dio­vas­cu­lar risk. Our pri­or­i­ty now is to thor­ough­ly an­a­lyze these im­por­tant da­ta and dis­cuss them with reg­u­la­to­ry agen­cies.”

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About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

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