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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The cell and gene therapies (CGT) sector offers unprecedented opportunities for patient disease management across virtually all therapeutic areas. However, finding the right accredited clinical teams to take a therapy through to the clinic and manage the regulatory process can be a major challenge for biotechs with a CGT product.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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Troy Wilson, Kura CEO

UP­DAT­ED: FDA hits the red light on an ear­ly-stage AML study af­ter a pa­tient dies

The FDA has slapped a clinical hold on the early-stage program for one of Kura Oncology’s cancer drugs following a patient’s death in a clinical trial.

The biotech $KURA reported early Wednesday that the Phase Ib study of KO-539 for acute myeloid leukemia would be halted, suspending enrollment, while researchers and the FDA probed the death. Patients already on the drug can continue taking it.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Mar­ket­ingRx roundup: Am­gen, Lil­ly, Bio­haven mi­graine brand re­call low, study says; No­var­tis looks to re­make drug launch mod­el

Forget the migraine marketing brand wars. When it comes to patients, many can’t even name one despite substantial advertising efforts, according to a new study from Phreesia that concludes CGRP migraine drugmakers still need to work on brand recognition.

Almost half (47%) of the patients Phreesia surveyed couldn’t name one preventative migraine brand. The best performer was Topamax, a small molecule anticonvulsant that’s been around since 2004, which 26% of migraine patients could recall. Among the new CGRP brand names recognized, Amgen’s Aimovig ranked highest with 8% recall, while Eli Lilly’s Emgality and Biohaven’s Nurtec tied at 7% and Teva’s Ajovy was remembered by 3% of patients.

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Emma Walmsley, GlaxoSmithKline CEO (Fang Zhe/Xinhua/Alamy Live News)

Glax­o­SmithK­line places a risky bet on Ar­row­head­'s RNA drug in the fail­ure-strewn NASH field

As activist investors champ at the bit for change at drug giant GlaxoSmithKline, the pharma giant has turned over many rocks to find an R&D success to present to its detractors. In NASH, a field strewn with failures, GSK hopes a new license deal can churn out a much-needed winner.

GSK will pay $120 million in upfront cash and $910 million in downstream milestones to develop and sell ARO-HSD, Arrowhead Pharmaceuticals’ RNA interference drug targeting fatty liver disease nonalcoholic steatohepatitis (NASH), the companies said Monday.

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Name that vac­cine: From Comir­naty to Spike­vax to Nu­vax­ovid, Covid-19 shot­s' brand names re­main lit­tle-known

Most people know if they’re “Team Pfizer” or “Team Moderna,” but few know if they got the Comirnaty or Spikevax Covid-19 vaccine. Those are the brand names of Pfizer and Moderna vaccines, respectively, however they have yet to take hold with consumers, media or even medical professionals.

And there are others. Covid vaccine brand names also include AstraZeneca’s Vaxzevria, Novavax’s Nuvaxovid, and Sanofi and GlaxoSmithKline’s Vidprevtyn. J&J’s Janssen-developed Covid vaccine is the lone major holdout and is still yet to be named, if ever. In EMA filings approving its conditional use, the brand name is listed simply as “Covid-19 Vaccine Janssen.”

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Joan Perelló, Sanifit CEO

Joan Perel­ló set out 17 years ago to de­vel­op a drug. And to­day he's be­ing re­ward­ed with a $424M biotech buy­out

Joan Perelló beat all the odds with his little Spanish biotech startup Sanifit.

Working on the far perimeter of the big US/European drug development scene, he took a drug born out of his PhD work and got enough seed cash to get started. That’s one near miracle. In the second near miracle he gathered a previously unheard of venture raise in Spain — helping build an industry ecosystem from scratch — to pursue a successful search for solid human data for his drug, SNF472. And while gathering a virtual team of developers from Europe and the US, the CEO/co-founder steered it into the late-stage arena.

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