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.”

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for new Bio­haven with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the new Biohaven post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Mar­ket­ingRx roundup: No­var­tis re­cruits NFL coach for Leqvio cam­paign; Pfiz­er pro­motes ‘Sci­ence’ merch on so­cial me­dia

Novartis is turning to a winning coach to talk about Leqvio and the struggles of high cholesterol — including his own. Bruce Arians, the retired NFL head coach of the Arizona Cardinals and Super Bowl-winning Tampa Bay Buccaneers, is partnering with the pharma for its “Coaching Cholesterol” digital, social and public relations effort.

In the campaign, Arians talks about the potential for “great comebacks” in football and heart health. Once nicknamed a “quarterback whisperer,” he is now retired from fulltime coaching (although still a front-office consultant for Tampa Bay), and did a round of media interviews for Novartis, including one with People and Forbes.

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Amy West, Novo Nordisk head of US digital innovation and transformation (Illustration: Assistant Editor Kathy Wong for Endpoints News)

Q&A: No­vo Nordisk dig­i­tal in­no­va­tion chief Amy West dis­cuss­es phar­ma pain points and a health­care 'easy but­ton’

Amy West joined Novo Nordisk more than a decade ago to oversee marketing strategies and campaigns for its US diabetes portfolio. However, her career path shifted into digital, and she hasn’t looked back. West went from leading Novo’s first digital health strategy in the US to now heading up digital innovation and transformation.

She’s currently leading the charge at Novo Nordisk to not only go beyond the pill with digital marketing and health tech, but also test, pilot and develop groundbreaking new strategies needed in today’s consumerized healthcare world.

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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.