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.”

Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.

Seer adds ex-FDA chief Mark Mc­Clel­lan to the board; Her­cules Cap­i­tal makes it of­fi­cial for new CEO Scott Bluestein

→ On the same day it announced a $17.5 million Series C, life sciences and health data company Seer unveiled that it had lured former FDA commissioner and ex-CMS administrator Mark McClellan on to its board. “Mark’s deep understanding of the health care ecosystem and visionary insights on policy reform will be crucial in informing our thinking as we work to bring our liquid biopsy and life sciences products to market,” said Seer chief and founder Omid Farokhzad in a statement.

Daniel O'Day

No­var­tis hands off 3 pre­clin­i­cal pro­grams to the an­tivi­ral R&D mas­ters at Gilead

Gilead CEO Daniel O’Day’s new task hunting up a CSO for the company isn’t stopping the industry’s dominant antiviral player from doing pipeline deals.

The big biotech today snapped up 3 preclinical antiviral programs from pharma giant Novartis, with drugs promising to treat human rhinovirus, influenza and herpes viruses. We don’t know what the upfront is, but the back end has $291 million in milestones baked in.

Vas Narasimhan, AP Images

On a hot streak, No­var­tis ex­ecs run the odds on their two most im­por­tant PhI­II read­outs. Which is 0.01% more like­ly to suc­ceed?

Novartis CEO Vas Narasimhan is living in the sweet spot right now.

The numbers are running a bit better than expected, the pipeline — which he assembled as development chief — is performing and the stock popped more than 4% on Thursday as the executive team ran through their assessment of Q2 performance.

Year-to-date the stock is up 28%, so the investors will be beaming. Anyone looking for chinks in their armor — and there are plenty giving it a shot — right now focus on payer acceptance of their $2.1 million gene therapy Zolgensma, where it’s early days. And CAR-T continues to underperform, but Novartis doesn’t appear to be suffering from it.

So what could go wrong?

Actually, not much. But Tim Anderson at Wolfe pressed Narasimhan and his development chief John Tsai to pick which of two looming Phase III readouts with blockbuster implication had the better odds of success.

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On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.