Fight­ing a gener­ic on­slaught, No­var­tis adds CAR-T to its grow­ing list of late-stage block­busters

One of the rea­sons why No­var­tis isn’t be­ing forced to bid in­to the stratos­phere for late-stage drugs is that its in­dus­try-top­ping R&D bud­get — $9 bil­lion last year — has al­ready fund­ed one of the biggest late-stage pipelines in the in­dus­try. The phar­ma gi­ant un­der­scored that to­day as it out­lined 13 prospec­tive block­busters with up­com­ing piv­otal read­outs in the com­ing months and years, a group that now in­cludes its lead CAR-T ther­a­py for the very first time. And it added more de­tails on its im­muno-on­col­o­gy strat­e­gy, which has lagged be­hind lead­ers like Mer­ck, Bris­tol-My­ers Squibb and Roche.

The CDK 4/6 in­hibitor LEE011 is its most ad­vanced ther­a­py in Phase III. But No­var­tis is plan­ning an am­bi­tious roll­out of da­ta and reg­u­la­to­ry fil­ings as it looks to push past some pun­ish­ing gener­ic com­pe­ti­tion that has blunt­ed its rev­enue growth. It’s al­so look­ing at a slate of sec­ond-gen­er­a­tion im­muno-on­col­o­gy pro­grams, with some 20 clin­i­cal stud­ies in the field un­der­way in ear­ly 2017.

As we al­ready knew, its CAR-T CTL019 will be filed for pe­di­atric ALL some­time in the very near fu­ture, with piv­otal tri­al da­ta wait­ing in Q2. An­oth­er fil­ing for DL­B­CL is com­ing up in the sec­ond half of the year – with a ma­jor read­out from JULI­ET – and No­var­tis is step­ping up its game by bull­ish­ly as­sert­ing its $1 bil­lion-plus an­nu­al sales po­ten­tial.

Jef­feries’ Pe­ter Welford not­ed this morn­ing that the CAR-T up­date is par­tic­u­lar­ly sig­nif­i­cant.

“No­var­tis has, for the first time, in­clud­ed CTL019 on its pipeline of pos­si­ble block­busters, un­der­scor­ing its con­fi­dence in the prod­uct’s com­mer­cial po­ten­tial. De­spite lo­gis­ti­cal chal­lenges, we fore­cast at least $1bn WW peak sales for £65-75m in­come to OXB (Ox­ford Bio­Med­ica) p.a. pro­vid­ing an im­por­tant sus­tain­able rev­enue stream for c.5p/share NPV at 80% prob­a­bil­i­ty, more than un­der­pin­ning the cur­rent share price.”

No­var­tis’ bull­ish fore­cast fol­lows its con­tro­ver­sial move to shut­ter its in­de­pen­dent cell and gene ther­a­py unit, ax­ing about 120 staffers in the process. The phar­ma gi­ant, though, spec­i­fied that it not on­ly hasn’t aban­doned its CAR-T pipeline as it en­gi­neered its lat­est glob­al re­or­ga­ni­za­tion of R&D, it’s up­ping its game.

That could present some new pres­sure on Kite, which is hus­tling along its own rolling sub­mis­sion for a pi­o­neer­ing CAR-T, while Juno has yet to de­cide what it will do with its trou­bled lead CAR-T, now stymied by a num­ber of pa­tient deaths.

No­var­tis al­so has a cat­a­lyst rich year planned, with sub­mis­sions on AMG334 for mi­graine, part­nered with Am­gen, as well as BAF312 for sec­ondary pro­gres­sive MS. You can get the full pic­ture here, on pages 57 and 58.

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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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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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.