Ab­b­Vie gets a big boost in the ma­jor league rheuma­toid arthri­tis fi­nals with promis­ing PhI­II da­ta

Ab­b­Vie passed on a big part­ner­ship it had set up with Gala­pa­gos on the promis­ing rheuma­toid arthri­tis drug fil­go­tinib so it could fo­cus all of its ef­forts on an in-house pro­gram for upadac­i­tinib (ABT-494). And to­day the block­buster gam­ble was re­ward­ed with a round of stel­lar da­ta from their first Phase III study of the oral JAK in­hibitor.

Both the 15 mg and 30 mg dos­es swept the pri­ma­ry and sec­ondary end­points in the study, with 64% and 66% re­spec­tive­ly hit­ting ACR20, with a min­i­mum 20% im­prove­ment in the dis­ease score.  ACR50 came in at 38% and 43%. Low dis­ease ac­tiv­i­ty was marked by about half of the pa­tients while on­ly 17% of the place­bo arm could say the same.

Here’s the full chart:

There have been a host of ma­jor league ri­vals go­ing af­ter RA re­cent­ly, with mixed re­sults. So how does ABT-494 stack up?

At the top of the set­back list is Eli Lil­ly’s baric­i­tinib, part­nered with In­cyte, which the FDA re­ject­ed in April for large­ly un­known rea­sons. J&J and Glax­o­SmithK­line re­cent­ly stum­bled in a head-to-head with sirukum­ab against Hu­mi­ra, a main­stay in the mar­ket. The 50 mg and 100 mg sirukum­ab num­bers hit 27% and 35% on ACR50 com­pared to 32% of the Hu­mi­ra group. But Re­gen­eron and Sanofi scored with sar­ilum­ab (Kevzara), win­ning an ap­proval for the IL-6 drug re­cent­ly af­ter be­ing de­layed over man­u­fac­tur­ing is­sues.

Ab­b­Vie has high hopes for the oral upadac­i­tinib, wide­ly tapped as a block­buster-to-be. It’s al­ready well in­to a late-stage pro­gram on pso­ri­at­ic arthri­tis fol­lowed by Crohn’s dis­ease, ul­cer­a­tive col­i­tis and atopic der­mati­tis. And Ge­of­frey Porges at Leerink was quick to of­fer the com­pa­ny ku­dos for the way this ther­a­py is be­ing po­si­tioned. He not­ed:

The place­bo-ad­just­ed ACR20 ben­e­fit rates for upadac­i­tinib with methotrex­ate of 28%-30% are nu­mer­i­cal­ly su­pe­ri­or to com­peti­tor LLY (OP)/IN­CY’s (OP) baric­i­tinib of 22-26% in the same tri­al with pa­tients who had in­ad­e­quate re­spons­es to DMARD, and the more strin­gent place­bo-ad­just­ed ACR50 and ACR70 rates for upadac­i­tinib are al­so high­er than seen in the baric­i­tinib tri­al. We cur­rent­ly mod­el $1.6bn in peak sales for upadac­i­tinib com­pared to con­sen­sus ex­pec­ta­tions of $2.5bn in 2027E, and we be­lieve that the su­pe­ri­or da­ta and re­cent FDA re­jec­tion of baric­i­tinib fa­vor­ably po­si­tion Ab­b­Vie in the JAK mar­ket seg­ment, and could lead to ma­te­r­i­al up­side to fore­casts.

The phar­ma com­pa­ny was so pumped about its prospects with this drug, with peak sales pro­jec­tions run­ning in­to the bil­lions, that it walked away from its $150 mil­lion up­front on a ri­val oral ther­a­py, which Gilead quick­ly scooped up for it­self.

Gerd Burmester

“Achiev­ing the tar­get of low dis­ease ac­tiv­i­ty in near­ly half of the pa­tients by 12 weeks and do­ing so at both high and low dose lev­els is en­cour­ag­ing,” said Gerd Burmester, pro­fes­sor of med­i­cine, De­part­ment of Rheuma­tol­ogy and Clin­i­cal Im­munol­o­gy, Char­ité Berlin, in a state­ment. “Cur­rent treat­ment rec­om­men­da­tions rec­og­nize the im­por­tance of this clin­i­cal tar­get for pa­tients, as achiev­ing low dis­ease ac­tiv­i­ty has re­mained an un­met need in rheuma­toid arthri­tis.”

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.

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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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.