Ab­b­Vie wins a 5-year free pass on mega-block­buster Hu­mi­ra in biosim set­tle­ment with ri­val Am­gen

It was clear from a re­cent sit-down with Leerink’s Ge­of­frey Porges that Ab­b­Vie was feel­ing good about keep­ing its mega-block­buster Hu­mi­ra fran­chise in the US to it­self through 2022. And this morn­ing we got a peek in­to why they were so bull­ish.

Richard Gon­za­lez

Am­gen, which scored the first ap­proval for a biosim­i­lar of Hu­mi­ra in the US, has signed off on a set­tle­ment agree­ment with Ab­b­Vie that will de­lay its roll­out un­til ear­ly 2023. Am­gen can get start­ed in the EU in the fall of next year, with a mar­ket­ing pact that calls on the com­pa­ny to pay roy­al­ties to Ab­b­Vie.

Ab­b­Vie’s shares $AB­BV shot up 6% this morn­ing.

The de­tails on this deal are be­ing kept un­der wraps, but the set­tle­ment re­moves one of the most liti­gious com­pa­nies in the in­dus­try from Ab­b­Vie’s pact. As Ever­cor­eISI’s Umer Raf­fat said in a quick note this morn­ing, the court dates over the patent fight could well have left any fi­nal ap­peals de­ci­sion un­til 2021.

Ab­b­Vie CEO Rick Gon­za­lez is ea­ger to make Hu­mi­ra in­to a $20 bil­lion a year drug be­fore hav­ing to com­pete against biosim­i­lars, and there are at least 10 oth­ers in the late-stage pipeline now with vir­tu­al­ly every­one in the gener­ic bi­o­log­ics busi­ness tack­ling the king of the mar­ket.

The FDA has be­come quite wel­com­ing to new biosim­i­lar ap­pli­ca­tions over the past year. But get­ting an ap­proval and carv­ing up mar­ket share at two com­plete­ly dif­fer­ent things, as Pfiz­er found out when it went af­ter J&J’s Rem­i­cade. Pfiz­er’s knock­off bare­ly made a dent in the mar­ket, and the phar­ma gi­ant re­cent­ly ac­cused J&J of us­ing im­prop­er meth­ods in bar­ring com­pe­ti­tion — a po­si­tion that J&J says was dri­ven by an em­bar­rass­ing in­abil­i­ty to mar­ket the ther­a­py prop­er­ly.

Ab­b­Vie, which has now de­layed the lead threat to its biggest cash cow for an­oth­er five years, was care­ful not to gloat this morn­ing.

Lau­ra Schu­mach­er, ex­ec­u­tive vice pres­i­dent, ex­ter­nal af­fairs, gen­er­al coun­sel and cor­po­rate sec­re­tary, Ab­b­Vie, had this to say:

In reach­ing this agree­ment, we have achieved the bal­ance be­tween pro­tect­ing in­vest­ment in in­no­va­tion and pro­vid­ing ac­cess to biosim­i­lars, which will play an im­por­tant role in our health care sys­tem. We will con­tin­ue to de­fend our in­tel­lec­tu­al prop­er­ty and to rein­vest in fur­ther ad­vance­ments in med­i­cine to bring choic­es to pa­tients in need.

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.