Top 20 block­buster drugs in the late-stage pipeline — Eval­u­atePhar­ma

Every time news hits about an­oth­er biosim­i­lar to Hu­mi­ra, an­a­lysts are re­mind­ed that Ab­b­Vie $AB­BV is liv­ing on bor­rowed time. Ever since the big split with Ab­bott, the com­pa­ny has been wheel­ing and deal­ing its way in­to Phase III in a huge gam­ble that it can hold off copy­cats long enough to field a slate of drugs ca­pa­ble of re­plac­ing a ther­a­py that now de­liv­ers $16 bil­lion a year.

The new list from Eval­u­atePhar­ma on the top 20 late-stage drugs in the pipeline — in­clud­ed in its big an­nu­al re­port on the in­dus­try — un­der­scores just how hard that is, and al­so how much progress Ab­b­Vie is mak­ing.

Ab­b­Vie has 4 drugs in late-stage de­vel­op­ment that fall in the top 20, more than any oth­er com­pa­ny on the list. These drugs range from Ro­va-T (with a 2022 sales es­ti­mate of $1.5 bil­lion), fol­lowed by elagolix ($1.5 bil­lion), its promis­ing JAK1 in­hibitor ABT-494 ($1.2 bil­lion) and gle­capre­vir/pi­brentasvir ($1.2 bil­lion), which has been wide­ly ig­nored re­cent­ly as it made its way through late-stage hep C tri­als just as the mar­ket has be­gun to shrink fast.

Risky? The $5.4 bil­lion of col­lec­tive­ly pro­ject­ed an­nu­al rev­enue in­cludes a can­cer drug that many be­lieve Ab­b­Vie over­spent on in buy­ing Stem­cen­trx. And even if they all suc­ceed, it’s on­ly a por­tion of what Hu­mi­ra is good for, as long as they can hold on to patent pro­tec­tion.

If Eval­u­ate is right, Gilead $GILD could eas­i­ly ri­val Ab­b­Vie’s pack­age just with its lat­est cock­tail for HIV, adding bicte­gravir to the mix with po­ten­tial an­nu­al sales of $4.4 bil­lion — the high­est mon­ey­mak­er on the list and the on­ly one field­ed by Gilead, which has been hav­ing some trou­ble in the clin­ic over the past year.

No­vo Nordisk al­so helps demon­strate why one big drug in a big dis­ease field can be worth more than a host of small­er ther­a­pies. Its GLP-1 en­try semaglu­tide comes with $2.2 bil­lion in peak sales fore­cast.

J&J $JNJ comes in num­ber two in terms of to­tal num­ber of po­ten­tial block­busters, with three prod­ucts on the list: apa­lu­tamide ($1.6 bil­lion; re­mem­ber ARN-509 from Aragon?) fol­lowed by guselkum­ab ($1.5 bil­lion) and sirukum­ab ($1.1 bil­lion).

Two of the big biotechs, Bio­gen $BI­IB and Cel­gene $CELG, are rep­re­sent­ed here by ad­u­canum­ab — an­oth­er high-risk, high-re­ward play aimed at Alzheimer’s pegged at $1.5 bil­lion — and ozan­i­mod, sucked up in­to Cel­gene’s pipeline dur­ing one of the longest deal sprees in in­dus­try his­to­ry. Ozan­i­mod is as­signed 2022 po­ten­tial sales of $1.8 bil­lion.

In­cyte $IN­CY could ri­val ozan­i­mod sales though, with a sim­i­lar amount pro­vid­ed for epaca­do­stat, its lead­ing IDO1 drug which has fig­ured promi­nent­ly in the news re­cent­ly.

Not every­one is like­ly to agree that Kite’s lead CAR-T $KITE is worth twice the an­nu­al sales of No­var­tis’ leader $NVS in the field, as Eval­u­ate lists these fig­ures. But they’ll like­ly be giv­en plen­ty of op­por­tu­ni­ty to demon­strate their po­ten­tial fol­low­ing loom­ing PDU­FA dates on both.

As­traZeneca $AZN, which bad­ly needs to start gen­er­at­ing more rev­enue, is down to one on the list, now that dur­val­um­ab was ap­proved as the 5th PD-(L)1 check­point. But the CT­LA-4 cat­e­go­ry has been the cause of some fret­ting late­ly, and the drug falls just shy of block­buster sta­tus on the list.

Down­load the full re­port here: World Pre­view 2017, Out­look to 2022

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.