The 10 most pop­u­lar re­ports in End­points News — so far

A lit­tle more than 5 months ago, Ar­salan Arif and I launched the main edi­tion of End­points News. We hit the ground run­ning and gun­ning for a dai­ly in­dus­try re­port that would pro­vide some re­al in­sights on the deals, da­ta and dra­ma flow­ing around the bio­phar­ma world every day.

We’re all about the lat­est news in con­text, guid­ed by 13+ years of dai­ly cov­er­age. And we re­cent­ly passed is­sue #100, with about a quar­ter mil­lion words of search­able con­tent.

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We’re us­ing the Thanks­giv­ing break to high­light what you, our read­ers, have vot­ed as the most pop­u­lar con­tent we’ve put up in that time. The top 10 links, ranked by web traf­fic, starts with a scoop and ends with two sto­ries about back-to-back dis­as­ters that oc­curred ear­li­er this week and im­me­di­ate­ly went se­mi-vi­ral.

So with­out more ado, here’s the most clicked sto­ries of 2016, so far.

1. Scoop: No­var­tis dis­bands its pi­o­neer­ing cell and gene ther­a­py unit

We got a tip ear­ly on Au­gust 31 that No­var­tis was dis­solv­ing its 400-per­son cell and stem cell unit and lay­ing off a bunch of the staffers. When I first heard it, I thought it had to be wrong. Why now? Just as the first cell ther­a­pies in CAR-T were head­ing for reg­u­la­tors? And with com­pe­ti­tion breath­ing down its neck? It didn’t make any sense. The com­pa­ny, though, con­firmed the sto­ry, and our news break trig­gered a seis­mic re­ac­tion in the in­dus­try, which al­so wasn’t ex­pect­ing it. The moral of this sto­ry is that we are all ears. If you send us a good tip, we’ll check it out. (You can se­cure­ly send us things us­ing PGP.)

This is one of sev­er­al big changes we’ve tracked at No­var­tis in re­cent months. Al­so among our top sto­ries: No­var­tis un­veils a new glob­al R&D struc­ture, cre­at­ing cen­ters in Cam­bridge, MA and Basel. And there was this: No­var­tis’ re­treat on CAR-T in­cludes ax­ing most of its se­nior ex­ecs on the team.

 

2. Where the mon­ey is: The top 100(+) VCs in­vest­ing in the US

There are few in­dus­tries where da­ta is more high­ly re­gard­ed than in biotech. So it’s no sur­prise that a de­tailed list of the top VC out­fits op­er­at­ing in the US — ranked by the num­bers — was a hit just as we start­ed the new on­line news source. And it con­tin­ues to at­tract a steady stream of traf­fic from an in­dus­try which is fu­eled by bil­lions in ven­ture cash each year. Cal­i­for­nia, with a big Bay Area clus­ter and a siz­able hub in San Diego, clear­ly at­tract­ed most of the cash. And Boston/Cam­bridge is clear­ly the sec­ond big US hub. Keep an eye on this site: We’ll be back in 2017 with more de­tailed num­bers.

 

3. The 15 top R&D spenders in the glob­al bio­phar­ma busi­ness

More num­bers, this time break­ing our the top 15 re­search spenders in the in­dus­try. This is the life blood of in­no­va­tion, as we know it. And the con­tin­ued in­vest­ment in R&D is at the heart of the grow­ing de­bate over drug pric­ing in Amer­i­ca. The top 15 spenders ac­count for the li­on’s share of re­search spend­ing in bio­phar­ma, and I’ve been fol­low­ing the chang­ing struc­tures and strate­gies be­hind each of these com­pa­nies for more than a decade. Each year we see more R&D group over­hauls, but un­der­ly­ing every­thing has been a big com­mit­ment to seek­ing out and part­ner­ing with ex­ter­nal col­lab­o­ra­tors. That’s been re­ward­ed with mixed re­sults.

 

4. Top 10 pipeline blowups, set­backs and sna­fus in H1 2016

It’s al­ways a bit of a strug­gle to come up with my lat­est set of top pipeline blowups. Not be­cause they’re rare. Quite the op­po­site. Lim­it­ing my­self to 10 can be dif­fi­cult. At the top of this first list for End­points is Clo­vis, which has nev­er ful­ly ex­plained the mys­te­ri­ous switch-up in the da­ta it pre­sent­ed on rocile­tinib. The com­pa­ny stopped re­spond­ing to my queries months ago as it hun­kered down to weath­er a tsuna­mi of law­suits and a fed­er­al in­ves­ti­ga­tion. Mean­while, it’s been fo­cused on its PARP in­hibitor ru­ca­parib, which looks to be squar­ing off against some tough com­pe­ti­tion. Some of the top 10 are the un­for­tu­nate con­se­quence of a sim­ple bi­o­log­ic mis­take. Some are cau­tion­ary tales that of­fer a glimpse of how not to go about drug de­vel­op­ment. Some­times, that can be hard to dis­tin­guish. But it’s al­ways in­ter­est­ing.

 

5. Mer­ck trig­gers a new round of lay­offs in R&D re­or­ga­ni­za­tion, push­ing more jobs in­to Cam­bridge, San Fran­cis­co

One of the biggest sin­gle trends over the past few years has been the mi­gra­tion of bio­phar­ma R&D in­to the big hubs. And Mer­ck demon­strat­ed its com­mit­ment to that hub strat­e­gy back in Ju­ly as it set off a new round of lay­offs while mov­ing more of its re­search op­er­a­tions in­to Boston and the Bay Area, the two gi­ant clus­ters in the US. In just the last few months we’ve seen new over­hauls — both big and small — at No­var­tis, As­traZeneca, Pfiz­er and Glax­o­SmithK­line as well, con­tin­u­ing a years-long process. It may nev­er end. Con­stant change is the rule in R&D, whether you push it or it push­es you.

 

6.  Two more pa­tients die as Juno’s lead CAR-T turns lethal again; tri­al halt­ed

This is not your typ­i­cal pipeline cat­a­stro­phe. Juno al­ready ex­pe­ri­enced an ex­tra­or­di­nar­i­ly short clin­i­cal hold for its lead CAR-T back in the sum­mer, fol­low­ing the deaths of 4 pa­tients in two stud­ies. At the time, they man­aged to con­vince the FDA that they were quite cer­tain that drop­ping one of the drugs used to con­di­tion pa­tients would solve that nasty neu­ro­tox­i­c­i­ty is­sue. The FDA agreed in a mat­ter of days, and now two more pa­tients have been killed. I sus­pect that Juno’s next move will be to drop JCAR015 and in­stant­ly shift fo­cus to JCAR017, their next top pipeline hope­ful. But we need a much, much bet­ter ac­count­ing of what hap­pened here, from the com­pa­ny as well as the FDA. A call with an­a­lysts by the com­pa­ny and a long-wind­ed ‘no com­ment’ from the FDA isn’t go­ing to cut it.

 

7. Don­ald Trump sends a vague­ly word­ed love let­ter to bio­phar­ma as stock ral­ly con­tin­ues

I’ll ad­mit that we don’t have a whole lot of de­tailed in­sight in­to what Don­ald Trump is think­ing about when it comes to bio­phar­ma. Maybe that’s one rea­son why this sto­ry about his en­thu­si­as­tic, though com­plete­ly un­ex­plained, po­si­tion sup­port­ing a re­formed FDA and faster drug ap­provals at­tract­ed so much at­ten­tion. We want to know what he’s think­ing, but for now we’ll have to set­tle for what we can get. Based on sev­er­al sur­veys we did dur­ing the cam­paign, it’s clear that the big ma­jor­i­ty of ex­ecs in the in­dus­try were op­posed to a Trump pres­i­den­cy. But a stock ral­ly af­ter the elec­tion and an up­beat at­ti­tude about a sup­port­ive pol­i­cy — with­out any new hints about Medicare ne­go­ti­a­tions on drug prices or reim­por­ta­tion — has start­ed to turn the tide in his fa­vor. Bio­phar­ma may nev­er love Trump, but the in­dus­try is start­ing to like what lit­tle it’s seen so far.

 

8. Al­ny­lam shares crater af­ter tri­al deaths force in­ves­ti­ga­tors to scrap PhI­II RNAi drug

Any­time a promi­nent com­pa­ny gets hit with an un­ex­pect­ed dis­as­ter, like this one at Al­ny­lam, it tends to raise big­ger ques­tions. Did the fail­ure of one drug have im­pli­ca­tions for the pipeline? How about ri­vals? How did it get this far? Al­ny­lam tried might­i­ly to put the col­lapse of its late-stage ef­fort in­to a more com­fort­ing con­text, but the de­ci­sion to halt the pro­gram clear­ly rat­tled in­vestors. Now any new hint of trou­ble is like­ly to get the spot­light of care­ful at­ten­tion, along with a bliz­zard of mixed com­ments on Twit­ter.

 

9. It’s over: Eli Lil­ly shares tank af­ter its huge gam­ble on Alzheimer’s drug solanezum­ab ends in fail­ure

Give Eli Lil­ly points for try­ing. But be sure to deduct a few for re­fus­ing to ad­mit de­feat. When you run a huge Phase III study and your drug flops, maybe it’s time to walk away. For Eli Lil­ly, though, there was enough clin­i­cal ev­i­dence of suc­cess to war­rant an­oth­er mon­u­men­tal­ly ex­pen­sive ef­fort. CEO John Lech­leit­er has al­ready timed his de­par­ture, so you can’t say he re­signed over this mess. But this is one black eye that will cause more ex­ecs to be more care­ful about how they spend their in­vestors’ mon­ey. So­la at best may have turned in­to a weak but mar­ketable drug. Its loss shouldn’t be mourned. We’re bet­ter off look­ing at bet­ter al­ter­na­tives in the pipeline. And maybe now com­pa­nies will stop tout­ing their prospects to the press. Pa­tients don’t need to be giv­en false hope. This is a ter­ri­ble, tough dis­ease. And for the past decade, all in­ves­ti­ga­tors have ex­pe­ri­enced when it comes to ac­tu­al­ly slow­ing this dis­ease is de­feat.

 

10. Clin­ton cam­paign staff: “We have start­ed the war with phar­ma!!”

Cred­it where it’s due. End­points News‘ Shehla Shakoor re­al­ly got in­to search­ing the Wik­iLeaks col­lec­tion of emails from the Clin­ton cam­paign, and she found a re­al eye-open­er in this one. It turns out that Clin­ton’s care­ful­ly aimed barb at Mar­tin Shkre­li was part of a care­ful­ly cal­i­brat­ed plan to spot­light her pledge to rein in drug prices and bad ac­tors like Shkre­li. And se­nior staffers were ready to do a high-five as the mar­kets made quite a to-do over the Twit­ter af­fair. In­ter­est­ing­ly, ab­solute­ly noth­ing came out of the hub­bub. No one reined in Tur­ing or its big price hike. Shkre­li was in­dict­ed on un­re­lat­ed charges and Clin­ton lost. But the po­lit­i­cal war with phar­ma goes on.


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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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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.