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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Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Tim Van Hauwermeiren, argenx CEO

Ar­genx pur­chas­es $100M+ FDA pri­or­i­ty re­view vouch­er from blue­bird bio

Argenx’s Vyvgart is due for a speedy review at the FDA, thanks to a $102 million priority review voucher (PRV).

The Netherland-based biotech picked up the PRV from bluebird bio, the companies announced on Wednesday. PRVs shorten a drug’s FDA review period from 10 months to 6 months, though they often sell on the open market for around $100 million each.

Argenx plans on using the express ticket on efgartigimod, its neonatal Fc receptor (FcRn) blocker marketed as Vyvgart for adults with generalized myasthenia gravis (gMG). While Vyvgart won its first approval last December for the chronic neuromuscular disease — which is characterized by difficulties with facial expression, speech, swallowing and breathing — CEO Tim Van Hauwermeiren said in a news release that he plans to “be active in fifteen disease targets by 2025.”

Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Lil­ly's Covid-19 mAb no longer au­tho­rized due to Omi­cron sub­vari­ants, FDA says

The FDA on Wednesday announced that Eli Lilly’s Covid-19 drug bebtelovimab is no longer authorized to treat Covid-19 because of the rising numbers of two new subvariants that the drug does not work against.

The Centers for Disease Control and Prevention last week published new estimates that the combined proportion of Covid-19 cases caused by the Omicron subvariants BQ.1 and BQ.1.1 are greater than 57% nationally, and already above 50% in all individual regions but one.

Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Uğur Şahin, BioNTech CEO (ddp images/Sipa USA/Sipa via AP Images)

BioN­Tech bets on dif­fi­cult STING field via small mol­e­cule pact with a Pol­ish biotech

BioNTech is beefing up its relatively thin small molecule pipeline by adding weight to a clinically difficult corner of oncology R&D: STING agonists. To do so, BioNTech is teaming up with a 15-year-old Polish biotech and doling out €40 million, about $41.5 million, to start.

The deal is broken into two parts: First, BioNTech obtains an exclusive global license to develop and market Ryvu Therapeutics’ STING agonist portfolio as small molecules, whether alone or in combination with other agents.

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