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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The 20 un­der 40: In­side the next gen­er­a­tion of bio­phar­ma lead­ers

“Each generation needs a new music,” Francis Crick wrote in 1988, reflecting back on his landmark discovery. Crick was 35, then, in 1953, when he began working with a 23-year-old named James Watson, and 37 when the pair unveiled the double helix. Rosalind Franklin, whose diffraction work undergirded their metal model, was 32.

The model would become the score for a new era in biology, one devoted to cracking the basic structures turning inside life. Subsequent years would bring new conductors and new rhythms: Robert Swanson, 29 when he convinced a 39-year-old Herb Boyer to build a company off his work and call it Genentech; Phillip Sharp, 29 when he discovered RNA splicing and 34 when he co-founded Biogen; Frances Arnold, 36 when she pioneered directed evolution; Feng Zhang, 31 when he published his CRISPR paper.

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Chart-top­ping ven­ture cash? Strong deal flow? In the month Covid-19 ripped around the globe? Yup

It turns out that even sending everyone from the CEO to rank-and-file staffers home to work in the middle of a Category 5 pandemic wasn’t enough to put a crimp in the flow of venture cash into biopharma. And even dealmaking held its own against the howling winds of misfortune — largely because a group of savvy players was quick to adjust to the new reality.

Our deal expert Chris Dokomajilar ran the numbers for us on a month-to-month basis and found that not only was venture money flowing during the panicky month of March, but it was also hitting home in record sums compared to the last 26 months of deal flow.

Say what?

As you can see in the top chart below, Dokomajilar outlined how the industry racked up $2.41 billion in total for March, just barely ahead of one other topper during the heady days of August 2018.

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FDA Commissioner Stephen Hahn and President Donald Trump at a press briefing on March 19, 2020. (AP Images)

Biotech ex­ecs warn that the FDA is fum­bling their re­sponse to the Covid-19 open-door promise, de­lay­ing progress

A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks.

Bioregnum Opinion Column by John Carroll

Decisions that once required months would be measured in hours under the Coronavirus Treatment Acceleration Program. “In many cases” trial protocols could be hammered out in less than a single day. If you had a potential solution to the crisis, the appropriate staffer would be in touch “to get studies underway quickly.”

It would be the ultimate high-speed regulatory pathway from Phase I to approval. Red tape was banished.

But it’s clear that for some — and quite likely many — biopharma execs, the actual agency response has not measured up to the promise. Beyond the front ranks of advanced companies in the field, like Gilead, or for drugs endorsed by President Trump, it may not even come close.

“The first response is this form letter everyone gets,” says one biotech CEO who’s reached out to the FDA on Covid-19. And when you try to cut through that, the ball gets dropped as it is passed from top officials to the frontline staff actually charged with getting things done.

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GSK's Hal Bar­ron buys a $250M stake in George Scan­gos' Vir and makes a bee­line to the clin­ic with Covid-19 an­ti­bod­ies

GlaxoSmithKline is diving straight into the swirling waters of Covid-19 R&D work, and investing $250 million to grab a chunk of equity in one of the emerging stars in infectious disease research to make it official.

GSK put out word this morning that it is partnering with Vir Biotechnology $VIR, the infectious disease startup founded in the Bay Area by former Biogen CEO George Scangos. They’re planning a leap into Phase II studies for 2 preclinical antibody candidates — VIR-7831 and VIR-7832 — that have been engineered to target the SARS-CoV-2 spike protein.

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UP­DAT­ED: A small, ob­scure biotech just won big with their IPO. In this mar­ket. Are you kid­ding me?

How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Category 6 financial hurricane and sail through with a $165 million IPO?

And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development?

The biotech is a company called Zentalis. The crew there nabbed an $85 million crossover round late last year — notably waiting 5 years before waving the numbers around to attract attention, according to my read of a FierceBiotech story. Perceptive joined in, but the syndicate was not in general the kind of marquee affair that gets tongues wagging.

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Ready to de­clare a de­fin­i­tive come­back in two months, Im­munomedics stops PhI­II ear­ly, re­cruits new CEO

More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, adieu and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer.

Today the biotech said their stars are finally aligning. Not only is Novartis Oncology vet Harout Semerjian coming on board as CEO to steer what they believe will be a smooth sail to a new PDUFA date in June, Immunomedics has also been informed that their late-stage trial can be stopped early due to “compelling evidence of efficacy.”

An­oth­er day, an­oth­er boat­load for biotech. Deer­field adds $840M to rush of ven­ture dol­lars

The biotech dollars just keep rolling in.

Even as the world economy faces an economic contraction unprecedented in nature, biotech venture capital firms are announcing huge new investment pots. The latest? Deerfield Management Co.

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Small mol­e­cules, bi­o­log­ics and now gene ther­a­pies: Ger­many's Evotec adds an­oth­er feath­er to its R&D cap

German drug discovery company Evotec — which has a thriving rolodex of biopharma partners such as Bayer, Boehringer Ingelheim, Novartis, Novo Nordisk, Pfizer, Sanofi, and Takeda — is now venturing into gene therapies.

The company swallowed Seattle-based Just Biotherapeutics, a company focused on reducing the cost of manufacturing protein therapies last year. It is now setting up a dedicated R&D site for gene therapies in Austria, in an effort to achieve a “modality-agnostic” repertoire — small molecules, biologics and now gene therapies.

A pair of PhI­II fail­ures spells last rites for Men­lo’s once-promis­ing Mer­ck drug

Four months after an intercontinental merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders and the drug.

In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs. Serlopitant has long been the company’s only drug and as recently as 2018, it looked promising enough to support a stock price of $37. In April of that year, a Phase II failure demolished the stock price overnight: $35 to $9. Other subsequent stumbles trickled the ticker down to just above $2.