The top 10 sto­ries from End­points News in 2018

We’ll end this year with a look back at the 10 sto­ries our au­di­ence found most in­ter­est­ing, based on web traf­fic. It’s al­ways fas­ci­nat­ed me when one of our sto­ries gets a vi­ral boost. This year we had a world-class scan­dal that fac­tored in, sev­er­al moves by Big Phar­ma to ex­it key re­search are­nas and some up-and-com­ing in­dus­try play­ers who made the kind of news that at­tract­ed wide­spread at­ten­tion.

One steady theme: Read­ers are in­ter­est­ed in peo­ple now more than mon­ey. Yes, what bleeds still of­ten leads, and there are plen­ty of things that are in des­per­ate shape in this in­dus­try. But a come-from-be­hind suc­cess sto­ry will at­tract a block­buster crowd, too.

The top 10 list this year is par­tic­u­lar­ly in­ter­est­ing to me be­cause we’ve seen a ris­ing tide of ac­tiv­i­ty in bio­phar­ma as new com­pa­nies spring up and go pub­lic faster than ever be­fore. There’s just a lot more R&D-re­lat­ed news these days, so get­ting to the top is hard­er.

And with­out more ado, here’s the top 10.

1 No­var­tis sac­ri­fices its top at­tor­ney in an at­tempt to quell clam­or over $1.2M in Co­hen pay­ments — while ex-CEO Jimenez strug­gles to ex­plain

It’s not of­ten that the head­lines at End­points News re­flect the hur­ley bur­ley of 24/7 ca­ble news cov­er­age. But with Don­ald Trump in the White House, any­thing is pos­si­ble. So it was as No­var­tis $NVS grap­pled with a glob­al up­roar that fol­lowed the rev­e­la­tion that it had qui­et­ly paid Don­ald Trump’s per­son­al lawyer Michael Co­hen more than a mil­lion dol­lars — fun­neled in­to the same busi­ness ac­count that cov­ered mon­ey paid out to porn ac­tress Stormy Daniels fol­low­ing her al­leged af­fair with the pres­i­dent. Hush mon­ey she called it. Now Co­hen is go­ing to jail for the pay­outs while No­var­tis and ex-CEO Joe Jimenez like to call this one over and done with. For No­var­tis, which has been mired in a se­ries of ethics scan­dals, the Co­hen up­roar has to mark a low point. And it def­i­nite­ly left a per­ma­nent mark.

No­var­tis sac­ri­fices its top at­tor­ney in an at­tempt to quell clam­or over $1.2M in Co­hen pay­ments — while ex-CEO Jimenez strug­gles to ex­plain

2 Phar­ma’s bro­ken busi­ness mod­el: An in­dus­try on the brink of ter­mi­nal de­cline

Kelvin Stott put his fin­ger right on one of the sor­est spots in the in­dus­try with this lengthy con­tributed col­umn. Big Phar­ma spends bil­lions on R&D but is steadi­ly los­ing the war on in­no­va­tion. Re­turns from their in­vest­ments have been shrink­ing for years. And Stott came up with his own math to high­light what he called a drift to the brink of ter­mi­nal de­cline. Iron­i­cal­ly, the R&D cri­sis is reach­ing the brink at a time the ma­jors are un­der tremen­dous pres­sure to cap prices, re­mov­ing the an­nu­al hikes that have fu­eled steadi­ly ris­ing rev­enue num­bers for many. They will now be forced to re­ly on their own abil­i­ty to cre­ate a block­buster pipeline, or buy one, be­cause these num­bers from Stott don’t work in the long run.

Phar­ma’s bro­ken busi­ness mod­el: An in­dus­try on the brink of ter­mi­nal de­cline

3 Pfiz­er is ax­ing its neu­ro­sciences di­vi­sion, lay­ing off 300 and dis­card­ing new drugs

None of the Big Phar­ma’s are ever quite fin­ished with re­align­ing their core R&D fo­cus­es, as we’ve seen re­cent­ly at Glax­o­SmithK­line. But af­ter years of heavy in­vest­ments with noth­ing to show for it, Pfiz­er $PFE still man­aged to shock every­one with its abrupt ex­it out of neu­ro­sciences. And true to form, the phar­ma gi­ant sim­ply took out the ax and cut the di­vi­sion out. Can­cer has been a much more lu­cra­tive are­na for Pfiz­er. Maybe they will get back in­to neu­ro some day, when peo­ple ac­tu­al­ly fig­ure out how to make new drugs for the field. In the mean­time, their de­par­ture un­der­scores the harsh re­al­i­ties of R&D. At some point, you have to put up or stop do­ing the work.

Pfiz­er is ax­ing its neu­ro­sciences di­vi­sion, lay­ing off 300 and dis­card­ing new drugs

4 CRISPR pi­o­neer Feng Zhang co-founds a ‘lim­it­less’ biotech up­start with big plans for speed­ing new drug de­vel­op­ment

Just about any sto­ry on CRISPR tech­nol­o­gy could get eye­balls this year. The promise of gene edit­ing as a new tool for tack­ling dis­ease has fas­ci­nat­ed every­one in and out­side the in­dus­try for years. And when one of the field’s founders, the Broad’s Feng Zhang, backs a start­up, you can ex­pect the news will turn heads. The mon­ey in­volved was rel­a­tive­ly small, on­ly $15.6 mil­lion. But peo­ple are more im­por­tant than mon­ey in at­tract­ing an au­di­ence. Zhang has been at the cen­ter of a bit­ter patent dis­pute in­volv­ing the pi­o­neers in this field. But he al­ways main­tained that the field was still in its in­fan­cy, with much more work to be done re­fin­ing and im­prov­ing the tech­nol­o­gy. You can ex­pect more head­lines from Zhang in the year ahead. 

CRISPR pi­o­neer Feng Zhang co-founds a ‘lim­it­less’ biotech up­start with big plans for speed­ing new drug de­vel­op­ment

5 No­var­tis joins the Big Phar­ma ex­o­dus out of an­tibi­otics, dump­ing re­search, cut­ting 140 and out-li­cens­ing pro­grams

Think neu­ro is tough? Try mak­ing com­mer­cial sense out of an­tibi­otics. The R&D work is high risk and the mar­ket, dom­i­nat­ed by cheap gener­ics, looks ex­treme­ly low mar­gin. That’s not the kind of pro­file that Big Phar­ma ever en­joyed. One of the big sur­pris­es here is that No­var­tis was still di­rect­ly en­gaged in the re­search work, while most of the ma­jors had bowed out long ago. Pub­lic health of­fi­cials glob­al­ly have been sound­ing the alarm about drug-re­sis­tant pathogens, rais­ing a hue and cry for new an­tibi­otics. But un­til the mon­ey starts to look at­trac­tive, there won’t be near­ly enough R&D work done to avert a grow­ing threat. Some­thing needs to change, but it nev­er does.

No­var­tis joins the Big Phar­ma ex­o­dus out of an­tibi­otics, dump­ing re­search, cut­ting 140 and out-li­cens­ing pro­grams

6 Ax­o­vant: That pos­i­tive p-val­ue we re­port­ed yes­ter­day? Um, we screwed that up too

Ax­o­vant $AX­ON had been try­ing to find a sil­ver lin­ing around the time that its Alzheimer’s drug blew up in Phase III when they stum­bled — bad­ly — on this mon­u­men­tal screwup. Who­ev­er did the num­bers for this par­tic­u­lar p-val­ue failed to dou­ble check the math, and a com­pa­ny that al­ready had egg on its face had to awk­ward­ly walk it back a day lat­er. Built by Vivek Ra­maswamy and then helmed by David Hung, Ax­o­vant ul­ti­mate­ly had to lev­el the pro­grams for its first two drugs and start all over again as a gene ther­a­py com­pa­ny un­der new man­age­ment. But this is the kind of cau­tion­ary tale that should in­spire every­one to make ab­solute­ly cer­tain not to get slop­py with da­ta. Some things re­al­ly are in­ex­cus­able. 

Ax­o­vant: That pos­i­tive p-val­ue we re­port­ed yes­ter­day? Um, we screwed that up too

7 Stormy Daniels’ lawyer: No­var­tis made $400K in ‘sus­pi­cious’ pay­ments to Trump at­tor­ney Michael Co­hen

This was the sto­ry that got me start­ed on the role No­var­tis had to play in the epic Stormy Daniels saga. Of course, the mon­ey was big­ger than ini­tial­ly re­port­ed, and No­var­tis CEO Vas Narasimhan hun­kered down in Basel to wait out the storm as com­pa­ny ex­ecs point­ed the fin­ger at the re­cent­ly de­part­ed Joe Jimenez for his role in mak­ing it hap­pen. No­var­tis in­sist­ed the con­tact with Co­hen was dra­mat­i­cal­ly short lived, but a probe by Sen­ate De­moc­rats reached a dif­fer­ent con­clu­sion. Scan­dals tend to linger in phar­ma­land long af­ter the head­lines are for­got­ten. Here’s an­oth­er one. 

Stormy Daniels’ lawyer: No­var­tis made $400K in ‘sus­pi­cious’ pay­ments to Trump at­tor­ney Michael Co­hen

8 Mer­ck’s Keytru­da com­bo wows again, ac­ing PhI­II over­all sur­vival goal for lung can­cer ear­ly

Here’s an­oth­er top sto­ry of the year that un­der­scores a ma­jor theme for the year. Af­ter watch­ing Bris­tol-My­ers Squibb $BMY take a com­mand­ing lead on the PD-1 front, Mer­ck’s R&D team $MRK un­der Roger Perl­mut­ter ex­e­cut­ed a mas­sive R&D ef­fort to catch up. Their prime strat­e­gy was a com­bi­na­tion of Keytru­da with chemo, while oth­ers went with CT­LA-4. Chemo won and over the course of 2018 Mer­ck caught up and then passed Bris­tol-My­ers as the leader in mar­ket­ing check­points for non-small cell lung can­cer. Mer­ck now has hun­dreds of tri­als un­der­way to help main­tain its mo­men­tum. Bris­tol-My­ers may have won the first bat­tle, but now the war is go­ing Mer­ck’s way.

Mer­ck’s Keytru­da com­bo wows again, ac­ing PhI­II over­all sur­vival goal for lung can­cer ear­ly

9 Back­ers of Tes­la and SpaceX fund 29-year-old Al­ice Zhang’s AI-pow­ered neu­ro­science start­up

In an in­dus­try that heaps praise on the el­der states­men, it’s the up-and-com­ers like Al­ice Zhang — just like Feng Zhang — that read­ers grav­i­tate to­ward the most. A new name and a new tech­nol­o­gy like AI is all but as­sured wide at­ten­tion. There are no sure things in bio­phar­ma, of course, and new tech­nolo­gies com­mon­ly take years be­fore they tru­ly re­veal their po­ten­tial for dis­rup­tion. But the Cal­i­for­nia dream­ers are get­ting their shot.

Back­ers of Tes­la and SpaceX fund 29-year-old Al­ice Zhang’s AI-pow­ered neu­ro­science start­up

10 The un­der-40s: How does the next gen­er­a­tion of bio­phar­ma ex­ec­u­tives view the fu­ture?

Just to dri­ve that point about new faces and new tech­nol­o­gy home for you, our fi­nal piece for this year’s top 10 fea­tured some of the most promi­nent younger ex­ecs on the way up the lad­der in bio­phar­ma. You can see for your­self who made the first list. We’ve al­ready be­gun to plan for our sec­ond look in 2019, so be sure to keep a look­out when we ask for nom­i­na­tions. Peo­ple care. It’s im­por­tant.

The un­der-40s: How does the next gen­er­a­tion of bio­phar­ma ex­ec­u­tives view the fu­ture?


Im­age: SHUT­TER­STOCK

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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No­var­tis chips in $10M for IPO-bound part­ner Pli­ant; Tenax shares soar on heart drug da­ta

Novartis is coming in with $10 million to help support the looming IPO of a partner. Pliant Therapeutics posted a new filing with the SEC showing that Novartis is buying the shares at $15, the mid-point of the range. It’s adding several million shares to the offering, bringing the total to around $135 million. Biotech companies have been enjoying quite a run on virtual Wall Street, with investors boosting new offerings to some big hauls.