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

Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors. 

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

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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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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H1 analy­sis: The high-stakes ta­ble in the biotech deals casi­no is pay­ing out some record-set­ting win­nings

For years the big trend among dealmakers at the major players has been centered on ratcheting down upfront payments in favor of bigger milestones. Better known as biobucks for some. But with the top 15 companies competing for the kind of “transformative” pacts that can whip up some excitement on Wall Street, with some big biotechs like Regeneron now weighing in as well, cash is king at the high stakes table.

We asked Chris Dokomajilar, the head of DealForma, to crunch the numbers for us, looking over the top 20 deals for the past decade and breaking it all down into the top alliances already created in 2019. Gilead has clearly tipped the scales in terms of the coin of the bio-realm, with its record-setting $5 billion upfront to tie up to Galapagos’ entire pipeline.

Dokomajilar notes:

We’re going to need a ‘three comma club’ for the deals with over $1 billion in total upfront cash and equity. The $100 million-plus club is getting crowded at 164 deals in the last decade with new deals being added towards the top of the chart. 2019 already has 14 deals with at least $100 million in upfront cash and equity for a total year-to-date of over $9 billion. That beats last year’s $8 billion and sets a record.

Add upfronts and equity payments and you get $11.5 billion for the year, just shy of last year’s record-setting $11.8 billion.

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Part club, part guide, part land­lord: Arie Bellde­grun is blue­print­ing a string of be­spoke biotech com­plex­es in glob­al boom­towns — start­ing with Boston

The biotech industry is getting a landlord, unlike anything it’s ever known before.

Inspired by his recent experiences scrounging for space in Boston and the Bay Area, master biotech builder, investor, and global dealmaker Arie Belldegrun has organized a new venture to build a new, 250,000 square foot biopharma building in Boston’s Seaport district — home to Vertex and a number of up-and-coming biotech players.

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