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

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.