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

2019 Trin­i­ty Drug In­dex Eval­u­ates Ac­tu­al Com­mer­cial Per­for­mance of Nov­el Drugs Ap­proved in 2016

Fewer Approvals, but Neurology Rivals Oncology and Sees Major Innovations

This report, the fourth in our Trinity Drug Index series, outlines key themes and emerging trends in the industry as we progress towards a new world of targeted and innovative products. It provides a comprehensive evaluation of the performance of novel drugs approved by the FDA in 2016, scoring each on its commercial performance, therapeutic value, and R&D investment (Table 1: Drug ranking – Ratings on a 1-5 scale).

How to cap­i­talise on a lean launch

For start-up biotechnology companies and resource stretched pharmaceutical organisations, launching a novel product can be challenging. Lean teams can make setting a launch strategy and achieving your commercial goals seem like a colossal undertaking, but can these barriers be transformed into opportunities that work to your brand’s advantage?
We spoke to Managing Consultant Frances Hendry to find out how Blue Latitude Health partnered with a fledgling subsidiary of a pharmaceutical organisation to launch an innovative product in a
complex market.
What does the launch environment look like for this product?
FH: We started working on the product at Phase II and now we’re going into Phase III trials. There is a significant unmet need in this disease area, and everyone is excited about the launch. However, the organisation is still evolving and the team is quite small – naturally this causes a little turbulence.

UP­DAT­ED: FDA’s golodirsen CRL: Sarep­ta’s Duchenne drugs are dan­ger­ous to pa­tients, of­fer­ing on­ly a small ben­e­fit. And where's that con­fir­ma­to­ry tri­al?

Back last summer, Sarepta CEO Doug Ingram told Duchenne MD families and investors that the FDA’s shock rejection of their second Duchenne MD drug golodirsen was due to some concerns regulators raised about the risk of infection and the possibility of kidney toxicity. But when pressed to release the letter for all to see, he declined, according to a report from BioPharmaDive, saying that kind of move “might not look like we’re being as respectful as we’d like to be.”

He went on to assure everyone that he hadn’t misrepresented the CRL.

But Ingram’s public remarks didn’t include everything in the letter, which — following the FDA’s surprise about-face and unexplained approval — has now been posted on the FDA’s website and broadly circulated on Twitter early Wednesday.

The CRL raises plenty of fresh questions about why the FDA abruptly decided to reverse itself and hand out an OK for a drug a senior regulator at the FDA believed — 5 months ago, when he wrote the letter — is dangerous to patients. It also puts the spotlight back on Sarepta $SRPT, which failed to launch a confirmatory study of eteplirsen, which was only approved after a heated internal controversy at the FDA. Ellis Unger, director of CDER’s Office of Drug Evaluation I, notes that study could have clarified quite a lot about the benefit and risks associated with their drugs — which can cost as much as a million dollars per patient per year, depending on weight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Eli Lil­ly’s $1.6B can­cer drug failed to spark even the slight­est pos­i­tive gain for pa­tients in its 1st PhI­II

Eli Lilly had high hopes for its pegylated IL-10 drug pegilodecakin when it bought Armo last year for $1.6 billion in cash. But after reporting a few months ago that it had failed a Phase III in pancreatic cancer, without the data, its likely value has plunged. And now we’re getting some exact data that underscore just how little positive effect it had.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

Stephen Hahn, AP

The FDA has de­val­ued the gold stan­dard on R&D. And that threat­ens every­one in drug de­vel­op­ment

Bioregnum Opinion Column by John Carroll

A few weeks ago, when Stephen Hahn was being lightly queried by Senators in his confirmation hearing as the new commissioner of the FDA, he made the usual vow to maintain the gold standard in drug development.

Neatly summarized, that standard requires the agency to sign off on clinical data — usually from two, well-controlled human studies — that prove a drug’s benefit outweighs any risks.

Over the last few years, biopharma has enjoyed an unprecedented loosening over just what it takes to clear that bar. Regulators are more willing to drop the second trial requirement ahead of an accelerated approval — particularly if they have an unmet medical need where patients are clamoring for a therapy.

That confirmatory trial the FDA demands can wait a few years. And most everyone in biopharma would tell you that’s the right thing for patients. They know its a tonic for everyone in the industry faced with pushing a drug through clinical development. And it’s helped inspire a global biotech boom.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: New play­ers are jump­ing in­to the scram­ble to de­vel­op a vac­cine as pan­dem­ic pan­ic spreads fast

When the CNN news crew in Wuhan caught wind of the Chinese government’s plan to quarantine the city of 11 million people, they made a run for one of the last trains out — their Atlanta colleagues urging them on. On the way to the train station, they were forced to skirt the local seafood market, where the coronavirus at the heart of a brewing outbreak may have taken root.

And they breathlessly reported every moment of the early morning dash.

In shuttering the city, triggering an exodus of masked residents who caught wind of the quarantine ahead of time, China signaled that they were prepared to take extreme actions to stop the spread of a virus that has claimed 17 lives, sickened many more and panicked people around the globe.

CNN helped illustrate how hard all that can be.

The early reaction in the biotech industry has been classic, with small-cap companies scrambling to headline efforts to step in fast. But there are also new players in the field with new tech that has been introduced since the last of a series of pandemic panics that could change the usual storylines. And they’re volunteering for a crash course in speeding up vaccine development — a field where overnight solutions have been impossible to prove.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 70,400+ biopharma pros reading Endpoints daily — and it's free.

Wuhan virus out­break trig­gers in­evitable small-biotech ral­ly

Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.

Things are no different, as the coronavirus outbreak in Wuhan, China takes hold. There have been close to 300 confirmed human infections in China, and at least four deaths. Coronaviruses are a large family of viruses, which include MERS and SARS. On Tuesday, the CDC reported the virus was detected in a US traveler returning from Wuhan.

Mer­ck KGaA spin­out gets first fund­ing to bring dual-act­ing can­cer mol­e­cules in­to the clin­ic

Two and a half years after launch, Merck KGaA spinout iOnctura is getting its first major round of funding.

The oncology startup raised €15 million ($16.6 million) to put its lead drug into the clinic and get its second drug past IND-enabling tests. INKEF Capital and VI Partners co-led the round and were joined by the biotech’s longtime backer M Ventures, an arm of Merck KGaA, and Schroder Adveq.

Am­gen aug­ments Asia foothold by tak­ing over Astel­las joint ven­ture in Japan

California-based Amgen, which does the bulk of its business in the United States, made its ambition to reinvigorate its growth prospects by expanding its presence in Asia clear at the sidelines of the JP Morgan healthcare conference in San Francisco earlier this month.

The Thousand Oaks-based company on Thursday executed its plan to dissolve the joint venture with Astellas — created in 2013 — to operate the unit independently in Japan. With its rapidly aging population, the region represents an appealing market for Amgen’s osteoporosis treatments Prolia and Evenity as well as a cholesterol-lowering injection Repatha.