The 10 most pop­u­lar sto­ries in End­points News — so far in 2017

John Car­roll

Since Ar­salan Arif and I ramped up the main edi­tion of End­points News 16 months ago, we’ve pub­lished more than a mil­lion words on bio­phar­ma R&D.

Tol­stoy, eat your heart out.

This year we’ve in­creased web traf­fic, track­ing close to an av­er­age of 20,000 read­ers per day — with more than 22,000 email sub­scribers — which is con­sid­er­ably high­er than where we start­ed in the mid­dle of 2016.

So what are bio­phar­ma peo­ple read­ing in End­points?

Every Black Fri­day we mark the hol­i­day with our top 10 list of our most pop­u­lar re­ports (here’s last year’s ver­sion). Read­ers vot­ed with their fin­gers, and here are their top 10 sto­ries.


1 Mer­ck was hit hard by a vi­cious cy­ber­at­tack yes­ter­day. Here is what we know.

Pub­lish­er Ar­salan Arif wrote the best-read re­port of the year at End­points News af­ter hear­ing about a glob­al cy­ber­at­tack which blast­ed Mer­ck, caus­ing chaos at the phar­ma gi­ant. Over time, we would hear about hun­dreds of mil­lions in dam­ages, which are still rack­ing up at the com­pa­ny. Mer­ck says it did what it could to pro­tect it­self, but this virus hit hard. Chances are, cy­ber­se­cu­ri­ty has tak­en on a whole new mean­ing at Mer­ck.


2 Top 20 block­buster drugs in the late-stage pipeline — Eval­u­atePhar­ma

If there’s one thing 15 years in the trench­es of biotech re­port­ing has taught me, it’s that in­dus­try read­ers like some in­sights on the big drugs in the late-stage pipeline. It tells us who’s do­ing the best work, which com­pa­nies have the best prospects and where the big bets are be­ing made. There’s a lot more to this than peak sales, but the drugs picked by Eval­u­atePhar­ma rep­re­sent a ver­i­ta­ble trea­sure trove of block­busters worth po­ten­tial­ly more than $30 bil­lion. Check it out.


3 The top 15 spenders in the glob­al drug R&D busi­ness: 2017

Those com­pa­nies that dom­i­nate the late-stage pipeline are al­so typ­i­cal­ly the ones that foot the li­ons’s share of the bill for drug de­vel­op­ment. Last year, the big bill due for the top 15 com­pa­nies’ re­search bud­gets re­sult­ed in a wimpy pay­out, with a big drop in new drug ap­provals, but that’s be­ing sand­wiched be­tween two sol­id years of suc­cess­es at the FDA. I’ve been fol­low­ing this R&D num­ber for a long while now. And while the fo­cus may change and peo­ple are hired and fired, the en­gine of drug de­vel­op­ment over­all re­mains in high gear. It’s al­so true that high gear is not good enough, and that longterm pro­duc­tiv­i­ty is­sue con­tin­ues to haunt the in­dus­try’s fu­ture.


4 British bil­lion­aire Jim Mel­lon and high-pro­file part­ners roll the dice on an an­ti-ag­ing up­start

We are on the cusp of a tidal shift in biotech R&D, with more and more com­pa­nies look­ing to de­vel­op ther­a­pies that can add bet­ter life to your years, and grad­u­al­ly more years to your life. British bil­lion­aire Jim Mel­lon wrote a book on the top­ic, and now he and some close col­leagues are div­ing in di­rect­ly to raise cash and start work. These trends take years to play out, so don’t look for any overnight rev­o­lu­tions in drug R&D. Still, the wheels are turn­ing, and read­ers are pay­ing close at­ten­tion.


5 In stag­ger­ing set­back, tox­ic re­ac­tion kills Cel­lec­tis’ first CAR-T pa­tient, forc­ing tri­al halt

CAR-T has a safe­ty is­sue, as any­one fa­mil­iar with the field knows all too well. Cel­lec­tis is out to make one of these new can­cer ther­a­pies — now craft­ed from pa­tient cells — so they can be made in bulk and tak­en down from the shelf as need­ed. But an ear­ly death helped raise the red flag for this new kind of CAR-T as well. The FDA lift­ed this hold re­cent­ly, al­low­ing Cel­lec­tis to go back in­to the clin­ic, but on­ly af­ter the French biotech came up with a host of new safe­ty mea­sures. Rev­o­lu­tions are nev­er easy. Or safe. This was a time­ly re­minder that those fac­tors re­al­ly nev­er change.


6 The scoop: Marathon’s R&D pro­gram for Duchenne MD drug like­ly came in at a bar­gain base­ment price

This is one of my fa­vorite sto­ries of the year. I’m glad it was one of yours, too. Marathon Phar­ma was try­ing to pull a fast one when it slipped through an ap­pli­ca­tion on an old cheap steroid as an or­phan ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy. Quite a few par­ents pre­ferred de­flaza­cort over a re­al­ly cheap gener­ic al­ter­na­tive, pay­ing around $1,000 a year to get it from a Lon­don sup­pli­er. Ac­cord­ing to Marathon, it had to charge $84,000 a year for its new ther­a­py — point­ing to the big clin­i­cal pro­gram need­ed for the ap­proval. We blew that the­o­ry sky high with some pro­fes­sion­al es­ti­mates of what it re­al­ly cost, and how the com­pa­ny looked to make a killing. The sto­ry blew up, law­mak­ers got in­volved and Marathon de­cid­ed to sell it off and take the mon­ey and run. Now PTC is the proud own­er, and its new price runs along a slid­ing scale based on weight. It’s not re­al­ly cheap­er at all, but the con­tro­ver­sy has blown over — for now.


7 Ter­ri­ble op­tics: As­traZeneca shares take a hit fol­low­ing re­port that CEO So­ri­ot is mov­ing to Te­va

Months lat­er, this head­line still sur­pris­es me. And I wrote it. Pas­cal So­ri­ot had been fight­ing for a turn­around at As­traZeneca for the past 5 years. To re­port­ed­ly be in­ter­est­ed in tak­ing the Te­va job would be an­oth­er way of say­ing ‘so long, suck­ers’ to every­one he man­aged at As­traZeneca. So­ri­ot even­tu­al­ly made it clear that he wasn’t leav­ing As­traZeneca, and even­tu­al­ly Te­va an­nounced it had signed a new CEO. But So­ri­ot nev­er de­nied he dis­cussed the open­ing. And this sto­ry al­ways re­mains in the back of every­one’s heads as As­traZeneca makes a halt­ing jour­ney back from the val­ley of death it’s been in.


8 King can­cer: The top 10 ther­a­peu­tic ar­eas in bio­phar­ma R&D

There’s no doubt that 2017 is the year of can­cer R&D. New projects are peak­ing, break­throughs are gain­ing land­mark ap­provals and more mon­ey than ever has flowed in­to the field. As a re­sult, as we point­ed out in this break­down of R&D projects by ther­a­peu­tic field, there’s now can­cer R&D and every­thing else that is go­ing on. We’ve fol­lowed up with more da­ta points that un­der­score this over­whelm­ing trend. And you can ex­pect to hear a lot more about this as com­pa­nies com­pete over a fi­nite num­ber of pa­tients and mar­ket share. Some trends have con­se­quences, and this is one of them.


9 Al­ny­lam achieves break­through RNAi suc­cess as PhI­II patisir­an study hits all goals, shares soar

This re­al­ly was a re­mark­able year for ma­jor break­throughs. Al­ny­lam’s suc­cess with the Phase III for patisir­an sets up its first ever FDA ap­pli­ca­tion, af­ter 15 years of hard work. This com­pa­ny stayed true to the RNAi faith while big phar­ma com­pa­nies bailed and doubts grew that any­one could ever make a com­mer­cial suc­cess out of it. But the crew at Alnlyam made it hap­pen. That kind of suc­cess de­serves to be rec­og­nized, and the in­dus­try clear­ly didn’t over­look the im­pli­ca­tions.


10 In a stun­ning set­back, Roche says its top can­cer drug Tecen­triq failed a key PhI­II study

Iron­i­cal­ly, I’m writ­ing this up on the same day that Roche’s stock jumped 6%, large­ly be­cause its triple com­bo of Tecen­triq, Avastin and chemo proved ef­fec­tive in in­creas­ing pro­gres­sion-free sur­vival for first-line lung can­cer. Back in May, though, its fail­ure for a Phase III blad­der can­cer tri­al, af­ter an ac­cel­er­at­ed ap­proval, un­der­scored just how frag­ile suc­cess can be in the PD-1/L1 check­point are­na. One com­pa­ny grabs the lead, the next day they blow up in the clin­ic, or a ri­val does bet­ter in its cho­sen are­na. Now sev­er­al years in­to the check­point rev­o­lu­tion, the sur­pris­es keep on com­ing with amaz­ing reg­u­lar­i­ty, dri­ving on more com­pe­ti­tion for what is rapid­ly be­com­ing a wild­ly over­crowd­ed mar­ket niche. This was just one chap­ter of a sto­ry that shows no signs of com­ing to a close — but change is com­ing.

Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Paul Hudson, Sanofi CEO (Romuald Meigneux/Sipa via AP Images)

Sanofi and DN­Di aim to elim­i­nate sleep­ing sick­ness in Africa with promis­ing Ph II/III re­sults for new drug

The Drugs for Neglected Diseases initiative (DNDi) and Sanofi today said that their potential sleeping sickness treatment saw success rates of up to 95% from a Phase II/III study investigating the safety and efficacy of single-dose acoziborole.

The potentially transformative treatment for sleeping sickness would mainly be targeted at African countries, according to data published today in The Lancet Infectious Diseases medical journal. The clinical trial was led by DNDi and its partners in the Democratic Republic of the Congo (DRC) and Guinea, with the authors noting:

Lex­i­con slams FDA over hear­ing de­nial fol­low­ing a CRL for its SGLT2 in­hibitor can­di­date

Lexicon Pharmaceutical is not giving up on its Type I diabetes candidate, despite FDA’s repeated rejections. This week the company laid out is argument again for a hearing on sotagliflozin in response to the FDA’s most recent denial.

The issue goes back to March 2019 when the FDA made very clear to Lexicon and its now departed partner Sanofi that it would not approve their application for a potential Type I diabetes drug because it does not appear to be safe.

Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Emily Leproust, Twist Bioscience CEO

Twist Bio­science’s 'fac­to­ry of the fu­ture' in Ore­gon could de­liv­er with com­pet­i­tive pric­ing, SVB Se­cu­ri­ties says

The synthetic DNA manufacturer Twist Bioscience has given a peek behind the curtain to several analysts into its “factory of the future” as well as insight into the cost structure, workflow and technology at the site.

The 110,000-square-foot manufacturing site in the city of Wilsonville, OR, just south of Portland, which was announced back in 2020, will double Twist’s production capacity and bring around 400 jobs to the area.

Digital render of CPI's Medicines Manufacturing Innovation Centre in Glasgow, Scotland (Image: uk-cpi.com)

CPI opens the doors to a new $100M+ man­u­fac­tur­ing fa­cil­i­ty in Scot­land

A manufacturing site that has received interest and investments from large pharma companies and the UK government is opening its doors in Scotland.

The manufacturer CPI (Centre for Process Innovation) has opened a new £88 million ($105 million) “Medicines Manufacturing Innovation Centre” in Glasgow, Scotland, to accelerate the development of manufacturing tech and solve longstanding challenges in medicine development and manufacturing.

Pro­tect­ing its megablock­buster, Janssen chal­lenges Am­gen's Ste­lara biosim­i­lar ahead of planned 2023 launch

Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.

If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.