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.

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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Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

UP­DAT­ED: With loom­ing ‘apoc­a­lypse of drug re­sis­tance,’ Mer­ck’s com­bi­na­tion an­tibi­ot­ic scores FDA ap­proval on two fronts

Merck — one of the last large biopharmaceuticals companies in the beleaguered field of antibiotic drug development — on Wednesday said the FDA had sanctioned the approval of its combination antibacterial for the treatment of complicated urinary tract and intra-abdominal infections.

To curb the rise of drug-resistant bacteria and maintain the efficacy of the therapy, Recarbrio (and other antibacterials) — the drug must be used to treat or prevent infections that are proven or strongly suspected to be caused by susceptible gram-negative bacteria, Merck $MRK said.

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John McHutchison in 2012. Getty Images

The $1.1M good­bye: Gilead CSO John McHutchi­son is out as Daniel O’Day shakes up the se­nior team

Just a little more than a year after John McHutchison grabbed a promotion to become CSO at Gilead in the wake of Norbert Bischofberger’s exit, he’s out amid a shakeup of the senior team that is also triggering the departure of two other top execs.

Gilead stated that McHutchison “has decided to step down” from the job as of August 2nd. And their SEC filing notes that he’ll be getting a $1.1 million check to settle up on his contract.

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Thomas Gajewski, David Steinberg. (CRI, Pyxis)

Bay­er, Long­wood back star re­searcher's deep dive in­to the tu­mor mi­croen­vi­ron­ment for new I/O tar­gets

From PD-1 targeting to the RAS pathway to the STING complex, Thomas Gajewski has spent the past two decades of his career decoding the various ways the immune system can be unleashed to defend against cancer. So when the University of Chicago professor comes around to putting all his findings into a new platform for finding new targets, VCs and pharma groups alike pay attention.

“He’s been studying T cells for 20 years, plus he’s one of the world’s leaders if not the world leader in the space,” David Steinberg, partner at Longwood Fund, said. “Furthermore, let me add he did a lot of the foundational research and also some of the seminal clinical trials in the existing set of I/O agents. He understands the space really well, he understands the current strengths, and I think he understood really well what was missing, so he knew where to look.”

Kamala Harris speaking yesterday at the Des Moines Register Iowa Presidential Candidate Forum [via Getty]

Who’s the tough­est on drug prices? A game of po­lit­i­cal one-up­man­ship is dri­ving the pol­i­cy de­bate in Wash­ing­ton

Earlier this week we got a look at Senator Kamala Harris’ position on drug prices. She’s proposing that HHS take an average price from single-payer systems like the UK, Germany and Canada — which leverage market access for lower prices — and use that to set the US price. Anything drug companies collect above that would be taxed at a rate of 100%.

And the rhetoric is scathing:
While families struggle to make it to the end of the month, pharmaceutical companies are turning record profits. They’re spending nearly as much on advertising as R&D. They’re manipulating their market power to hike prices on lifesaving generic drugs. They’re making twice the profit of the average industry in America and still increased drug prices by 10.5% over the past six months alone. Meanwhile, they are charging dramatically higher prices to American consumers.
That’s an escalation on Joe Biden’s plan, which includes drug importation from those cheaper markets as well as allowing Medicare to negotiate prices — something that virtually all Dems agree on now.

SJ Lee [File photo]

Go­ing in­side cells, Sung Joo Lee has sketched some big goals for his small — but glob­al — team of drug hunters

For a small biotech based in South Korea with a research arm in Cambridge, MA, Orum Therapeutics has sketched out some big goals aimed at developing antibodies for intracellular targets. And now they have a new $30 million round to push the work forward, aiming at a slate of currently undruggable quests.

Orum has been working on a platform tech out of Ajou University that relies on endocytosis to smuggle antibodies and their cargo inside a cell. They’ve published work in Nature that illustrates its preclinical potential in RAS mutations, and KRAS is on their list of targets. 

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Astel­las buys in­to Fre­quen­cy's re­gen­er­a­tive med strat­e­gy with a $625M al­liance on hear­ing loss

The executive team at Frequency Therapeutics never oversold the results of their maiden Phase I/II study for a new drug to rectify hearing loss. It was, they said back in April, primarily about safety and tolerability, where their drug FX-322 performed as they had hoped. 

That early glimpse of efficacy everyone searches for in their first try on humans? 

(I)mprovements in hearing function, including audiometry and word scores, were observed in multiple FX-322 treated patients.

We don’t know exactly what that means. But whatever the details, Astellas found enough in the data to jump in with a sizable collaboration deal.

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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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