The End­points poll: Clin­ton v Trump and wide­spread fret­ting that the FDA just blun­dered bad­ly

Who would be a bet­ter pres­i­dent  for biotech? Hillary Clin­ton or Don­ald Trump? Is there even a dif­fer­ence? And what did the in­dus­try think of that con­tro­ver­sial Duchenne mus­cu­lar dy­s­tro­phy drug ap­proval? Did it mark a drop in FDA stan­dards? We asked our au­di­ence and heard back — loud and clear.

End­points News pulled off its first snap poll at the end of last week, with pub­lish­er Ar­salan Arif send­ing out a sin­gle query to a tar­get­ed seg­ment from our 10,000 email sub­scribers. About 95% of our au­di­ence is di­rect­ly en­gaged in the bio­phar­ma busi­ness, with a big fo­cus on drug de­vel­op­ment. Our goal: get a sense of the in­dus­try’s think­ing on pres­i­den­tial pol­i­tics and that re­cent con­tro­ver­sial FDA OK for the Duchenne drug eteplirsen.

The re­spons­es came in hard and fast, leav­ing lit­tle doubt how the ma­jor­i­ty is feel­ing on both is­sues. Al­to­geth­er, Arif col­lect­ed 494 re­spons­es from qual­i­fied bio­phar­ma in­dus­try pro­fes­sion­als.

1. Who would be the bet­ter Pres­i­dent for the bio­phar­ma in­dus­try? (Please, no per­son­al feel­ings.)

Hillary Clin­ton 52% 259
Don­ald Trump 27% 134
No dif­fer­ence 20% 101
To­tal 494

First, on the elec­tion. Rather than sim­ply ask who peo­ple are plan­ning to vote for, we went for a some­what dif­fer­ent take. Who do you think will most like­ly be bet­ter for biotech? Don­ald Trump or Hillary Clin­ton? A slight, over­all ma­jor­i­ty marked Clin­ton as the bet­ter of the two can­di­dates for the in­dus­try. Trump came in at about half that num­ber. And he beat out “no dif­fer­ence” by a mere 7 points, with 1 in 5 fail­ing to see any kind ad­van­tage in one over the oth­er.

Clin­ton may be win­ning the biotech vote, but with so many dis­af­fect­ed pro­fes­sion­als un­able to mark a pref­er­ence, you can’t say that any kind of ma­jor­i­ty is over-the-moon about the idea of a Clin­ton pres­i­den­cy. Trump, though, is a dis­tant sec­ond in the hearts of the biotech in­dus­try. Come the No­vem­ber elec­tion, Clin­ton takes the biotech vote — heav­i­ly clus­tered in De­mo­c­ra­t­ic strong­holds like Boston and the Bay Area — in a cake walk.

2. Should the FDA have ap­proved Ex­ondys 51/eteplirsen?

All Clin­ton + Trump + No diff.
No 66% (324) 67% (173) 65% (87) 63% (64)
Yes 34% (170) 33% (86) 35% (47) 37% (37)

There’s no doubt­ing how to in­ter­pret these num­bers. Two thirds of the peo­ple we polled felt that the FDA should not have ap­proved Sarep­ta’s Ex­ondys 51 (eteplirsen). This was a non-par­ti­san fa­vorite. There was vir­tu­al­ly no dif­fer­ence on which way they leaned on the pres­i­den­tial show­down, ei­ther. Whether they thought Trump or Clin­ton was bet­ter for biotech, the ma­jor­i­ty clear­ly felt that the agency had made a mis­take.

Sarep­ta helped fo­ment one of the biggest pa­tient ad­vo­ca­cy cam­paigns ever mount­ed for an ap­proval. But sev­er­al top FDA of­fi­cials made it clear that the com­pa­ny had nev­er suc­cess­ful­ly made its case for this drug. FDA Com­mis­sion­er Robert Califf al­so cit­ed the com­pa­ny for play­ing fast and loose with some of the da­ta the com­pa­ny used to make its case with pa­tients and in­vestors. But he bowed to the de­ci­sion made by CDER di­rec­tor Janet Wood­cock. And that, says the ma­jor­i­ty, was a mis­take.

3. Did the ap­proval of Ex­ondys 51/eteplirsen mark a drop in the FDA’s stan­dards?

All Wrong ap­proval Right ap­proval
Yes 68% (337) 92% (299) 22% (38)
No 32% (157) 8% (25) 78% (132)

Rough­ly the same num­ber of in­dus­try pros who ob­ject­ed to the ap­proval al­so con­clud­ed that the con­di­tion­al ap­proval for mar­ket­ing marked a drop in the agency’s stan­dards. It is note­wor­thy, though, that 22% of the in­dus­try pro­fes­sion­als who felt it was the right de­ci­sion al­so felt that it marked a drop in ap­proval stan­dards. A much small­er per­cent­age of the “wrong” vote – 8% – did not feel that it re­flect­ed a drop in stan­dards.

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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Norbert Bischofberger. Kronos

Backed by some of the biggest names in biotech, Nor­bert Bischof­berg­er gets his megaround for plat­form tech out of MIT

A little over a year ago when I reported on Norbert Bischofberger’s jump from the CSO job at giant Gilead to a tiny upstart called Kronos, I noted that with his connections in biotech finance, that $18 million launch round he was starting off with could just as easily have been $100 million or more.

With his first anniversary now behind him, Bischofberger has that mega-round in the bank.

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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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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).

On a glob­al romp, Boehringer BD team picks up its third R&D al­liance for Ju­ly — this time fo­cused on IPF with $50M up­front

Boehringer Ingelheim’s BD team is on a global deal spree. The German pharma company just wrapped its third deal in 3 weeks, going back to Korea for its latest pipeline pact — this time focused on idiopathic pulmonary fibrosis.

They’re handing over $50 million to get their hands on BBT-877, an ATX inhibitor from Korea’s Bridge Biotherapeutics that was on display at a science conference in Dallas recently. There’s not a whole lot of data to evaluate the prospects here.

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Servi­er scoots out of an­oth­er col­lab­o­ra­tion with Macro­Gen­ics, writ­ing off their $40M

Servier is walking out on a partnership with MacroGenics $MGNX — for the second time.

After the market closed on Wednesday MacroGenics put out word that Servier is severing a deal — inked close to 7 years ago — to collaborate on the development of flotetuzumab and other Dual-Affinity Re-Targeting (DART) drugs in its pipeline.

MacroGenics CEO Scott Koenig shrugged off the departure of Servier, which paid $20 million to kick off the alliance and $20 million to option flotetuzumab — putting a heavily back-ended $1 billion-plus in additional biobuck money on the table for the anti-CD123/CD3 bispecific and its companion therapies.

Den­mark's Gen­mab hits the jack­pot with $500M+ US IPO as small­er biotechs rake in a com­bined $147M

Danish drugmaker Genmab A/S is off to the races with perhaps one of the biggest biotech public listings in decades, having reaped over $500 million on the Nasdaq, as it positions itself as a bonafide player in antibody-based cancer therapies.

The company, which has long served as J&J’s $JNJ key partner on the blockbuster multiple myeloma therapy Darzalex, has asserted it has been looking to launch its own proprietary product — one it owns at least half of — by 2025.