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.

From left to right: Lilian Kim, Associate Director Business Development; John Moller, CEO; Yooni Kim, Executive Director, Asia Operations; Michelle Park, Director South Korea Operations.

Novotech CRO sees 26% growth in Asia tri­al ac­tiv­i­ty from biotechs, but still plen­ty of ca­pac­i­ty

As the Asia-Pacific clinical trials sector continues to grow rapidly, Novotech the Asia-Pacific-based CRO is seeing biotech clinical activity up by 26%. But says there is still plenty of capacity in the region that features advanced medical facilities, supportive regulatory environments, and more than 2.3 billion people, largely treatment naïve, living in urban areas.

China, South Korea and Australia have the most studies registered as recruiting or about to recruit according to ClinicalTrials.Gov.

Hal Barron and Rick Klausner (GSK, Lyell)

Ex­clu­sive: GSK’s Hal Bar­ron al­lies with Rick Klaus­ner’s $600M cell ther­a­py start­up, look­ing to break new ground blitz­ing sol­id tu­mors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Pfizer, South San Francisco — Jeff Rumans for Endpoints News

UP­DAT­ED: Pfiz­er takes aim at a flag­ship fran­chise at Sanofi and Re­gen­eron — and scores a few di­rect hits

Count Pfizer in as a top player in the blockbuster game of JAK1 inhibitors.

Over the weekend the pharma giant posted some stellar Phase III efficacy data for their heavyweight contender abrocitinib in atopic dermatitis (eczema) that lines up ahead of a booming Dupixent (dupilumab), a blockbuster in the portfolios of Regeneron and Sanofi. And they put some real distance ahead of Eli Lilly’s trailing Olumiant, which made a delayed initial arrival on the market for rheumatoid arthritis after the FDA hobbled it with some additional hurdles on safety concerns.

JADE-MONO-1 scores well for Pfizer, teeing up what will be an intensely followed breakdown of the JADE MONO-2 data, which the pharma giant recently top-lined as “similar” to the first Phase III when tested against a placebo — a control group that has been easily outclassed by all the drugs in this market niche.

As of now, Pfizer looks to be equipped to run into the review stage — advantaged by a breakthrough therapy designation that is intended to speed up the regulatory process.

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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech head­ed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

Patrick Mahaffy, Getty Images

Court green-lights Clo­vis case af­ter de­tail­ing ev­i­dence the board ‘ig­nored red flags’ on false safe­ty and ef­fi­ca­cy da­ta

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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Bill Gates backs Gink­go Biowork­s' $350M raise to fu­el the buzzy syn­thet­ic bi­ol­o­gy 'rev­o­lu­tion'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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UCB bags a ri­val to Soliris in $2.1B buy­out deal — but will an in­creas­ing­ly vig­i­lant FTC sign off?

UCB is buying out Ra Pharma $RARX, announcing an acquisition deal that rings up at $48 a share, or $2.1 billion net of cash, and puts them toe-to-toe with Alexion on a clinical showdown.

Ra shares closed at $22.70 on Wednesday.

There’s a small pipeline in play at Ra, but UCB is going for the lead drug — a C5 inhibitor called zilucoplan in Phase III for myasthenia gravis (MG) looking to play rival to Alexion’s Soliris. Soliris has the market advantage, though, with a much earlier approval in MG in late 2017 that UCB feels confident in challenging.

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A new play­er is tak­ing the field in a push for a he­mo­phil­ia A gene ther­a­py, and it’s a big one

BioMarin, the execs at Spark (and buyer-to-be Roche) as well as the Sangamo/Pfizer team have a new rival striding onto the hemophilia block. And it’s a big one.

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