Am­gen R&D chief Sean Harp­er hits the ex­its with a one-way tick­et to ear­ly-stage biotech

Sean Harp­er is join­ing the mi­gra­tion out of big bio­phar­ma and in­to the world of emerg­ing biotechs.

The head of R&D at Am­gen has turned in his no­tice, 6 years af­ter tak­ing the se­nior R&D po­si­tion va­cat­ed by Roger Perl­mut­ter.

We don’t know right now where he’s head­ed, but in a state­ment Am­gen said that the 55-year-old is leav­ing Am­gen and “plans to pur­sue op­por­tu­ni­ties in the ear­ly-stage biotech­nol­o­gy com­mu­ni­ty.”

Harp­er was al­ways a ready ad­vo­cate for Am­gen in­ter­ests, man­ning the bat­tle sta­tions as the com­pa­ny fought for cov­er­age on Repatha and ready to cite stats as need­ed to back up his case.  And if every­thing didn’t worked out ex­act­ly as planned, well, that’s drug R&D. 

David Reese

The move opens the door for David Reese, cur­rent­ly se­nior vice pres­i­dent of trans­la­tion­al sci­ences and on­col­o­gy at Am­gen, to move up the lad­der to Harp­er’s spot. He’ll now be in a po­si­tion to run a group that spends about $3.5 bil­lion on drug re­search, fit­ting in­to the world’s top 15 play­ers.

The re­volv­ing door at Am­gen is al­so lead­ing to the re­tire­ment of the glob­al op­er­a­tions chief, An­tho­ny C. Hoop­er, who is be­ing re­placed by Bris­tol-My­ers Squibb vet Mur­do Gor­don.

Harp­er has had some no­table suc­cess­es, and his share of flops, along the way. Just a few weeks ago Am­gen and No­var­tis won first-mover ad­van­tage in the CGRP mi­graine world, scor­ing a land­mark ap­proval for Aimovig. And they’ve been duk­ing it out with Re­gen­eron and Sanofi in the PC­SK9 world — in the mar­kets and in the courts — af­ter gain­ing a pi­o­neer­ing ap­proval for what all these com­pa­nies de­vout­ly main­tain is a block­buster-mar­ket-to-be.

Among his fiz­zles in­clude an odd deal to buy Dez­i­ma in a $1.55 bil­lion buy­out — with $300 mil­lion up front —  just be­fore CETP col­lapsed en­tire­ly as a dis­ease tar­get. He’s al­so been re­quired to make ad­just­ments as re­quired by the grand­fa­ther of all biotechs, which long ago stopped act­ing like a biotech and start­ed main­tain­ing Big Phar­ma tra­di­tions. That led to a down­siz­ing last fall that claimed 200 jobs — one of sev­er­al cullings that marked his tenure.

Chances are, he won’t have any­thing like 200 to­tal jobs at his next po­si­tion. But like a long line­up of Big Phar­ma re­search ex­ecs, Harp­er is hear­ing the call of a biotech post at a time pri­vate and pub­lic fi­nanc­ings have hit a fever pitch.

You don’t have to look past last May to find an­oth­er sim­i­lar ex­am­ple. Nor­bert Bischof­berg­er left Gilead af­ter a 30-year ca­reer to take the helm of a start­up as em­ploy­ee #5. For some at this lev­el, it’s a chance to hang up the ad­min­is­tra­tive du­ties and get back to hands-on drug de­vel­op­ment work, with the promise of a hefty eq­ui­ty pay­out if it all works out. And pri­vate in­vestors love to bring in these heavy­weights, with re­as­sur­ing re­sumes that in­clude block­buster suc­cess sto­ries.

Im­age: Sean Harp­er. AM­GEN via YOUTUBE

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

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Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Sanofi/Re­gen­eron mus­cle ahead of a ri­val No­var­tis/Roche team, win first ap­proval in key rhi­nos­i­nusi­tis field

Re­gen­eron and their part­ners at Sanofi have beat the No­var­tis/Roche team to the punch on an­oth­er key in­di­ca­tion for their block­buster an­ti-in­flam­ma­to­ry drug Dupix­ent. The drug team scored an ac­cel­er­at­ed FDA ap­proval for chron­ic rhi­nos­i­nusi­tis with nasal polyps, mak­ing this the first such NDA for the field.

An­a­lysts have been watch­ing this race for awhile now, as Sanofi/Re­gen­eron won a snap pri­or­i­ty re­view for what is now their third dis­ease in­di­ca­tion for this treat­ment. And they’re not near­ly done, build­ing up hopes for a ma­jor fran­chise.

Two biotech uni­corns swell pro­posed IPOs, eye­ing a $600M-plus wind­fall

We’ve been wait­ing for the ar­rival of Bridge­Bio’s IPO to top off the wave of new biotech of­fer­ings sweep­ing through Nas­daq at the end of H1. And now we learn that it’s been sub­stan­tial­ly up­sized.

Ini­tial­ly pen­ciled in at a uni­corn-sized $225 mil­lion, the KKR-backed biotech has spiked that to the neigh­bor­hood of $300 mil­lion, look­ing to sell 20 mil­lion shares at $14 to $16 each. That’s an added 5 mil­lion shares, re­ports Re­nais­sance Cap­i­tal, which fig­ures the pro­posed mar­ket val­u­a­tion for Neil Ku­mar’s com­pa­ny at $1.8 bil­lion.

No­var­tis holds back the copy­cat brigade's at­tack on its top drug fran­chise — for now

A fed­er­al judge has put a gener­ic chal­lenge to No­var­tis’ block­buster mul­ti­ple scle­ro­sis drug Gilenya on hold while a patent fight plays out in court.

Judge Leonard P. Stark is­sued a tem­po­rary in­junc­tion ear­li­er this week, forc­ing My­lan, Dr. Red­dy’s Lab­o­ra­to­ries and Au­robindo Phar­ma to shelve their launch plans to al­low the patent fight to pro­ceed. He ruled that al­low­ing the gener­ics in­to the mar­ket now would per­ma­nent­ly slash the price for No­var­tis, even if it pre­vails. 

Top an­a­lyst finds a sil­ver lin­ing in Ab­b­Vie’s $63B Al­ler­gan buy­out — but there’s a catch

Af­ter get­ting beat up on all sides from mar­ket ob­servers who don’t much care for the lat­est mega-deal to ar­rive in bio­phar­ma, at least one promi­nent an­a­lyst now is start­ing to like what he sees in the num­bers for Ab­b­Vie/Al­ler­gan.

But it’s go­ing to take some en­cour­age­ment if Ab­b­Vie ex­ecs want it to last.

Ab­b­Vie’s mar­ket cap de­clined $20 bil­lion on Tues­day as the stock took a 17% hit dur­ing the day. And SVB Leerink’s Ge­of­frey Porges can see a dis­tinct out­line of an up­side af­ter re­view­ing the fun­da­men­tals of the deal.

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

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While Ako­rn works to re­vive its for­tunes, the FDA hits it with an­oth­er warn­ing let­ter

Ako­rn just can’t dig it­self out of its hole.

The spe­cial­ty gener­ic drug­mak­er has re­ceived yet an­oth­er warn­ing let­ter from the FDA this year. With­out dis­clos­ing any specifics, the Lake For­est, Illi­nois-based drug­mak­er on Wednes­day said the US reg­u­la­tor had is­sued the let­ter, cit­ing an in­spec­tion of its Som­er­set, New Jer­sey man­u­fac­tur­ing fa­cil­i­ty in Ju­ly and Au­gust of 2018. The com­pa­ny’s shares $AKRX dipped about 1.7% to $4.65 be­fore the bell.