FSD Phar­ma scoops GW Phar­ma ex­ec to guide cannabi­noid de­vel­op­ment; Zealand Phar­ma is look­ing for a new CEO

→ Just a month af­ter GW Phar­ma­ceu­ti­cals launched its pi­o­neer­ing cannabis-de­rived drug in the US, its head of mar­ket­ing has jumped to lead FSD Phar­ma, a Cana­di­an biotech that wants to fol­low GW’s foot­steps. Ru­pert Haynes will set up his own CEO of­fice in the UK, where he’s been based. FSD’s pipeline will con­sist large­ly of pain, mi­graine and CNS treat­ments like Tourette syn­drome, ob­tained through a re­cent ac­qui­si­tion of Is­rael’s Ther­a­pix.

Nick Sta­ples

→ Now that Ar­tios Phar­ma has closed its $84 mil­lion de­vel­op­ment round, chief busi­ness of­fi­cer Nick Sta­ples is mov­ing on to be­come CEO at Lo­cate Bio. The Uni­ver­si­ty of Not­ting­ham spin­out emerged from stealth mode ear­li­er this year with £2 mil­lion ded­i­cat­ed to hir­ing and ap­ply­ing its drug de­liv­ery sys­tem and gene edit­ing tech in or­tho­pe­dic re­gen­er­a­tive med­i­cine. Robin Quirk, who filled the role ad in­ter­im, is now COO.

→ Fol­low­ing a cou­ple of ca­reer de­tours via Bioven­tus and Ethicon, Sam­son Tom has re­turned to Osiris Ther­a­peu­tics $OSIR. As pres­i­dent and CEO, Tom will over­see both R&D and com­mer­cial­iza­tion of Osiris’ wound care, or­tho­pe­dics, and sports meds. In­ter­im CEO Ja­son Keefer will tran­si­tion to the CCO role.

Britt Meel­by Jensen

Zealand Phar­ma is los­ing CEO Britt Meel­by Jensen to a “non-com­pet­ing com­pa­ny” out­side its na­tive Den­mark. Jensen’s four years at the helm was marked by sev­er­al fundrais­ing ef­forts to fi­nance its new fo­cus on rare dis­ease, in­clud­ing a $77 mil­lion IPO and a $205 mil­lion roy­al­ties sale to long­time part­ner Sanofi. The search is now on for her suc­ces­sor.

→ Just 6 months af­ter land­ing the top job at Abeona Ther­a­peu­tics $ABEO, CEO Carsten Thiel has been un­cer­e­mo­ni­ous­ly boot­ed from the ex­ec­u­tive suite, ac­cused of un­spec­i­fied “per­son­al mis­con­duct” in­volv­ing his in­ter­ac­tions with col­leagues at the com­pa­ny. Ac­cord­ing to Abeona, a cell and gene ther­a­py start­up, “Thiel’s ter­mi­na­tion fol­lows an in­ves­ti­ga­tion by in­de­pen­dent mem­bers of the Com­pa­ny’s Board of Di­rec­tors and ex­ter­nal coun­sel in­to al­le­ga­tions of mis­con­duct to­wards col­leagues that the Board con­clud­ed vi­o­lat­ed the Com­pa­ny’s Code of Busi­ness Con­duct and Ethics and was in­con­sis­tent with its ex­pec­ta­tions for Abeona’s CEO.” He’s be­ing re­placed on an in­ter­im ba­sis by an­oth­er new staffer: R&D chief João Sif­fert, who was brought in just a few weeks ago.

→ No­var­tis-backed Al­tim­mune has tapped Vipin Garg to suc­ceed out­go­ing pres­i­dent and CEO Bill En­right, en­trust­ing him with grow­ing the vac­cine pipeline and ex­plor­ing part­ner­ships. Be­tween the helms of Neos Ther­a­peu­tics and Tranzyme Phar­ma, Garg has run both dis­cov­ery-stage and com­mer­cial op­er­a­tions.

→ Hav­ing as­sem­bled a large­ly pre­clin­i­cal pipeline of gene ther­a­pies through a cou­ple of li­cens­ing pacts, Ax­o­vant is ex­pand­ing the crew charged with ex­e­cut­ing its high-stakes turn­around mis­sion. All five ex­ecs com­ing on board are sea­soned vets from big-name bio­phar­ma com­pa­nies, with ex­per­tise rang­ing from man­u­fac­tur­ing and tech­ni­cal op­er­a­tions to reg­u­la­to­ry af­fairs and com­mer­cial­iza­tion.

  • Greg MacMichael, SVP of tech­ni­cal op­er­a­tions, was the for­mer glob­al head of cell and gene ther­a­py tech­ni­cal de­vel­op­ment and man­u­fac­tur­ing at No­var­tis
  • Parag Meswani, SVP of com­mer­cial strat­e­gy and op­er­a­tions, joins from Spark Ther­a­peu­tics — a US pi­o­neer of the field
  • Paul Ko­rner, SVP of clin­i­cal de­vel­op­ment, held the VP of med­ical strat­e­gy and clin­i­cal de­vel­op­ment role at Sarep­ta Ther­a­peu­tics, an­oth­er emerg­ing gene ther­a­py play­er
  • Greg Stew­art, SVP of vec­tor de­liv­ery and op­ti­miza­tion, had a stint at neu­rol­o­gy-fo­cused Voy­ager Ther­a­peu­tics
  • Sean O’Bryan, VP of reg­u­la­to­ry af­fairs, jumps from the same role at Lyso­gene

Im­muno­Gen is part­ing ways with David John­ston in the af­ter­math of a ju­ry ver­dict that found the CFO li­able for se­cu­ri­ties fraud at a pre­vi­ous com­pa­ny. The SEC con­vinced the ju­ry that John­ston had played an ac­tive role in a scheme to mis­lead in­vestors of Aveo On­col­o­gy, push­ing the line that tivozanib was head­ed for the mar­ket — fail­ing to tell them of the many big is­sues that the FDA had about their tri­al de­sign and how it was de­scribed to in­vestors. Im­muno­Gen CEO Mark Enyedy will step in with the fi­nan­cial and in­vestor re­la­tions work when John­ston leaves at year-end.

Car­lo In­cer­ti

Sanofi Gen­zyme vet Car­lo In­cer­ti is mak­ing the leap to VC life as op­er­at­ing part­ner at For­bion. Cur­rent­ly SVP, CMO and head of glob­al med­ical af­fairs of the French drug­mak­er’s rare dis­ease unit, In­cer­ti will lend a hand to the com­pa­ny build­ing work to be bankrolled by For­bion’s lat­est €360 mil­lion fund and lever­age his net­work to help star­tups in the port­fo­lio.

Thomas Jung

→ Fresh off a $46 mil­lion round led by For­bion, In­fla­zome has tapped Thomas Jung to spear­head its clin­i­cal chal­lenge to prove NL­RP3 is a great an­ti-in­flam­ma­to­ry tar­get. Jung pre­vi­ous­ly spent 13 years do­ing im­muno­log­i­cal re­search at No­var­tis — one of In­fla­zome’s found­ing in­vestors — with the no­table ex­pe­ri­ence of lead­ing de­vel­op­ment for the ill-fat­ed canakinum­ab.   

→ Ahead of an FDA de­ci­sion on its key drug Jakafi’s use in graft vs. host dis­ease, In­cyte $IN­CY has lost its chief sci­en­tif­ic of­fi­cer Reid Hu­ber to promi­nent health­care ven­ture firm Third Rock, but is bring­ing in Janssen’s Dashyant Dhanak to fill the gap.

Dhanak will need to get his act to­geth­er be­fore the up­com­ing Amer­i­can So­ci­ety of Hema­tol­ogy (ASH) con­fer­ence slat­ed for this week­end, where In­cyte is mak­ing mul­ti­ple da­ta pre­sen­ta­tions, in­clud­ing up­dat­ed da­ta for Jakafi in com­bi­na­tion with its PI3K-delta in­hibitor IN­CB50465 in pa­tients with myelofi­bro­sis. This com­bi­na­tion is ex­pect­ed to play a crit­i­cal role in ex­pand­ing the Jakafi fran­chise in myelo­pro­lif­er­a­tive neo­plasms, a group of rare dis­or­ders of the bone mar­row that cause an in­crease in the num­ber of blood cells.

Dhanak joins In­cyte as CSO and ex­ec­u­tive VP from J&J’s $JNJ Janssen, where he most re­cent­ly served as glob­al head, dis­cov­ery sci­ences. Be­fore Janssen, he spent a quar­ter of a cen­tu­ry at Glax­o­SmithK­line $GSK. Mean­while, Hu­ber, who was a found­ing mem­ber of In­cyte’s sci­en­tif­ic team, is join­ing Third Rock as a part­ner af­ter 16 years with the drug­mak­er.

Philip Gutry is the new chief busi­ness of­fi­cer at Kro­nos Bio, charged with man­ag­ing al­liances, ex­pand­ing clin­i­cal op­por­tu­ni­ties and beef­ing up the can­cer pipeline. A for­mer BD ex­ec at Re­gen­eron and a prin­ci­pal at MPM Cap­i­tal, Gutry’s re­sume al­so fea­tured a stint at Gilead Sci­ences, where Kro­nos CEO Nor­bert Bischof­berg­er led R&D for 30 years.

Con­stel­la­tion Phar­ma­ceu­ti­cals has giv­en Patrick Tro­jer a pro­mo­tion to mark his 10-year an­niver­sary with the biotech. The new CSO was one of the found­ing sci­en­tists who built the team that even­tu­al­ly came up with Con­stel­la­tion’s two clin­i­cal and oth­er pre­clin­i­cal as­sets, all aimed at mod­u­lat­ing gene ex­pres­sion.

Are­na Phar­ma­ceu­ti­cals $AR­NA has hired Robert Lisic­ki away from Re­gen­eron af­ter on­ly six months as VP car­dio-meta­bol­ic and in­flam­ma­tion. Lisic­ki is tak­ing on the chief com­mer­cial of­fi­cer at a time Are­na is mak­ing a sec­ond shot at com­mer­cial suc­cess — co-head­lined by a PAH drug that Unit­ed Ther­a­peu­tics has bought in­to — af­ter a near-death ex­pe­ri­ence with its di­et pill. A new SVP of med­ical af­fairs, Paul Au­d­hya, has al­so been on board in an ef­fort to es­tab­lish a pres­ence in Boston, the San Diego com­pa­ny not­ed.

→ Cap­ping a year of pos­i­tive piv­otal da­ta roll­out — trig­ger­ing spikes in its volatile stock price Foamix $FOMX has re­cruit­ed Jazz Phar­ma ex­ec Matt Wi­ley as its chief com­mer­cial of­fi­cer. The Is­raeli der­ma­tol­ogy biotech is start­ing to plan launch­es of FMX101 for ac­ne and FMX103 for rosacea as it gears up reg­u­la­to­ry fil­ings.

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.

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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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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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.