Syn­er­gy CEO pass­es torch to CCO Troy Hamil­ton; Pres­i­dent Steven Kaf­ka re­signs from Foun­da­tion; Ab­b­Vie vet John Leonard to helm In­tel­lia

Troy Hamil­ton

→ Mark­ing a new phase for the biotech, Syn­er­gy Phar­ma­ceu­ti­cals $SYGP an­nounced that co-founder and Tru­lance co-in­ven­tor Gary Ja­cob is pass­ing the CEO ba­ton to Troy Hamil­ton. Join­ing Syn­er­gy in 2015, Hamil­ton was chief com­mer­cial of­fi­cer and EVP, steer­ing the launch and com­mer­cial­iza­tion of Tru­lance. The chron­ic id­io­path­ic con­sti­pa­tion drug is right up Hamil­ton’s al­ley, as he man­aged the gas­troin­testi­nal unit at Shire for nine years af­ter spend­ing much of his ca­reer at Janssen and Mc­Neil Spe­cial­ty Prod­ucts. “One of my ini­tial ar­eas of fo­cus will be to work with our CFO, Gary Gemignani, and the Syn­er­gy man­age­ment team to con­tin­ue to re­fine our busi­ness plan and fo­cus on achiev­ing cost ef­fi­cien­cies through­out the com­pa­ny while pri­or­i­tiz­ing in­vest­ments that will dri­ve sig­nif­i­cant Tru­lance growth,” Hamil­ton said in the state­ment. He al­so made sure to thank Ja­cob, who will con­tin­ue his in­volve­ment with the com­pa­ny as ex­ec­u­tive chair­man of the board.

Steven Kaf­ka

→ Pres­i­dent and COO Steven Kaf­ka has in­formed Foun­da­tion Med­i­cine $FMI of his in­ten­tion to re­sign next Feb­ru­ary, trig­ger­ing a lead­er­ship reshuf­fle that adds the pres­i­dent ti­tle to CEO Troy Cox and COO role to SVP of in­ter­na­tion­al mar­kets Kon­stan­tin Fiedler. Kaf­ka’s tenure at Foun­da­tion last­ed al­most five years, no­tice­ably longer than his stints at oth­er biotechs in­clud­ing Mil­len­ni­um Phar­ma­ceu­ti­cals and Aileron Ther­a­peu­tics. Cox and Fiedler are both rel­a­tive­ly new to the biotech, but each had spent time at some big name com­pa­nies be­fore land­ing here.

→ Cam­bridge, MA-based start­up Dis­arm Ther­a­peu­tics has lured Pe­ter Keller to join as chief busi­ness of­fi­cer af­ter sev­en years at Se­lec­ta Bio­sciences. Keller hasn’t al­ways worked in biotech — he was a man­age­ment con­sul­tant for a decade — but while in the in­dus­try, he has been in­volved in an ac­qui­si­tion, a big IPO and a bil­lion-dol­lar deal. While we haven’t heard much about where Dis­arm’s ax­on­al de­gen­er­a­tion-pre­vent­ing tech is head­ed, we now know Keller will be shap­ing part of it.

Joe Jimenez

→ As Joe Jimenez con­tin­ues to search for his next big break af­ter No­var­tis (ide­al­ly in Sil­i­con Val­ley), he will spend some time in Cincin­nati as a mem­ber of Proc­ter & Gam­ble’s board of di­rec­tors. Con­sumer busi­ness is fa­mil­iar turf for Jimenez, who worked top jobs at Heinz be­fore tak­ing the reins of the Swiss phar­ma gi­ant.

→ In a clear sig­nal that CRISPR/Cas9 play­er In­tel­lia Ther­a­peu­tics is piv­ot­ing to a Phase I, John Leonard, found­ing chief med­ical of­fi­cer, is be­ing kicked up to the CEO’s of­fice. Hav­ing led the biotech $NT­LA through a quick and suc­cess­ful IPO in 2016, At­las part­ner Nes­san Berming­ham will re­turn to biotech ven­ture cap­i­tal. The R&D trek will like­ly be long, with ri­vals Ed­i­tas and CRISPR Ther­a­peu­tics — who are still fight­ing over the IP — de­ter­mined to have a slice of the mar­ket. The board is putting its faith in Leonard, the for­mer top sci­en­tist at Ab­b­Vie who worked on HIV and HCV while tak­ing a lead role on Hu­mi­ra dur­ing his 22-year tenure.

Gen­zyme vet Marc Beck­er will be Con­cert Phar­ma’s new CFO, af­ter a brief stint at CRISPR Ther­a­peu­tics. The Lex­ing­ton, MA-based biotech $CNCE is prepar­ing to broad­en its pipeline of deu­teri­um chem­istry prod­uct can­di­dates — a pipeline where four out of five pro­grams are cur­rent­ly part­nered — and Beck­er will be very much in­volved in that, ac­cord­ing to a state­ment.

→ Paris-based Ac­ti­cor Biotech has tapped Yan­nick Plé­tan as its first chief med­ical of­fi­cer. A spin­off from the French Na­tion­al In­sti­tute of Health and Med­ical Re­search, the 4-year-old com­pa­ny is de­vel­op­ing an an­tithrom­bot­ic agent for the acute phase of is­chemic stroke. Plé­tan’s clin­i­cal and med­ical ex­pe­ri­ence at Roche and Pfiz­er will be im­por­tant as Ac­ti­cor nav­i­gates the next tri­al phase for its lead can­di­date ACT017.

Ra­jesh Shrotriya, the 15-year chair­man and CEO of Spec­trum Phar­ma­ceu­ti­cals, has been fired, the com­pa­ny an­nounced Sun­day. The ter­mi­na­tion trig­gered a chain of lead­er­ship changes: cur­rent pres­i­dent and COO Joseph Tur­geon is now pres­i­dent and CEO, as well as a board of di­rec­tor mem­ber; di­rec­tor Stu­art Krass­ner fills the chair­man seat; and Thomas Riga (EVP, CCO and head of busi­ness de­vel­op­ment) be­comes COO. Tur­geon is an Am­gen vet who used to over­see com­mer­cial ac­tiv­i­ties for Spec­trum.

→ For­est Labs vet Charles Ryan will take the CEO’s job at Neu­rotrope $NTRP fol­low­ing the res­ig­na­tion of Su­sanne Wilke.

→ In line with CEO George Scan­gos’ vi­sion for Vir Biotech­nol­o­gy to be a sci­ence-dri­ven com­pa­ny, im­mu­nol­o­gist An­to­nio Lan­za­vec­chia has been brought on as SVP and se­nior re­search fel­low. His main charge is to pro­vide sci­en­tif­ic lead­er­ship for Vir’s tech­ni­cal pro­grams look­ing in­to se­ri­ous in­fec­tious dis­eases. While do­ing that for the San Fran­cis­co up­start, he will con­tin­ue his roles as di­rec­tor of the In­sti­tute for Re­search in Bio­med­i­cine in Bellinzona, Switzer­land and as pro­fes­sor at the Uni­ver­sità del­la Svizzera ital­iana.

→ Fol­low­ing No­vem­ber’s IPO, Apel­lis Phar­ma­ceu­ti­cals $APLS has ap­point­ed Tim­o­thy Sul­li­van, for­mer­ly a VC firm part­ner, as CFO. Sul­li­van has spent the past three years as an ob­serv­er on Apel­lis’ board of di­rec­tors, as the Ken­tucky biotech took its Soliris ri­val drug and age-re­lat­ed mac­u­lar de­gen­er­a­tion ther­a­py fur­ther along the pipeline, rais­ing mon­ey even af­ter a foiled first IPO at­tempt. Now Apel­lis is ready to en­ter Phase III tri­als for both pro­grams in 2018, and in his new role, Sul­li­van will lead the de­vel­op­ment of its fi­nanc­ing and growth strat­e­gy.

→ Long­time EVP and CFO Ryan May­nard is re­sign­ing from South San Fran­cis­co-based Rigel Phar­ma­ceu­ti­cals $RIGL for undis­closed rea­sons (but cer­tain­ly not due to a dis­pute or dis­agree­ment with the com­pa­ny, ac­cord­ing the to SEC fil­ing). Nel­son Ca­bat­u­an, cur­rent VP of fi­nance, will step in as the in­ter­im prin­ci­pal ac­count­ing of­fi­cer while the biotech search­es for a re­place­ment ahead of its lead drug’s PDU­FA date.

Bellerophon Ther­a­peu­tics $BLPH has qui­et­ly hired a new CFO, As­saf Ko­rner, to re­place Megan Schoeps, who re­signed a cou­ple weeks ago. Ko­rner has worked a slate of fi­nan­cial jobs at med­ical de­vice and con­sumer prod­uct com­pa­nies such as Syneron Med­ical, Ilu­mi­nage Beau­ty and KP­MG.

→ Af­ter wow­ing in­vestors with its BC­MA-tar­get­ing CAR-T at ASH, blue­bird bio $BLUE turned to its in­ter­nal op­er­a­tions and named Ko­ry Went­worth VP of fi­nance and prin­ci­pal ac­count­ing of­fi­cer. A vet­er­an of big pub­lic ac­count­ing firms, Went­worth cut his teeth in biotech con­troller­ship dur­ing his 9-year run at Alex­ion. He fills the shoes of Jef­frey Walsh, the biotech’s chief fi­nan­cial and strat­e­gy of­fi­cer, who will con­tin­ue to serve in the prin­ci­pal fi­nan­cial role.

→ British dis­cov­ery and de­vel­op­ment ser­vice provider Con­cept Life Sci­ences has hired An­drew Scott as head of bioas­say de­vel­op­ment and screen­ing, and Ma­g­a­lie Fer­bach as busi­ness de­vel­op­ment di­rec­tor for South­ern and Cen­tral Eu­rope. Scott has ex­pe­ri­ence span­ning phar­ma, biotech and CRO, while Fer­bach’s back­ground is in agro­chem­i­cals. These ap­point­ments wrap up Con­cept’s ex­pand­ing year, marked by the ac­qui­si­tion of Aquila Bio­med­ical in Ed­in­burgh and open­ing of new lab­o­ra­to­ry space at Alder­ly Park.

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.