John Kaiser finds next CEO role at Duke spin­out Evecx­ia; Im­muno­core vet Namir Has­san moves to I/O biotech Zel­lu­na

Duke spin­out Evecx­ia has re­cruit­ed bio­phar­ma vet John Kaiser to steer clin­i­cal and busi­ness plans for its 5-hy­drox­ytryp­to­phan slow-re­lease de­pres­sion treat­ment. This will be his third time in a CEO role. Af­ter leav­ing a 28-year sales and mar­ket­ing ca­reer at Eli Lil­ly, Kaiser found­ed and ran a now-de­funct biotech, then had a stint as in­ter­im CEO at Cere­cor, where he had or­ches­trat­ed sev­er­al li­cens­ing deals as chief busi­ness of­fi­cer (Cere­cor is al­so de­vel­op­ing, among oth­er things, a de­pres­sion drug). Evecx­ia is now in the clin­ic with EVX-101, a first-line ad­junc­tive treat­ment for de­pressed pa­tients re­spond­ing in­ad­e­quate­ly to con­ven­tion­al an­ti­de­pres­sants, though it’s un­clear ex­act­ly what stage they are in.

Steven Paul has de­cid­ed to ex­tend a 35-year track record with one last shot at a big de­vel­op­ment pro­gram. He is the new chief ex­ec­u­tive of Karuna, a start­up which wants to show that one of the drugs he once cham­pi­oned at Eli Lil­ly can now be read­ied for prime time as a sig­nif­i­cant new an­ti-psy­chot­ic for schiz­o­phre­nia — and then some. Paul, who’s been serv­ing as chair­man at Karuna, stepped down near the be­gin­ning of the year as CEO of Voy­ager, the gene ther­a­py start­up he co-found­ed.

→ Strug­gling to shed a bad rep for a string of ethics scan­dals capped by the ex­plo­sive ac­cu­sa­tions of sev­er­al US Sen­a­tors that com­pa­ny ex­ecs re­cent­ly mis­rep­re­sent­ed the cozy re­la­tion­ship be­tween for­mer CEO Joe Jimenez and Pres­i­dent Don­ald Trump’s per­son­al at­tor­ney Michael Co­hen, No­var­tis is once again look­ing to clean up its act. CEO Vas Narasimhan has re­cruit­ed a promi­nent Ger­man at­tor­ney to lead their ethics, risk and com­pli­ance ef­forts.

Klaus Moos­may­er will now be charged with keep­ing the com­pa­ny clear of any new ethics scan­dals, which have come fast and fre­quent­ly at the phar­ma gi­ant. The lawyer has spent the past few years as chief com­pli­ance of­fi­cer at Siemens and chairs the An­ti-Cor­rup­tion Task­force of the Busi­ness and In­dus­try Ad­vi­so­ry Com­mit­tee at the Or­ga­ni­za­tion for Eco­nom­ic Co-op­er­a­tion and De­vel­op­ment. Moos­may­er is tak­ing the place of Shan­non Thyme Klinger, new­ly pro­mot­ed to group gen­er­al coun­sel in the wake of Fe­lix Ehrat’s abrupt res­ig­na­tion dur­ing the cri­sis that hit No­var­tis as it strug­gled with rev­e­la­tions about their $1.2 mil­lion in pay­ments to Co­hen.

→ The ex­o­dus of top ex­ecs out of a high-per­form­ing Gilead is con­tin­u­ing. The biotech not­ed Tues­day night that Chief Med­ical Of­fi­cer An­drew Cheng is leav­ing the com­pa­ny “to pur­sue an­oth­er op­por­tu­ni­ty.” As of now, we don’t know what that oth­er op­por­tu­ni­ty is, but Gilead $GILD has re­cent­ly seen the de­par­ture of chief R&D ex­ec Nor­bert Bischof­berg­er (to a start­up) as well as the an­nounced ex­its of CEO John Mil­li­gan and long­time com­pa­ny ex­ec John Mar­tin, ex­ec­u­tive chair­man.

Cheng plans to stay on to Sep­tem­ber 7 to help with the tran­si­tion, ac­cord­ing to Gilead. Mean­while Gregg Al­ton has been ap­point­ed to the new­ly cre­at­ed po­si­tion of chief pa­tient of­fi­cer while Di­ana Brainard was pro­mot­ed to Se­nior Vice Pres­i­dent, HIV and Emerg­ing Vi­ral In­fec­tions. Cheng joined Gilead 19 years ago to lead the com­pa­ny’s de­vel­op­ment-stage pro­grams in HIV/AIDS. He was named Ex­ec­u­tive Vice Pres­i­dent in 2015 and CMO in March.

→ Af­ter tak­ing off the past 7 months to trav­el the world and spend time with fam­i­ly, for­mer Foun­da­tion Med­i­cine ex­ec Steve Kaf­ka is join­ing the start­up foundry Third Rock Ven­ture as their lat­est ven­ture part­ner. Kaf­ka has spent the bulk of his ca­reer in fi­nance and op­er­a­tions at var­i­ous bio­phar­ma out­fits, most re­cent­ly serv­ing as pres­i­dent and COO of Foun­da­tion. This will be Kaf­ka’s first post in the VC world, but that’s not un­usu­al for Third Rock part­ners, which prides it­self on op­er­at­ing like a “start­up stu­dio.” “For me, the ear­ly-stage com­pa­ny build is the best part,” Kaf­ka told us. “To be able to go do that again — and again and again — sounds so in­cred­i­bly fun and im­pact­ful to me.”

Al­ler­gan $AGN has re­cruit­ed top can­cer ex­ec­u­tive Charles Hugh-Jones, the guy who’s been lead­ing Pfiz­er On­col­o­gy as CMO, to serve as the phar­ma gi­ant’s new se­nior vice pres­i­dent and chief med­ical of­fi­cer. The move comes just 16 months af­ter Hugh-Jones joined Pfiz­er’s on­col­o­gy arm. Be­fore that, he was a long timer at Sanofi in New Jer­sey, where he held sev­er­al ex­ec­u­tive roles, end­ing up at chief med­ical of­fi­cer in North Amer­i­ca. The move to Al­ler­gan will take Hugh-Jones back to New Jer­sey, as the new gig is at Al­ler­gan’s US head­quar­ters in Madi­son. There, he’ll be re­port­ing to ex­ec­u­tive vice pres­i­dent and chief R&D of­fi­cer David Nichol­son.

→ Af­ter walk­ing away from a long ca­reer in Big Phar­ma last year — on­ly to bail from his start­up of choice on­ly 10 months lat­er — ex-Pfiz­er ex­ec Geno Ger­mano is back on the move. The re­spect­ed bio­phar­ma chief has joined New York-based Elu­ci­da On­col­o­gy, a tiny Cor­nell spin­out work­ing on some fas­ci­nat­ing nanopar­ti­cle tech with ap­pli­ca­tions in can­cer. At Elu­ci­da, Ger­mano will serve as pres­i­dent and CEO — the first full-time post he’s tak­en up since his ab­bre­vi­at­ed stint at In­trex­on, the flashy syn­thet­ic bio start­up he ex­it­ed from last No­vem­ber.

At Pfiz­er, he cul­ti­vat­ed a $14 bil­lion op­er­a­tion and over­saw a port­fo­lio of drugs span­ning sev­er­al ther­a­peu­tics ar­eas. He al­so worked at the top of Pfiz­er’s on­col­o­gy and spe­cial­ty care busi­ness units and di­rect­ed the in­te­gra­tion of in­dus­try gi­ant Wyeth af­ter the mas­sive $68 bil­lion ac­qui­si­tion.

→ As Sig­ilon CEO Paul Wot­ton leaves the post to han­dle a fam­i­ly health is­sue, the com­pa­ny is putting Roge­rio Vi­val­di — a for­mer se­nior ex­ec at Biover­a­tiv ahead of the Sanofi buy­out ear­li­er this year — in his place at the helm. It will be Vi­val­di’s job now to get the start­up in the clin­ic, look­ing to move the up­start’s stem cell ther­a­py pipeline be­yond its ini­tial for­ays in­to di­a­betes, he­mo­phil­ia and lyso­so­mal stor­age dis­or­ders. An en­docri­nol­o­gist by train­ing, Vi­val­di had been ex­ec­u­tive vice pres­i­dent, chief glob­al ther­a­peu­tic op­er­a­tions of­fi­cer at Biover­a­tiv. Vi­val­di al­so co-found­ed and helmed Min­er­va Ther­a­peu­tics.

→ Af­ter ris­ing up the ranks at British T cell re­cep­tor biotech Im­muno­core, Namir Has­san is mov­ing to Nor­way for his next gig in TCR. As chief sci­en­tif­ic of­fi­cer of Oslo-based Zel­lu­na Im­munother­a­py, Has­san is re­spon­si­ble for both man­ag­ing the ex­ist­ing port­fo­lio and lead­ing ef­forts to ex­pand it, all the while build­ing out the re­search team and fa­cil­i­ties. Im­muno­core, a biotech uni­corn not­ed for scor­ing a stun­ning $320 mil­lion Se­ries A, had seen the de­par­tures of CEO Eliot Forster and CFO Paul Fry in the past few months.

→ Now that Pfenex $PFNX looks set to file an NDA for its For­teo me-too, chief med­ical and sci­en­tif­ic of­fi­cer Hu­bert Chen is turn­ing in his no­tice. The San Diego-based com­pa­ny said that while they are search­ing for a suc­ces­sor, his de­par­ture will not af­fect the tra­jec­to­ry of PF708 as they be­lieve their lead as­set al­ready has the FDA’s bless­ing. Be­sides, he will re­main as an ad­vi­sor, sup­port­ing Pfenex’s reg­u­la­to­ry in­ter­ac­tions. Be­sides PF708, Jazz-part­nered Pfenex is de­vel­op­ing a hodge­podge of “ther­a­peu­tic equiv­a­lents,” biosim­i­lars and vac­cines.

Al­lo­gene Ther­a­peu­tics has en­list­ed an­oth­er es­teemed bio­phar­ma ex­ec in its am­bi­tious plan to bring the first al­lo­gene­ic CAR-T can­cer ther­a­pies to mar­ket. Named chief de­vel­op­ment of­fi­cer, Susie Jun is tasked with ac­cel­er­at­ing clin­i­cal de­vel­op­ment of Al­lo­gene’s pre­clin­i­cal as­sets by lever­ag­ing her ex­pe­ri­ence in trans­la­tion­al re­search. Well versed in hema­tol­ogy and on­col­o­gy, Jun had di­rect­ed clin­i­cal re­search at Am­gen and Gilead be­fore land­ing at her most re­cent role in Ab­b­Vie-Stem­cen­trx.

→ Hav­ing seen through Ar­mo Bio­sciences’ promis­ing im­muno-on­col­o­gy drug all the way to an ac­qui­si­tion by Eli Lil­ly, Joseph Lev­eque has found his next stop at Syn­thorx. While his deep I/O ex­per­tise — honed dur­ing stints at Bris­tol-My­ers Squibb and Mer­ck KGaA where he took a front-row seat in the de­vel­op­ment of Op­di­vo, Yer­voy and Baven­cio — made him a stand­out for the job, the new CMO will al­so be re­spon­si­ble for dri­ving the au­toim­mune ap­pli­ca­tions of Syn­thorx’s par­tial­ly syn­thet­ic bi­o­log­ics. The start­up, based in San Diego, builds its tech on a syn­thet­ic DNA base pair en­gi­neered by Scripps pro­fes­sor Floyd Romes­berg that has the po­ten­tial to tweak pro­teins by in­tro­duc­ing nov­el amino acids.

→ Long­time in­vest­ment banker An­tho­ny Gib­ney is jump­ing to the CBO seat at Achillion $ACHN for a change. Hav­ing ob­served the com­pa­ny from the oth­er side of the ta­ble as co-head of the biotech team at Leerink, Gib­ney will now be in­volved in cor­po­rate strat­e­gy, busi­ness de­vel­op­ment, in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions. Bri­an Di­Do­na­to, an­oth­er for­mer banker, has been hired to work un­der Gib­ney.

Car­ol Suh is the lat­est mem­ber of the biotech in­vest­ment team at Arch Ven­ture Part­ners, where she’s worked as a con­sul­tant/in­tern since Feb­ru­ary. Fresh out of Stan­ford’s busi­ness school, the 28-year-old has pre­vi­ous­ly worked on Ma­gen­ta Ther­a­peu­tics’ launch and, be­fore that, served as an in­no­va­tion fel­low at Glax­o­SmithK­line spe­cial­iz­ing in stem cell and re­gen­er­a­tive med­i­cines.

→ We now know where Alan Mus­so is go­ing af­ter Bel­licum. Pelo­ton Ther­a­peu­tics has tapped the sea­soned fundrais­er as its first CFO. The Dal­las-based com­pa­ny, which is de­vel­op­ing what it hopes will be a first-in-class can­cer drug, is al­so count­ing on Mus­so for in­vestor re­la­tions, ac­count­ing, hu­man re­sources, in­for­ma­tion sys­tems, and op­er­a­tions.

Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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UP­DAT­ED: Pay­back? An­a­lysts say Sarep­ta was blind­sided by an FDA re­jec­tion dri­ven by reg­u­la­to­ry re­venge

In one of the least anticipated moves of the year, the FDA has rejected Sarepta’s application for an accelerated approval of its Duchenne MD drug golodirsen after fretting over safety issues.

In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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FDA de­ci­sion on Ver­tex's CF triple will come just ahead of planned CEO shake­up

Vertex has clinched a priority review for the all-important cystic fibrosis triple that will blaze the trail for treating a large group of patients unhelped by its current drugs.

FDA regulators have set a PDUFA date of March 19, 2020, just a year after the Boston biotech posted positive Phase III results showing that people with two F508del mutations experienced statistically significant improvements in lung function after a 4-week regimen of VX-445, tezacaftor and ivacaftor. After reviewing 24-week data among patients with one F508del mutation and one minimal function mutation — and thoroughly comparing the VX-445 triple with another combo featuring VX-659 on scores like safety, drug-drug interactions, and photosensitivity — Vertex ultimately went with VX-445.

An MIT spin­out kills one of its ‘liv­ing ther­a­peu­tics’ af­ter flunk­ing an ear­ly-stage study — shares rout­ed

Just a few weeks after bagging $80 million in a deal to collaborate with Gingko Bioworks on its special blend of engineered bacteria used for “living therapeutics,” little Synlogic in Boston $SYBX is tossing one of its two clinical programs after watching an early-stage study go down in defeat.

Their Phase Ib/IIa study for SYNB1020 to counter the accumulation of ammonia in the body, a condition called hyperammonemia or urea cycle disorder, floundered at the interim readout, forcing the biotech to kill it and reserve its cash for pipeline therapies with greater potential.

Elan­co to buy Bay­er's an­i­mal health busi­ness for $7.6B, as deal­mak­ing gath­ers steam in the sec­tor

Last week, Elanco explicitly dodged answering questions about its rumored interest in Bayer’s animal health business in its post-earnings call. On Tuesday, the Eli Lilly spinoff disclosed it was purchasing the German drug maker’s veterinary unit in a cash-and-stock deal worth $7.6 billion. 

Elanco $ELAN has been busy on the deal-making front. In April, it laid out plans to swallow its partner, Kansas-based pet therapeutics company Aratana $PETX. A July report by Reuters suggested a potential Bayer deal was being explored, and Bloomberg last week said the deal was imminent, citing sources. 

As­traZeneca's di­a­betes drug Farx­i­ga helps pa­tients with heart dis­ease and with­out di­a­betes in land­mark tri­al

Months ago, data on J&J’s $JNJ Invokana indicated the diabetes drug conferred cardiovascular (CV) benefit in patients who do and do not have preexisting CV disease. On Tuesday, AstraZeneca’s $AZN rival treatment, Farxiga, was shown to cut the risk of CV death or the worsening of heart failure in patients with heart disease, in a landmark trial.

The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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