Ex-Ax­o­vant COO Mar­i­on Mc­Court lands at Re­gen­eron; GT Bio­phar­ma el­e­vates Shawn Cross to CEO in ex­ec reshuf­fle

Mar­i­on Mc­Court

→ While our eyes were fixed on CEO David Hung’s de­par­ture from strug­gling Ax­o­vant, COO Mar­i­on Mc­Court al­so qui­et­ly jumped ship — to Re­gen­eron $REGN. The com­pa­ny an­nounced Mon­day (the same day Mc­Court’s res­ig­na­tion from Ax­o­vant was made pub­lic) that it has ap­point­ed her as SVP and head of com­mer­cial. The ap­point­ment filled a va­can­cy left by Robert Ter­i­fay, who re­signed last month in the mid­dle of a med­ical leave and plans to re­tire in Ju­ly. A sea­soned ex­ec with foot­prints at As­traZeneca, Am­gen and Medi­va­tion, Mc­Court will lead the com­mer­cial­iza­tion for both ap­proved med­i­cines and de­vel­op-stage pipeline.

Michael Nolte is the new CEO at clin­i­cal tech­nol­o­gy and ser­vice provider Brack­et, suc­ceed­ing Jeff Kin­nell. Nolte was for­mer­ly the CEO of In­flu­ence Health, which makes soft­ware for health care or­ga­ni­za­tions.

→ An am­bi­tious GT Bio­phar­ma has reshuf­fled its ex­ec­u­tive lead­er­ship in a strate­gic tran­si­tion: cur­rent pres­i­dent and COO Shawn Cross will take the helm as chair­man and CEO, while co-founder and ex-CEO Kath­leen Clarence-Smith con­cen­trates on the neu­rol­o­gy di­vi­sion. An­tho­ny Catal­do, an­oth­er co-founder who cham­pi­oned the com­pa­ny’s on­col­o­gy pro­file, will re­main on the board and be­come a con­sul­tant. An in­vest­ment banker by train­ing, Cross has tall or­ders ahead of him, in­clud­ing lead­ing the Wash­ing­ton, DC-based biotech through a list­ing on Nas­daq, at­tract­ing in­sti­tu­tion­al in­vest­ment and an­a­lyst cov­er­age, and guid­ing the first clin­i­cal tests of a trispe­cif­ic AD­CC NK cell en­gager.

→ As Ar­a­digm $ARDM con­tends with the af­ter­math of a dis­as­trous reg­u­la­to­ry jour­ney, it has let go of three of its top ex­ec­u­tives in an ap­par­ent mea­sure to cut costs. CEO Ig­or Gon­da, CMO Juer­gen Froehlich and CFO Nan­cy Peco­ta have re­signed from all of their po­si­tions at the trou­bled biotech. John Siebert, cur­rent chair­man of the board, will step in as ex­ec­u­tive chair­man and in­ter­im prin­ci­pal ex­ec­u­tive of­fi­cer. If Ar­a­digm wants an­oth­er chance at the FDA for its in­haled an­tibi­ot­ic Lin­haliq, which it in­di­cat­ed it would like to do, it would need fresh cash to fu­el a whole new PhI­II pro­gram.

→ Lit­tle Arc­turus $ARCT is go­ing through a dra­mat­ic shake­up this month. Short­ly af­ter news that its founder and CEO Joseph Payne was boot­ed from the com­pa­ny (with board mem­bers al­leged­ly con­spir­ing on his ouster), Arc­turus is now los­ing an­oth­er top ex­ec­u­tive. The com­pa­ny’s chief sci­en­tif­ic of­fi­cer and chief op­er­at­ing of­fi­cer Pad Chivuku­la is step­ping down, the com­pa­ny said in a state­ment. That’s in­ter­est­ing, con­sid­er­ing Payne re­cent­ly not­ed that both he and Chivuku­la had been left out of par­tic­i­pa­tion in board dis­cus­sions and votes. Chivuku­la will stay on as sci­en­tif­ic ad­vi­sor to Arc­turus, the com­pa­ny said. The news comes in con­junc­tion with a new state­ment filed with the SEC not­ing that Payne, the ex-CEO, is de­mand­ing an “ex­tra­or­di­nary meet­ing” of the board to vote on an ouster of his own de­sign. In the let­ter, he calls for the boot to four com­pa­ny di­rec­tors — Stu­art CollinsonCraig Wil­lettDaniel Gef­fken, and David Shapiro — who he says en­gaged in an in­trigue that vi­o­lat­ed the rules es­tab­lished by the Is­raeli laws that gov­ern its op­er­a­tions. Payne is sug­gest­ing four new di­rec­tors take their place, in­clud­ing some of the biggest names in San Diego biotech: Mag­da Mar­quetPe­ter Far­rellAn­drew Sas­sine, and James Bar­low. Mar­quet, founder and co-chair of Althea Tech­nolo­gies, is a well-known in­dus­try ex­ec­u­tive who’s a bit of a leg­end in San Diego. And Far­rell, is the founder and for­mer long-term CEO and cur­rent chair­man of ResMed, one of the largest med­ical de­vice com­pa­nies in San Diego.

Jef­frey Goater

→ Sur­face On­col­o­gy has pro­mot­ed its BD chief to run the com­pa­ny. Jef­frey Goater is tak­ing the helm of the Cam­bridge, MA-based biotech, fo­cused on new drugs tar­get­ing CD47 and CD73 in the tu­mor mi­croen­vi­ron­ment. He’s re­plac­ing As­traZeneca vet Detlev Bin­iszkiewicz, who was re­cruit­ed a lit­tle less than three years ago. There’s no im­me­di­ate word on Bin­iszkiewicz’s next step.

→ Je­re­my Cald­well is trad­ing the CSO seat at Arde­lyx $ARDX for a CEO job at an undis­closed “ear­ly stage biotech start-up com­pa­ny based in San Diego,” the Fre­mont, CA-based com­pa­ny an­nounced to­day. His de­par­ture from the biotech, best known for IBS drug tena­panor, fol­lows a bumpy three-year ride that set tena­panor on course for an NDA sub­mis­sion de­spite some doubts along the way. No suc­ces­sor has been named just yet. “I be­lieve that tena­panor will play a crit­i­cal role in treat­ing both hy­per­phos­phatemia and IBS-C in the fu­ture. I’m proud of what we’ve dis­cov­ered with the RDX013 pro­gram, as it rep­re­sents an en­tire­ly new ap­proach to treat­ing hy­per­kalemia,” Cald­well said in a state­ment.

Uro­Gen Phar­ma $URGN is try­ing out a dif­fer­ent man­age­ment style with the ap­point­ment of Stephen Mul­len­nix — a vet­er­an ex­ec in the en­er­gy in­dus­try — as chief op­er­at­ing of­fi­cer. Mul­len­nix is tasked with build­ing a com­mer­cial en­ter­prise for the uro-on­col­o­gy fo­cused biotech, which has a PhI­II and a cou­ple of PhII pro­grams planned for the year.

→ As Swe­den’s So­bi looks to grow its pres­ence in North Amer­i­ca, it has brought on Lin­ea As­pe­si as VP of hu­man re­sources in the re­gion. As­pe­si will be ex­er­cis­ing the mus­cles she’s built up over the past 20 years — most re­cent­ly at Sanofi — to de­vise strate­gies for ac­quir­ing, man­ag­ing and re­tain­ing tal­ent at the rare dis­ease com­pa­ny.

→ Hav­ing served as chief busi­ness of­fi­cer at Aptinyx — and led fi­nanc­ing rounds to­tal­ing up­wards of $135 mil­lion — since the com­pa­ny was spun out in 2015, Ashish Khan­na is adding the ti­tle of CFO to his busi­ness card. Be­fore that, he was a VP of cor­po­rate de­vel­op­ment at Nau­rex, where he played a part in the $560 mil­lion Al­ler­gan ac­qui­si­tion that re­sult­ed in the cre­ation of NM­DA-tar­get­ing Aptinyx. His new role overs over­sight of all fi­nance and ac­count­ing in ad­di­tion to busi­ness de­vel­op­ment for the Evanston, IL biotech.

→ A month af­ter ex­pe­ri­enc­ing one of the most hu­mil­i­at­ing set­backs in biotech, David Hung is bow­ing out as CEO of Ax­o­vant $AX­ON. Hung, you’ll re­call, had on­ly re­cent­ly com­plet­ed a $14 bil­lion deal to sell Medi­va­tion to Pfiz­er when he agreed to take the helm at Vivek Ra­maswamy’s Alzheimer’s com­pa­ny just 10 months ago. Their 5HT6 drug, once tout­ed with great hope, failed to make a mark on symp­toms of the dis­ease, be­fore an am­a­teur­ish sta­tis­ti­cal er­ror dealt an­oth­er blow to the com­pa­ny’s im­age. Along with Hung went his whole camp: “(d)irec­tors Kate Fal­berg, Tony Ver­non, and Patrick Macha­do have re­signed as mem­bers of the com­pa­ny’s board of di­rec­tors.” Ex-McK­in­sey con­sul­tant and Har­vard Med grad­u­ate Pa­van Cheru­vu is tak­ing Hung’s place. George Bick­er­staff, the for­mer CFO of No­var­tis Phar­ma, joined Ax­o­vant’s board of di­rec­tors along with ex-Unit­ed Ther­a­peu­tics CEO Roger Jeffs.

Sang­amo Ther­a­peu­tics, the long­time gene edit­ing play­er that scored the field’s first hu­man ex­per­i­ment, has hired Heather Turn­er to over­see all le­gal mat­ters as the com­pa­ny ad­vances its zinc fin­ger nu­cle­ase tech. Pre­vi­ous­ly at Atara Bio­ther­a­peu­tics and Orex­i­gen Ther­a­peu­tics, the SVP and gen­er­al coun­sel will ad­vise Sang­amo $SG­MO through late-stage de­vel­op­ment and com­mer­cial­iza­tion.

→ As Hous­ton-based Im­munoMet con­tin­ues to fill its C-suite, it has re­cruit­ed Big Phar­ma vet Vin­cent O’Neill as CMO ex-Syn­dax ex­ec Al­lan Shaw as CFO. Af­ter work­ing on sev­er­al big on­col­o­gy projects at Genen­tech and Glax­o­SmithK­line, O’Neill made a jump to can­cer biotech Mir­na Ther­a­peu­tics, de­sign­ing and man­ag­ing a Phase I clin­i­cal tri­al of its lead prod­uct. That’s the ex­act same phase that Im­munoMet’s lead prod­uct, IM156, is in. Shaw’s ex­per­tise lies more in fi­nance than life sci­ences, and the com­pa­ny — a spin­out of Ko­re­an bio­phar­ma HanAll — hopes that will help them in fundrais­ing.

Kei­th Nazareth is re­tir­ing from phar­ma/nu­traceu­ti­cal man­u­fac­tur­ing com­pa­ny ACG, fol­low­ing a 27-year ca­reer that cul­mi­nat­ed in the VP of Eu­rope po­si­tion. His suc­ces­sor is Steven Fac­er, a vet­er­an of the CRO in­dus­try.

→ Just a day be­fore Ar­bu­tus put the word out about its ex­clu­sive talks with backer Roivant Sci­ences, it an­nounced that CFO and EVP Bruce Cousins is leav­ing the com­pa­ny. Ko­ert Van­de­nEn­den, cur­rent­ly VP of fi­nance, will take over his re­spon­si­bil­i­ties in the in­ter­im.

→ Eye­ing reg­u­la­to­ry fil­ings for three pro­grams over the next two years, blue­bird bio $BLUE has pro­mot­ed Al­i­son Fin­ger as chief com­mer­cial of­fi­cer. Fin­ger joined the CAR-T star as SVP of mar­ket­ing and prod­uct launch in 2015, af­ter two decades launch­ing prod­ucts at Bris­tol-My­ers Squibb. Her new man­date cov­ers com­mer­cial strat­e­gy and ac­cess man­age­ment — which in­cludes the hot is­sues of pric­ing and re­im­burse­ment.

→ For­mer FDA Com­mis­sion­er Robert Califf is join­ing yet an­oth­er San Fran­cis­co com­pa­ny’s board. Less than a year af­ter ac­cept­ing a board seat at Al­pha­bet’s Ver­i­ly, Califf is of­fer­ing his guid­ance to Cy­to­ki­net­ics $CYTK — a com­pa­ny whose ALS fail­ure made our list of biggest pipeline flops last year. Califf is a tenured pro­fes­sor of car­di­ol­o­gy at Duke and has led sev­er­al clin­i­cal car­di­ol­o­gy re­search stud­ies over the course of his ca­reer. That ex­pe­ri­ence will come in handy as Cy­to­ki­net­ics fo­cus­es its at­ten­tion on its heart fail­ure drug can­di­date ome­cam­tiv mer­car­bil — a drug that ac­ti­vates car­diac myosin, amp­ing up the heart’s abil­i­ty to con­tract.

Igny­ta’s CFO Ja­cob Chacko has joined the board at neu­ro­tax­in play­er Bon­ti, where long­time di­rec­tor David Ram­say’s tran­si­tion to CFO like­ly left an open­ing for some­one with fi­nan­cial ex­per­tise.

No­var­tis vet Rick Pan­icuc­ci has joined the board of Q Bio­med, sup­port­ing the prod­uct de­vel­op­ment busi­ness with the ex­pe­ri­ence he’s gained as VP of phar­ma­ceu­ti­cal de­vel­op­ment of a WuXi AppTec sub­sidiary.

→ Fol­low­ing Geno­cea’s $55 mil­lion pub­lic of­fer­ing led by New En­ter­prise As­so­ci­ates, NEA part­ner Ali Be­hba­hani will join the board of the can­cer vac­cine de­vel­op­er $GN­CA.

Aim­mune Ther­a­peu­tics $AIMT, the biotech be­ing watched for its peanut al­ler­gy drug, has re­cruit­ed two more al­ler­gy ex­perts to his sci­en­tif­ic ad­vi­so­ry board: George du Toit of King’s Col­lege Lon­don and Wayne Shref­fler, who splits his time be­tween Mass­a­chu­setts Gen­er­al Hos­pi­tal and Har­vard Med­ical School.

Hal Barron, GSK

Break­ing the death spi­ral: Hal Bar­ron talks about trans­form­ing the mori­bund R&D cul­ture at GSK in a crit­i­cal year for the late-stage pipeline

Just ahead of GlaxoSmithKline’s Q2 update on Wednesday, science chief Hal Barron is making the rounds to talk up the pharma giant’s late-stage strategy as the top execs continue to woo back a deeply skeptical investor group while pushing through a whole new R&D culture.

And that’s not easy, Barron is quick to note. He told the Financial Times:

I think that culture, to some extent, is as hard, in fact even harder, than doing the science.

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Some Big Phar­mas stepped up their game on da­ta trans­paren­cy — but which flunked the test?

The nonprofit Bioethics International has come out with their latest scorecard on data transparency among the big biopharmas in the industry — flagging a few standouts while spotlighting some laggards who are continuing to underperform.

Now in its third year, the nonprofit created a new set of standards with Yale School of Medicine and Stanford Law School to evaluate the track record on trial registration, results reporting, publication and data-sharing practice.

Busy Gilead crew throws strug­gling biotech a life­line, with some cash up­front and hun­dreds of mil­lions in biobucks for HIV deal

Durect $DRRX got a badly needed shot in the arm Monday morning as Gilead’s busy BD team lined up access to its extended-release platform tech for HIV and hepatitis B.

Gilead, a leader in the HIV sector, is paying a modest $25 million in cash for the right to jump on the platform at Durect, which has been using its technology to come up with an extended-release version of bupivacaine. The FDA rejected that in 2014, but Durect has been working on a comeback.

In­tec blitzed by PhI­II flop as lead pro­gram fails to beat Mer­ck­'s stan­dard com­bo for Parkin­son’s

Intec Pharma’s $NTEC lead drug slammed into a brick wall Monday morning. The small-cap Israeli biotech reported that its lead program — coming off a platform designed to produce a safer, more effective oral drug for Parkinson’s — failed the Phase III at the primary endpoint.

Researchers at Intec, which has already seen its share price collapse over the past few months, says that its Accordion Pill-Carbidopa/Levodopa failed to prove superior to Sinemet in reducing daily ‘off’ time. 

Cel­gene racks up third Ote­zla ap­proval, heat­ing up talks about who Bris­tol-My­ers will sell to

Whoever is taking Otezla off Bristol-Myers Squibb’s hands will have one more revenue stream to boast.

The drug — a rising star in Celgene’s pipeline that generated global sales of $1.6 billion last year — is now OK’d to treat oral ulcers associated with Behçet’s disease, a common symptom for a rare inflammatory disorder. This marks the third FDA approval for the PDE4 inhibitor since 2014, when it was greenlighted for plaque psoriasis and psoriatic arthritis.

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Francesco De Rubertis

Medicxi is rolling out its biggest fund ever to back Eu­rope's top 'sci­en­tists with strange ideas'

Francesco De Rubertis built Medicxi to be the kind of biotech venture player he would have liked to have known back when he was a full time scientist.

“When I was a scientist 20 years ago I would have loved Medicxi,’ the co-founder tells me. It’s the kind of place run by and for investigators, what the Medicxi partner calls “scientists with strange ideas — a platform for the drug hunter and scientific entrepreneur. That’s what I wanted when I was a scientist.”

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Af­ter a decade, Vi­iV CSO John Pot­tage says it's time to step down — and he's hand­ing the job to long­time col­league Kim Smith

ViiV Healthcare has always been something unique in the global drug industry.

Owned by GlaxoSmithKline and Pfizer — with GSK in the lead as majority owner — it was created 10 years ago in a time of deep turmoil for the field as something independent of the pharma giants, but with access to lots of infrastructural support on demand. While R&D at the mother ship inside GSK was souring, a razor-focused ViiV provided a rare bright spot, challenging Gilead on a lucrative front in delivering new combinations that require fewer therapies with a more easily tolerated regimen.

They kept a massive number of people alive who would otherwise have been facing a death sentence. And they made money.

And throughout, John Pottage has been the chief scientific and chief medical officer.

Until now.

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Vlad Coric (Biohaven)

In an­oth­er dis­ap­point­ment for in­vestors, FDA slaps down Bio­haven’s re­vised ver­sion of an old ALS drug

Biohaven is at risk of making a habit of disappointing its investors.

Late Friday the biotech $BHVN reported that the FDA had rejected its application for riluzole, an old drug that they had made over into a sublingual formulation that dissolves under the tongue. According to Biohaven, the FDA had a problem with the active ingredient used in a bioequivalence study back in 2017, which they got from the Canadian drugmaker Apotex.

Apotex, though, has been a disaster ground. The manufacturer voluntarily yanked the ANDAs on 31 drugs — in late 2017 — after the FDA came across serious manufacturing deficiencies at their plants in India. A few days ago, the FDA made it official.

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Chas­ing Roche's ag­ing block­buster fran­chise, Am­gen/Al­ler­gan roll out Avastin, Her­ceptin knock­offs at dis­count

Let the long battle for biosimilars in the cancer space begin.

Amgen has launched its Avastin and Herceptin copycats — licensed from the predecessors of Allergan — almost two years after the FDA had stamped its approval on Mvasi (bevacizumab-awwb) and three months after the Kanjinti OK (trastuzumab-anns). While the biotech had been fielding biosimilars in Europe, this marks their first foray in the US — and the first oncology biosimilars in the country.