Roivant brings Pfiz­er vets Azoulay, Gul­fo in­to its C-suite; Aileron CEO Joseph Yanchik is out

Sa­lomon Azoulay

Vivek Ra­maswamy has ush­ered two Pfiz­er vets in­to Roivant’s C-suite as he con­tin­ues to build his vi­sion for a Vant king­dom. New CMO Sa­lomon Azoulay most re­cent­ly held the same role at Pfiz­er Es­sen­tial Health, the busi­ness unit in charge of a slate of mar­ket­ed drugs. Adele Gul­fo, who’s now chief of com­mer­cial de­vel­op­ment, got her start launch­ing Lip­i­tor and used to run the busi­ness de­vel­op­ment for As­traZeneca be­fore join­ing Pfiz­er.

Adele Gul­fo

Roivant not so long ago upped its in­volve­ment in both Chi­na and the in­fec­tious dis­ease mar­ket by bag­ging rights to Nabri­va’s lefa­mulin in the re­gion. And then there was the launch of Genevant just a month ago, born out of a part­ner­ship with the RNAi spe­cial­ists at Ar­bu­tus. With Ax­o­vant’s spec­tac­u­lar fail­ure in Alzheimer’s still fresh in every­one’s mind, it’s a crit­i­cal time for CEO Ra­maswamy, a skilled fundrais­er and fi­nan­cial en­gi­neer, to prove he is equal­ly good in ac­tu­al­ly de­liv­er­ing new drugs.

“As the scale and scope of our pipeline con­tin­ue to grow and we ap­proach com­mer­cial­iza­tion for sev­er­al ther­a­pies across the Vants, Sam and Adele will work to en­sure that our med­i­cines reach pa­tients as quick­ly as pos­si­ble,” said Ra­maswamy in a state­ment.

→ Hav­ing steered Aileron Ther­a­peu­tics $AL­RN in­to clin­i­cal stage and through an IPO, Joseph Yanchik is leav­ing his com­pa­ny of 12 years and all his roles, in­clud­ing pres­i­dent, CEO and board mem­ber. Bio­phar­ma con­sul­tant and two-time CEO John Lon­ge­neck­er has been brought in to fill the role on an in­ter­im ba­sis. The Cam­bridge, MA-based biotech did not give a rea­son for Yanchik’s sud­den de­par­ture in its press re­lease, choos­ing in­stead to high­light mid-stage clin­i­cal plans for its lead on­col­o­gy can­di­date. A ven­ture part­ner at Ap­ple Tree, Yanchik had helped found Aileron in 2005.

Bryan Irv­ing

Genen­tech vet Bryan Irv­ing just got a pro­mo­tion at Five Prime Ther­a­peu­tics $FPRX, where he will now be EVP and CSO. Irv­ing, a key re­searcher in the de­vel­op­ment of Tecen­triq, has a broad man­date to set dis­cov­ery strat­e­gy and pri­or­i­ties for Five Prime’s im­muno-on­col­o­gy pro­tein ther­a­peu­tics pipeline. Pri­or to join­ing the South San Fran­cis­co biotech, he spent sev­er­al years di­rect­ing can­cer im­munol­o­gy at Cy­tomX.

→ Phase I da­ta in hand, Sen­sei Bio­ther­a­peu­tics has named John Celebi pres­i­dent and CEO to ce­ment its im­muno-on­col­o­gy plat­form and be the face of its new iden­ti­ty (un­til ear­li­er this year, the com­pa­ny was known as Panacea Phar­ma­ceu­ti­cals). Celebi paid his dues as COO of X4 Phar­ma­ceu­ti­cals and CBO of Igeni­ca Bio­ther­a­peu­tics, lead­ing — re­spec­tive­ly — their on­col­o­gy and im­munother­a­py pro­grams. He brings a string of deal­mak­ing and al­liance man­age­ment records to Gaithers­burg, MD-based Sen­sei, where his ini­tial pri­or­i­ty will be lead drug can­di­date SNS-301, a can­cer vac­cine de­vel­oped with the SPIR­IT plat­form which tar­gets neoanti­gens or al­tered self-anti­gens en­cod­ed by tu­mor-spe­cif­ic mu­tant genes.

→ Af­ter co-found­ing and lead­ing gener­ics com­pa­ny Am­neal Phar­ma­ceu­ti­cals for 15 years, Chin­tu Pa­tel is set­ting his sight on biosim­i­lars. He is now the CEO of Adel­lo Bi­o­log­ics, a mon­o­clon­al an­ti­body spe­cial­ist head­quar­tered in Pis­cat­away, NJ and cur­rent­ly fo­cused on can­cer. He suc­ceeds Pe­ter Moes­ta, Adel­lo’s CEO for al­most three years.

→ Di­a­betes ex­pert Pawel Fludzin­s­ki has jumped from Eli Lil­ly to the helm of Amide­Bio. He re­places found­ing CEO Misha Plam, who will re­main as pres­i­dent and chair­man of the board. “Amide­Bio’s nov­el ap­proach to de­vel­op­ing glu­cose re­spon­sive in­sulins (GRI) promis­es to rad­i­cal­ly im­prove di­a­betes treat­ment,” said Fludzin­s­ki in a state­ment. “I look for­ward to lead­ing the GRI ef­fort as well as oth­er growth op­por­tu­ni­ties.” Dur­ing his lengthy tenure at Lil­ly, Fludzin­s­ki led a cross-func­tion­al team work­ing through late-stage stud­ies and glob­al reg­is­tra­tion of Trulic­i­ty — a key fran­chise for its di­a­betes busi­ness unit.

→ For­mer Ac­er­ta Phar­ma ex­ec Fran­cis­co Sal­va is tak­ing his fi­nance and op­er­a­tion ex­per­tise to the CEO post at Com­plexa. The Berwyn, PA-based com­pa­ny is de­vel­op­ing a drug dubbed CXA-10 in pul­monary ar­te­r­i­al hy­per­ten­sion and fo­cal seg­men­tal glomeru­loscle­ro­sis — both or­phan in­di­ca­tions — and has tasked Sal­va with ad­vanc­ing its Phase II de­vel­op­ment. Sal­va, who worked as a VC be­fore mov­ing on to start Ac­er­ta, is al­so ex­pect­ed to beef up the pipeline with more next-gen ni­trat­ed fat­ty acid com­pounds to treat fi­brot­ic and in­flam­ma­tion based dis­eases.

Jeanne Ma­gram

Quen­tis Ther­a­peu­tics has put its $48 mil­lion of Se­ries A dol­lars to use, re­cruit­ing Jeanne Ma­gram back to New York City from Toron­to’s North­ern Bi­o­log­ics. As CSO, Ma­gram will build on the young biotech’s sci­en­tif­ic foun­da­tion about the en­do­plas­mic retic­u­lum (ER) path­ways — with sci­ence com­ing out of Lau­rie Glim­ch­er’s lab at Dana Far­ber — guid­ing drug dis­cov­ery and de­vel­op­ment in “im­muno-on­col­o­gy and be­yond.” While the spot­light now goes to a small mol­e­cule IRE1α in­hibitor sched­uled to en­ter the clin­ic in 2019, a pipeline of pre­clin­i­cal pro­grams is ex­pect­ed to fol­low. That kind of ear­ly stage work is the sweet spot for Ma­gram, who pre­vi­ous­ly led Pfiz­er’s Cen­ters for Ther­a­peu­tic In­no­va­tion and did drug dis­cov­ery work at Boehringer In­gel­heim.

→ Af­ter tack­ling a num­ber of on­col­o­gy pro­grams at Astel­las Phar­ma, Pfiz­er and Eli Lil­lyStephen Eck will now ze­ro in on T cell ther­a­pies as CMO of Im­mat­ics. The biotech is based in Hous­ton, with sub­stan­tial ties to the MD An­der­son Can­cer Cen­ter — a col­lab­o­ra­tor Eck has got­ten to know while co­or­di­nat­ing clin­i­cal tri­als for Astel­las. Eck is tasked with steer­ing the pre­clin­i­cal-heavy pipeline to­ward clin­i­cal de­vel­op­ment.

Ray­mond Ur­ban­s­ki is get­ting pro­mot­ed to pres­i­dent at GT Bio­phar­ma, on top of the CMO role that he’s been in for about eight months. Ac­cord­ing to CEO Shawn Cross, that re­flects the crit­i­cal con­tri­bu­tions that Ur­ban­s­ki has made to the im­muno-on­col­o­gy biotech, rang­ing from sci­en­tif­ic and clin­i­cal ac­tiv­i­ties to tal­ent re­cruit­ment and in­ter­nal process man­age­ment. While the ex­pe­ri­enced CMO had played sim­i­lar roles at his for­mer work­places, in­clud­ing Pfiz­er, My­lan and MannKind, this marks his first time be­ing pres­i­dent of a com­pa­ny.

Astel­las is hand­ing Bern­hardt Zei­her, cur­rent­ly pres­i­dent of de­vel­op­ment, the ad­di­tion­al role of CMO. The pro­mo­tion means Zei­her will now be re­spon­si­ble for qual­i­ty as­sur­ance in re­search and clin­i­cal ac­tiv­i­ties, plan­ning and ad­min­is­tra­tion, as well as reg­u­la­to­ry af­fairs. A Pfiz­er vet, Zei­her joined Astel­las’ North­brook, IL head­quar­ters as a leader of its in­flam­ma­tion, im­munol­o­gy and in­fec­tious dis­eases unit. He now has a much broad­er man­date re­gard­ing the whole pipeline — part of a cor­po­rate strate­gic plan de­vised by new­ly mint­ed CEO Ken­ji Ya­sukawa.

→ Faced with a grow­ing cri­sis over its $1.2 mil­lion in pay­ments to Pres­i­dent Don­ald Trump’s per­son­al at­tor­ney Michael Co­hen, No­var­tis $NVS an­nounced ear­ly Wednes­day that the com­pa­ny’s top lawyer has abrupt­ly re­signed in hopes of bring­ing the whole tawdry af­fair to an end. “Al­though the con­tract (with Co­hen) was legal­ly in or­der, it was an er­ror,” said Fe­lix Ehrat, group gen­er­al coun­sel of No­var­tis, in a state­ment. “As a co-sig­na­to­ry with our for­mer CEO, I take per­son­al re­spon­si­bil­i­ty to bring the pub­lic de­bate on this mat­ter to an end.”

→ With its Epi­tope-Spe­cif­ic Im­muno-Ther­a­py plat­form, Im­mu­sanT has wooed Ken Tru­itt away from Dai­ichi Sankyo to be­come its CMO. Though Tru­itt is ini­tial­ly fo­cused on the Phase II clin­i­cal de­vel­op­ment for Nex­vax2 in celi­ac dis­ease, CEO Leslie Williams hired him with the long view in mind, bank­ing on his ex­pe­ri­ence from pre­clin­i­cal up to NDA. The Arch-backed start­up plans to ex­plore its tech in oth­er au­toim­mune dis­eases in­clud­ing type 1 di­a­betes.

→ In a bid to emerge as a “glob­al, mul­ti-prod­uct on­col­o­gy com­pa­ny,” Seat­tle Ge­net­ics $SGEN has tapped Roger Dansey — a for­mer Mer­ck ex­ec of Keytru­da fame — as CMO. Pre­vi­ous­ly the ther­a­peu­tic head for late-stage on­col­o­gy at Mer­ck, Dansey in­her­its fran­chise drug Ad­cetris and a slate of ear­ly- to mid-stage drugs from long­time CMO Jonathan Drach­man. Ad­cetris was re­cent­ly ap­proved for front­line Hodgkin lym­phoma, its fifth in­di­ca­tion, with plans for more. The com­pa­ny is count­ing on Dansey’s de­vel­op­ment and ap­proval ex­pe­ri­ence, dat­ing back from his Gilead and Am­gen days, to dri­ve suc­cess­ful piv­otal tri­als for oth­er can­cer drugs in its bas­ket, some of which it picked up from the $614 mil­lion Cas­ca­di­an buy­out pact ex­e­cut­ed in Jan­u­ary. Drach­man will be on hand as a strate­gic ad­vis­er.   

Rodin Ther­a­peu­tics has re­cruit­ed three new ex­ecs in its quest to tack­le synap­tic re­silience in Alzheimer’s dis­ease — and be­yond. Michael Ryan, a physi­cian-sci­en­tist with neu­ro­science re­search back­grounds in No­var­tis and Pfiz­er, has been named CMO; Ex-Sunovion ex­ec Anne Sul­li­van will lead cor­po­rate strat­e­gy as CBO; Steven Sweeney, for­mer­ly of In­fin­i­ty Phar­ma and Arteaus Ther­a­peu­tics, is now VP of clin­i­cal de­vel­op­ment op­er­a­tions. Guid­ing their ef­forts will be David Bleak­man, a long­time Eli Lil­ly re­search ex­ec who’s joined the sci­en­tif­ic ad­vi­so­ry board.

→ A new ap­point­ment has brought glo­be­trot­ter Ralph Laufer to Cam­bridge, MA and Paris, where he will run gene ther­a­py pro­grams as CSO of Lyso­gene. Pri­or to join­ing the biotech, which fo­cus­es on or­phan dis­ease of the cen­tral ner­vous sys­tem, Laufer man­aged small mol­e­cule dis­cov­ery and non­clin­i­cal de­vel­op­ment for Is­rael’s Te­va — and that’s af­ter di­rect­ing a sci­ence park for a CRO in Italy.

Eliel Bayev­er has land­ed his first CMO role at Cana­da’s On­co­Quest, con­tin­u­ing his ca­reer-long in­volve­ment with on­col­o­gy ther­a­peu­tics. With an im­munother­a­py as­set in var­i­ous stages of de­vel­op­ment for dif­fer­ent in­di­ca­tions, the com­pa­ny is count­ing on Bayev­er’s ex­per­tise in both ear­ly and late stage clin­i­cal stud­ies to move its ovar­i­an, pan­cre­at­ic and breast can­cer pro­grams along. For Bayev­er, for­mer­ly of J&J and Mer­ri­mack, the po­ten­tial that ore­gov­omab has shown for front­line ovar­i­an can­cer in Phase II is the most ex­cit­ing.

TP Ther­a­peu­tics has brought in in­dus­try vet­er­an Athena Coun­tou­ri­o­tis as EVP and CMO. In ad­di­tion to her ex­ten­sive ex­pe­ri­ence in the job — hav­ing served in the role at Ad­verum, Halozyme and Am­bit — the Or­bimed-backed biotech al­so likes their align­ment in the ki­nase in­hibitor area. As San Diego-based TP Ther­a­peu­tics un­veils Phase I da­ta for lead as­set TPX-0005 (ropotrec­tinib), Coun­tou­ri­o­tis will help dri­ve strat­e­gy for this and oth­er pro­grams ad­dress­ing re­sis­tance to onco­gene tar­get­ing can­cer treat­ments.

→ New Haven, CT-based Tre­vi Ther­a­peu­tics has ap­point­ed Christo­pher Seit­er as CFO, putting all fi­nan­cial, trea­sury and ac­count­ing func­tions in his hands as it pur­sues late-stage stud­ies of Nal­buphine ER in chron­ic pru­rit­ic con­di­tions. An in­vest­ment banker of 23 years, Seit­er made the jump to biotech op­er­a­tions a cou­ple years back at Mil­len­do Ther­a­peu­tics.

Kei­th Ven­dola is bring­ing his in­vest­ment bank­ing back­ground to Re­zo­lute, a meta­bol­ic and or­phan dis­eases com­pa­ny based in Col­orado. With two as­sets in Phase I and II, along­side plans to file an IND this year, the com­pa­ny be­lieves Ven­dola’s ex­per­tise in fi­nance and deal­mak­ing could come in­to play.

Liq­uidia Tech­nolo­gies is al­ready think­ing about com­mer­cial­iza­tion for its pul­monary ar­te­r­i­al hy­per­ten­sion treat­ment, and it has re­cruit­ed Jeri Thomas to de­vel­op those plans as SVP, com­mer­cial. Her march­ing or­ders will be to lead the launch of LIQ861, cur­rent­ly be­ing eval­u­at­ed in a Phase III safe­ty tri­al. Be­fore jump­ing to a mar­ket­ing agency, Thomas made her rounds from Bris­tol-My­ers Squibb and Roche to Janssen and The Med­i­cines Com­pa­ny, in a va­ri­ety of com­mer­cial roles.

→ Wall Street an­a­lyst Michael King has made the jump to biotech, tak­ing up the po­si­tion of en­tre­pre­neur in res­i­dence at Fortress Bio’s $FBIO NYC of­fices. He is ex­pect­ed to lever­age his eye for promis­ing ther­a­pies and knowl­edge about cor­po­rate struc­tures to help ex­pand Fortress Bio’s port­fo­lio in on­col­o­gy and un­der-the-radar dis­eases, adding to its 10 sub­sidiaries and over 25 de­vel­op­ment-stage ther­a­pies.

Rock­et Phar­ma­ceu­ti­cals $RCKT has named Gay­a­tri Rao its first VP of reg­u­la­to­ry pol­i­cy and pa­tient ad­vo­ca­cy. Lean­ing on her ex­pe­ri­ence as a for­mer di­rec­tor of the FDA’s Of­fice of Or­phan Prod­ucts De­vel­op­ment, Rao will be trust­ed for di­rec­tion to glob­al reg­u­la­to­ry poli­cies and strate­gies for Rock­et’s rare dis­ease pro­grams, some of which have read­outs this week.

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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Aca­dia is mak­ing the best of it, but their lat­est PhI­II Nu­plazid study is a bust

Acadia’s late-stage program to widen the commercial prospects for Nuplazid has hit a wall. The biotech reported that their Phase III ENHANCE trial flat failed. And while they $ACAD did their best to cherry pick positive data wherever they can be found, this is a clear setback for the biotech.

With close to 400 patients enrolled, researchers said the drug flunked the primary endpoint as an adjunctive therapy for patients with an inadequate response to antipsychotic therapy. The p-value was an ugly 0.0940 on the Positive and Negative Syndrome Scale, which the company called out as a positive trend.

Their shares slid 12% on the news, good for a $426 million hit on a $3.7 billion market cap at close.

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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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