Shinichi Tamu­ra re­claims the throne at So­sei; Jeff Abbey ex­its Ar­gos for No­vadip; Frank Cz­er­wiec is the new CMO at Goldfinch

Jeff Abbey is jump­ing to the helm of Bel­gium’s No­vadip Bio­sciences af­ter lead­ing Ar­gos Ther­a­peu­tics as pres­i­dent and CEO for the past eight years. Hav­ing led No­vadip’s au­tol­o­gous cell ther­a­py through a Phase I/IIa tri­al in spinal fu­sion pa­tients, found­ing CEO Jean-François Pol­let de­cid­ed it’s time to pass the reins to a more ex­pe­ri­enced chief ex­ec­u­tive. And Abbey — whose ex­pe­ri­ence in­cludes over­see­ing a Phase III tri­al, rais­ing over $250 mil­lion in pri­vate fi­nanc­ings and an IPO, and seal­ing sev­er­al part­ner­ships — fits the bill.

Daniel O’Day

→ The sus­pense over who will suc­ceed John Mil­li­gan at Gilead has fi­nal­ly end­ed. Daniel O’Day, cur­rent CEO of Roche’s phar­ma di­vi­sion, has been tapped for the top job, Gilead an­nounced days be­fore Mil­li­gan is set to de­part from his cor­ner of­fice. O’Day’s ap­point­ment ush­ers in a new era for the Fos­ter City, CA-based big biotech, which Mil­li­gan and his pre­de­ces­sor, John Mar­tin, ran for near­ly three decades, cre­at­ing an HIV pow­er­house and an in­dus­try-dom­i­nat­ing he­pati­tis C fran­chise.

Be­fore O’Day as­sumes his role on March 1, 2019, Gregg Al­ton — a 20-year vet­er­an of the com­pa­ny who’s served as gen­er­al coun­sel and, most re­cent­ly, chief pa­tient of­fi­cer — will man the fort as in­ter­im CEO.

Shinichi Tamu­ra’s ex­per­i­ment with putting a West­ern­er at the helm of So­sei in a bid to make the Japan­ese phar­ma com­pa­ny a more glob­al op­er­a­tion has come to a close. Tamu­ra — who found­ed the com­pa­ny — is now re­claim­ing the helm he hand­ed to Pe­ter Bains af­ter lim­it­ing him­self to the chair­man’s po­si­tion.

So­sei, which ac­quired UK-based Hep­tares’ GPCR plat­form in a $400 mil­lion deal back in 2015, isn’t back­ing away from the move to go glob­al. Tamu­ra says he is still in­tent on that strat­e­gy, with new in­vest­ments be­ing planned in R&D.

Jeff Jonker — an ex-lawyer who was part of the ex­ec­u­tive team at NGM Bio that inked a $450 mil­lion re­search deal with Mer­ck in 2015 — has risen to the ranks of CEO, at Third Rock-backed Am­bys Med­i­cines. The an­nounce­ment comes months af­ter the com­pa­ny — named af­ter the Mex­i­can sala­man­der famed for re­gen­er­at­ing limbs — se­cured $140 mil­lion in launch mon­ey and an elu­sive deal with Japan’s Take­da. The Red­wood City, Cal­i­for­nia-based com­pa­ny is tar­get­ing liv­er dis­ease on three fronts: cell ther­a­py for liv­er re­gen­er­a­tion; gene ther­a­py for liv­er restora­tion; and small mol­e­cule ther­a­py to re­place lost pro­tein func­tion.

Jonker takes over the reins from Third Rock’s ven­ture part­ner Jeff Tong, who was brought in to serve as in­ter­im CEO un­til a per­ma­nent ex­ec­u­tive was found. Tong will now move to the role of chair­man.

Tiffany Burt

→ En­ter­ing a sea­son of change, RNA biotech Pro­QR $PRQR has ap­point­ed four new ex­ecs as it pre­pares for two re­tire­ments. Aniz Girach, CMO, jumps from the same role at Night­star Ther­a­peu­tics to lead the reti­nal dis­ease pro­gram; No­var­tis vet Tiffany Burt will be VP, head of com­mer­cial; Cel­gene’s Lisa Hayes has been hired as VP of in­vestor re­la­tions and cor­po­rate com­mu­ni­ca­tions; CFO Smi­tal Shah will add chief busi­ness of­fi­cer to her ti­tle. Mean­while chief cor­po­rate de­vel­op­ment of­fi­cer and gen­er­al coun­sel René Beuke­ma and Robert Cor­nelisse — chief of peo­ple and or­ga­ni­za­tion — will re­tire at year-end 2018.

→ With an IND in sight for its lead pro­gram, Goldfinch Bio has scooped Frank Cz­er­wiec from Ot­su­ka Phar­ma, where he’s worked for 20 years end­ing in VP, glob­al clin­i­cal de­vel­op­ment role. As CMO, Cz­er­wiec will have over­sight on the en­tire kid­ney dis­ease pipeline with a keen eye on the lat­est break­throughs in the ge­net­ics of what trig­gers the ail­ments.

→ More than a year in­to Geno­cea’s $GN­CA quest to re­make it­self in­to a play­er in per­son­al­ized ther­a­pies, the com­pa­ny is ready to scout some deals. En­ter Girish Aakalu, the new chief busi­ness of­fi­cer with stints at Ipsen, Pfiz­er and Genen­tech. “(W)e be­lieve that Girish will help us max­i­mize our pipeline op­por­tu­ni­ties and cap­i­tal­ize on the myr­i­ad of pos­si­ble ap­pli­ca­tions of our AT­LAS plat­form, which us­es each pa­tient’s im­mune re­sponse ma­chin­ery to iden­ti­fy and char­ac­ter­ize anti­gens, rather than re­ly­ing on pre­dic­tive ap­proach­es,” said Chip Clark, pres­i­dent and CEO.

→ As Adap­ti­m­mune $ADAP tran­si­tions in­to the clin­i­cal stage, chief tech­nol­o­gy of­fi­cer Gwen Binder is sign­ing off her his­toric role at the com­pa­ny to pur­sue oth­er op­por­tu­ni­ties in ear­ly de­vel­op­ment and tech­ni­cal in­no­va­tion. Binder first joined the biotech’s US of­fice in 2011, man­ag­ing what be­gan as a one-woman trans­la­tion­al col­lab­o­ra­tion with the Uni­ver­si­ty of Penn­syl­va­nia. She will de­part in Jan­u­ary 2019.

Adam Schechter is step­ping down as pres­i­dent of glob­al hu­man health at Mer­ck, trig­ger­ing a re­or­ga­ni­za­tion of the phar­ma gi­ant’s com­mer­cial or­ga­ni­za­tion. Frank Clyburn has been pro­mot­ed to chief com­mer­cial of­fi­cer while Micheal Nal­ly as­sumes the chief mar­ket­ing of­fi­cer post.

Saila­ja Put­ta­gun­ta has joined Is­raeli biotech Bio­mX as CMO, tasked with steer­ing its mi­cro­bio­me pro­grams in ac­ne and ir­ri­ta­ble bow­el dis­ease to the clin­ic — with tri­als slat­ed for mid 2019 and 2020 re­spec­tive­ly. An an­ti-in­fec­tive ex­pert for­mer­ly of Pfiz­er and Al­ler­gan, Put­ta­gun­ta most re­cent­ly served as VP of de­vel­op­ment at Iterum Ther­a­peu­tics.

→ Can­cer de­tec­tion com­pa­ny Grail has ap­point­ed ex-Mor­gan Stan­ley man­ag­ing di­rec­tor Cather­ine Fried­man to the head of its board, re­plac­ing Bill Rastet­ter. Con­cur­rent­ly Alex Ar­a­va­nis, a co-founder, is get­ting pro­mot­ed to the CSO and head of R&D role.

→ Push­ing a plan to es­tab­lish com­mer­cial man­u­fac­tur­ing ca­pa­bil­i­ties in the US, Cel­lec­tis has tapped Den­dreon vet William Mon­tei­th to over­see the cell man­u­fac­tur­ing plant it’s build­ing to sup­port its off-the-shelf CAR-T ther­a­pies.

→ Fol­low­ing a cou­ple of deals to beef up its im­muno-on­col­o­gy pipeline, CStone Phar­ma has hired Archie Tse to fill the new­ly cre­at­ed role of SVP and chief trans­la­tion­al med­i­cine of­fi­cer, re­spon­si­ble for ear­ly-stage as­sets up to proof-of-con­cept. Trained at Memo­r­i­al Sloan Ket­ter­ing, Tse has pre­vi­ous­ly led on­col­o­gy pro­grams at Mer­ck and Dai­ichi Sankyo.

Nkar­ta Ther­a­peu­tics has hired Matthew Plun­kett to be CFO and SVP, cit­ing his mix of man­age­ment — at the likes of Mede­or Ther­a­peu­tics and CTI Bio­Phar­ma — and in­vest­ment bank­ing ex­pe­ri­ence.

En­zy­vant, a mem­ber of the Roivant fam­i­ly fo­cused on rare dis­eases, has ap­point­ed bio­phar­ma vet George El­ston as CFO and head of cor­po­rate de­vel­op­ment. El­ston was most re­cent­ly pres­i­dent and CEO of 2X On­col­o­gy.

Chris­t­ian Jones is the first chief com­mer­cial of­fi­cer at Nanoform, join­ing the drug par­ti­cle en­gi­neer­ing com­pa­ny with a back­ground in API de­vel­op­ment and man­u­fac­tur­ing.

UP­DAT­ED: In sur­prise switch, Bris­tol-My­ers is sell­ing off block­buster Ote­zla, promis­ing to com­plete Cel­gene ac­qui­si­tion — just lat­er

Apart from revealing its checkpoint inhibitor Opdivo blew a big liver cancer study on Monday, Bristol-Myers Squibb said its plans to swallow Celgene will require the sale of blockbuster psoriasis treatment Otezla to keep the Federal Trade Commission (FTC) at bay.

The announcement — which has potentially delayed the completion of the takeover to early 2020 — irked investors, triggering the New York-based drugmaker’s shares to tumble Monday morning in premarket trading.

Celgene’s Otezla, approved in 2014 for psoriasis and psoriatic arthritis, is a rising star. It generated global sales of $1.6 billion last year, up from the nearly $1.3 billion in 2017. Apart from the partial overlap of Bristol-Myers injectable Orencia, the company’s rival oral TYK2 psoriasis drug is in late-stage development, after the firm posted encouraging mid-stage data on the drug, BMS-986165, last fall. With Monday’s decision, it appears Bristol-Myers is favoring its experimental drug, and discounting Otezla’s future.

The move blindsided some analysts. Credit Suisse’s Vamil Divan noted just days ago:

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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.

Fol­low­ing news of job cuts in Eu­ro­pean R&D ops, Sanofi con­firms it’s of­fer­ing US work­ers an 'ear­ly ex­it'

Ear­li­er in the week we learned that Sanofi was bring­ing out the bud­get ax to trim 466 R&D jobs in Eu­rope, re­tool­ing its ap­proach to car­dio as re­search chief John Reed beefed up their work in can­cer and gene ther­a­pies. And we’re end­ing the week with news that the phar­ma gi­ant has al­so been qui­et­ly re­duc­ing staff in the US, tar­get­ing hun­dreds of jobs as the com­pa­ny push­es vol­un­tary buy­outs with a fo­cus on R&D sup­port ser­vices.

Suf­fer­ing No­var­tis part­ner Cona­tus is pack­ing it in on NASH af­ter a se­ries of un­for­tu­nate tri­al events

The NASH par­ty is over at No­var­tis-backed Cona­tus. And this time they’re turn­ing off the lights.

More than 2 years af­ter No­var­tis sur­prised the biotech in­vest­ment com­mu­ni­ty with its $50 mil­lion up­front and promise of R&D sup­port to part­ner with the lit­tle biotech on NASH — ig­nit­ing a light­ning strike for the share price — Cona­tus $CNAT is back with the lat­est bit­ter tale to tell about em­ri­c­as­an, which once in­spired con­fi­dence at the phar­ma gi­ant.

Dean Hum. Nasdaq via YouTube

Gen­fit goes to Chi­na with a deal worth up to $228M for NASH drug

Fresh off the high of its Nas­daq IPO de­but, and the low of com­par­isons to Cymabay — whose NASH drug re­cent­ly stum­bled — Gen­fit on Mon­day un­veiled an up to $228 mil­lion deal with transpa­cif­ic biotech Terns Phar­ma­ceu­ti­cals to de­vel­op its flag­ship ex­per­i­men­tal liv­er drug — elafi­bra­nor — in Greater Chi­na.

The deal comes more than a week af­ter Gen­fit $GN­FT is­sued a fiery de­fense of its dual PPAR ag­o­nist elafi­bra­nor, when com­peti­tor Cymabay’s PPARδ ag­o­nist, se­ladel­par, fiz­zled in a snap­shot of da­ta from an on­go­ing mid-stage tri­al. The main goal at the end of 12 weeks was for se­ladel­par to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in liv­er fat con­tent, but da­ta showed that pa­tients on the place­bo ac­tu­al­ly per­formed bet­ter.

Alex­ion wins pri­or­i­ty re­view for Ul­tomiris' aHUS in­di­ca­tion; FDA ex­pands ap­proval of Ver­tex's Symdeko

→ Alex­ion $ALXN has scored a speedy re­view for Ul­tomiris for pa­tients with atyp­i­cal he­molyt­ic ure­mic syn­drome (aHUS) af­ter post­ing pos­i­tive da­ta from a piv­otal study in Jan­u­ary. The drug is the rare dis­ease com­pa­ny’s shot at pro­tect­ing its block­buster blood dis­or­der fran­chise that is cur­rent­ly cen­tered around its flag­ship drug, Soliris, which is a com­ple­ment in­hibitor typ­i­cal­ly ad­min­is­tered every two weeks. Ul­tomiris has a sim­i­lar mech­a­nism of ac­tion but re­quires less-fre­quent dos­ing — every eight weeks. The de­ci­sion date has been set to Oc­to­ber 19. Late last year, Ul­tomiris se­cured ap­proval for noc­tur­nal he­mo­glo­bin­uria (PNH) pa­tients.

Bet­ter than Am­bi­en? Min­er­va soars on PhI­Ib up­date on sel­torex­ant for in­som­nia

A month af­ter roil­ing in­vestors with what skep­tics dis­missed as cher­ry pick­ing of its de­pres­sion da­ta, Min­er­va is back with a clean slate of da­ta from its Phase IIb in­som­nia tri­al.

In a de­tailed up­date, the Waltham, MA-based biotech said sel­torex­ant (MIN-202) hit both the pri­ma­ry and sev­er­al sec­ondary end­points, ef­fec­tive­ly im­prov­ing sleep in­duc­tion and pro­long­ing sleep du­ra­tion. In­ves­ti­ga­tors made a point to note that the ef­fects were con­sis­tent across the adult and el­der­ly pop­u­la­tions, with the lat­ter more prone to the sleep dis­or­der.

Gene ther­a­py biotech sees its stock rock­et high­er on promis­ing re­sults for rare cas­es of but­ter­fly dis­ease

Shares of Krys­tal Biotech took off this morn­ing $KRYS af­ter the lit­tle biotech re­port­ed promis­ing re­sults from its gene ther­a­py to treat a rare skin dis­ease called epi­der­mol­y­sis bul­losa.

Fo­cus­ing on an up­date with 4 new pa­tients, re­searchers spot­light­ed the suc­cess of KB103 in clos­ing some stub­born wounds. Krys­tal says that of 4 re­cur­ring and 2 chron­ic skin wounds treat­ed with the gene ther­a­py, the KB103 group saw the clo­sure of 5. The 6th — a chron­ic wound, de­fined as a wound that had re­mained open for more than 12 weeks — was par­tial­ly closed. That brings the to­tal so far to 8 treat­ed wounds, with 7 clo­sures.

Ab­b­Vie gets a green light to re­sume re­cruit­ing pa­tients for one myelo­ma study — but Ven­clex­ta re­mains un­der a cloud

Three months af­ter reg­u­la­tors at the FDA forced Ab­b­Vie to halt en­rolling pa­tients in its tri­als of a com­bi­na­tion us­ing Ven­clex­ta (vene­to­clax) to treat drug-re­sis­tant cas­es of mul­ti­ple myelo­ma, the agency has green-light­ed the re­sump­tion of one of those stud­ies, while keep­ing the rest on the side­lines.

The CANO­VA (M13-494) study can now get back in busi­ness re­cruit­ing pa­tients to test the drug for a pop­u­la­tion that shares a par­tic­u­lar ge­net­ic bio­mark­er. To get that per­mis­sion, Ab­b­Vie — which is part­nered with Roche on this pro­gram — was forced to re­vise the pro­to­col, mak­ing un­spec­i­fied changes in­volv­ing risk mit­i­ga­tion mea­sures, pro­to­col-spec­i­fied guide­lines and an up­dat­ed fu­til­i­ty cri­te­ria.