Col­in Fre­und takes new CEO job at Mod­ra Phar­ma; Com­pass re­cruits Pfiz­er, Bio­gen vets to C-suite

Col­in Fre­und

→ Am­s­ter­dam-based Mod­ra Phar­ma­ceu­ti­cals has tapped a per­ma­nent CEO to guide its pipeline of oral chemother­a­pies as it wraps up a Phase Ib/IIa study for the lead pro­gram — a tablet for­mu­la­tion of do­c­etax­el. Col­in Fre­und comes with fresh CEO ex­pe­ri­ence at Que On­col­o­gy as well as a pre­vi­ous stints at Trangene and GPC Biotech. Er­ic van der Put­ten, the Agla­ia Bio­med­ical Ven­tures part­ner who was fill­ing the role ad in­ter­im, will re­cede to a board di­rec­tor role. Mean­while Ed­win De Wit has al­so joined the com­pa­ny as head of on­col­o­gy de­vel­op­ment.

No­var­tis’ in­sis­tence on cen­tral­iz­ing top ex­ecs in its Swiss head­quar­ters has cost the phar­ma gi­ant a key leader: Liz Bar­rett has put in her no­tice just 10 months af­ter tak­ing on the on­col­o­gy chief role.

“Af­ter much per­son­al re­flec­tion, it be­came clear that my fam­i­ly would be un­able to re­lo­cate to Basel where the on­col­o­gy head­quar­ters is based,” Bar­rett said in a state­ment.

Su­sanne Schaf­fert, pres­i­dent of No­var­tis sub­sidiary Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, is re­plac­ing Bar­rett as CEO of the on­col­o­gy busi­ness unit. Bar­rett is mov­ing to the helm of a US-based biotech, though she told End­points she can’t say which just yet.

Or­biMed– and Thiel-backed Com­pass Ther­a­peu­tics has scooped Pfiz­er’s head of ear­ly clin­i­cal de­vel­op­ment, Yu Liu, to over­see the slate of pro­grams gen­er­at­ed from its an­ti­body dis­cov­ery plat­form. The new CMO will have a chance to work on tar­gets in can­cer, in­flam­ma­tion and au­toim­mune dis­ease. lever­ag­ing a di­verse range of ex­pe­ri­ence ac­crued over the years at Bio­gen, Bris­tol-My­ers Squibb, Es­sen­tialis Ther­a­peu­tics and Am­gen. Fel­low Bio­gen vet Lynne Sul­li­van — who al­so han­dled tax­es for Mer­ck KGaA is com­ing on board as CFO.

No­var­tis may still have big plans for CAR-T, but the phar­ma gi­ant con­tin­ues to bleed top tal­ent from the group ex­pect­ed to car­ry out the work. Cam­bridge, MA-based Sem­ma Ther­a­peu­tics — which is de­vel­op­ing a hoped-for stem cell cure for Type 1 di­a­betes — said that they have re­cruit­ed No­var­tis CAR-T chief David Leb­wohl as their new chief med­ical of­fi­cer. Sem­ma has al­so re­cruit­ed David DiGius­to as chief tech­nol­o­gy of­fi­cer and Ann Dar­da as head of hu­man re­sources. Last fall in­vestors put up $114 mil­lion to fund a pi­o­neer­ing hu­man study that will put a new de­liv­ery tech to the test in di­a­betes.

Daphne Qui­mi just got a pro­mo­tion at Am­i­cus Ther­a­peu­tics $FOLD, where she will be­come CFO in the be­gin­ning of next year as Chip Baird leaves for a new job. The hand­off caps the first year Am­i­cus be­came a com­mer­cial com­pa­ny with a con­tro­ver­sial OK for its Fab­ry dis­ease drug Galafold. Sev­er­al oth­er ex­ecs are get­ting new roles: Al­iba­ba alum­nus David Clark has been ap­point­ed chief peo­ple of­fi­cer; Ellen Rosen­berg has been pro­mot­ed to chief le­gal of­fi­cer; An­drew Mul­berg is now SVP, glob­al reg­u­la­to­ry af­fairs; and An­tho­ny Sileno will be SVP, clin­i­cal op­er­a­tions and trans­la­tion­al sci­ences.

Sono­ma Phar­ma­ceu­ti­cals, a spe­cial­ty phar­ma now fo­cused on der­ma­tol­ogy, has hired Fred­er­ick (Bub­ba) Sand­ford to ex­e­cute the com­pa­ny’s turn­around plan. He will take the roles of both CEO Jim Schutz and CFO Bob Miller, who re­signed from the com­pa­ny $SNOA.

→ As Johns Hop­kins spin­out Wind­MIL Ther­a­peu­tics opens a new of­fice to con­sol­i­date its cell ther­a­py work and at­tract tal­ent in Philadel­phia, two ex­ecs are join­ing the out­post. Monil Shah, chief de­vel­op­ment of­fi­cer, comes with a string of roles at Brook­lyn Im­munoTher­a­peu­tics, Ven­trus Bio­sciences, Cel­gene, Fi­bro­Gen, Am­gen and oth­ers on his re­sume. New VP of op­er­a­tions Patrick Dougher­ty was the chief of staff to the SVP of R&D at Glax­o­SmithK­line. Wind­MIL closed a $32.5 mil­lion round ear­li­er this year for its work on mem­o­ry T cells re­sid­ing in the bone mar­row and a “sig­nif­i­cant ex­pan­sion” of its team.

→ The first snap­shot of ef­fi­ca­cy for Avro­bio’s lead gene ther­a­py to treat Fab­ry dis­ease might have spooked in­vestors, but the Cam­bridge, MA-based biotech $AVRO is keen to re­gain their con­fi­dence with four new hires. Bir­gitte Vol­ck, a rare dis­ease ex­pert for­mer­ly of So­bi and GSK, has been tapped as pres­i­dent of R&D; Erik Os­trows­ki joins as CFO from the same role at Sum­mit Ther­a­peu­tics; for­mer FDA staffer Josie Yang is the new head of reg­u­la­to­ry af­fairs; while Bio­gen vet Steven Avruch be­comes gen­er­al coun­sel.

→ Parisian biotech Bio­phytis has pro­mot­ed Jean-Christophe Mon­tigny to COO, from his pre­vi­ous role of su­per­vis­ing all things fi­nan­cial and le­gal for the com­pa­ny. Mean­while, Bio­phytis has al­so named Daniel Schnei­der­man as CFO. Schnei­der­man, who served most re­cent­ly as VP of fi­nance and con­troller at Boston-based pre­ci­sion med­i­cine com­pa­ny Meta­S­tat, will be based at the com­pa­ny’s Cam­bridge of­fice in the Unit­ed States as Bio­phytis ex­pands its op­er­a­tions in the re­gion. “We plan to con­tin­ue build­ing…in­fra­struc­ture in Boston with ad­di­tion­al key hires in 2018 and 2019, as we ex­e­cute the clin­i­cal de­vel­op­ment of SAR­CO­NEOS through our…clin­i­cal phase 2b tri­al for the treat­ment of sar­cope­nia in both the Unit­ed States and Eu­rope, as well as progress SAR­CO­NEOS…in Duchenne mus­cu­lar dy­s­tro­phy (DMD) and MA­CU­NEOS…in dry age-re­lat­ed mac­u­lar de­gen­er­a­tion (AMD), CEO Stanis­las Veil­let said. 

Ed Kaye has re­cruit­ed two for­mer Sarep­ta col­league to his team as he moves Stoke Ther­a­peu­tics in­to a larg­er R&D space in Bed­ford, MA. Shamim Ruff, pre­vi­ous­ly Sarep­ta’s chief reg­u­la­to­ry af­fairs of­fi­cer and SVP, head of qual­i­ty, will have the ti­tle SVP of reg­u­la­to­ry af­fairs and qual­i­ty. Nan­cy Wyant comes on board as VP, head of clin­i­cal op­er­a­tions af­ter con­sult­ing with Stoke for the past few months fol­low­ing stints at Idera and BeiGene.

→ Ahead of a Phase III read­out of its NSCLC treat­ment, OSE Im­munother­a­peu­tics has ap­point­ed for­mer Sanofi $SNY ex­ec­u­tive Julien Per­ri­er as chief com­mer­cial of­fi­cer. Per­ri­er most re­cent­ly served as the head of Ab­b­Vie’s $AB­BV im­munol­o­gy di­vi­sion in France, where he was in charge of the com­mer­cial op­er­a­tions for Hu­mi­ra, as well as prep­ping the launch of two oth­er im­munol­o­gy prod­ucts. “Julien’s ex­pe­ri­ence in im­munol­o­gy and bi­o­log­ics will al­so prove es­sen­tial as we plan next steps for FR104, a Phase 2-ready, first-in-class CD28 an­tag­o­nist with ex­cit­ing po­ten­tial to treat au­toim­mune dis­ease,” OSE chief Alex­is Pey­roles said.

Boehringer In­gel­heim’s Hen­ning Ger­schews­ki is head­ing over to an­oth­er Ger­man firm where he will serve as as vice pres­i­dent of man­u­fac­tur­ing, sci­ence and tech­nol­o­gy. The com­pa­ny, Rentschler Bio­phar­ma SE, fo­cus­es on con­tract de­vel­op­ment and man­u­fac­tur­ing for bio­phar­ma­ceu­ti­cal com­pa­nies.  


With con­tri­bu­tion by Na­tal­ie Grover.

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.

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.

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.

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.