Bris­tol-My­ers bumps off chief sci­en­tist in an­oth­er big shake­up, bring­ing in Cel­gene and No­var­tis ex­ecs

Just 2 years af­ter Tom Lynch stepped from the board room to the top sci­en­tif­ic po­si­tion at Bris­tol-My­ers Squibb, he’s out.

Ru­pert Vessey Cel­gene

The phar­ma gi­ant re­port­ed Wednes­day morn­ing that Lynch will leave his post as CSO in four months, mov­ing Cel­gene R&D ex­ec Ru­pert Vessey in­to the top re­search po­si­tion af­ter the big merg­er while re­cruit­ing No­var­tis on­col­o­gy de­vel­op­ment head Samit Hi­rawat for chief med­ical of­fi­cer with com­mand of the de­vel­op­ment group.

Lynch him­self was brought in to fix what was wrong at Bris­tol-My­ers Squibb but in­stead was tagged with a se­ries of set­backs af­ter con­tin­u­ing a flawed re­search strat­e­gy on Op­di­vo that Wall Street lost faith in as the mega-block­buster steadi­ly lost ground to Keytru­da.

Samit Hi­rawat No­var­tis via Twit­ter

The move does pro­vide Bris­tol-My­ers with a way of main­tain­ing a fo­cus on the line­up of re­search projects they’re buy­ing with the Cel­gene ac­qui­si­tion. And in raid­ing No­var­tis, they’ll be gain­ing an ex­ec­u­tive from a win­ning team with a string of suc­cess­es to its cred­it this year.

The high-lev­el re­or­ga­ni­za­tion trig­gered by the merg­er al­so ex­tends in­to the com­mer­cial are­na.

While Chris Boern­er will re­main chief com­mer­cial of­fi­cer, Nadim Ahmed has been named pres­i­dent of hema­tol­ogy who will al­so over­see the cell ther­a­py unit. And Cel­gene CFO David Elkins is tak­ing the top fi­nance post at the merged com­pa­ny, re­plac­ing Charles Ban­croft, who will re­tire next year af­ter com­plet­ing 35 years at the com­pa­ny.

One po­si­tion that won’t be chang­ing: The CEO role.

Gio­van­ni Caforio has no in­ten­tion of giv­ing up that post as he sets about the chal­leng­ing task of liv­ing up to the promis­es he made in­vestors dur­ing the leap to the big buy­out. Not all of the com­pa­ny’s biggest in­vestors liked this deal, and they’re go­ing to need some con­vinc­ing that it was in their best in­ter­ests.

Caforio had tout­ed Lynch as a ma­jor new force, pri­vate­ly ac­knowl­edg­ing that they need­ed to change R&D course as Mer­ck be­gan to gain ground in the crit­i­cal PD-1 field — par­tic­u­lar­ly in lung can­cer. Mer­ck though found a win­ning strat­e­gy in com­bin­ing Keytru­da with chemo, while Bris­tol-My­ers at­tempt­ed to push an ap­proach us­ing their CT­LA-4 drug Yer­voy as well as con­cen­trat­ing on high tu­mor mu­ta­tion­al bur­dens in iden­ti­fy­ing the best pa­tient pop­u­la­tion for their drug.

That large­ly failed — at least so far. The ju­ry is still out on TMB, while Mer­ck widens its lead in the field.

Hi­rawat, mean­while, ran the suc­cess­ful Kisqali pro­gram as No­var­tis beefed up its on­col­o­gy pro­gram.

Here’s the full line­up in the new struc­ture at Bris­tol-My­ers:

  • Nadim Ahmed, Pres­i­dent, Hema­tol­ogy
  • Charles Ban­croft, Ex­ec­u­tive Lead for In­te­gra­tion
  • Paul Bion­di, Head, Strat­e­gy and Busi­ness De­vel­op­ment
  • Chris Boern­er, Ph.D., Ex­ec­u­tive Vice Pres­i­dent & Chief Com­mer­cial­iza­tion Of­fi­cer
  • Adam Dubow, Chief Com­pli­ance Of­fi­cer
  • Joseph Eid, M.D., Head, Glob­al Med­ical Af­fairs
  • John Elick­er, Head, Cor­po­rate Af­fairs and In­vestor Re­la­tions
  • David Elkins, Ex­ec­u­tive Vice Pres­i­dent & Chief Fi­nan­cial Of­fi­cer
  • Samit Hi­rawat, M.D., Chief Med­ical Of­fi­cer, Glob­al Drug De­vel­op­ment
  • Sev­er­ine La­court, Chief of Staff to the Chief Ex­ec­u­tive Of­fi­cer
  • San­dra Le­ung, Ex­ec­u­tive Vice Pres­i­dent & Gen­er­al Coun­sel
  • Ann Pow­ell, Chief Hu­man Re­sources Of­fi­cer
  • Lou Schmuk­ler, Pres­i­dent, Glob­al Prod­uct De­vel­op­ment & Sup­ply
  • Ru­pert Vessey, M.A., B.M., B.Ch., F.R.C.P., D.Phil., Pres­i­dent, Re­search & Ear­ly De­vel­op­ment
  • Paul von Aut­en­ried, Chief In­for­ma­tion Of­fi­cer

Im­age: Tom Lynch at an End­points News event in Boston, June 2018 — Pho­to by Rob Tan­nen­baum, End­points News

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:

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Bris­tol-My­ers star Op­di­vo fails sur­vival test in a matchup with Nex­avar aimed at shak­ing up the big HCC mar­ket

Bris­tol-My­ers Squibb has suf­fered an­oth­er painful set­back in its years-long quest to ex­pand the reach of Op­di­vo. The phar­ma gi­ant this morn­ing not­ed that their Check­mate-459 study com­par­ing Op­di­vo with Bay­er’s Nex­avar in front­line cas­es of he­pa­to­cel­lu­lar car­ci­no­ma — the most com­mon form of liv­er can­cer — failed to hit the pri­ma­ry end­point on over­all sur­vival.

This was a sig­nif­i­cant mile­stone in Bris­tol-My­ers’ tal­ly of PD-1 cat­a­lysts this year. Nex­avar (so­rafenib) has been the stan­dard of care in front­line HCC for the past decade, though Op­di­vo has been mak­ing head­way in sec­ond-line HCC cas­es, where it’s go­ing toe-to-toe with Bay­er’s Sti­var­ga (re­go­rafenib) af­ter re­cent ap­provals shook up the mar­ket.

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.