BD chief George Golumbes­ki is the lat­est top ex­ec to ex­it Cel­gene dur­ing man­age­ment over­haul

George Golumbes­ki (SO­TIO)

Over the past decade, George Golumbes­ki rose to be­come an ex­ec­u­tive vice pres­i­dent at Cel­gene, fre­quent­ly laud­ed for his high-pro­file role in lead­ing one of the most ag­gres­sive BD teams in biotech. 

But Golumbes­ki has qui­et­ly slipped out the back door at Cel­gene at a time CEO Mark Alles has been ex­e­cut­ing a se­ries of man­age­ment changes af­ter a string of prat­falls has been rais­ing ques­tions about the com­pa­ny’s com­pe­tence on ex­e­cut­ing on a longterm strat­e­gy.

Ac­cord­ing to a note on Golumbes­ki’s re­sume post­ed at Mor­phoSys AG, which just ap­point­ed him as a new su­per­vi­so­ry board mem­ber, the BD ex­ec of­fi­cial­ly left Cel­gene April 16, tran­si­tion­ing to a new role as an in­de­pen­dent con­sul­tant af­ter gath­er­ing a slate of new roles for his post-Cel­gene life. He’s al­so a sci­en­tif­ic ad­vis­er at new­ly launched KSQ, the start­up run by ex-Gen­zyme chief David Meek­er, and is list­ed as a ven­ture part­ner at ARCH.

In­vestors didn’t like the sound of it. Cel­gene’s stock plunged 5% af­ter the sto­ry came out.

The tran­si­tion last month, though, has been in the works for close to two and a half years, Golumbes­ki tells me to­day. That’s when he sat down with Bob Hug­in and Alles and some oth­ers to say that af­ter some 20 years on the deal side of the busi­ness, with more than 9 years at Cel­gene, he was ready to do some­thing new and dif­fer­ent.

“I com­mu­ni­cat­ed I was very hap­py to stay on,” he adds, “but in­tend­ed to leave in Q1 or Q2 2017.” For a va­ri­ety of rea­sons, his stay last­ed un­til April. And he em­pha­sizes his de­par­ture was com­plete­ly am­i­ca­ble all around.

Now Golumbes­ki has a va­ri­ety of new gigs, most­ly cen­tered on up and com­ing biotech com­pa­nies, where he plans to play a role in re­cruit­ing top ex­ecs, rais­ing mon­ey and fo­cus­ing on some game-chang­ing med­i­cines. And this way he al­so gets to spend more time with the fam­i­ly.

“I’m in a good place,” he adds. “I want to help to the ex­tent I can these young com­pa­nies.”

Cel­gene me­dia con­tacts nev­er re­spond­ed di­rect­ly to ques­tions abut Golumbes­ki’s de­par­ture.

Mark Alles

Work­ing un­der ex-Cel­gene CEO Bob Hug­in and in close part­ner­ship with ex-R&D chief Tom Daniel, Golumbes­ki was the chief ar­chi­tect of a strat­e­gy to snag a mul­ti­tude of drug rights in an ef­fort to ex­pand be­yond their block­buster Revlim­id. Cel­gene bought in­to Juno sev­er­al years ago, then fol­lowed up with a $9 bil­lion buy­out. Over­all, the com­pa­ny liked do­ing deals that left the part­ners in charge of the re­search, as they did suc­cess­ful­ly with Agios and oth­ers.

“We do a bet­ter job lis­ten­ing to what a part­ner has to say,” Golumbes­ki told me sev­er­al years ago, when he was in the midst of a deal fren­zy worth bil­lions in up­fronts and mile­stones.

Sev­er­al of his high-pro­file pacts, though, have been un­rav­el­ing or hit with se­vere set­backs. Right on the heels of the im­plo­sion of its $710 mil­lion cash roll of the dice on the in­flam­ma­to­ry bow­el dis­ease drug mon­gersen (GED-301), the FDA hit the com­pa­ny with a refuse-to-file for its would-be MS block­buster ozan­i­mod.

Scott Smith

In re­sponse, Alles has en­gi­neered some big changes at Cel­gene. Just days be­fore Golumbes­ki’s of­fi­cial de­par­ture, COO Scott Smith head­ed out the ex­its, leav­ing Alles in charge of every­thing from clin­i­cal de­vel­op­ment to reg­u­la­to­ry, the all-im­por­tant hema­tol­ogy and on­col­o­gy fran­chise as well as in­flam­ma­tion and im­munol­o­gy.


Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

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Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three ma­jor buy­outs an­nounced: Take­da/Shire; Bris­tol-My­ers/Cel­gene and now Ab­b­Vie/Al­ler­gan. And with this lat­est deal it’s in­creas­ing­ly clear that the sharp fall from grace suf­fered by high-pro­file play­ers which have seen their share prices blast­ed has cre­at­ed an open­ing for the growth play­ers in big phar­ma to up their game — in sharp con­trast to the pop­u­lar bolt-on deals that have been dri­ving the growth strat­e­gy at No­var­tis, Mer­ck, Roche and oth­ers.

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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.

With 4 more biotech IPOs due to wrap up Q2, how is the class of 2019 far­ing?

With 22 biotech IPOs on the books and four more set to price in the last week of June, in­vest­ment ad­vis­er Re­nais­sance Cap­i­tal has tak­en the pulse of the re­cent rush.

By the IPO ex­perts’ count, 25 out of 32 health­care of­fer­ings this year have been from biotechs — dif­fer­ing slight­ly from Brad Lon­car’s tal­ly — and the over­all pic­ture is one of un­der­per­for­mance. While they av­er­aged a first-day re­turn of 9.0%, col­lec­tive­ly they have trad­ed down to a 5.9% re­turn. Turn­ing Point $TP­TX and Cor­texyme $CRTX emerged on top at the half-year mark, ris­ing 135% and 109% re­spec­tive­ly.

Eye­ing a $500M peak sales pot, Almi­rall dou­bles down on le­brik­izum­ab as Der­mi­ra lines up PhI­II

With eyes on what it be­lieves is a $500 mil­lion peak rev­enue op­por­tu­ni­ty in Eu­rope, Barcelona-based Almi­rall has stepped up with $50 mil­lion in cash to take up the op­tion on Der­mi­ra’s IL-13 an­ti-in­flam­ma­to­ry drug le­brik­izum­ab just ahead of the start of Phase III. And there’s an­oth­er $30 mil­lion due as the late-stage pro­gram gets geared up.

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Suf­fer­ing No­var­tis part­ner Cona­tus grabs the ax and packs it in on NASH af­ter a se­ries of set­backs

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 weeks 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.