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.


Un­pack­ing the Aduhelm de­ci­sion, Ver­tex's half full glass, a $525M J&J breakup, and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

By now you have surely read about the FDA’s controversial approval of Biogen’s Alzheimer’s drug and all its reverberations. But I’d still recommend checking out the meaty recap below to make sure you didn’t miss all the angles that the Endpoints team has covered. If you’d rather look ahead, look no further than our three-day virtual panels next week at BIO, where we will discuss what the new normal means for every part of the industry.

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What does a clear ma­jor­i­ty of the bio­phar­ma in­dus­try think of the FDA ap­proval of ad­u­canum­ab? 'Hor­ri­fy­ing' 'Dan­ger­ous' 'Con­fus­ing' 'Dis­as­ter'

Over the years, we’ve become used to seeing a consensus emerge early in our industry polls at Endpoints News. And when we took the pulse of drug hunters on the heels of a controversial FDA approval for aducanumab this week, it became immediately apparent that the vast majority of our readers — heavily concentrated among biopharma staffers and execs — were incensed by what they had just witnessed.

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Aaron Kesselheim (Scott Eisen/AP Images for AIDS Healthcare Foundation)

Har­vard’s Aaron Kessel­heim re­signs from ex­pert pan­el in wake of ad­u­canum­ab OK, blast­ing FDA for ‘worst drug ap­proval de­ci­sion in re­cent U.S. his­to­ry'

A third member of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee has resigned in the wake of Biogen’s controversial Aduhelm approval, slamming the agency as he left and further deepening the controversy surrounding the decision.

Harvard University professor Aaron Kesselheim quit in protest Thursday afternoon, calling the Aduhelm OK “probably the worst drug approval decision in recent U.S. history.” Kesselheim follows both Joel Perlmutter, a neurologist from Washington University in St. Louis, and David Knopman, a neurologist from the Mayo Clinic, out the door.

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David Knopman (Mayo Clinic via YouTube)

A sec­ond ad­comm mem­ber aban­dons his post in af­ter­math of con­tro­ver­sial ad­u­canum­ab de­ci­sion

As the fallout from the FDA’s approval of Alzheimer’s med aducanumab grows, a second member of the adcomm overseeing that drug’s review has walked away. But even with two experts now having resigned from that committee in protest, is there enough broad-level outrage to prevent another aducanumab from getting approved?

The FDA on Wednesday lost another member of its Peripheral and Central Nervous System Drugs Advisory Committee as Mayo Clinic neurologist David Knopman hit the exit over the agency’s decision to approve Biogen’s Alzheimer’s drug Aduhelm despite the committee’s near-unanimous vote against it.

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FDA au­tho­rizes about 10M J&J vac­cine dos­es, trash­es 60M more from trou­bled Emer­gent plant

The FDA on Friday released about 10 million doses of J&J’s vaccine for use, and disposed of another 60 million doses that were manufactured at the now-shuttered Emergent BioSolutions facility in Baltimore where cross-contamination occurred.

The agency said it’s not yet ready to allow the Emergent plant to be included in the J&J EUA, but that may occur soon. FDA came to the decision to authorize some of the doses after reviewing facility records and quality testing results.

An ex­pen­sive watch, shell com­pa­nies and fake in­voic­es: How two Is­raeli traders tapped in­to a $100M glob­al biotech in­sid­er trad­ing ring

It appears that we have reached the end of the saga about the global insider trading ring that collectively reaped $100 million from placing “timely, profitable” trades in biotech stocks like Ariad, Pharmacyclics and Receptos.

Tomer Feingold and Dov Malnik — Israeli traders living in Switzerland — were the last out of eight to be charged as the SEC unraveled the scheme, which ran from 2013 through 2017. Together, according to a statement in March, the pair had pocketed more than $4 million.

Janet Woodcock, acting FDA commissioner, at Thursday's Senate Appropriations hearing (Bill Clark/CQ Roll Call via AP Images)

Sen­a­tors lam­bast new Alzheimer’s drug’s price but give Janet Wood­cock a free pass on the ap­proval de­ci­sion

Senate Finance Democrats took aim at Biogen’s pricey new Alzheimer’s drug on Thursday, but members on both sides of the aisle at a separate appropriations hearing didn’t question acting FDA commissioner Janet Woodcock on the approval.

“I was appalled that Biogen priced their Alzheimer’s drug approved by the FDA at $56,000 per year — I’m not going to debate whether this is effective or not, but it’s double the household median income for Michiganders over the age of 65,” Sen. Debbie Stabenow (D-MI) said at the finance hearing.

Reshma Kewalramani, Vertex CEO (BIO via YouTube)

UP­DAT­ED: Ver­tex strikes out on its lat­est big shot at a rare ge­net­ic dis­ease. But they're go­ing to keep on swing­ing

It’s been several months since Vertex culled one of its small molecules for alpha-1 antitrypsin deficiency (AATD), taking a big hit after evidence of liver damage surfaced in a key Phase II trial. Now we learned that the company has whiffed on its second shot, and there’s nothing left in the clinic to treat the rare genetic disease — but that won’t stop it from trying.

Despite avoiding the safety issues that plagued the last candidate, Vertex $VRTX is taking the axe to VX-864 after Phase II results revealed the magnitude of the drug’s response is “unlikely to translate into substantial clinical benefit.” As a result of the news, the company’s stock fell 12.5% after hours.

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FDA plans new stud­ies on ac­cel­er­at­ed ap­proval dis­clo­sures in bio­phar­ma ads

When people read biopharma companies’ websites about new drugs approved via the FDA’s accelerated pathway, like Biogen’s new Alzheimer’s drug, do they understand that these drugs may only be reasonably likely to predict clinical benefit and still require confirmatory studies?

That’s what the FDA’s Office of Prescription Drug Promotion wants to firm up as an agency analysis of direct-to-consumer websites for accelerated approval drugs previously found that only 21% of the disclosures used language directly from the label.

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