Why did Abl­ynx board chair­man Pe­ter Fell­ner re­sign in wake of Novo's buy­out of­fer?; Am­gen vet Richard Paul­son tapped to run Ipsen North Amer­i­ca

Pe­ter Fell­ner

→ What’s hap­pen­ing at Abl­ynx? On the same day Dan­ish bio­phar­ma No­vo Nordisk $NVO went pub­lic with its lat­est, $3.1 bil­lion of­fer to buy Abl­ynx $ABLX, the Bel­gian biotech an­nounced that Pe­ter Fell­ner has de­cid­ed to re­sign from its board. That abrupt de­par­ture trig­gered a lot of buzz that the un­usu­al over­ture from No­vo — not the kind of com­pa­ny you might typ­i­cal­ly find muscling a buy­out — has trig­gered some dis­sen­sion in the board. A for­mer mem­ber of the ad­vi­so­ry group to No­vo Nordisk Foun­da­tion’s in­vest­ing arm, Fell­ner has been on mul­ti­ple cor­po­rate boards. Bo Jes­per Hansen, a non-ex­ec­u­tive di­rec­tor and ex-CEO of Swedish Or­phan In­ter­na­tion­al, re­placed him as chair­man.

→ Fol­low­ing a decade at Am­gen, Richard Paul­son is now EVP and CEO of Ipsen North Amer­i­ca, head­ing all com­mer­cial op­er­a­tions in the re­gion for the Paris-based phar­ma with R&D spread across on­col­o­gy, neu­ro­sciences and rare dis­eases. He re­places for­mer pres­i­dent of North Amer­i­ca Cyn­thia Schwalm as she leaves Ipsen to pur­sue oth­er in­ter­ests. Paul­son was most re­cent­ly VP and gen­er­al man­ag­er of the on­col­o­gy unit at Am­gen, but his ca­reer — which in­clud­ed a stint at Pfiz­er — has tak­en him to jobs across North Amer­i­ca, Eu­rope and Africa. “I am hon­ored to join Ipsen at this time of rapid trans­for­ma­tion and growth, as the com­pa­ny pro­gress­es in its evo­lu­tion as a lead­ing glob­al bio­phar­ma com­pa­ny,” Paul­son said.

→ France’s In­nate Phar­ma has con­vinced aca­d­e­m­ic and doc­tor Er­ic Vivi­er to start his in­volve­ment with the in­dus­try as its CSO and SVP. Cur­rent­ly a pro­fes­sor at Aix-Mar­seille Uni­ver­si­ty and the Mar­seille Pub­lic Hos­pi­tals, Vivi­er has built up an ex­per­tise on in­nate im­munol­o­gy and nat­ur­al killer cells through­out his ca­reer, which took him to a few elite in­sti­tu­tions in the US. “Join­ing In­nate Phar­ma is a nat­ur­al step for me as be­ing both part of acad­e­mia and in­dus­try is now be­com­ing a stan­dard to de­liv­er bio­med­ical in­no­va­tion,” Vivi­er said in a state­ment. “It is al­so con­sis­tent with the trans­la­tion­al ap­proach which is be­com­ing in­creas­ing­ly cen­tral in the fight against can­cer.” In­nate is hop­ing this is al­so a step up the R&D op­er­a­tion and to­wards com­mer­cial­iza­tion, af­ter suf­fer­ing a sec­ond set­back on lead can­cer drug lir­ilum­ab late last year.

→ Low pro­file Bio­Clin Ther­a­peu­tics has built out its ex­ec­u­tive team with the ap­point­ments of COO Graeme Cur­rie and CMO Es­te­ban (Steve) Abel­la, an an­nounce­ment made a few months af­ter the fact. Cur­rie worked his way up a bio­phar­ma ca­reer that start­ed at GSK, fea­tured Re­gen­eron, and most­ly re­cent­ly made a stop at Dy­navax. For Abel­la, who pre­vi­ous­ly held roles in Am­gen and Gilead, this is an op­por­tu­ni­ty to lead the clin­i­cal de­vel­op­ment strat­e­gy as Bio­Clin ad­vances B-701 for metasta­t­ic blad­der can­cer in the clin­ic.

Liz Bar­rett

No­var­tis $NVS has found a suc­ces­sor to out­go­ing on­col­o­gy chief Bruno St­rig­i­ni — at Pfiz­er. Liz Bar­rett, cur­rent glob­al pres­i­dent of on­col­o­gy at Pfiz­er, has been tapped to run the show at No­var­tis. The Swiss drug­mak­er has tak­en up a large pres­ence in can­cer since hir­ing St­rig­i­ni — who’s says he’s re­tir­ing from the in­dus­try al­to­geth­er — in the sum­mer of 2014, but Bar­rett’s CV sug­gests she’s well equipped for the task. A J&J vet­er­an, Bar­rett has been with Pfiz­er $PFE since 2009. Dur­ing the last three years when she was glob­al pres­i­dent of on­col­o­gy, the phar­ma gi­ant has man­aged to ac­com­plish some break­throughs in that field. Andy Schmeltz will suc­ceed Bar­rett in run­ning Pfiz­er’s glob­al can­cer drug unit. Schmeltz is cur­rent­ly SVP, pa­tient & health im­pact, with pre­vi­ous ex­pe­ri­ence lead­ing the North Amer­i­ca on­col­o­gy busi­ness dur­ing his 15-year tenure at the com­pa­ny.

→ As Cin­gu­late Ther­a­peu­tics looks to launch its clin­i­cal pro­grams for AD­HD in full swing, it has named co-founder and board mem­ber Matthew Brams CMO. An ex­pe­ri­enced lead in­ves­ti­ga­tor in psy­chi­a­try, Brams is ex­pect­ed to help ex­e­cute an am­bi­tious plan: ini­ti­ate and com­plete Phase I/II tri­als for both CTX-1301 and CTX-1302 in 2018, as well as be­gin Phase III tri­als.

→ Sig­nalling a new di­rec­tion for Clin­i­cal­RM, par­ent com­pa­ny Icon $ICLR has tapped James Cum­mings to re­place founder Vic­to­ria Tifft at the helm. Cum­mings, for­mer­ly a VP at vac­cine de­vel­op­er No­vavax, is a re­tired colonel whose clin­i­cal work at the De­part­ment of De­fense aligns with Clin­i­cal­RM’s fo­cus in gov­ern­ment spon­sored re­search. His ti­tle will be pres­i­dent; Tifft will leave the of­fice of CEO and be­come a non-ex­ec­u­tive di­rec­tor. Dublin, Ire­land-head­quar­tered Icon ac­quired the US-based CRO in 2016 in hopes of di­ver­si­fy­ing its client base.

Cindy Elkins

→ Along its jour­ney to re­gain its foothold in the CAR-T field, Juno $JUNO has re­cruit­ed IT ex­pert Cindy Elkins to its team. The new chief in­for­ma­tion of­fi­cer led the US com­mer­cial tech­nol­o­gy in­te­gra­tion when Roche ac­quired Genen­tech, back when she was VP, IT for the Amer­i­c­as at the biotech gi­ant.

Dale Lud­wig is mov­ing on from his 9-year VP tenure at Eli Lil­ly to be­come CSO at Ac­tini­um Phar­ma $AT­NM. Lud­wig will lead the ra­dioim­munother­a­py play­er’s ini­tia­tives on a tech­nol­o­gy plat­form pow­ered by the al­pha emit­ting ra­dioiso­tope ac­tini­um-225, cre­at­ing an­ti­body ra­dio-con­ju­gates. The biotech is al­so count­ing on him to spear­head pre­clin­i­cal pro­gram de­vel­op­ment and sup­port trans­la­tion­al re­search ef­forts.

Neu­ro­crine $NBIX has wel­comed new CMO Eiry Roberts on­board as Christo­pher O’Brien is slat­ed to re­tire in Feb­ru­ary af­ter more than 12 years in the po­si­tion. Hav­ing over­seen the ap­proval of In­grez­za (and the sub­se­quent study flops) and beefed up the San Diego com­pa­ny’s pipeline, O’Brien will re­main as an ex­clu­sive con­sul­tant. In join­ing the CNS/en­docrinol­o­gy spe­cial­ist, Roberts has left her VP, R&D post at Eli Lil­ly, where she has worked since 2002. She will be in­volved in ex­e­cut­ing the biotech’s com­mer­cial­iza­tion and clin­i­cal plans, with two pro­grams Parkin­son’s dis­ease and en­dometrio­sis at the fore­front.

→ Berke­ley, CA-based Aduro Biotech $ADRO is switch­ing up its C-suite: As COO Greg Schafer heads out the door in March, SVP of fi­nance Jen­nifer Lew is be­ing pro­mot­ed to CFO. A Dy­navax vet, Lew start­ed at Aduro in 2013 and played a role in the com­pa­ny’s 2015 IPO. Pri­or to Lew’s pro­mo­tion, Schafer had served as the prin­ci­pal fi­nan­cial of­fi­cer.

Michael Trem­blay’s re­tire­ment from Astel­las Phar­ma Cana­da has trig­gered a slate of lead­er­ship changes in Cana­da and the Unit­ed States. Steve Sabus will re­lo­cate to Markham, On­tario to lead AP­CA as gen­er­al man­ag­er. Cor­re­spond­ing­ly, Astel­las US is pro­mot­ing Lynn Fenic­chia Ger­ber and Kevin O’Keefe to split the du­ties Sabus pre­vi­ous­ly ful­filled. A long­time em­ploy­ee who joined in the Ya­manouchi days, Ger­ber will lead sales ef­forts for the over­ac­tive blad­der, an­ti-fun­gal, car­dio­vas­cu­lar and trans­plant fran­chis­es. Mean­while, O’Keefe will be re­spon­si­ble for over­see­ing sales ef­forts and de­vel­op­ing tal­ent with­in the sales force.

→ British CRO Con­cept Life Sci­ences has ap­point­ed He­len Mc­K­eev­er as pro­gram man­ag­er and David Halver­son as US head of sales. As Con­cept works to broad­en its drug dis­cov­ery and an­a­lyt­i­cal ser­vices, Mc­K­eev­er will be in charge of process man­age­ment while Halver­son will lead the busi­ness de­vel­op­ment team.

→ Over-the-counter and gener­ic drug com­pa­ny Per­ri­go $PR­GO has picked Uwe Röhrhoff as its new CEO as John Hen­drick­son plans to re­tire. Be­fore join­ing the Dublin-based man­u­fac­tur­er, Röhrhoff had the top job at a Ger­man phar­ma glass and pack­ag­ing com­pa­ny.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Pfiz­er scoops up an an­tibi­ot­ic in rare M&A deal, bag­ging a vir­tu­al start­up op­er­at­ing on a shoe­string bud­get

Pfizer is stepping up with a rare antibiotics buyout deal today, grabbing Palo Alto, CA-based Arixa Pharmaceuticals in a bid to add a new oral version of avibactam, a beta lactamase inhibitor — or BLI — approved back in 2015 as part of the IV treatment Avycaz.

The Arixa acquisition follows some encouraging Phase I responses demonstrating that 60% to 80% of the oral drug is absorbed into the bloodstream. Only 7% of the IV version is absorbed orally, far below the 30% threshold Arixa has pointed to as a therapeutic threshold. The buyout gives Pfizer’s hospital group a line on a new oral combo with antibiotics like ceftibuten to go after drug-resistant cases of urinary tract infections and other ailments.

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News brief­ing: UK biotech 4D phar­ma heads for Nas­daq via SPAC; Dr. Red­dy's shuts down man­u­fac­tur­ing af­ter cy­ber­at­tack

Another pharma company is intending to use a SPAC to join the Nasdaq.

4D pharma, a UK-based biotech, is reverse-merging with a blank check company in a deal worth up to $37.6 million. The move will give 4D pharma a new Nasdaq ticker, which will be $LBPS, using the American Depositary Share program.

As a result of the move, 4D pharma will gain $14.6 million in cash held by the blank check company, dubbed Longevity. The merger is expected to be completed in early 2021, after which shares will be immediately tradeable.

Can B cells break the bound­aries of cell ther­a­py? Long­wood start­up has $52M to prove a new en­gi­neer­ing tech

Back in December 2017, as the cell therapy world was still basking in the virtually back-to-back approvals of two pioneering CAR-Ts, researchers at Seattle Children’s Research Institute reported a scientific first in a different corner of the field: engineer B cells to treat disease.

The team, led by David Rawlings and Richard James, eventually worked with Longwood Fund to start a biotech around those findings. And now Atlas Venture and RA Capital Management are coming on board to lead a $52 million launch round, joined by Alta Partners, for Be Biopharma.

Jason Kelly, Gingko Bioworks CEO (Mike Blake/Reuters via Adobe)

Ex­clu­sive: Eye­ing big Covid-19 test­ing ex­pan­sion, Gink­go rolls out 50M rapid anti­gen di­ag­nos­tics

In what they hope will be a key part of an extensive effort to boost Covid-19 testing in the US, Ginkgo Bioworks is acquiring and distributing 50 million rapid antigen tests that can potentially be used for virus surveillance in schools and communities and for quick, on the ground diagnoses.

The tests, developed by SD Biosensor, are in line with proposals from the Rockefeller Foundation and Harvard epidemiologists, among others, to blanket the country with fast, low-cost tests. Although not yet authorized in the US, they are a key part of testing efforts from the Bill and Melinda Gates Foundation, who announced plans last month to distribute 120 million of them in low and middle income countries. Roche has commercialized the diagnostic in Europe.

Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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HHS secretary Alex Azar (at the podium) and FDA commissioner Stephen Hahn (Pete Marovich/Getty Images)

Covid-19 roundup: Azar open­ly plan­ning Hahn ouster — re­port; Vul­ner­a­ble pop­u­la­tions like­ly to get vac­cines by Jan­u­ary

The relationship between HHS secretary Alex Azar and FDA commissioner Stephen Hahn has deteriorated to the point where Azar has suggested replacing Hahn, according to a Politico report.

Azar was angered by the FDA’s pushback of the Trump administration’s proposals for authorizing Covid-19 vaccines, so much so that he began openly floating potential replacements for Hahn. The report cited six unnamed sources that said Azar discussed bringing up Hahn’s removal to the White House.

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Jean-Pierre Sommadossi, Atea president and CEO (file photo)

Roche wades deep­er in­to Covid-19 fight, ink­ing an­tivi­ral pact with $350M cash fol­low­ing Re­gen­eron deal

Roche is making its first bet on an antiviral against Covid-19 in style, shelling out $350 million in cash to grab ex-US rights.

The drug comes from Atea Pharmaceuticals, the 7-year-old biotech created by Pharmasset co-founder Jean-Pierre Sommadossi, which essentially rebranded itself as a Covid-19 fighter in May when it closed a whopping $215 million venture round. Over a dozen investors bought in, including marquee names like Bain Capital and RA Capital.