Ru­bius snaps up No­var­tis vet Pablo Cagnoni as CEO; MiMedx dumps two ex­ecs fol­low­ing in­ter­nal in­ves­ti­ga­tion

David Ep­stein has re­cruit­ed an­oth­er fel­low No­var­tis vet to Ru­bius Ther­a­peu­tics, the cell ther­a­py start­up that he’s chair­ing — this time straight to the top job. New CEO Pablo Cagnoni joins Flag­ship Pi­o­neer­ing part­ner Tor­ben Straight Nis­sen, who’s been lead­ing the com­pa­ny as pres­i­dent. The Cam­bridge, MA-based com­pa­ny be­lieves it can en­gi­neer red blood cells to trans­port pro­teins, in­stead of oxy­gen, need­ed to fight dis­eases. The ap­pli­ca­tions span from can­cer — which Cagnoni is in­ti­mate­ly fa­mil­iar with, first as an on­col­o­gist and then as an ex­ec at No­var­tis on­col­o­gy and Onyx Phar­ma — to au­toim­mune and rare dis­eases. With a pre­clin­i­cal biotech that’s eye­ing a whole new class of ther­a­pies, Cagnoni has his work cut out for him, but thanks to a re­cent­ly com­plet­ed mega-round, he al­so has $220 mil­lion in the bank to help.

Robert Azel­by

→ Now that the dust has set­tled on Juno’s sale, chief com­mer­cial of­fi­cer Robert Azel­by is mov­ing on to chart a mar­ket­ing path for Alder Bio­Phar­ma­ceu­ti­cals $AL­DR. He re­places in­ter­im pres­i­dent and CEO Paul Cleve­land, who was in turn fill­ing in for Randy Schatz­man af­ter the co-founder left the com­pa­ny in March. Azel­by, an Am­gen vet with ex­ten­sive back­ground in the on­col­o­gy busi­ness, will now lead lit­tle Alder’s fight in the in­tense CGRP mi­graine ri­val­ry with No­var­tis/Am­gen and Eli Lil­ly, among oth­ers.

→ Cana­da’s Ad­vanced Pro­teome Ther­a­peu­tics has ap­point­ed two-time CEO Bill Dick­ie to over­see de­vel­op­ment of its tar­get­ed can­cer ther­a­pies as the biotech con­tin­ues to build out its an­ti­body-drug con­ju­gate plat­form. A founder of di­ag­nos­tic com­pa­ny Atreus Phar­ma­ceu­ti­cals and for­mer leader of car­dio-fo­cused Liponex, Dick­ie’s ap­point­ment fills a va­can­cy left by Ran­dal Chase, who re­signed in April af­ter on­ly one year at the helm. The fu­ture strat­e­gy of Ad­vanced Pro­teome Ther­a­peu­tics will lean on joint ven­tures, col­lab­o­ra­tions and li­cens­ing agree­ments, Dick­ie said in a state­ment.

→ En­gulfed in a cu­ri­ous se­ries of reg­u­la­to­ry and fi­nan­cial woes, MiMedx $MDXG is let­ting its CFO Michael Senken go af­ter wrap­ping up an in­ter­nal in­ves­ti­ga­tion in­to its sales and dis­tri­b­u­tion prac­tices. Al­so shown the door: John Cranston, the cor­po­rate con­troller and trea­sur­er. An in­ter­im CFO, Ed­ward Borkows­ki, has been brought in to re­state fi­nan­cial state­ments from the past six years, as the com­pa­ny claims that in­for­ma­tion can no longer be re­lied up­on. That’s a con­clu­sion of the still on­go­ing in­ves­ti­ga­tion by its own au­dit com­mit­tee, which be­gan this Feb­ru­ary and de­layed the re­lease of 2017’s fi­nan­cial re­sults (the com­pa­ny still doesn’t have a time­line for fil­ing its 10-K). The in­ter­nal re­view was quick­ly fol­lowed by a re­port­ed pre­lim­i­nary probe by the US Jus­tice De­part­ment in the same mat­ter as well as whether the tis­sue graft mak­er over­charged the gov­ern­ment for its prod­ucts. Ma­ri­et­ta, Geor­gia-based MiMedx, which has a trou­bled his­to­ry with short sell­ers, saw its stock fall by close to 13%.

→ Fresh off a new fi­nanc­ing round, Gele­sis has re­cruit­ed for­mer Wal­greens CMO Har­ry Lei­der to lead its med­ical strat­e­gy. That in­volves in­ter­act­ing with med­ical as­so­ci­a­tions, pa­tients ad­vo­ca­cy groups and oth­er or­ga­ni­za­tions in ser­vice of its pipeline of gas­troin­testi­nal drugs — in­clud­ing a weight loss drug dubbed Gele­sis100. Lei­der has been an ad­vis­er to PureTech Health, which has a 20% own­er­ship stake in the com­pa­ny. His ap­point­ment co­in­cides with a move for found­ing CMO Has­san Hesh­mati, free­ing Hesh­mati up to fo­cus on a dif­fer­ent set of clin­i­cal ac­tiv­i­ties as EVP, en­docrinol­o­gy and me­tab­o­lism. Help­ing guide some of their work will be Paul Fonteyne, chair­man and for­mer CEO of Boehringer In­gel­heim USA, who’s just joined the board of di­rec­tors.

Louise Rodi­no-Kla­pac

Sarep­ta $SRPT is on an ex­ec­u­tive hir­ing spree. First, the Cam­bridge, MA-based com­pa­ny of Ex­ondys-51 fame has snagged a top ex­ec­u­tive from one of its part­ners, Louise Rodi­no-Kla­pac, to lead its new­ly cre­at­ed gene ther­a­py unit. Rodi­no-Kla­pac is com­ing from Na­tion­wide Chil­dren’s Hos­pi­tal, where she was head­ing up the lab­o­ra­to­ry for gene ther­a­py re­search for mus­cu­lar dy­s­tro­phies, and will con­tin­ue to dou­ble as the CSO of My­onexus, an­oth­er part­ner of Sarep­ta’s. A few days lat­er, Sarep­ta an­nounced ex-Bio­gen ex­ec­u­tive Gilmore O’Neill will be­come the CMO, a po­si­tion held briefly by Re­gen­eron vet Cather­ine Stehman-Breen. O’Neill’s range of drug dev ex­pe­ri­ence spans Tec­fidera, Zin­bry­ta, Ple­gridy, and Spin­raza, the com­pa­ny said. And that’s all in line with Sarep­ta’s over­all strat­e­gy: CEO Doug In­gram told End­points that the com­pa­ny has grown its staff by 100 peo­ple since the start of 2018, from 240 t0 340, with plans to reach near­ly 480 by the end of the year.

An­tho­ny Di­Ton­no is up­ping his in­volve­ment with Tenax Ther­a­peu­tics $TNEX, tak­ing up an ap­point­ment to the CEO seat. Un­til re­cent­ly, the board di­rec­tor head­ed up a med­ical de­vice com­pa­ny, but can now de­vote him­self to ex­e­cut­ing a busi­ness strat­e­gy he helped form. The pri­or­i­ty will be ad­vanc­ing lev­osi­men­dan, a crit­i­cal care drug for a sub­set of pul­monary hy­per­ten­sion pa­tients that’s avail­able in over 60 coun­tries but not the US, through a Phase II tri­al.

→ Ex-Mallinck­rodt ex­ec Ronald Lloyd is the new pres­i­dent and CEO of Aziyo Bi­o­log­ics, tak­ing over com­mer­cial strat­e­gy and busi­ness de­vel­op­ment for the com­pa­ny, which is mar­ket­ing a slate of re­gen­er­a­tive med­i­cine from grafts to car­dio im­plants.

→ Just one month af­ter Por­to­la won a long-await­ed FDA ap­proval of its bleed­ing an­ti­dote for blood thin­ners, the com­pa­ny’s chief ex­ec­u­tive is re­lin­quish­ing the reins to re­tire. CEO William Lis, who’s been lead­ing the com­pa­ny since 2008, will stay on un­til Au­gust 1, then ex­it both the com­pa­ny and the board. Por­to­la $PT­LA has ap­point­ed the com­pa­ny’s EVP of R&D John Cur­nutte and CFO Mar­di Di­er as in­ter­im co-pres­i­dentson top of their cur­rent po­si­tions.

David Chang and Arie Bellde­grun have wooed a heavy­weight ex­ec to the C-suite of Al­lo­gene Ther­a­peu­tics, the next chap­ter of their biotech ca­reer af­ter sell­ing Kite to Gilead. Al­i­son Moore, for­mer­ly of Am­gen and Genen­tech, will now take charge of the nit­ty grit­ty de­tails nec­es­sary to turn their al­lo­gene­ic CAR-T dreams in­to re­al­i­ty. Her of­fi­cial ti­tle is chief tech­ni­cal of­fi­cer, and her re­spon­si­bil­i­ty cov­ers every­thing from prod­uct sci­ences, sup­ply chain, man­u­fac­tur­ing, qual­i­ty to tech­ni­cal op­er­a­tions. She is join­ing in very ear­ly days of Al­lo­gene, which launched in April with $300 mil­lion from well-heeled in­vestors and a port­fo­lio of can­cer cell ther­a­pies from Pfiz­er.

→ Phar­ma vet Yap­ing Shou is mak­ing the jump to biotech at Tril­li­um Ther­a­peu­tics $TRIL, sign­ing on as CMO just as the com­pa­ny preps its CD47 drug for first-in-hu­man tri­als. Be­tween Glax­o­SmithK­line, No­var­tis and most re­cent­ly Take­da, Shou has amassed 18 years of clin­i­cal ex­pe­ri­ence, much of which was in on­col­o­gy.

→ A boom­ing Zai Lab $ZLAB has poached As­traZeneca’s top on­col­o­gy drug mar­keter in Chi­na to help with the planned launch of its first can­cer drugs in the mas­sive Asian mar­ket. William Liang played a key role in bur­nish­ing As­traZeneca’s Q1 num­bers with the suc­cess­ful growth in Tagris­so sales, which the phar­ma gi­ant bad­ly needs to prove to an­a­lysts that the next chap­ter at the com­pa­ny will in­clude grow­ing rev­enue num­bers. Dur­ing his stretch at As­traZeneca as vice pres­i­dent of the on­col­o­gy busi­ness unit, Liang’s sales group grew from 500 to around 2,000.

→ Af­ter play­ing a key role in No­var­tis’ ac­qui­si­tion of AveX­is, Phillip Do­nen­berg has joined Lake For­est, IL-based De­pomed as CFO — the same role he had at the gene ther­a­py start­up and a few oth­er com­pa­nies. Au­gust Moret­ti, who’s had the job for six years, is re­turn­ing to Cal­i­for­nia (where De­pomed has just re­lo­cat­ed from) for his next gig. De­pomed ex­ecs like the com­bi­na­tion of fi­nance, M&A and op­er­a­tions ex­pe­ri­ence that Do­nen­berg brings to the ta­ble as they nav­i­gate a way out of opi­oids and in­to new dis­ease ar­eas.

Roivant-part­nered Ar­bu­tus $ABUS has found a per­ma­nent CFO in David Hast­ings, a long­time CFO of In­cyte. Ko­ert Van­de­nEn­den, who’s been do­ing the job ad in­ter­im, will con­tin­ue to shoul­der some ac­count­ing re­spon­si­bil­i­ties dur­ing the tran­si­tion and be­yond.

→ For­mer Gilead ex­ec Ut­pal Kop­pikar is bring­ing his glob­al fi­nan­cial man­age­ment skills to Atara Bio­ther­a­peu­tics $ATRA as the South San Fran­cis­co com­pa­ny po­si­tions it­self for a Phase III read­out of one of its al­lo­gene­ic T cell im­munother­a­pies. As CFO, he will al­so be in­volved in pre-com­mer­cial ac­tiv­i­ties.  

→ Still con­tend­ing with a clin­i­cal hold, a strug­gling Ad­vax­is $ADXS has en­list­ed Mol­ly Hen­der­son as its CFO, pulling her out of the con­sult­ing busi­ness and back on the front lines of biotech. Her hir­ing comes just a day be­fore the im­munother­a­py com­pa­ny an­nounced it’s ax­ing a clin­i­cal pro­gram — a par­al­lel ef­fort to slash burn rate and guard cash.

→ NASH drug de­vel­op­er Med­i­ci­No­va $MNOV has tak­en on an­oth­er CFO af­ter Ryan Sel­horn re­signed from the po­si­tion. Like Sel­horn, Car­la Reyes is an out­sources ex­ec from the ac­count­ing ser­vices firm Sig­na­ture An­a­lyt­ics.

→ With Phase III stud­ies of its mon­o­clon­al an­ti­bod­ies — which it be­lieves can treat both hema­to­log­i­cal ma­lig­nan­cies and au­toim­mune dis­eases — un­der­way, TG Ther­a­peu­tics $TGTX has scooped Adam Wald­man from Cel­gene’s hema­tol­ogy-on­col­o­gy unit. As chief com­mer­cial of­fi­cer, he is ex­pect­ed to build a team from scratch in an­tic­i­pa­tion of sev­er­al launch­es in the com­ing years.

At­las Ven­ture has brought on An­drea Arm­strong as its chief tal­ent of­fi­cer, trust­ing her to re­cruit and nur­ture star ex­ecs for both at the VC firm and for the ear­ly-stage biotechs it’s in­cu­bat­ing. A sea­soned hu­man re­sources pro­fes­sion­al, Arm­strong has served in a va­ri­ety of ad­min­is­tra­tion and or­ga­ni­za­tion­al roles at C4 Ther­a­peu­tics, the New York Genome Cen­ter and In­fin­i­ty Phar­ma.

→ New York’s Uro­Gen Phar­ma $URGN is los­ing its CFO Gary Ti­tus, the com­pa­ny an­nounced Tues­day. Uro­Gen is putting its COO Stephen Mul­len­nix in an in­ter­im CFO role while the com­pa­ny hunts for his re­place­ment. Uro­Gen al­so an­nounced the ad­di­tion of Ja­son Pa­tel, the for­mer se­nior di­rec­tor of ac­count­ing and fi­nance at Kite, as the com­pa­ny’s new VP of fi­nance.

→ Af­ter get­ting blast­ed by the fail­ure of its lead drug for Alzheimer’s, Vivek Ra­maswamy’s Ax­o­vant $AX­ON is go­ing to try and blaze a new path for­ward by de­vel­op­ing a gene ther­a­py for Parkin­son’s. To hus­tle along the as­set, which Ax­o­vant is pay­ing Ox­ford Bio­Med­ica $30 mil­lion for, CEO Pa­van Cheru­vu has re­cruit­ed Fras­er Wright — who had a se­nior role at gene ther­a­py pi­o­neer Spark Ther­a­peu­tics — as chief tech­nol­o­gy of­fi­cer. A for­mer Penn in­ves­ti­ga­tor, Wright is al­so a vet­er­an of the gene ther­a­py pro­gram at The Chil­dren’s Hos­pi­tal of Philadel­phia, which pro­vid­ed Spark with its ini­tial pipeline in gene ther­a­py.

→ Fol­low­ing a ca­reer in gov­ern­ment, Marykay Marchi­giani is now CFO at ABL, a con­tract re­search and man­u­fac­tur­ing or­ga­ni­za­tion head­quar­tered in Rockville, MD.

Gilead $GILD is pro­mot­ing An­drew Dick­in­son to EVP, cor­po­rate de­vel­op­ment and strat­e­gy, in prepa­ra­tion for Mar­tin Sil­ver­stein’s de­par­ture. Dick­in­son, who’s head­ed up a cou­ple of ac­qui­si­tion ef­forts since join­ing the com­pa­ny in 2016, will now have an ex­pand­ed role.

Sage Ther­a­peu­tics CEO Jeff Jonas has tak­en a board seat at At­las-backed Gen­er­a­tion Bio.

 

Martin Shkreli [via Getty]

Pris­on­er #87850-053 does not get to add drug de­vel­op­er to his list of cred­its

Just days after Retrophin shed its last ties to founder Martin Shkreli, the biotech is reporting that the lead drug he co-invented flopped in a pivotal trial. Fosmetpantotenate flunked both the primary and key secondary endpoints in a placebo-controlled trial for a rare disease called pantothenate kinase-associated neurodegeneration, or PKAN.

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We­bi­nar: Re­al World End­points — the brave new world com­ing in build­ing fran­chise ther­a­pies

Several biopharma companies have been working on expanding drug labels through the use of real world endpoints, combing through the data to find evidence of a drug’s efficacy for particular indications. But we’ve just begun. Real World Evidence is becoming an important part of every clinical development plan, in the soup-through-nuts approach used in building franchises.

I’ve recruited a panel of 3 top experts in the field — the first in a series of premium webinars — to look at the practical realities governing what can be done today, and where this is headed over the next few years, at the prodding of the FDA.

ZHEN SU — Merck Serono’s Senior Vice President and Global Head of Oncology
ELLIOTT LEVY — Amgen’s Senior Vice President of Global Development
CHRIS BOSHOFF — Pfizer Oncology’s Chief Development Officer

A premium subscription to Endpoints News is required to attend this webinar. Please upgrade to either an Insider or Enterprise plan for access. Already have Endpoints Premium? Please sign-in below. You can contact our Subscriptions team at help@endpointsnews.com with any issues.

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Hal Barron. GSK

GSK's Hal Bar­ron her­alds their sec­ond pos­i­tive piv­otal for cru­cial an­ti-BC­MA ther­a­py, point­ing to a push for quick OKs in a crowd­ed field

Hal Barron has his second positive round of Phase III data in hand for his anti-BCMA antibody drug conjugate belantamab mafodotin (GSK2857916). And GSK’s research chief says the data paves the way for their drive in search of an FDA approval for treating multiple myeloma.

It’s hard to overestimate the importance of this drug for GSK, a cornerstone of Barron’s campaign to make a dramatic impact on the oncology market and provide some long-lost excitement for the pharma giant’s pipeline. They’re putting this BCMA program at the front of that charge — looking to lead a host of rivals all aimed at the same target.

We don’t know what the data are yet, but DREAMM-2 falls on the heels of a promising set of data delivered 5 months ago for DREAMM-1. There investigators noted that complete responses among treatment-resistant patients rose to 15% in the extra year’s worth of data to look over, with a median progression-free survival rate of 12 months, up from 7.9 months reported earlier. The median duration of response was 14.3 months.

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UP­DAT­ED: An em­bold­ened As­traZeneca splurges $95M on a pri­or­i­ty re­view vouch­er. Where do they need the FDA to hus­tle up?

AstraZeneca is in a hurry.

We learned this morning that the pharma giant — not known as a big spender, until recently — forked over $95 million to get its hands on a priority review voucher from Sobi, otherwise known as Swedish Orphan Biovitrum.

That marks another step down on price for a PRV, which allows the holder to slash 4 months off of any FDA review time.

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Brian Kaspar. AveXis via Twitter

AveX­is sci­en­tif­ic founder fires back at No­var­tis CEO Vas Narasimhan, 'cat­e­gor­i­cal­ly de­nies any wrong­do­ing'

Brian Kaspar’s head was among the first to roll at Novartis after company execs became aware of the fact that manipulated data had been included in its application for Zolgensma, now the world’s most expensive therapy.

But in his first public response, the scientific founder at AveXis — acquired by Novartis for $8.7 billion — is firing back. And he says that not only was he not involved in any wrongdoing, he’s ready to defend his name as needed.

I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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Why would Am­gen want to buy Alex­ion? An­a­lysts call hot­ly ru­mored takeover un­like­ly, but seize the mo­ment

A rumor that Amgen is closing in on buyout deal for Alexion has sparked a guessing game on just what kind of M&A strategy Amgen is pursuing and how much Alexion is worth.

Mizuho analyst Salim Syed first lent credence to the report out of the Spanish news outlet Intereconomía, which said Amgen is bidding as much as $200 per share. While the source may be questionable, “the concept of this happening doesn’t sound too crazy to me,” he wrote.

FDA asks why No­var­tis took two months to launch for­mal in­ter­nal probe, af­ter AveX­is flagged da­ta ma­nip­u­la­tion

And the plot thickens. Novartis $NVS officials are reportedly now scrambling to explain to the FDA why it took them two months to open an internal investigation into data discrepancies for their $2.1 million gene-therapy for spinal muscular dystrophy — the world’s most expensive drug.

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Build­ing on suc­cess­ful PD-1 pact, Eli Lil­ly li­cens­es di­a­betes drug to Chi­nese part­ners at In­novent

Eli Lilly is expanding its partnership with China’s Innovent in a deal involving a diabetes drug sitting in its Phase I reserves.

The two companies had jointly developed one of China’s first homegrown PD-1 agents, scoring an approval for Tyvyt (sintilimab) late last year for relapsed/refractory classical Hodgkin’s lymphoma. This time around, Lilly is out-licensing a piece of its diabetes pipeline, a leading franchise that has historically produced the top-selling Trulicity and Humalog.

Am­gen, Al­ler­gan biosim­i­lar of Roche's block­buster Rit­ux­an clears an­oth­er US piv­otal study 

Novartis $NVS may have given up, but Amgen $AMGN and Allergan $AGN are plowing ahead with their knockoff of Roche’s blockbuster biologic Rituxan in the United States.

Their copycat, ABP 798, was found to have a clinically equivalent impact as Rituxan — meeting the main goal of the study involving CD20-positive B-cell non-Hodgkin’s lymphoma patients. This is the second trial supporting the profile of the biosimilar. In January, it came through with positive PK results in patients with rheumatoid arthritis.