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.

 

RWE chal­lenges for to­day's bio­phar­ma

The rapid development of technology — and the resulting avalanche of data — are catalysts for significant change in the biopharmaceutical industry. This translates into urgent pressures for today’s biopharma, including a need to quickly and affordably develop products with proven therapeutic efficacy and value. This urgency is expedited by the growth of value-based contracting, where access to reimbursement and profit depends on these abilities.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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As shares suf­fer from a lin­ger­ing slump, a bruised Alk­er­mes slash­es 160 jobs in R&D re­struc­tur­ing

With its share price in a deep slump after suffering through a regulatory debacle over their depression drug ALKS 5461, Alkermes CEO Richard Pops is taking the ax to its R&D organization in a restructuring aimed at cutting costs ahead of its next attempt at a rollout in a tough field.

Richard Pops, Endpoints via Youtube

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Acor­da's Ron Co­hen brings the ax back out as new drug sales on­ly trick­le in while cash cow is led to the slaugh­ter

With its new drug earning meager sums and its one-time cash cow reduced to a bony shadow of its former self, Acorda Therapeutics today is rolling out a new restructuring aimed at slashing the staff and cutting costs to get through the hard times ahead.

The biotech is chopping a quarter of its staff today, carving back R&D as well as SG&A expenses. And CEO Ron Cohen is cutting deep.

Under the new austerity budget, Acorda’s R&D expenses for the full year 2019 are expected to be $55 – $60 million, reduced from $70 – $80 million. SG&A expenses for the full year 2019 are expected to be $185 – $190 million, reduced from $200 – $210 million. R&D expenses for the full year 2020 are expected to be $20 – $25 million and SG&A
expenses for the full year 2020 are expected to be $160 – $165 million.

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RAPT Ther­a­peu­tics re­turns to Wall Street to re­vive IPO bid

On May 24, FLX Bio, a small cancer and inflammation biotech with backing from GV, changed its name to RAPT Therapeutics and filed confidentially for an IPO. On July 5th, they filed to raise up to $86 million. On July 22, they announced the IPO with a $75 million goal.  And on August 1, they abruptly and without explanation called it all off.

Now, without explanation, they’re reviving the bid, filing again for a $75 million IPO, this time with a new bookrunner and a new drug candidate in the clinic. The terms will be the same: 5 million shares at $14-$16 per share. It would give them a diluted market value of $351 million.

EY vet set to re­place re­tir­ing Am­gen CFO Meline

Ahead of its third-quarter results next week, Amgen on Tuesday disclosed the planned retirement of David Meline, who has served as the company’s chief financial officer since 2014.

Meline will be replaced by Ernst & Young vet, Peter Griffith, as CFO come January 1, 2020 — but until then Griffith will serve as executive vice president, finance.

“Over the last 5 years at Amgen, Meline instituted many major changes that led to operational efficiencies and margin expansion while successfully returning cash to shareholders. Now that Amgen is on solid footing, it was a good time to step away,” Cowen’s Yaron Werber wrote in a note. “We do not anticipate any major changes to strategy or operations immediately due to this transition as Amgen is on solid footing.”

Eli Lil­ly’s USA, di­a­betes chief En­rique Con­ter­no is head­ing out af­ter 27 years, and he’s be­ing re­placed by a com­pa­ny in­sid­er

Close to 3 years after Eli Lilly CEO Dave Ricks added the title of president of the US operations to Enrique Conterno’s resume, which included his helmsmanship of the diabetes franchise, the Peruvian born exec is set to retire after a 27-year run at the pharma giant.

Lilly put out the news just as it was posting Q3 results, with a mix of upbeat and downbeat results in the latest set of numbers from Lilly.
Conterno — a grizzled, deeply experienced and sometimes gruff veteran of the pharma world — was a high-profile figure at Lilly, stepping up to expanded duties as the company was forced to deal with intense pricing pressure on the diabetes side of the business. He had replaced outgoing US president Alex Azar, who later popped up as head of Health and Human Services in the Trump administration.
As head of the diabetes unit, Conterno had to deal with an extraordinarily competitive field as payers demanded bigger discounts. Trulicity’s success helped generate new revenue for the company, but Q3’s miss on revenue had a lot to do with the need for discounting the drug ahead of Novo Nordisk’s rival therapy, Rybelsus, which was priced on the wholesale level at an almost identical rate.

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Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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No­var­tis hands off $80M in cash to part­ner up with a top biotech play­er in the fi­bro­sis sec­tor

Never underestimate the power of a good showing at a scientific conference.
In a presentation late last year, the researchers at Pliant Therapeutics launched a series of discussions about the preclinical data they were pulling together around their work on their small-molecule integrin inhibitor aimed at transforming growth factor beta, or TGF-β, a key pathway involved in fibrosis.
And they got some serious attention for the work.
“We got interest from pharma partners and at the end Novartis basically made it,” says Pliant CEO Bernard Coulie.