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.

 

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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